Self-Audit Procedures
The following checklist should be used as an aid in reviewing your facility’s compliance with industry environmental and health & safety regulations and requirements.
Additional Information: This checklist is based on the current laws and regulations as of the date of publication. Regulations frequently change.
Therefore, you should review current laws and regulations for any recent changes in the requirements. Some of the items you should check include:
Additional Requirements: In addition to recent changes in the requirements, you should also consider additional Cal/OSHA standards that might apply to your facility.
These might include any of the following:
Employer postings; ergonomics; process safety management; use of asbestos, formaldehyde, or lead containing substances; blood borne
pathogens; welding operations; use of compressed air and gases; boiler operations; use of power tools, hoists and grinding equipment; spray coating; elevated platforms; aisle way, ramp, door and exit requirements; fire sprinkler requirements; and seismic requirements.
Legal Authority : The compliance requirements provided on the following pages are taken from the respective laws and regulations, as indicated in the references column. In addition to the statutory and regulatory requirements, some compliance items that reflect improved and accepted management practices have been included. These management practices have been included because of their overall industry acceptance and their potential to reduce environmental risk and improve compliance.
Monday, October 12, 2009
ISO 14001 – Specifications With Guidance for Use
ISO 14001 – Specifications with Guidance For Use
Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.
The heart of the specification is in the EMS Requirements, the principles of which are summarized below:
Principle #1 – Commitment and Policy Top management must make a commitment to the program.
Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.
Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.
Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)
Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.
Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.
The heart of the specification is in the EMS Requirements, the principles of which are summarized below:
Principle #1 – Commitment and Policy Top management must make a commitment to the program.
Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.
Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.
Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)
Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.
ISO 14001 – Certification/Registration
ISO 14001 – Certification/Registration
Similar to the organized approach to problem solving contained in ISO 9000
and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.
If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.
It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.
But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.
Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.
Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.
Similar to the organized approach to problem solving contained in ISO 9000
and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.
If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.
It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.
But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.
Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.
Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.
ESTABLISHING THE INITIAL STATE OF THE QMS For SME
Establishing The Initial State of The ISO 9001 QMS For SME
The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.
However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.
A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.
The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.
However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.
A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.
The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008
The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008
Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.
Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.
Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:- Develop an environmental policy statement appropriate for your company- Integrate processes for identifying environmental aspects and impacts- Identify environmental objectives, set related targets, and establish programs for achieving results- Integrate environmental responsibilities and authorities into a management system- Outline an environmental awareness and training program- Establish environmental metrics and indicators for monitoring performance- Integrate requirements on non-conformance and corrective and preventive actions into your existing system- Understand the purpose and scope of the environmental management review- Integrate document control requirements of ISO 14001:2004 into your current system- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS
Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.
Optimize understanding and retention with the Plexus Learning Model- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.- Hands-on insights. Lecturing is minimized so learning is maximized.- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.
Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.
Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.
Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:- Develop an environmental policy statement appropriate for your company- Integrate processes for identifying environmental aspects and impacts- Identify environmental objectives, set related targets, and establish programs for achieving results- Integrate environmental responsibilities and authorities into a management system- Outline an environmental awareness and training program- Establish environmental metrics and indicators for monitoring performance- Integrate requirements on non-conformance and corrective and preventive actions into your existing system- Understand the purpose and scope of the environmental management review- Integrate document control requirements of ISO 14001:2004 into your current system- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS
Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.
Optimize understanding and retention with the Plexus Learning Model- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.- Hands-on insights. Lecturing is minimized so learning is maximized.- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.
Demonstrating conformity with ISO 9001:2008
Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective
evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective
evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
Guidance on Clause 4.2 of ISO 9001:2008
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples
may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples
may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
ISO 9001:2008 Documentation Requirements
ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual documented procedures required by this International Standard documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual documented procedures required by this International Standard documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
SUMMARY OF CHANGES TO ISO 14001:2004
SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.
