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    ISO 9001 version 2008

    ISO 9001 version 2008, officially denoted as ISO 9001:2008, was published in the year 2008. It is the most current version of the ISO 9001 standard, which provides the requirements for a quality management system. (For more details, see What is a Quality Management System & What is ISO 9001.) The previous revision of the standard was ISO 9001 version 2000, officially denoted as ISO 9001:2000, which had been the first big change since the standard was first released in 1987. The update for ISO 9001:2000 to ISO 9001:2008 provided minor tweaks to the requirements, but no major changes in philosophy or requirements. The requirements for getting a certificate for ISO 9001 version 2008 remained unchanged from before.


    ISO 9001 version 2008 changes

    Clarifications: Many of the changes were made to provide clarification, but did not substantially change the requirement. Some examples are: clarifying “product quality” to be “conformity to product requirements” in clauses 6.2.2 & 8.1, adding personal data as being included in customer property in clause 7.5.4, and changing the term “measuring devices” to “measuring equipment” in clause 7.6, including a note that these pieces of equipment can be both calibrated and verified – not just one or the other as before.

    As these did not change the requirement, there was little change in practice.

    Added Notes: Some notes were added to provide clarity to the requirements. These included notes identifying what post-delivery activities could include (clause 7.2.1) and a note that information on product preservation could be included in product and service information (clause 7.3.3). As these were notes, they didn’t change practices greatly, and resulted in few required updates. There were two notes that may have required some changes; the first being a note stating that the design and development reviews, verification and validation had distinct purposes and could be conducted either separately or combined, however the company found suitable (clause 7.3.1). The second note added some methods of measuring customer satisfaction (clause 8.2.1), and these may have changed the ideas a company had on how this was accomplished.

    Requirement Changes: In a few places, changes were made that resulted in some need to make small updates to processes and procedures unless a company had added these requirements already due to customer or internal demands. The first change added a requirement to clause 4.2.4 that records remain legible, identifiable and retrievable. Secondly, a clarification was added that product identification should be applied throughout the product cycle in clause 7.5.3 (in some cases it was not maintained throughout). The third main requirement update changed a previous statement into a specific part of the requirement in the non-conforming product process (clause 8.3). This now specifically included products already delivered with a non-conformance as part of the process. The last big change was in changing the review of corrective and preventive actions taken into a review of the effectiveness of the actions taken (clauses 8.5.2 & 8.5.3).

    As you can see, on the whole, very little changed between these two versions of the standard, more or less providing clarity in the processes already in place rather than requiring changes to be made.

    For a better understanding of what has changed with the newest ISO 9001:2015 revision, and how to adapt your business to the new requirements, check this free white paper Twelve-step transition process from ISO 9001:2008 to the 2015 revision.

    Advisera Mark Hammar
    Author
    Mark Hammar
    Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality, and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.