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ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach?

Q

QA compliance

#1
I am re-doing our QMS documents to add a common system with our sister companies. Is it better for the company to write the procedures using a process approach vs a compliance approach? Many of our SOP's should be work instructions and visa versa. (I have recently taken this over)
I have always done the compliance approach, but from what I am reading, the company is actually better protected using a process approach.
Thoughts?
 
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DannyK

Trusted Information Resource
#2
Re: ISO 13485, ISO 9001 QMS and FDA reqmts.

I am re-doing our QMS documents to add a common system with our sister companies. Is it better for the company to write the procedures using a process approach vs a compliance approach? Many of our SOP's should be work instructions and visa versa. (I have recently taken this over)
I have always done the compliance approach, but from what I am reading, the company is actually better protected using a process approach.
Thoughts?
Your company's documents are for the people that work in the company and have to use the documents. Do what is best for them.

You should follow the process approach when performing internal audits. That does not mean that the documents should follow the process approach.
 
Last edited:

sagai

Quite Involved in Discussions
#3
this is one of my favourite.
I only would warn you not to confuse between documented process and documented procedure.
Process and procedure are NOT the same.
Standards and regulations are mostly requires documented procedure, which can not be the documented process.
Reason is simple, the process defined with its inputs and outputs, on the other hand, procedure are almost equal with work instruction, describing how to do something, not what are the inputs and outputs only.
br
Sz.
 
Q

QA compliance

#4
Thank you, Sagai!
I meant that I had always written to the standard and added extra required per company after that. I wondered if it would be better to first write our core processes as our main SOP's and go from there.
 

sagai

Quite Involved in Discussions
#5
:eek:
u do not have to write process definition, when it is not required by standard, or regulation, or there is no special request for that from your management.
:eek:
:notme:
Sz.
 
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