Change In ISO 14001:2004 – Documentation
Change In ISO 14001:2004 – Documentation
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
ISO 14001:2004 Evaluation of compliance
ISO 14001:2004 Evaluation of compliance
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs
KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs
There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.
Consideration of QMS as Parallel Function
In the case of all of the transitions depicted, real benefits from the QMS are more likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.
Training
In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:
1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.
2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.
Auditing
As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak [11]. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.
There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.
Consideration of QMS as Parallel Function
In the case of all of the transitions depicted, real benefits from the QMS are more likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.
Training
In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:
1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.
2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.
Auditing
As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak [11]. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
Role of Governments in ISO 14001 Standards
Role of Governments in ISO 14001 Standards
Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop thebasic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certificationservices. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.
Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.
Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop thebasic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certificationservices. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.
Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.
ISO 9001 Standards & ISO 14001 Standards Related Blogs
ISO 9001 Standards & ISO 14001 Standards Related Blogs are as follows:
http://iso14001-standard.blogspot.com/
http://environmental-management-system.blogspot.com/
http://iso9001systems.blogspot.com/
http://iso-9000softwares.blogspot.com/
http://iso14000-series.blogspot.com/
http://iso9001qualitysystem.blogspot.com/
http://iso-14000-ems.blogspot.com/
http://iso-9001standards.blogspot.com/
http://iso9000-standard.blogspot.com/
http://iso-9001-quality-manual.blogspot.com/
http://iso-14000-standards.blogspot.com/
http://iso-14001-standards.blogspot.com/
http://iso-9001-quality-system.blogspot.com/
http://iso-9001-standard.blogspot.com/
http://iso-environmental-management-systems.blogspot.com/
http://iso-9001-quality-management-system.blogspot.com/
http://iso9000qualitymanagementsystem.blogspot.com/
http://iso-9001-standard.blogspot.com/
http://iso-14001ems.blogspot.com/
http://iso-14001-quality-system.blogspot.com/
http://iso-14001-quality-manual.blogspot.com/
http://www.iso14000store.com/blog
http://www.iso9001-standard.us
http://iso14001-standard.blogspot.com/
http://environmental-management-system.blogspot.com/
http://iso9001systems.blogspot.com/
http://iso-9000softwares.blogspot.com/
http://iso14000-series.blogspot.com/
http://iso9001qualitysystem.blogspot.com/
http://iso-14000-ems.blogspot.com/
http://iso-9001standards.blogspot.com/
http://iso9000-standard.blogspot.com/
http://iso-9001-quality-manual.blogspot.com/
http://iso-14000-standards.blogspot.com/
http://iso-14001-standards.blogspot.com/
http://iso-9001-quality-system.blogspot.com/
http://iso-9001-standard.blogspot.com/
http://iso-environmental-management-systems.blogspot.com/
http://iso-9001-quality-management-system.blogspot.com/
http://iso9000qualitymanagementsystem.blogspot.com/
http://iso-9001-standard.blogspot.com/
http://iso-14001ems.blogspot.com/
http://iso-14001-quality-system.blogspot.com/
http://iso-14001-quality-manual.blogspot.com/
http://www.iso14000store.com/blog
http://www.iso9001-standard.us
ISO 14001 Template
The ISO 14001Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.
The ISO 14001 Template features:-
• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.• Professional design and layout.• It is designed to fulfill the ISO 14001 : 2004 requirements. .• Easy to read, easy to understand, and easy to implement.• Easy to audit as it follows the structure of ISO 14001: 2004..• Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:
a. ISO 14001 EMS Manual TemplateThe Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.ISO 14001 Manual Template Consist of:• Section 1: General EMS Requirement• Section 2: Environment Policy – Objectives, Targets & Programmes• Section 3: EMS Planning• Section 4: Implementation & Operation• Section 5: Checking & Monitoring• Section 6: Management Review
b. ISO 14001 Operating ProcedureThe ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.
