Audit Checklist for ISO 13485:2016

A

al40

Quite Involved in Discussions
Does anybody have a checklist I could use?
Thanks Al40
 
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R

randomname

I never understand the rationale for this question. The checklist is the standard. Simply evaluate whether each "shall" is being met. Put a question mark at the end of each sentence. ...
 
A

al40

Quite Involved in Discussions
Yes,
I know I am trying to put together a presentation and wanted to show an example of an checklist.
Thanks,
AL40
 
S

Sunny1

Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?

Thanks ( new to this so be gentle :) )
 
Sidney Vianna

Sidney Vianna

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Sunny1 said:
Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?
Click to expand...
Nobody here saw the internal audit checklist you are referring to, because, as implied, is internal to an organization.

What kind of business is it? A distributor? If so, 7.5 would still apply, but 7.6 might be a justifiable "exclusion".
 
A

AndyN

Moved On
Sunny1 said:
Hi does anyone know why the Internal Audit checklist for ISO 13485-2016 does not have clause 7.5 and 7.6?

Thanks ( new to this so be gentle :) )
Click to expand...

Because they forgot to add it? Anything which comes from the internet, from an unqualified source has to be treated with extreme caution. As others have stated, internal audits shouldn't be done to the ISO 13485 standard as the (only) criterion...
 
W

Wolf.K

Quite Involved in Discussions
The best thing is always to create your own checklist. You need to know the differences to 13485:2003 anyway. Just get the last version of the standard, prepare a table with corresponding headlines, and just rephrase the sentences of the standard as questions. You can use the list posted in this thread as a starting point and just update it corresponding to the new version. Then you will learn the differences. This just takes two or three days.
 
R

RichardV

I don't have a copy of the new standard and was curious as to if it contains the clause 9 and 10 like 9001?
 
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