Periodic Quality Manual and Procedure Review Requirements

T

TrishDish

#1
Hi everyone, this is my first post since signing up so please bear with me. I probably don't have this question in the correct 'thread' but didn't see a better place.

I am new to my company (we are ISO 9001 registered) and I am looking for others' thoughts and recommendations concerning evidence of periodic review (e.g., annually) of your quality manual and procedures. Should a company be able to provide objective evidence of periodic review by nature of a form, appendix to each document, etc.? Otherwise how do you prove that you've done the review? I know if your manual and/or procedures say you do a periodic review you've got to provide the evidence but if your documents don't say you do it do you think it will be questioned in a 3rd party audit?
Thank you in advance for your thoughts on this subject.
 
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P

Pudge 72

#2
Re: Periodic QM and Procedure Review

I would make sure that what you are describing is included in my Internal Auditing program. When you use the cascade approach to auditing, you are basically starting with the standard, reffering to the Quality Manual, filtering down to the Procedure, and reviewing associated work instructions for whatever particular process that it is you are auditing. Essentially, you are constantly reviewing the documents that you mentioned specific to the element and the standard. The biggest benefit of course is that the results of the audit are documented - so, you always have the objective evidence that this "review" was completed as well as the results and findings of conformance and effectiveness. Your specific document or procedure numbers and revisions will be listed within the body of the audit report - easy for an auditor to see that it actually took place.

Hope that helps.
 

sagai

Quite Involved in Discussions
#3
Re: Periodic QM and Procedure Review

Hi Trish,
internal audit (8.2.2) and management review (5.6) responsible for that with documented results and planned follow ups.
br
Sz.
 

qusys

Trusted Information Resource
#4
Re: Periodic QM and Procedure Review

Hi everyone, this is my first post since signing up so please bear with me. I probably don't have this question in the correct 'thread' but didn't see a better place.

I am new to my company (we are ISO 9001 registered) and I am looking for others' thoughts and recommendations concerning evidence of periodic review (e.g., annually) of your quality manual and procedures. Should a company be able to provide objective evidence of periodic review by nature of a form, appendix to each document, etc.? Otherwise how do you prove that you've done the review? I know if your manual and/or procedures say you do a periodic review you've got to provide the evidence but if your documents don't say you do it do you think it will be questioned in a 3rd party audit?
Thank you in advance for your thoughts on this subject.
Hi TrishDish,
welcome in the forum and nice to meet you.
What you say shall be included in the mandatory procedure for the documentation control, as per related ISO 9001 clause.
Clearly it is up to the organization to establish how to meet the requirement to provide review. For example, some organizations that I visited as a quality auditor set a periodical review of the quality documentation ( I intend procedures and work instruction) each two years at a minimum, if in the meantime no modification were done to the document.
They use to put again the procedure in the approval workflow and update the revision history putting the comment "periodical biennial review", also updating the revision in the template as well as the revision date .
THere are also some electronic document mgmt software that remembers the due date coming to the expiration for each procedure, otherwise you should create a list of all quality documentation and procedures and setting a reminder for reviewing on outlook calendar for each procedure owner.
Hope this helps
see you and let us know:bigwave:
 
Last edited:
T

TrishDish

#5
Re: Periodic QM and Procedure Review

This is exactly what I was looking for! Thank you so much for your help.
 
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