ISO 9001:2015 Highway: The Revolution

J.P. Russell provided a handout at the 2013 ASQ Audit Conference titled the “ISO 9001:2015 Highway: The Revolution”. With his permission, I am reproducing the handout for our newsletter readers:

There are major events taking place in the standards community that may change the ISO 9001 worldwide community forever.  It is as if we have all been traveling down this super highway and suddenly signs popped up indicating that the road ahead has changed. So, now we will need to assess the situation and make some decisions on how we are going continue our trip.

Note: The following comments represent my personal observations and conclusions and not that of any organization I am a member or active participant. Nor is this an analysis of proposed requirement changes you may expect in the future. JP Russell

The major event is that the leaders of European-based International Organization for Standardization (ISO) have decided that all of the management system standards should have the same structure and same common text. They claim this need is based upon user feedback. In turn, a high level committee (or board) of the ISO community unilaterally developed and issued guidelines of what the high level structure and common text should be for all future management system standards such as the ISO 9001 and ISO 14001.  At a high level, it seems like the right thing to do; but this has caused major angst for many USA organizations and organizations that represent worldwide industry sectors such as automotive and medical devices.

I am not writing this to take sides. I believe the changes are going to be made no matter the objections of some USA voices, industry sectors and users.  In addition, many want the changes that will result in common clause numbers and titles, and the same words to describe requirements. The big picture is for all requirements in management system standards to have the same structure and common text. For example there may be some differences in document control between ISO 9001 (generic quality), ISO 14001 (environmental) and ISO 13485 (medical device quality) but you would expect that 90% or more of the requirements would be common to all three. However, concerns start to surface when this approach is applied to all clauses of a management system standard.

I would describe the context of the situation to be that ISO 9001 is a mature quality management system standard. Maturity normally means that there is very little need to make significant changes in requirements. Some requirements can be traced back as far as the 1963 quality program standard called MIL Q 9858A. Also, several industry sectors have followed suggestions to base their quality management system standard on ISO 9001.  The current version of the ISO 9001 standard has widespread use and acceptance among an estimated over one million organizations with ISO 9001 certificates hanging on walls.

There is general agreement on some changes, but disagreement with others due to perceived cost to implement the changes and lack of added value.

Change: Common Structure

Benefits: It would help organizations that implement several management system standards (MSS) to structure their management system controls such as all documenting, recording, designing, purchasing, communicating, validating, measuring and correcting, which have the same title and number. New clause titles may be: context of the organization, leadership, planning, support, operation, performance evaluation and continual improvement.

Issues: Some ask why the standard that overwhelmingly has the most users (ISO 9001) should now be required to adapt their QMS to a new structure that has no added intrinsic benefit for them other than it will now be in the same structure as other MSS. Of course, that new standard will state that restructuring will not be required; however, most  organizations will feel compelled to renumber and restructure their QMS documents for accountability, communication and control purposes. The cost to make the structural changes may be significant and some are asking why they have to change.

Change: Common Text

Benefits: It would be very advantageous if there was common text for clauses such as documenting, purchasing, planning, communicating, validating, measuring and correcting.

Issues: The current proposed version of common text reworded many of the existing requirements and added requirements not originally proposed or agreed to by the quality technical committees (which is the normal path). There will now be no clear traceability of requirements from prior QMS standards.

If the different management system standard developers (such as ISO 9001 and ISO 14001) are allowed to change the common text to fit their sector, then one of the very key benefits of the revision will be lost. This is somewhat of a quandary since the standards developers for their sectors want to ensure current controls are not lost and unnecessary controls are not added.

Summary

I have heard some folks characterize the proposed version of the ISO 9001:2015 standard as “an accident waiting to happen.” Some organizations will no longer see the value of continuing on the super highway.  Others will stay on the super highway because they think it is still the best route or simply stay on the super highway because they have no practical choice to get to where they need to be.  The cost to stay on the super highway may be high. Organizations may need to restructure their management system, implement new requirements that may not add value, and understand there may be education and training costs. It is as if there is a toll booth coming up ahead and organizations will need to decide if they want to pay the toll to stay on the super highway or exit on to an alternate path. The automotive and medical device sectors have already announced that they are exiting the super highway to seek their own QMS route.

I think that the growth of the worldwide supply chain network will continue to fuel the need for common standards. Plus the new version of the standard will include some new requirements that add value such as considering risk in the design of the QMS. The super highway is not in danger; however, there may be a drop in traffic as some will decide they are not willing to pay this toll.

J.P. Russell is the founder and managing director of QualityWBT Center for Education. He also is an ASQ fellow, ASQ-certified quality auditor, voting member of the American National Standards Institute/ASQ Z1 committee and member of the U.S. technical advisory group for International Organization for Standardization technical committee 176. Russell is a recipient of the Paul Gauthier Award from the ASQ Audit Division. You can contact J. P. at www.JP-Russell.com.