ISO 14001 Operating Procedures Consist Of:• Objective & Targets Procedure• Environmental Management Program Procedure• Environmental Aspect & Impact Identification & Evaluation Procedure• Environmental Monitoring & Measuring Procedure• Legal & Others Requirement & Evaluation Of Compliance Procedure• Emergency Preparedness & Response Procedure• Chemical Control Procedure• Waste Management Procedure• 5S House Keeping Procedure
c. ISO 14001 FormsISO 14001 Forms Consist Of :• Environmental Non-Conformance Master List• Environmental Non-Conformance Notice Form• Environmental Management Program Form• Environmental Aspect & Impact Identification Form• Green Environment Internal Audit Master Plan• Green Environment Plan & Activities Form• Green Environment Material Purchase Master List• ISO 14001:2004 Internal Audit Summary Report• Equipment Monitoring Master List• Environment Preventive Action Report (PAR) Master List• Environment Preventive Action Report (PAR) Form.• Environmental Responsible Form• EMS Organization Chart.• Waste Management Schedule Form• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
For more information, please visit us at:
http://www.e-wia.comhttp://www.iso-consults.comhttp://www.iso9000-software.com
The ISO 14001 Template features:-
• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.• Professional design and layout.• It is designed to fulfill the ISO 14001 : 2004 requirements. .• Easy to read, easy to understand, and easy to implement.• Easy to audit as it follows the structure of ISO 14001: 2004..• Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:
a. ISO 14001 EMS Manual TemplateThe Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.ISO 14001 Manual Template Consist of:• Section 1: General EMS Requirement• Section 2: Environment Policy – Objectives, Targets & Programmes• Section 3: EMS Planning• Section 4: Implementation & Operation• Section 5: Checking & Monitoring• Section 6: Management Review
b. ISO 14001 Operating ProcedureThe ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.
ISO 14001 Operating Procedures Consist Of:• Objective & Targets Procedure• Environmental Management Program Procedure• Environmental Aspect & Impact Identification & Evaluation Procedure• Environmental Monitoring & Measuring Procedure• Legal & Others Requirement & Evaluation Of Compliance Procedure• Emergency Preparedness & Response Procedure• Chemical Control Procedure• Waste Management Procedure• 5S House Keeping Procedure
c. ISO 14001 FormsISO 14001 Forms Consist Of :• Environmental Non-Conformance Master List• Environmental Non-Conformance Notice Form• Environmental Management Program Form• Environmental Aspect & Impact Identification Form• Green Environment Internal Audit Master Plan• Green Environment Plan & Activities Form• Green Environment Material Purchase Master List• ISO 14001:2004 Internal Audit Summary Report• Equipment Monitoring Master List• Environment Preventive Action Report (PAR) Master List• Environment Preventive Action Report (PAR) Form.• Environmental Responsible Form• EMS Organization Chart.• Waste Management Schedule Form• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
For more information, please visit us at:
http://www.e-wia.comhttp://www.iso-consults.comhttp://www.iso9000-software.com
How To Implement ISO 9001 Standards Using Template & Softwares
There are few ways of implementing the ISO 9000 in a particular organization. One of the easy way is hiring a ISO 9000 consultant in a turn key project basis. This definitely will incur cost. However, some of the organization will appoiint an employee to start up the ISO 9000, by learning thru seminar, preparing the ISO 9000 Quality Manual, Procedure & Form by using some of the ISO 9000 Template sell at internet. Some of the provider such as http://www.iso-consults.com & http://www.quality-template.com are providing such services.
Normally, the template provide will provides the ISO 9000 Quality Manual Template, Standand Procedure & also sample form for the ISO 9000 implementation. One of the provider like http://www.e-wia.com give a very complete set of the ISO 9000 Templates, which will help an organization to implement the ISO 9000 easily.
