ISO/AS Surveillance Audit - Minor for not updating my QA Manual to ISO 9001:2008

P

piney

#31
Any revision? It's a bold statement to make! If the ISO 9001 requirements changed in some respect that was an exclusion for the client, would you still say that? e.g Design? Would you 'force' a company to make a change to their manual to say they excluded the new 7.3 requirements? I rather doubt you'd get many takers if that's what you are suggesting by these sweeping statements.

The simple fact is that a manual that (slavishly) addresses each clause and requirement of the standard, with or without an exclusion, has never been a necessity, nor a requirement, neither is it desirable and it is often of little no value to management and only a paradigm that (certain) auditors are compelled to require.....
Where to start with your post... Yes you need to state within your manual if you have any exclusions!

Remember 4.2.2??? "The organization shall establish and maintain a quality manual that includes a)the scope of the quality management system, including details and justification for any exclusions."

If a company chooses to exclude design from their QMS, then the manual needs to state this with justification.
 
Elsmar Forum Sponsor
#32
Where to start with your post... Yes you need to state within your manual if you have any exclusions!

Remember 4.2.2??? "The organization shall establish and maintain a quality manual that includes a)the scope of the quality management system, including details and justification for any exclusions."

If a company chooses to exclude design from their QMS, then the manual needs to state this with justification.
yes, I'm aware of that, naturally. From your posts it seemed to me as if you were intending an organization to have a quality manual that addressed all the requirements (excluded or not) plus, if the requirements changed (which they didn't in 2008) to address those too.

So, are you still saying that a manual must have statements to address the ISO 9001 (version 'X') requirements???
 

Jim Wynne

Staff member
Admin
#33
Where to start with your post... Yes you need to state within your manual if you have any exclusions!

Remember 4.2.2??? "The organization shall establish and maintain a quality manual that includes a)the scope of the quality management system, including details and justification for any exclusions."

If a company chooses to exclude design from their QMS, then the manual needs to state this with justification.
The discussion was not about exclusions.
 
P

piney

#34
The discussion was not about exclusions.
Correct but a serious error was made that needed clarification.

Any revision? It's a bold statement to make! If the ISO 9001 requirements changed in some respect that was an exclusion for the client, would you still say that? e.g Design? Would you 'force' a company to make a change to their manual to say they excluded the new 7.3 requirements? I rather doubt you'd get many takers if that's what you are suggesting by these sweeping statements.

The simple fact is that a manual that (slavishly) addresses each clause and requirement of the standard, with or without an exclusion, has never been a necessity, nor a requirement, neither is it desirable and it is often of little no value to management and only a paradigm that (certain) auditors are compelled to require.....
 

howste

Thaumaturge
Super Moderator
#36
Correct but a serious error was made that needed clarification.
I think you misread what Andy was trying to communicate. Here's what I believe Andy was saying:

1) A manual meets the requirements of ISO 9001:2000 and includes details of and justification for the exclusion of clause 7.3.
2) Hypothetically the ISO 9001 standard was revised to change some requirements in clause 7.3.
3) The manual would not need to be updated to say that it now excludes different requirements in clause 7.3. It would still include the same details of and justification for the exclusion of clause 7.3.
 
P

Polly Pure Bread

#37
Disagree if you'd like, but Jim is right. There are no new requirements in ISO 9001:2008.
Why is it that one of our internal auditors was tagged nonconformity for conducting an internal audit without ISO 9001:2008 trainings, only ISO 9001:2000?
 

howste

Thaumaturge
Super Moderator
#38
Why is it that one of our internal auditors was tagged nonconformity for conducting an internal audit without ISO 9001:2008 trainings, only ISO 9001:2000?
In my opinion, it's because the 3rd party auditor is biased. S/he probably had some training from their CB to the 2008 standard, and so has assumed that everyone else must have training.

There is no explicit requirement for training to the ISO 9001:2008 standard. Auditors need to be competent to audit the requirements, including the clarifications in ISO 9001:2008. How this competence is achieved is left up to your organization.
 
#39
Why is it that one of our internal auditors was tagged nonconformity for conducting an internal audit without ISO 9001:2008 trainings, only ISO 9001:2000?
Because your CB auditor couldn't think of anything better to write an NC for?
Seriously, you should contest it with the CB's management. The auditor is wrong, plain and simple.
 
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