5 Main Changes Expected in ISO 9001:2015

from the 2014 Draft International Standard

(DIS)
Author: 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.