There are also some ISO 9000 Softwares which helps the organization in the ISO 9000 implementation. Some of the ISO 9000 Software are listed below:
a. Document Control Software – Software which Helps the organization to keep track & control of the ISO 9000 Documents.
b. Audit Control Software – Software which helps the organization to keep track of internal & external audit events.
c. Training Record Management Software – Software which helps the organization to keep track of Training records in a system.
d. Calibration Software – Software to maintain the calibration records for tool & machinery.
More Sites on ISO 9001 Standards Template & Softwares are as below:
http://www.iso9001store.com
http://www.iso14000store.com
Normally, the template provide will provides the ISO 9000 Quality Manual Template, Standand Procedure & also sample form for the ISO 9000 implementation. One of the provider like http://www.e-wia.com give a very complete set of the ISO 9000 Templates, which will help an organization to implement the ISO 9000 easily.
There are also some ISO 9000 Softwares which helps the organization in the ISO 9000 implementation. Some of the ISO 9000 Software are listed below:
a. Document Control Software – Software which Helps the organization to keep track & control of the ISO 9000 Documents.
b. Audit Control Software – Software which helps the organization to keep track of internal & external audit events.
c. Training Record Management Software – Software which helps the organization to keep track of Training records in a system.
d. Calibration Software – Software to maintain the calibration records for tool & machinery.
More Sites on ISO 9001 Standards Template & Softwares are as below:
http://www.iso9001store.com
http://www.iso14000store.com
Hidden Businees Opportunities
The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let me dispel any anxiety about the November 15, 2008 official “2008” release. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications. The changes to the ISO 9001 amendment, however, will have considerable benefit.As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System. It is the world’s most recognized business management standard. And it makes a strong business case. It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement. That translates to improved business results and a sustainable competitive advantage.
Overview of the Changes
The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.
Overview of the Changes
The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.
Understand Quality Management
Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.
Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.
The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.
iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.
In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.
Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.
There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.
Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.
The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.
iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.
In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.
Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.
There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.
ISO 14001 Standards – Complying with Environmental Laws and Regulations
One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.
IS0 14001 – HISTORICAL DEVELOPMENT
Firstly ISO 14000 environment system standards was prepared in June of 1992 year in Rio at world apex and this standard brooks decisions of this world apex and Rio contract principles. After 1 year, ISO established one technique committee which is yielded by 50 different country representatives to prepare international environment management system in 1993 year. ISO 14001 environment management system standard was issued in September of 1996 year with works of this committee. ISO 14001 standard is used as voluntary now but ISO 14001 will be burden by coercions of societies, international organizations, states in the future. Levels which environment management system passed are the following briefly:
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005
ISO 14001 and The Environment
The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.
ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT
In order to be in conformance with this provision of ISO 14001 an organization must be able to answer the overall question: “How does the organization conduct environmental audits of the EMS?”. In order to answer that question four specific tasks must be addressed under the Management System Audit section of the standard.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.
Reasons a Company Becomes Certified in ISO 9001 Standards
ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.
Transition from ISO 9001:2000 to ISO 9001:2008
Transition from ISO 9001:2000 to ISO 9001:2008
This reference guide was developed to help you understand the nature of the changes to the ISO 9001 standard.
Clause Change/Emphasis Not Auditable
0.1 General – Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard.
0.4 Compatibility with Other Management Systems Standards - Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible.
1.1 General
1.2 Application – “Statutory” was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word “product” appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer.
2. Normative Reference – Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005).
3. Terms and Definitions – The supplier/organization/customer model was removed. These relationships, in reality, are not always linears.
The Auditable RequirementsClause Change/Emphasis4.1In 4.1 a, “identify” was replaced with “determine” to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements.A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated.4.2.1References to records and documents were consolidated.Also, the organization can require records not specified in this international standard that are created and maintained.4.2.3Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1).4.2.4Rephrased, but no additional clarifications or emphasis added. Editorial change only.5.5.2The management representative must be from the organization’s management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not “out of touch” with the organization.6.2.1The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well.
