Implementing ISO 9001 Standards

Implementing ISO 9001 standards

If you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.

For implementing ISO 9001 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards

An ISO consultant performs the various activities and explains the course objectives :

• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship

• describe the purpose of Quality Management Systems and 8 Quality Management Principles

• Interpret the ISO 9001: 2008 in the context of audit

•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems

• Develop understanding of Roles & Responsibilities of Lead Auditors

Hiring a Consultant is a better and easiest way to implement ISO in your organization

Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

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.

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.

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.