ISO 13485 Certification - Internal Audit Program Required

#11
Rooster - no intention to "serve" (like a summons to appear in court, right?) but to "serve" in terms of setting the record straight rather then common "mythology". Many people have "heard", often because of what auditors have "interpreted" (read guessed) as a requirement, and that has become fact (in their minds) - so much so, that I wrote a book about them!

If your procedure says you use such a sheet - that's cool. Once again, I was hoping to differentiate for other readers that there's a big difference between auditors who ask for such a thing, when it's their "bias", auditors who understand your procedure and check to see if you comply and those who just don't get it!
 
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nmquality

#12
This is my first time using the Elsmar FORUM for help.

I am wondering if anyone had gone through BSI assessment and already created BSI Corrective Action submission FORM - which list the company response to BSI nonconformities (NCNS) that were issued during BSI assessment visits.

BSI provided the company with a presentation on how and what to include in a corrective action FORM but l like to see an example or template that I can use to address our correction action. Please let me know if anyone went through that and agree to share the FORM or template with me. I will be greatly appreciated.
 

Helmut Jilling

Auditor / Consultant
#13
This is my first time using the Elsmar FORUM for help.

I am wondering if anyone had gone through BSI assessment and already created BSI Corrective Action submission FORM - which list the company response to BSI nonconformities (NCNS) that were issued during BSI assessment visits.

BSI provided the company with a presentation on how and what to include in a corrective action FORM but l like to see an example or template that I can use to address our correction action. Please let me know if anyone went through that and agree to share the FORM or template with me. I will be greatly appreciated.
There are many examples of corrective action forms in the forms section, here on this forum. Look for CAR, CAPA, Corrective Action, 8D....and you should find a number of samples, some good, some not so good...
 
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