With a new year upon us there are many new and exciting opportunities to explore. There may also be changes in the way our businesses operate that cause stress and, in some cases, fear.
For companies registered to the ISO 9001 Quality Standard, there comes the ISO 9001:2015 revision that is causing anxiety for some business owners. As it stands, on the surface, we can expect many changes to the standard and for companies who are struggling to maintain their current documentation and system there will be many who will attempt to profit from your anxiety. I am here to tell you to take a breath, relax and to assure you it will be okay.
First of all, the standard has not been approved for official release and it is not expected to be released until September 2015. This means you have time to prepare and find out what the proposed changes are and what you can do now to work on a transition plan. The next draft is due for release by the end of February 2015 and it is not expected that much will change from February to September.
This means that you could have access to the standard several months before it is made "official" to work on your transition plan. The other good news is that you will have up to 3 years to transition to the new standard from the date of its official release. There is no reason to panic, but you need to take time now to understand the changes and how they will affect your business. Here are some expected changes to the new standard:
- There will be 10 clauses instead of 8. If your current manual is based around the clauses of the 2008 version of the standard (or earlier) this may be problematic. However, there is no expectation that you re-write your documentation to be inline with the new numbering system. You may want to create a table to assist auditors to show how your documentation meets the new requirements.
- Preventative Action has been replaced with Risk Management. While you do not have to implement a risk management program, you do have to be able to identify risks faced by the organization and how these are being addressed.
- There is a greater focus on customer expectations and how the organization will meet these expectations.
- The words “documents” and “records” have been replaced by “documented information”. There does not seem to be a requirement for a “Quality Manual”, however, this documented information must be maintained. I think this is an effort to prevent organizations from regurgitating the standard as their quality manual and forces them to create a system that is designed specifically for their organization and meets the needs of their customers.
At its core, the "spirit" of the standard has not changed, only the format and some of the requirements. If your quality management system is designed to strengthen your company and to meet customer requirements, you have very little to worry about.
If your quality management system is designed to keep a piece of paper on your wall, well, that is a different story.