Mark Hammar Since 2013, when the new committee draft of the ISO 9001 standard came out, people have been wondering what changes will be kept and what changes would be further updated. Now that the ISO committee has taken the next step and issued the draft international standard for ISO 9001:2015, we can see some of the main changes that are very likely to remain when the final standard update is released. It is important to note that although these changes look finalized, there may be some slight updates in the final draft international standard (FDIS) and even the final released version of the standard. So, what are the main changes from the previous committee draft, and what might these mean for your quality management system?
Reformatting to match Annex SL. As was expected from the committee draft, the clauses of the standard have been re-ordered and re-named to be compliant with Annex SL like other standards such as ISO 27001 & ISO 22301, which more closely follows the plan-do-check-act cycle. As I stated in the previous article, since the overall process flow should meet the company’s needs, this should not change the implementation of the QMS. This is, however, the reason why I do not like trying to match the numbering of the QMS documents with the standard requirements.
Section 4.4, Quality management system. While the committee draft had a separate section on the process approach, this has been merged into one section on the QMS and its processes. This does not mean the process approach is being removed from the ISO 9001 standard; all the requirements are there with different wording, but it is not explicitly stated as the “process approach.” This should not change the way people have implemented ISO 9001, as the process approach has been a key part of the standard since 2000.
Leadership. Although it seems like a small change, the new draft international standard has added a requirement for top management to take accountability for the effectiveness of the QMS. For some companies where this activity has been delegated to an internal audit team, the expectation will be more prevalent that the members of top management can speak about how effective the QMS is and how this is measured and improved. Improving top management involvement and knowledge of the QMS at this point could help with the introduction of new accountabilities when the new revision of ISO 9001 comes out.
Assessing and planning for risks. This remains a large addition to the standard, with some further clarifications and examples added to the notes. As I mentioned in my prior article, this is something that is very unlikely to be removed from the standard, and it is very likely the section that would most benefit companies trying to make improvements to the QMS now, in anticipation of the coming changes. Even without the upcoming changes to the ISO 9001 standard, I’ve written some ideas for adding risk activities to the QMS in this article: The role of Risk Assessment in the QMS. Small revisions to the section on planning of changes highlight the need for risk assessment before making a change in the quality management system.
Documented Information. It is important to note an overall change of this draft international standard from the current standard, ISO 9001:2008, around the concept of required documents. With the current standard there are several required documented procedures (such as Internal Audit and Control of non-conforming product). The wording of the new draft standard does not include these indications of required documents, but does this mean they are not necessary? This is, of course, not the case. The new draft uses the phrase “documented information” to denote when a company needs to document and retain such information. So, while there is no requirement for a documented internal audit procedure and audit records, there is a requirement to retain documented information as evidence of the implementation of the audit program and audit results. An audit procedure and records is still an acceptable way to provide this evidence.
Is the Quality Manual gone? As with documented procedures, there is no longer a stated requirement for a quality manual and what it will contain, as is present in the current standard (ISO 9001:2008). This does not mean that a company needs to necessarily destroy the idea of having a quality manual. There is still information that is required as documented information, such as the scope of the QMS, information to support the operational processes, and a quality policy. While it is true that these pieces of information can be documented separately, it is still acceptable to document them together in a document called a quality manual if your company finds this helpful. I still maintain, as I stated in my earlier article Writing a short Quality Manual, that a quality manual, if written concisely, can be a good sales tool for your organization.
It is not necessary to take action to update your QMS now; as always, you will have some time after the final version is released. But, this might be made easier if you start thinking of some of the main updates mentioned here and how you can address them. Keeping ahead of the curve on these updates might make implementation of changes easier, since you have more time. Extra planning now on the few items identified in this article can help improve your effectiveness later.
Click here to see a sample of Quality Manual.
