ISO 9001:2015 – Things to Consider

ISO 9001:2015 – Things to Consider

By Michael Haycock, Sr. BRC Consultant

The draft document for the 9001:2015 standard has been released, but is still being reviewed.  Here is a high level overview for you, along with some things to consider.

Changes to Structure – There are now 10 requirements instead of the current 8 for 9001:2008. The intent for the change to structure is “harmonization” – at some point the 9001/14001/18001 will structurally match up, and there would then eventually be changes to the industry standards also (Aerospace, Medical Devices, Testing & Calibration, Automotive, etc.). But in the meantime…for you…this means potential significant structural changes to your documentation.

Content – Aside from the structure, the content has been moved around. This is not a nice neat 1 for 1.

Portions of 2008 will in some cases be located in multiple sections of 2015.  A couple of quick examples:

• Documentation…which was in requirement 4…is now in requirement 7.
• Design…which was in section 7.3…is now in section 8.5.

Unfortunately this will not be the nice neat transition that we saw from ISO 9001:2000 to ISO 9001:2008.

Section 5 which was “Management Responsibility” is now “Leadership”. Top management appears to have more responsibility for the management of the QMS – much of which was delegated to the management representative in the past. While the need to address these requirements still appears to be present, there is no specific “role” of Management Representative identified (thus the additional inclusion of Top Management – just opinion.)

Risk has been identified and is expected to be covered throughout a variety of requirements. This doesn’t have to be difficult but it is a different focus than the QMS has had in previous editions. The actual applied concept of risk and the use of this language is (in my opinion) quite significant.

The word “context” has been used in this version, with the intent that the organization recognize it has some understanding of the impact it has on the world around it (the “context” is the environment in which it carries out it’s work).

There is no specific requirement for a Quality Manual, or documented procedures for that matter. The requirement is for “documented information”. There is not currently a separate sub-section for records – it is included in documented information.

There is control of nonconforming product (8.6.5) and, separately, nonconformity and corrective action (10.1). Ultimately, this will make things clearer for some of you and not so clear for others.

Preventive Action is no longer identified as a requirement. Requirement 10 is “Improvement” which includes section 10.2 Continual Improvement.

Canada has representatives on technical committees that create and change standards. Canada at one time had the Secretariat for TC176 which was the ISO 9000 series of standards. This was done primarily through CSA and SCC. If you have comment on what is occurring you should make an effort to have your voice heard. When it goes to final draft (FDIS) no more changes will be allowed – it will be voted up or down.

We hope what becomes known becomes a little less “frightening”. We have shared this little bit with you to give you a “heads up” but add a note of caution because the changes have not been finalized and there are some very subtle changes in the draft document.

Some thoughts for you on next steps…