EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances

J

Jnks_Meddev

#1
Hello Everyone,

I have a questions - We recently had a audit for ISO recertification and product registration. We had 10 minor conformities and the notified bodies informed us that we have demonstrated the capabilities needed to apply for Annex II conformity assessment route. So this will enable us to release our products to EU with same technology and same clinical application without requiring the "notified body" to release thus reducing product launch timelines.

Can someone help me understand how this works? I'm new to RA on associate level but trying to understand the process. Any advice/suggestion is appreciated.

Thanks!
 

yodon

Staff member
Super Moderator
#2
If I understand, there are multiple routes. The Annex II route is to have a certified quality management system and so you can claim conformance to that essential requirement. In the Annex III route, the NB does sampling of your product (each batch / lot, I think) before you can release.

I think that's what they're getting at. Hopefully someone else can weigh in if I'm off base.
 

Jean_B

Trusted Information Resource
#3
It's still contingent on more information then you provided, but with no major non-conformities and accepted corrective action plans on all of your minors they can provisionally grant you the (upgraded) EN ISO 13485:2016 certificate which stands in for the MDD annex 2 'full quality system' (when meeting the deviations given in the accompanying annex of the europan version of the standard). You'll need to keep them updated and resolve the audit non-conformities within (usually) 6 months, and they'll check whether you resolved the non-conformities to their satisfaction at your next audit with them.
It's conditional on conditional though, and if you do not adequately address some minors within 6 months those might escalate to major non-conformities at that time.
 
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