Q1, 9th Edition – Tougher Than It Looks

Here it is, March of 2014.

June 1, 2014 is the due date for existing API Monogram Program licensees and QMS certified companies to have their QMS updated to Q1, 9th Edition. Few have realized the seriousness and rigor of the new Q1.

The entire specification has been restructured.

It’s not just a revision that includes three new sections – Risk Assessment, Contingency Planning, and Management of Change; it’s a structural change, not to mention a change of focus from quality management system to a “risk-based” quality management system.

There are more criteria than just the three aforementioned sections. While some of the following may have been repurposed from the 8th Edition, other sections are new.

Here are some additional considerations:

• 4.4.4, Use of External Documents in Product Realization
• 5.7.1.4, Product Realization Capability Documentation
• 5.7.2, Product Quality Plans
• 5.7.8, Preventive Maintenance
• 5.9, Product Release

Likewise, new concepts such as the following have been introduced:

a) The word “critical” which appears in:

• 5.4, Design Output as in critical product/equipment
• 5.6, Purchasing as in critical suppliers
• 6.2.2, Internal Audits as in critical processes

Who in your organization will define the meaning of what critical means to the areas identified?

b) “External communication” has been introduced.

While clause 4.1.5.2 in the 9th Edition identifies four specific customer interactions, the specification as a whole addresses at least twice that number of interactions within its text. Additionally, have you thought about interaction with statutory and regulatory bodies where the need exists?

The bottom line is if you haven’t begun the revision of your quality management system, it is best to begin the process as soon as possible. A simple “cutting and pasting” of the new 9th Edition criteria into an 8th edition QMS will be insufficient to meet the need of this newly revised specification. In fact, such an approach will introduce risk to your organization, but QSI can help you navigate the roadmap of getting your QMS caught up to the 9th Edition.