By Denise Robitaille
With the release of the Final Draft International Standard (FDIS), the long-anticipated launch of ISO 9001:2015 looms ever closer on the horizon. With its impending release this fall, organizations are beginning to prepare for the ISO 9001:2015 transition.
It’s important to have a plan. This will ensure the appropriate involvement of key players, allocation of necessary resources, and equitable distribution of the workload.
Before developing an elaborate plan to implement changes, it’s beneficial to take stock of your existing system. It’s quite possible that new or revised ISO 9001:2015 requirements have already been incorporated into the fabric of your quality management system (QMS). Some requirements make such simple business sense that companies have implemented them as a matter of course over the years. Other requirements, such as enhanced attention to interested parties or change control, might have been driven by sector-specific requirements or customer needs. If that’s not the case for your organization, these additions to your QMS can be implemented with ease building on existing processes such as management review and data analysis.
There isn’t one cookie-cutter approach to what must be done. The ISO 9001:2015 transition will vary for every organization precisely because this new version endorses using a system that best fits your organization’s structure and needs.
Here are some general guidelines you can follow to help in the ISO 9001:2015 transition:
- Buy copies of both ISO 9001:2015 and ISO 9000:2015—and read them.
- Conduct a gap analysis to identify:*
- What needs to change
- What needs to be added
*If possible, get a couple of your internal auditors to read the new standard and participate in the gap analysis.
- Create a plan for the ISO 9001:2015 transition process:
- Review the results of your gap analysis to identify tasks.
- Put together a team so they can be engaged from the onset.
- Ensure top management involvement for two reasons:
- Some of the most important changes affect them.
- There will be a need for resources: time and training.
- Establish a deadline for completion
Some additional considerations when putting your ISO 9001:2015 transition plan together, include:
- Conduct a management review after the gap analysis. Top management must remain informed of both the requirements and the progress toward the project goals. Also, there may be some factors outside of the scope of the transition that come to light that will also warrant management’s attention and input.
- Schedule training sessions for affected departments and individuals.
- Communicate the high points of the transition plan to the entire organization through a town hall-style meeting or whatever method you generally employ for companywide notifications of importance.
- If the gap analysis reveals that the project will be large and elaborate, break it up into manageable junks and assign responsibility and authority to other personnel.
- Ensure that your internal auditors get adequate and effective training.
- Determine what processes are currently compliant and which need some work. Culling the vital few will streamline the process and dispel most of the confusion.
- Make use of the existing good practices you have in place for controlling document revisions and training on new procedures.
- Try not to protract the ISO 9001:2015 transition process. You will diffuse the focus and end up wasting time. Implement the changes that you must make incrementally. Don’t wait to approve all the changes at once.
- Don’t consume valuable time renumbering documents. ISO 9001:2015 has language specifically noting that there is no requirement for an organization’s documentation to mirror the structure of the standard. (If, however, you have compelling reasons to maintain clause number consistency, you may do so.)
- Communicate with your registrar about the ISO 9001:2015 transition schedule.
Above all, remember that this is your system. It must work for you.
About the author
Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She’s the author of numerous articles and more than a dozen books, including The Corrective Action Handbook, The Preventive Action Handbook, and her latest book, 9 Keys to Successful Audits, all published by Paton Professional.
TAG: ISO 9001:2015 transition.