Objectives of Internal Audit 8.2.2 (a) - Explanation needed in plain English!!

G

gspyrou

#11
I'm not sure you need to! An internal audit shouldn't be addressing - directly - the requirements of the ISO standard. The scope, criteria etc should be your organizations qms - those planned arrangements - not anything that ISO 9001 (13485 etc) states...

A clue is that if you find yourself having to interpret 'Iso-speak' there's something wrong!
Thanks for your reply.

I have the feeling that simply preparing a checklist and verifying whether practices of the company conform with what is written in QMS without referring/explaining to the auditee, during the opening meeting of the internal audit, the purpose/objectives of the audit (those required by ISO 8.2.2 and maybe any additional ones required by the company) is not the right approach.

I am of the opinion that the internal auditor should be in a position to briefly elaborate on the internal audit purposes/objectives as required by ISO 8.2.2.

In addition one of the requirements of ISO 8.2.2 is to determine conformity of the QMS with the ISO standard. When auditing the Internal Audit process it may be therefore required to explain how the ISO 8.2.2 requirement " to determine whether the QMS conforms with the planned arrangement" was addressed. If one is not able to define and understand exactly the meaning of "planned arrangements", how can he properly deal with this requirement and provide evidence of conformity.

May be I am looking into too much detail because I have not been dealing with ISO too long !! I simply like get the "Root Meaning" of standards (whether ISO, Accounting or any other standares) and not an approximate understanding.

Thanks once again
 
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#12
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J

JaneB

#13
Planned arrangements are all the arrangements made by the company to meet the requirements of the external and internal parties that directly affect or are affected by the company such as, clients, suppliers, regulatory bodies, management etc. They include agreements, contracts, proposals, laws, regulations policies, strategies, objectives e.t.c., and the prescriptive and descriptive documents derived therefrom. The audit establishes whether the QMS has been designed and includes all the necessary processes to implement and meet those requirements.
True, but as Andy says (my bolding added):

I'm not sure you need to! An internal audit shouldn't be addressing - directly - the requirements of the ISO standard. The scope, criteria etc should be your organization's qms - those planned arrangements - not anything that ISO 9001 (13485 etc) states...

A clue is that if you find yourself having to interpret 'Iso-speak' there's something wrong!
Exactamundo, Andy!

Example: suppose your organisation says that a department is to have departmental objectives/KPIs/what-have-you. If I were internally auditing, I'd need to know them/ask to see those and look for evidence that they're being applied and used. That might be as simple as regular reports to the GM (say), or a reference in dept meeting minutes. Boom - that's it.

Don't make too big a meal of it - the example clause you quote is something an external auditor will have in mind the whole time during, say a certification audit, and will find evidence in multiple areas that demonstrates it is so. But it ins't something you should be laboriously attempting to audit for in every internal audit.
 
J

JaneB

#15
I have the feeling that simply preparing a checklist and verifying whether practices of the company conform with what is written in QMS without referring/explaining to the auditee, during the opening meeting of the internal audit, the purpose/objectives of the audit (those required by ISO 8.2.2 and maybe any additional ones required by the company) is not the right approach.

I am of the opinion that the internal auditor should be in a position to briefly elaborate on the internal audit purposes/objectives as required by ISO 8.2.2.
Re. simply preparing a checklist and then verifying... well, no perhaps not. But depends on what kind of 'checklist' you're referring to, whether it's a good audit plan (the sorts of questions you plan to ask) or one of those silly 'paint by numbers' things.

Also, re an 'opening meeting' - that's a formal requirement for external auditors, and with good reason. For internal audits, it may often not be necessary, particularly if they're accustomed to the system and process. Or the background info (here's why I'm here & what I plan to do) can be covered very briefly in a minute or two.

There are big differences between internal audits and external audits, with reason. Different scopes, different purposes, different contexts, etc. Don't confuse the two, or try to model your internal audits on those done by external auditors. Bad idea! :nope:
 
A

Adam S

#16
An internal audit shouldn't be addressing - directly - the requirements of the ISO standard. The scope, criteria etc should be your organizations qms - those planned arrangements - not anything that ISO 9001 (13485 etc) states...!
I have a question about this - does't the statement

"...Determine whether the QMS:

a) conforms to the planned arrangements (7.1), to the requirements of this International Standard and to the QMS requirements..."

direct a company's Internal Audits to ensure that the requirements of this ISO standard are met by the Company's QMS?




The Internal Audits at my Company (Medical Device manufacturer) seek to establish the conformance of the company activity with:
- the QMS itself
- ISO 13485
- FDA 820 and other Regulatory bodies



This makes for rather messy audits. If there's room for us not to confirm conformance with ISO, I'd like to understand it
 
#17
I have a question about this - does't the statement

"...Determine whether the QMS:

a) conforms to the planned arrangements (7.1), to the requirements of this International Standard and to the QMS requirements..."

direct a company's Internal Audits to ensure that the requirements of this ISO standard are met by the Company's QMS?




The Internal Audits at my Company (Medical Device manufacturer) seek to establish the conformance of the company activity with:
- the QMS itself
- ISO 13485
- FDA 820 and other Regulatory bodies



This makes for rather messy audits. If there's room for us not to confirm conformance with ISO, I'd like to understand it
Good point, Adam! The fact is that many internal auditors only focus on the ISO requirements - after all that's (often) what they were taught in the (Lead) Auditor course they attended!:mg::notme:

In a nutshell, it the management system (of process) has been design and constructed to meet ISO requirements, and an internal auditor discovers no-conformity with that system, it will be non-conforming to the ISO requirements, won't it?
 
R

Richard Pike

#18
Re: Internal Audit ISO elem 8.2.2 (a) - Interpreatation needed in plain English!!

Many thanks for your explanation.

I was actully hoping to receive from someone a specific interpretation for each of these 2 requirements of ISO 9001 element 8.2.2.

I guess I did not phrase my post title accurately. I therefore changed it accordingly.

Thanks once again
Welcome

Dare I suggest that you first state what YOU expect to GET OUT of Internal Audits. Not in plain English, but in your English.

From there you can modify your expectations based on the advice you receive. Internal Auditing will then be 'owned" by you and not implemented to comply with whatever. It will be your document with the resultant accountability.

I suggest that if you do this; you will meet your own expectations and concurrently meet the requirements of the applicable standard.

Keep it simple - in your language - what do I want from Internal Audits - answer that honestly - and you are likely to meet the standards requirements - even if you have never read them.
 
A

Adam S

#19
Good point, Adam! The fact is that many internal auditors only focus on the ISO requirements - after all that's (often) what they were taught in the (Lead) Auditor course they attended!:mg::notme:

In a nutshell, it the management system (of process) has been design and constructed to meet ISO requirements, and an internal auditor discovers no-conformity with that system, it will be non-conforming to the ISO requirements, won't it?
Makes sense, yes :)

Our notified body audits ensure our QMS is on track as regards ISO and our internal audits ensure our QMS is in action. If we bear this in mind we can perhaps save time and energy looking so hard to tie internal audits into ISO
 
R

Richard Pike

#20
Makes sense, yes :)

Our notified body audits ensure our QMS is on track as regards ISO and our internal audits ensure our QMS is in action. If we bear this in mind we can perhaps save time and energy looking so hard to tie internal audits into ISO
I think that if the QMS itself ties itself somehow (x refer or whatever) into the Standard, then quite correctly the Internal Audit can concentrate on its own system effectiveness.

Perhaps with the exception of where the QMS has recently changed, where the Internal Audit would want to verify that such change/s still meet their purpose. That would however be identified in the SCOPE of the Internal Audit.
 
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