Audit NonConformance - Evidence of Post Market Vigilance and Product Recall.

C

CK lau

#1
Dear All Cove readers,

M Company just been certified to ISO 13485, however in the surveilace audit, non-conformities were found. One of it is : No evidence sighted for the inclusion of ISO 13485 requirements i.e post market vigilance & product recall etc during the recently concluded IQA exercise.
Can someone comment on this and how to show evidence in this aspect?

Thx.:cool:
 
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Ajit Basrur

Staff member
Admin
#3
Hi CK,

In addition to Harry's great inputs, I am attaching a GHTF document, Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy for your info.

Compliance to section 8.5.1 on Product Recalls should be demonstrated by having a documented procedure and if at all there were recalls in the past, the related documentation.

During IQA, performing dummy product recalls are best examples. You could also demonstrate the product traceabaility along with documents like Device History Record, both backwards (from finished products to raw materials) or forwards (raw materials to finished products).

Hope this clarifies.
 
C

CK lau

#4
Dear Cove readers,

Thank you so much for the most valuable information.

In our QMS iso 13485:2003, we have procedures as follow:
1. Identification and traceability Procedure
2. Control of NC Product Procedure
3. Handling Customer Complaint Procedure
4. Feebdack Procedure( Customer survey)
5. Risk Assessment Procedure (FMEA)
6. NC Product Return Authorization Procedure
7. Advisory Notices Issuance and Implementation Procedure

But the product recall and post market vigilance have not been mentioned.

From your experience, where or which is the best procedure that I can insert these requirements? :nopity:

Thank you!:thanx:
 

Ajit Basrur

Staff member
Admin
#5
Dear Cove readers,

Thank you so much for the most valuable information.

In our QMS iso 13485:2003, we have procedures as follow:
1. Identification and traceability Procedure
2. Control of NC Product Procedure
3. Handling Customer Complaint Procedure
4. Feebdack Procedure( Customer survey)
5. Risk Assessment Procedure (FMEA)
6. NC Product Return Authorization Procedure
7. Advisory Notices Issuance and Implementation Procedure

But the product recall and post market vigilance have not been mentioned.

From your experience, where or which is the best procedure that I can insert these requirements? :nopity:

Thank you!:thanx:
My :2cents:

You could combine "Handling Customer Complaint" and "Advisory Notices" as they are related and could have a new procedure for "product recall and post market vigilance"
 
R

Roland Cooke

#6
Vigilance procedures vary from country to country. Make sure you have specified how things work for each of the markets into which you sell.



A piece of advice for all - the revised MEDDEV on vigilance came into effect at the beginning of 2008; there are some significant changes. Little mercy will shown by Notified Bodies to manufacturers that haven't updated their procedures accordingly!
 
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