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 Requirements Clause Change/Emphasis 4.1 In 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. 4.2.1 References to records and documents were consolidated. Also, the organization can require records not specified in this international standard that are created and maintained. 4.2.3 Clarification 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). 4.2.4 Rephrased, but no additional clarifications or emphasis added. Editorial change only. 5.5.2 The management representative must be from the organizations 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. 6.2.1 The 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. 6.2.2 If 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 individuals experience.
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