Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste?

R

RAQABJM

#1
We just had our first stage I and our auditor seemed to find a large issue with the fact we are using a separate document to specifically reference our documented procedures. In the QM we reference this document and say all the documented procedures are referenced in this table. This document is a table which has the clause number and title of each section of ISO 13485:2003 and the procedures we have established for each section. Does this not meet what would be accepted as referenced? I considered putting the table as an appendix but we are a newer company and every time I add a procedure I would need to update my QM.

Overall, our auditor made it seem we had to literally copy and paste the standard into a document we call "Quality Manual" and put our name on it and label next to each section the procedures we have documented for that section. In fact, he told me to plagiarize and copy and paste the standard as much as I could. I have seen examples of this but I don't see this as a way to create a document that will actually be read in my organization, let alone, something that will be followed.

I'm fairly new to ISO, but I have some pretty good FDA background, and FDA always seemed to be much more of the mindset of "if you have it in some reasonable form then you're good." Is this not the way it is with ISO? or is it just this auditor?

Thank you for any and all help!
 
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somashekar

Staff member
Admin
#2
We just had our first stage I and our auditor seemed to find a large issue with the fact we are using a separate document to specifically reference our documented procedures. In the QM we reference this document and say all the documented procedures are referenced in this table. This document is a table which has the clause number and title of each section of ISO 13485:2003 and the procedures we have established for each section. Does this not meet what would be accepted as referenced? I considered putting the table as an appendix but we are a newer company and every time I add a procedure I would need to update my QM.

Overall, our auditor made it seem we had to literally copy and paste the standard into a document we call "Quality Manual" and put our name on it and label next to each section the procedures we have documented for that section. In fact, he told me to plagiarize and copy and paste the standard as much as I could. I have seen examples of this but I don't see this as a way to create a document that will actually be read in my organization, let alone, something that will be followed.

I'm fairly new to ISO, but I have some pretty good FDA background, and FDA always seemed to be much more of the mindset of "if you have it in some reasonable form then you're good." Is this not the way it is with ISO? or is it just this auditor?

Thank you for any and all help!
I am sorry to note that you are with some CB and they have such auditors as you describe. You are on the right track about referencing and before you go into stage 2 and get further stuck with the CB, escalate the matter and see if you can go with some reputed ISO13485 CB.
Please note that all your procedures that are under document control may not align to the ISO13485 clauses. Please also list them.
 
R

RAQABJM

#3
Thank you for the input Somashekar. I didn't think we were being unreasonable in our interpretation of this and it seems you agree with me. For procedures which didn't align with an ISO 13485 clause we put them in the bottom of the table and made sure everything was included.

We will escalate this issue with our CB and see how it goes.

Thank you
 

Marcelo

Inactive Registered Visitor
#4
Overall, our auditor made it seem we had to literally copy and paste the standard into a document we call "Quality Manual" and put our name on it and label next to each section the procedures we have documented for that section. In fact, he told me to plagiarize and copy and paste the standard as much as I could.
Bad auditor (there are many of those).

Your solution seems ok.

I'm fairly new to ISO, but I have some pretty good FDA background, and FDA always seemed to be much more of the mindset of "if you have it in some reasonable form then you're good." Is this not the way it is with ISO? or is it just this auditor?
The bad auditor. ISO in fact is more open-minded than the FDA requirements.
 
R

RAQABJM

#5
Thanks for the input Marcelo. This make me feel better about the work my company has done.

I may talk to the CB about switching auditors and if that doesn't work then maybe switch to a different CB, although that may be too expensive.
 

Marcelo

Inactive Registered Visitor
#6
I may talk to the CB about switching auditors and if that doesn't work then maybe switch to a different CB, although that may be too expensive.
Bad auditors or CBs can be much more expensive than anything due to their weird/wrong views :p
 
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