Preparing an audit plan for ISO 13485, MDD and CMDR for medical imaging company

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Marc

Marc

Fully vaccinated are you?
Leader
#2
#2
I'm assuming this is the first time you've done a combined systems audit? Do let us know how it turns out and any problems you encounter.
 
A

arios

#3
#3
I have done combined audits of 13485 with MDD and CMDR. It is not much of a problem, but it is important to indicate in your agenda where you will be expected to integrate regulatory questions into the QMS questions. E.g. in the Section for complaint handling, and adverse event reporting. Also particular questions may need to be made when it comes to reviews risk management, labeling requirements, content of Technical file, etc.
 
Marc

Marc

Fully vaccinated are you?
Leader
#5
#5
You'll probably want to ask what to include in the technical file in a forum post rather than in a blog.
 
G

Guest

#7
#7
We just went through a Stage 1 assessment for ISO 13485,... the question came up, that is...
Q: do all the elements in the QMS Manuel have to have a Quality Procedure... such as 5.0 thru 5.5.3 (11) in all. or can you just refer to QOP 5.6 (that one has a QOP)
 
Y

yana prus

#9
#9
ht2el;bt1015 said:
We just went through a Stage 1 assessment for ISO 13485,... the question came up, that is...
Q: do all the elements in the QMS Manuel have to have a Quality Procedure... such as 5.0 thru 5.5.3 (11) in all. or can you just refer to QOP 5.6 (that one has a QOP)
Click to expand...
First, you need to decide for each element, if it is applicable or not for your quality system. If not, you need to justify it. Once it is applicable, if there is a requirement in the standard to have a procedure in place, you should create a procedure. Otherwise it would be a major NC.

Good Luck,

Yana
 
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