6.2.2If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individual’s experience. The organization must prove to itself that this person can, in fact, perform.6.3Infrastructure also includes databases and information technology.6.4Emphasis is added in a note to highlight that the concept of “work environment” only extends to product quality.7.1 c“Measurement” is added.7.2.1“Post-delivery activity” is clarified in a note with examples.7.3.1A note emphasizes that design verification, validation, and review are different from one another and serve different purposes. Design review is where the organization evaluates if the design can meet requirements and if any changes need to be made. Design verification is where the organization has ensured that requirements have been met (e.g. is the widget blue and is it hexagonal?). Design validation is where the organization proves that the design can perform as required.However, the records of design verification, validation, and review do not have to be separate.7.3.3Production and service provisions also extend to how product is preserved, handled, etc., to ensure product conformity. See 7.5.1Design outputs must include requirements related to preservation. See 7.5.5.
7.5.2Notes were added to give examples of the types of processes where this requirement would apply along with a statement that service organizations should have additional considerations in the planning stages when deficiencies and conformity are not likely to be identified prior to delivery.7.5.3Product status must be identified throughout product realization, not just the final product. See 1.2.7.5.4Wording was modified to add clarity, but the intent of the requirement has not changed.7.5.5Again, emphasis is added that care must be given to preserving the product regardless of where it falls in the realization process.7.6An obsolete reference to another ISO document was replaced.The definition of “monitoring and measuring devices” has been clarified to include equipment and devices that are purposed for monitoring and measuring, regardless of their original or intended purpose.An additional note regarding software was added.8.2.2Document and record requirements were reworded and their placement modified to improve clarity.The reference to the auditing guidance document was updated (i.e. ISO 19011).
8.2.3Wording was modified to emphasize that correction and corrective actions are not only to be taken to preserve the conformity of the product, but also to preserve the quality management system. For example, internal rejection/scrap rates could show evidence that the organization is preserving product conformity and is taking intermediate action to prevent bad product from being shipped to their customers; however, it could also be a sign that the organization is not efficient since the higher rejection/scrap rates are undesirable.A note was added to clarify the meaning of “suitable methods” related to planning, monitoring and measurement processes. Suitability should be determined based on risk and the impact that nonconformity would have on the product or process.8.2.4Product can be released to other internal processes despite planned arrangements not being satisfactorily completed as long as it conforms prior to release to the customer. This relaxes requirements on intermediate inspection results and records.8.3Actions taken against nonconforming product must be proportional to its impact or potential impact. See 8.2.3 related to impact considerations for monitoring and measurement.This would mean that in the planning stages of a product, the organization needs to customize responses to nonconforming products based on the risk or potential risk to the organization.This requirement existed in ISO 9001:2000; however, its location has changed.
8.5.2Nonconformity can have multiple causes (“cause”; i.e. a singular reason, was used in the 2000 version); therefore, the organization must consider this when conducting root cause analysis.Also, it is not enough to simply review corrective action and ensure that procedures were changed, personnel have been re-trained, and that processes were amended. The organization must review whether or not the action(s) taken were effective; i.e. did they successfully eliminate the nonconforming condition?8.5.3Similar to the new emphasis on the effectiveness of corrective action, the organization must also document whether or not the preventive action(s) taken were effective in eliminating the risk of nonconformity.
This reference guide was developed to help you understand the nature of the changes to the ISO 9001 standard.
Clause Change/Emphasis Not Auditable
0.1 General – Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard.
0.4 Compatibility with Other Management Systems Standards - Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible.
1.1 General
1.2 Application – “Statutory” was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word “product” appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer.
2. Normative Reference – Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005).
3. Terms and Definitions – The supplier/organization/customer model was removed. These relationships, in reality, are not always linears.
