Auditor doesn't like Quality Manual Scope

[Paul Simpson]

Re: Auditor doesn't like scope for Quality Manual?

Hi all,

I've submitted my quality manual to the registrar for document review, and he doesn't like the scope. The Scope is as follows:

xxxxxxxxx, Inc. (hereinafter referred to as xxxx) has developed and implemented a quality management system to better satisfy the needs of our customers and to improve management and profitability of the company. The quality system complies with the technical specification ISO 9001:2000, with the exception Element 7.3, Design and Development. The system covers the production and delivery of the company’s machined components and related products.

The purpose of this manual is to define and describe the quality system and to provide the basis for quality assurance procedures for all activities comprising the quality system.

An additional purpose of this manual is to present the quality system to customers and to inform them what specific controls are implemented to assure product quality.

It has been decided by XXXX, that Element 7.3, Design and Development does not apply to the company due to the fact that XXXX is not design-responsible. Therefore, this section is not addressed in the Quality Manual


The auditor's response to this was: ISO 9001-2000, Clause 4.2.2.a –
The manual lacks a Scope Statement, defining which location(s) are addressed by the manual, and what (if any) exclusions, with justifications, are being claimed by the organization.

I'm confused as to what he means by this, especially the part about the "locations"? Any ideas? Suggestions?

Thanks!
Jonell

As far as I am concerned you have defined the scope very clearly. S/he is obviously putting their own interpretation on the standard. There is no requirement for you to write the word "Scope" in your manual. Your exclusions are clear and (from this distance) justified.

There is no requirement in ISO for anything to do with locations - although it may be that in defining the scope of your system you might refer to one or more locations.

Tell your registrar to go back and read the standard and then re-read your manual.

In the words of a very wise man - "Show me the shall!"

 

[AndyN]

I don't like the scope statement either, and I don't like your auditor's findings too..........

In general terms, I believe short and sweet does it. What's on your certificate (if you have one) or would go on it, is the 'scope' you're looking for. It took me a couple of readings to get to the fact that your company machines components. The rest of the verbiage is, frankly, unecessary 'standard speak'.

Your exclusions statement is O.K, so don't throw that away. But (I'm doing my best Simon Cowell here) I think the rest is boring and unimportant.

Andy

 

[Coury Ferguson]

Everyone has provided good suggestions either positive or negative.

The "Scope" is a simple statement of the type of business you are in. The "exclusion(s)" should be treated as a separate entity, in my opinion.

For example "Scope:" Manufacturing and machining of components parts.

For example "Exclusion:" Our company does not design parts or components and use the customer provided drawings to meet the customer's expectations. Therefore, we exclude section 7.3 as part of our business unit.

These are just my opinions.

 

[qualeety]

here is another example of stupidity...

one department has been iso registered and now the company wants to iso register....instead of keeping two separate QMs, it decided to develop one QM for the company....the company decided to maintain two registrations til 2009...

the troubles started when

1. survelliance audit for the department....the auditors won't accept the company QM, since scope includes the company, not department to be audited
2. registration audit for the company...the auditors won't accept the company QM since it contains the department which was excluded from the audit.

solution - two identical QMs except scope.

I know what iso requires but this is rediculous in my opinion....no wonder few people are pissed off at iso....there is NO common sense... ... but then i heard there is a shortage of common sense everywhere

 

[Jim Wynne]

In my experience, the purpose of a scope declaration is almost always overcomplicated in quality manuals. It should simply tell what and who the quality manual applies to, and declare exclusions--nothing more or less: "This quality manual applies to..." and "Sections x and y of the standard are excluded because..." That's it.

That being said, there is no requirement to declare multiple locations if there are none, and the same applies to exclusions. In the absence of such declarations, it should be assumed that the manual applies to the present location, and that there are no exclusions.

 

[Jonell]

Update to original post

Hi all ,

First of all let me say thank you to everyone who offered opinions/advice. I updated the quality manual to include the physical address of the company, and clearly defined the reason why we were excluding Element 7.3 from our system.

I'm happy to report that the auditor has now approved the manual!



Jonell

 

[SteelMaiden]

good for you, thanks for letting us know how it all turned out.

 

[Claes Gefvenberg]

good for you, thanks for letting us know how it all turned out.

Ditto.

/Claes

 

[Dave Dunn]

Re: Auditor doesn't like scope for Quality Manual?

Tyker

I would not have any problems either, but I have come across some auditors who take the view if you are processing then you have "designed" a process and thus it follows the process must be assessed even if the part is not designed by you.

My response to that would be that everything that is done to realize the customer's product is a process, from raw material receipt to packaging and shipping. While all processes affect the final realized product, none of that processing can change the customer's design specifications that the product is to be made to, so we do not "design" the product.

 

[Paul Simpson]

Re: Auditor doesn't like scope for Quality Manual?

.... I have come across some auditors who take the view if you are processing then you have "designed" a process and thus it follows the process must be assessed even if the part is not designed by you.

There are three issues here:

1. Is control of the design of processes a good thing - without a doubt
2. Is clause 7.3 good practice in applying to process design - this depends on your opinion. IMHO it is a good structure
3. Does ISO 9001 require clause 7.3 to be applied to process design - Answer - No

So your auditors can be thanked for their suggestion and then referred back to the Note in ISO 9001 that says 7.3 "may" be applied to development of processes for producing products / services (i.e. if you wish to)