Full QMS Audit and Internal Audit Question

K

ksuresh

#11
Dear All,

We are certified as per ISO 13485:2003, and in to ISO 13485:2016 updation process. Expected recertification audit is in end of this month. As per our MRM calendar we already finished our internal audits and MRM in April-2018. Our internal Audit and MRM frequency once in 6 months. Our next internal audit and MRM is scheduled in OCT-2018. We just started implementing the ISO 13485:2016 from June 2018. To prove our implementation do we need to conduct internal audit before NB audit which is scheduled in End of June-2018..?


Thanks
Suresh
 
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B

BhupinderSinghPawa

#12
Expectation for NB Stage 2 Audit is to have an adequate QMS compliant to 13485:2016, Internal Audit against the full QMS and MRM (preferred to have reviewed IQA results).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#14
We just started implementing the ISO 13485:2016 from June 2018. To prove our implementation do we need to conduct internal audit before NB audit which is scheduled in End of June-2018..?
So, you expect your CB (not NB) to certify your system against a standard that you, yourself DON'T KNOW if you are in compliance with? It is an obvious expectation that, prior to presenting the system for assessment, you should have ascertained internally that the system is in conformance and certifiable. The internal audits and leadership review are, obviously, critical components of the PDCA cycle in a system maintenance context. It is possible that your system is in conformance with the 2016 edition of ISO 13485 already, but don't you think that it makes sense for you to check that, before an external party does? That is conformity assessment 101.
 
B

BhupinderSinghPawa

#15
There is no "stage 2" after being certified... Even upgrades do not require a second "stage 2".
Certainly the Stage 1 and 2 are applicable for initial certification.

The 17021 clause 9.4.1.3 - Recertification audit activities may need to have a stage 1 audit in situations where there have been significant changes to the management system ...

Won't upgrade count as a significant change?

For upgrade I would assume that the prerequisites of fully defined and audited QMS along with Management Review still remains.
 
#16
Since the 3 year period is almost at an end and, to the best of my knowledge, no CB has been doing a stage 1 and stage 2, I'd suspect the answer is "no"...
 
K

ksuresh

#17
Thanks for your guidance, as per your suggestion planning an internal audit to ensure the implementation..
 
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