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Audit of essential QMS processes

G

glenn0004

#1
Audit of essential QMS processes
Over the past 12 months we have undertaken a programme of System Audits across all departments who are involved within the process of product realization. Our system audits are designed to account for ISO 9001 and I4001 requirements and how the department is accommodating the stated requirements. This includes, Document Control, Record Control, Non-Conformance, Corrective and Preventative Actions and Internal Audit, in effect we are auditing the net results of the six required procedures, within all other requirements.
During our external surveillance audit we pick-up a minor NC for not auditing all of the QMS i.e. we hadn't directly audited our Document Control Process. Our past approach to internal audit has never directly audited Document Control and has always audited the net results.
Does our approach meet the requirements of the standard or will we have to make arrangements for an un-associated person(s) to directly audit the big six?
 
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dsanabria

Quite Involved in Discussions
#2
If you could demonstrate that the results of Document control

"A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose."

were audited during the process then you have reason to appeal the ncr to the registrar. If not, then added to the processes for all your processes.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
I agree with dsanabria.

I do agree with sampling documents in the process of auditing all over the site where controlled documents are used. That can help ensure you're not missing a place where controls fall apart.

But there's an expectation that the entire standard gets audited. Demonstrating the support process's coverage as samples in process audits might be easier if a table is used in which the auditor could check off that a) through f) were addressed with the sample. I do this for Management Review too, especially where different clauses are covered in different meeting venues.
 
G

GoKats78

#4
We don't have Document Control identified as a process. Never been questioned by an auditor as to why not.

Document control happens across all processes and is audited as part of those audits. It is my long-help opinion that is NOT a process.
 

dsanabria

Quite Involved in Discussions
#5
We don't have Document Control identified as a process. Never been questioned by an auditor as to why not.

Document control happens across all processes and is audited as part of those audits. It is my long-help opinion that is NOT a process.
You are correct - this is why competent auditors will not ask you for it - documents are there to support the process and it is / should be audited as part of the processes by internal and external auditors.
 
#6
Audit of essential QMS processes
Over the past 12 months we have undertaken a programme of System Audits across all departments who are involved within the process of product realization. Our system audits are designed to account for ISO 9001 and I4001 requirements and how the department is accommodating the stated requirements. This includes, Document Control, Record Control, Non-Conformance, Corrective and Preventative Actions and Internal Audit, in effect we are auditing the net results of the six required procedures, within all other requirements.
During our external surveillance audit we pick-up a minor NC for not auditing all of the QMS i.e. we hadn't directly audited our Document Control Process. Our past approach to internal audit has never directly audited Document Control and has always audited the net results.
Does our approach meet the requirements of the standard or will we have to make arrangements for an un-associated person(s) to directly audit the big six?
Your auditor is making up requirements and has no clue about process based audits of a management system. Reject the nc back the the CB management and tell them you don't expect to have the same auditor back.
 

RoxaneB

Super Moderator
Super Moderator
#7
The way doc control was assessed at our organization was the individual departments to conformance to our documented doc control process...and the "owner" of the doc control process was assessed on the appropriateness of the doc control process.

It was two ways of looking at the process...(1) Are people following the process? (2) Is the established process appropriate?

I'm wondering if this is the approach taken by your auditor.
 
S

SmallBizDave

#9
I'm always looking for ways to protect myself from bad auditors without expending any effort. When I create my audit scripts I note the reference for each question as to what section of the standard and what section of the QMS procedures is covered. For example, if I am checking a management review record for required outputs, that question addresses items in section 5 as well as 4.2.4 since it's a record. The record has to be legible, controlled, etc. as well as containing the right information.

There is no standalone Record Control audit but there are questions covering section 4.2.4 (and 4.2.3) scattered through all process audits. So when the auditor wants to see that I have audited records control I can provide traceability to a series of scattered questions proving its been covered. It's not in the format they like but it is certainly compliant.
 

John Broomfield

Staff member
Super Moderator
#10
I agree with Dave's approach.

When process auditing you bring any applicable clause to bear on reporting the effectiveness of the process, and how well it is served by the system while making sure the audit fulfills its objective.

The idea of conducting a separate document control audit is laughable.

John
 
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