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Old 16th May 2018, 12:11 PM
AndyN's Avatar

Total Posts: 9,129
Let Me Help You re: ISO 13485:2016 Registration - NC on full cycle of internal audits

In Reply to Parent Post by regork View Post

Help, FYI, etc;
During our registration audit to ISO 13485:2016 of a medical device software manufacturer we got a minor ding for not completing a full audit cycle on our processes based on the ISO 13485 2016 revision of the standard. Instead of doing the audits, we developed a comprehensive audit plan to perform a gap analysis of changes, identify the changes, make the changes, establish the changes, and verify that the changes have been established. The elements of the plan against related procedures (and changes) were based on risk of meeting product quality and regulations.

We also had our audits planned at justified intervals over the next three years of the ISO certification period. All internal audits have been complete on time as required by our internal audit SOP.

I justified to the auditor that we transitioned to the new revision of the standard using a quality plan that included verification that the updated / new SOPs and QS documentation have been established. We agreed that we had no evidence that people were actually following the new procedures, in which the auditor said that the registration audit should not even be happening.

After licking our wound and understand that this transition to the new standard for everybody, what gives?

1. I do agree that we need to conduct internal audits to verify we conform to the standard and the updated requirements within, but what is your experience on the implicit time requirement of completing the full audit cycle before ISO 13485:2016 registration?

2. Have you used a quality plan to transition to rev 2016 to include verification the changed SOPs have been established instead of internal audit execution and records?

3. The standard has no requirement for conducting internal audits within a time frame or even that all internal audits have to take place within one year; however most auditors have an opinion that a company must conduct their internal audits each year for every process. I am very curios to get an updated view of this topic based on the new 2016 revision.

4. To solve the CAR, the auditor told us that we need to complete a full audit cycle of all our processes. I am of the mindset that our completed, verified quality plan for the transition is enough. what would you do to resolve the NC or escalate?

TIA - Regork.
I haven't found anyone who can define what a "full audit cycle" is so, to have received a non-conformity against an unspecified "requirement" seems a bit much to me. To force doing a whole QMS audit, when there were only a few changes to ISO 13485, seem "over-reach" to me. With other standards, I've seen the changes audited, which has been acceptable - and makes sense (to me at least).

Secondly, there IS no timeframe for getting audits done. A schedule isn't even a requirement, yet CB auditors demand them. Pack sand, I'd tell them! Your CB MAY have a contractual requirement to do audits annually (or similar), so check that first.

Most transitions need a plan - otherwise how do you know you've "arrived" having addressed the new stuff?

Last edited by AndyN; 16th May 2018 at 03:22 PM.
Thanks to AndyN for your informative Post and/or Attachment!

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