The Auditable RequirementsClause Change/Emphasis4.1In 4.1 a, “identify” was replaced with “determine” to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements.A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated.4.2.1References to records and documents were consolidated.Also, the organization can require records not specified in this international standard that are created and maintained.4.2.3Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1).4.2.4Rephrased, but no additional clarifications or emphasis added. Editorial change only.5.5.2The management representative must be from the organization’s management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not “out of touch” with the organization.6.2.1The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well.
6.2.2If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individual’s experience. The organization must prove to itself that this person can, in fact, perform.6.3Infrastructure also includes databases and information technology.6.4Emphasis is added in a note to highlight that the concept of “work environment” only extends to product quality.7.1 c“Measurement” is added.7.2.1“Post-delivery activity” is clarified in a note with examples.7.3.1A note emphasizes that design verification, validation, and review are different from one another and serve different purposes. Design review is where the organization evaluates if the design can meet requirements and if any changes need to be made. Design verification is where the organization has ensured that requirements have been met (e.g. is the widget blue and is it hexagonal?). Design validation is where the organization proves that the design can perform as required.However, the records of design verification, validation, and review do not have to be separate.7.3.3Production and service provisions also extend to how product is preserved, handled, etc., to ensure product conformity. See 7.5.1Design outputs must include requirements related to preservation. See 7.5.5.
7.5.2Notes were added to give examples of the types of processes where this requirement would apply along with a statement that service organizations should have additional considerations in the planning stages when deficiencies and conformity are not likely to be identified prior to delivery.7.5.3Product status must be identified throughout product realization, not just the final product. See 1.2.7.5.4Wording was modified to add clarity, but the intent of the requirement has not changed.7.5.5Again, emphasis is added that care must be given to preserving the product regardless of where it falls in the realization process.7.6An obsolete reference to another ISO document was replaced.The definition of “monitoring and measuring devices” has been clarified to include equipment and devices that are purposed for monitoring and measuring, regardless of their original or intended purpose.An additional note regarding software was added.8.2.2Document and record requirements were reworded and their placement modified to improve clarity.The reference to the auditing guidance document was updated (i.e. ISO 19011).
8.2.3Wording was modified to emphasize that correction and corrective actions are not only to be taken to preserve the conformity of the product, but also to preserve the quality management system. For example, internal rejection/scrap rates could show evidence that the organization is preserving product conformity and is taking intermediate action to prevent bad product from being shipped to their customers; however, it could also be a sign that the organization is not efficient since the higher rejection/scrap rates are undesirable.A note was added to clarify the meaning of “suitable methods” related to planning, monitoring and measurement processes. Suitability should be determined based on risk and the impact that nonconformity would have on the product or process.8.2.4Product can be released to other internal processes despite planned arrangements not being satisfactorily completed as long as it conforms prior to release to the customer. This relaxes requirements on intermediate inspection results and records.8.3Actions taken against nonconforming product must be proportional to its impact or potential impact. See 8.2.3 related to impact considerations for monitoring and measurement.This would mean that in the planning stages of a product, the organization needs to customize responses to nonconforming products based on the risk or potential risk to the organization.This requirement existed in ISO 9001:2000; however, its location has changed.
8.5.2Nonconformity can have multiple causes (“cause”; i.e. a singular reason, was used in the 2000 version); therefore, the organization must consider this when conducting root cause analysis.Also, it is not enough to simply review corrective action and ensure that procedures were changed, personnel have been re-trained, and that processes were amended. The organization must review whether or not the action(s) taken were effective; i.e. did they successfully eliminate the nonconforming condition?8.5.3Similar to the new emphasis on the effectiveness of corrective action, the organization must also document whether or not the preventive action(s) taken were effective in eliminating the risk of nonconformity.
