QMI Brief Newsletter

12/16/2008
ISO 9001:2008 ľ Revisions to the Standard - Clause by Clause

ISO 9001:2008 - Revisions to the Standard
This clause-by-clause overview shows the changes that were made in each section of the standard.

**Note: this overview is intended to be general in nature. For any company that is transitioning from ISO 9001:2000 to 2008, it is necessary to purchase a copy of the standard and thoroughly review each clause to see how the changes are relevant to their organization.




ClauseLikely Change
0.2Process ApproachWording changed from "identify" to "determine" to emphasize the importance of processes being capable of achieving desired outputs.
1.1ScopeSome clarification that "product" can also be "intermediate product" and an explanation that statutory and regulatory requirements can be referred to as legal requirements.
4.1General RequirementsA note has been added that clarifies requirements regarding outsourcing and the types of control that may be applied to such processes.
4.2.1General Documentation RequirementsAcknowledgement that documentation can also include records, and that the mandatory procedures may be combined in one document or that the requirements of one procedure may be covered in more than one document.
4.2.3Document ControlUseful clarification that only documents of external origin that affect the quality management system have to be controlled.
5.5.2Management RepresentativeInclusion of a statement that this person must be a member of the organizations own management.
6.2.2Competence, Training & AwarenessRequires organizations to ensure necessary competencies have been achieved.
6.3InfrastructureClarification that information systems are included as a part of the companys infrastructure, and therefore the management system.
6.4Work EnvironmentSome examples shown of what constitutes the Work Environment.
7.2.1Determination of Requirements related to the ProductExplanations of the sorts of post delivery activities should be covered, such as warranties, maintenance, recycling and so on.
7.3.1Design and Development PlanningClarification that review, verification and validation have distinct purposes but may be conducted and recorded separately or in any combination as appropriate to the product and the organization.
7.3.3Design and Development OutputsClarifies that product preservation (such as packaging) may be included for production and service provision.
7.5.4Customer PropertyClarification that intellectual property and personal data are to be considered as customer property.
7.6Control of Monitoring & Measuring DevicesClause has been re-titled and the term "devices" has been replaced by "equipment". A Note has been added relating to checking the conformity of software used for monitoring and measuring purposes.
8.2.1Customer SatisfactionA note has been added showing examples of how customer satisfaction data may be gathered.
8.2.3Monitoring & Measurement of ProcessesA clarification note has been added that methods of monitoring and measuring of processes are determined based on product conformity and the quality management system effectiveness.
8.2.4Monitoring & Measuring of ProductA clarification has been included, indicating that release of the product means to the customer, not just the next in-process stage.

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