Quality objectives - must they include CAPA and internal audit topic?

psp1234

Involved In Discussions
#1
Hi all,
Just finished hosting an ISO 13485:2016 audit with a registrar. :bonk:
The auditor wrote a non-conformance for not having quality objectives in the "CAPA" and "internal audit" areas (although these topics were presented in the management review).
Is it mandatory to have these objectives??

I was puzzled...

please advise

Sue
 
Elsmar Forum Sponsor
#2
Hi all,
Just finished hosting an ISO 13485:2016 audit with a registrar. :bonk:
The auditor wrote a non-conformance for not having quality objectives in the "CAPA" and "internal audit" areas (although these topics were presented in the management review).
Is it mandatory to have these objectives??

I was puzzled...

please advise

Sue
The auditor is asking for things which are, clearly, not required. Can you post the exact wording and the requirements of ISO 13485 being cited for the NC?
 

psp1234

Involved In Discussions
#5
Hi all,
I am so excited by the fast response, thank you!!

this is the cite of the auditor's non-con:

(b) Statement of Nonconformity:
The Doc 8.4 OP-01 Rev 10, Analysis of Data defines the requirements for establishing Quality Objectives and monitoring them for performance. The current list of Quality Objectives included objectives in 13 defined areas, and each was accompanied by a measurable target and planned monitoring interval. Numerous appropriate objectives and reporting metrics were established, including for complaints, customer satisfaction, conformity to product requirements, and suppliers, but there was no evidence that quality performance objectives were established for CAPA or Internal Audit processes, both which are key quality system processes whose performance must be reported at Management Review


I didn't see the requirement in the 13485 either...not sure why this is a non-con. ..and the items were shown in management review.

Thanks for your help,
Sue
 

psp1234

Involved In Discussions
#6
oh and this is the clasue cited:
(a) Applicable Standard(s) & respective Clause No.: ENISO 13485:2016
Clause 8.4 Analysis of data - The organization shall document procedures to determine, collect and analyze appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system. The procedures shall include determination of appropriate methods, including statistical techniques and the extent of their use. Relevant sources and include, at a minimum, input from: (a) feedback; (b) conformity to product requirements;
(c) characteristics and trends of processes and product, including opportunities for improvement; (d) suppliers; (e) audits; (f) service reports, as appropriate.
 
#7
Hi all,
I am so excited by the fast response, thank you!!

this is the cite of the auditor's non-con:

(b) Statement of Nonconformity:
The Doc 8.4 OP-01 Rev 10, Analysis of Data defines the requirements for establishing Quality Objectives and monitoring them for performance. The current list of Quality Objectives included objectives in 13 defined areas, and each was accompanied by a measurable target and planned monitoring interval. Numerous appropriate objectives and reporting metrics were established, including for complaints, customer satisfaction, conformity to product requirements, and suppliers, but there was no evidence that quality performance objectives were established for CAPA or Internal Audit processes, both which are key quality system processes whose performance must be reported at Management Review


I didn't see the requirement in the 13485 either...not sure why this is a non-con. ..and the items were shown in management review.

Thanks for your help,
Sue
A clue lies in the fact that both internal audits and corrective action requirements can be found in areas of the standard to do with measuring/monitoring etc. You should contact your CB and tell them this is non-conformity is incorrect. The Quality Objectives are applicable to the PRODUCT related processes (which is the focus of the standard) and NOT for everything else. If it were, document and records control, calibration etc should all have been cited too.

You should also tell your CB that you don't want that particular auditor to return UNTIL your CB can demonstrate COMPETENCY in understanding ISO 13485 requirements...
 

psp1234

Involved In Discussions
#8
Thanks Andy!
Do any of you have experience in contesting auditor's findings? would the registrar back them up or be open to "second opinion"?

Sue
 
#9
Thanks Andy!
Do any of you have experience in contesting auditor's findings? would the registrar back them up or be open to "second opinion"?

Sue
Many here do push back. Rarely, in my experience, does the CB act as anything but a second opinion and frequently side with the client. I only wish more would push back instead of taking the "easy route", keeping quiet, thus allowing the auditor to perpetuate a trail of "busy work"...
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#10
Every registrar has a mechanism for disputing findings. It should be in the audit report and a good auditor would have told you how to do this. Or go to their general help line for guidance.

Please do dispute it. Like Andy says too many "suck it up" and deal with it as-is. I'm guilty of that in my past too and it caused more work than necessary for the organization
 
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