ISO 9001 Standards Requirement – Product Realization
ISO 9001 Standards Requirement – Product Realization
Planning of Product RealizationPlan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:Quality objectives and product requirementsNeed for processes, documents, and resourcesVerification, validation, monitoring, measurement, inspection, and test activitiesCriteria for product acceptanceRecords as evidence the processes and resulting product meet requirements
Customer-Related Processes
Determination of Requirements Related to the ProductDetermine customer requirements:Specified for the product (including delivery and post-delivery activities)Not specified for the product (but needed for specified or intended use, where known)Determine:Statutory and regulatory requirements applicable to the productAny additional requirements considered necessary by the organization
Review of Requirements Related to the ProductReview the product requirements before committing to supply the product to the customer in order to:Ensure product requirements are definedResolve any requirements differing from those previously expressedEnsure its ability to meet the requirementsMaintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed requirements.NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material.
Customer CommunicationDetermine and implement effective arrangements for communicating with customers on:Product informationInquiries, contracts, or order handling (including amendments)Customer feedback (including customer complaints)
Planning of Product RealizationPlan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:Quality objectives and product requirementsNeed for processes, documents, and resourcesVerification, validation, monitoring, measurement, inspection, and test activitiesCriteria for product acceptanceRecords as evidence the processes and resulting product meet requirements
Customer-Related Processes
Determination of Requirements Related to the ProductDetermine customer requirements:Specified for the product (including delivery and post-delivery activities)Not specified for the product (but needed for specified or intended use, where known)Determine:Statutory and regulatory requirements applicable to the productAny additional requirements considered necessary by the organization
Review of Requirements Related to the ProductReview the product requirements before committing to supply the product to the customer in order to:Ensure product requirements are definedResolve any requirements differing from those previously expressedEnsure its ability to meet the requirementsMaintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed requirements.NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material.
Customer CommunicationDetermine and implement effective arrangements for communicating with customers on:Product informationInquiries, contracts, or order handling (including amendments)Customer feedback (including customer complaints)
ISO 9001 Standards Requirements – Design and Development
ISO 9001 Standards Requirements – Design and Development
Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.
Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.
What is a “document” In ISO 9001 Standard?
What is a “document” In ISO 9001 Standard?
The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.b) Evidence of conformity provision of evidence that what was planned, has actually been done.c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:papermagneticelectronic or optical computer discphotographmaster sample
The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.b) Evidence of conformity provision of evidence that what was planned, has actually been done.c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:papermagneticelectronic or optical computer discphotographmaster sample
Organizations preparing to implement a QMS For ISO 9001
Organizations preparing to implement a QMS For ISO 9001
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:- Identifying the processes necessary for the effective implementation of the quality management system- understanding the interactions between these processes.- documenting the processes to the extent necessary to assure their effective operation and control. (It may beappropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)These processes include the management, resource, product realization and measurement processes that are relevantto the effective operation of the QMS.Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:- Identifying the processes necessary for the effective implementation of the quality management system- understanding the interactions between these processes.- documenting the processes to the extent necessary to assure their effective operation and control. (It may beappropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)These processes include the management, resource, product realization and measurement processes that are relevantto the effective operation of the QMS.Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.
Outsourced Processes In ISO 9001 Standards
Outsourced Processes In ISO 9001 Standards
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.
One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).• The organization does not have the competence to carry out the process itself, and chooses to outsource it.
Demonstrating conformity with ISO 9001:2008
Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.Organizations may be able to demonstrate conformity without the need for extensive documentation.To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)Planning of product realization, and clause 8.2.4
Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.Organizations may be able to demonstrate conformity without the need for extensive documentation.To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)Planning of product realization, and clause 8.2.4
Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.
Records required by ISO 9001:2008
Records required by ISO 9001:2008
Clause Record required5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action
Clause Record required5.6.1 Management reviews6.2.2 e) Education, training, skills and experience7.1 d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product.8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained8.5.2 e) Results of corrective action8.5.3 d) Results of preventive action
Thursday, October 1, 2009
ISO 14001:2004 Evaluation of compliance
ISO 14001:2004 Evaluation of compliance
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
Subscribe to:
Posts (Atom)