Quality Assurance Exclusions- Writing my department's Quality Manual

[Wes Bucey]

I have a hunch we are dealing with an organization that provides internal auditors to other organizations on a contract basis for organizations which choose (for any of a number of valid reasons) not to perform internal audits with its own employees.

I think of these kind of services as valuable in much the same way as grocery and department stores hire outside contractors to perform inventory audits.

If this is the case, the poster's organization would only have purchasing associated with its services if it, in turn, were hiring independent contractors to perform the internal auditing of other companies (think of registrars which hire independent contractors as auditors for registration purposes.}

I hope the original poster will confirm or deny this interpretation.

 

[Al Rosen]

I have a hunch we are dealing with an organization that provides internal auditors to other organizations on a contract basis for organizations which choose (for any of a number of valid reasons) not to perform internal audits with its own employees.

I think of these kind of services as valuable in much the same way as grocery and department stores hire outside contractors to perform inventory audits.

If this is the case, the poster's organization would only have purchasing associated with its services if it, in turn, were hiring independent contractors to perform the internal auditing of other companies (think of registrars which hire independent contractors as auditors for registration purposes.}

I hope the original poster will confirm or deny this interpretation.

 

[D.Scott]

Dave, my initial take was to agree with you, but as we're ISO/TS registered and my approach is colored by that I double checked the ISO 9001 standard. For ISO 9001:2000, the requirement is 1.2: "Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

So yes, 7.5.4 can be excluded. In general, though your registrar and auditor will want to see some justification as to why you are excluding that part of the standard.

Rich - maybe a little more about your business - for me, it's a stretch to drop out purchasing as it sounds like you want to in your first post. Don't forget product is not just a physical entity, it can be a service.

Kevin, I think you are reading the ISO9001:2000 part of 1.2. Turn the page and read the additional TS text.

My brain is mushy this morning so I can't find what I'm looking for but maybe someone else can jump in to help. Somewhere there is a statement that if exclusions are made to section 7, no certification can be made to conformity of the QMS. Maybe as the day goes on I will find what I'm looking for but it sounds like it may be a moot point anyway once Rick further describes his company.

Dave

 

[Kevin H]

Dave - absolutely I'm going with the ISO requirement - as this is posted in the ISO forum, and not the ISO/TS 16949 one, those are the requirements I was using. If it's TS, the only section that can be excluded is product design - 7.3.

 

[D.Scott]

I agree then Kevin. Thanks for your clarification.

I wish I could find the statement I referred to :>)

Dave

 

[Al Rosen]

Al, are you sure about the 7.5.4 exclusion? I was under the impression that the only exclusions allowable were in 7.3 and then only when the company is not responsible for product design and development. See: 1.2 Application.

Dave

Yes! What Kevin said.

 

[sal881vw]

Hello all,
Maybe this site will help

https://isotc.iso.org/livelink/livelink/3554792/1.2Application.doc?func=doc.Fetch&nodeid=3554792

 

[D.Scott]

Thank you. Now I can relax my mushy brain.

Dave

 

[sal881vw]

You're welcome........

 

[Rich 1123]

Hello All,

Sorry I haven't been clear about my question or the work my org does. I'm new to this forum stuff. We are an on site, internal auditing organization (Quality Assurance), that audits the processes and procedures in a CASS format (Continuous Analysis and Surveillance System) for our company that does major repair work on Aircraft Engines. My org also audits outside vendors who supply parts and material to my company(approved vendors).
The director wants to look into ISO Certification for his QA Org. I have some past experience within ISO, but as we are a service, I was stuck about what exclusions to take in clause 7.0. We do not Design, so 7.3 is excluded. But I'm not sure what to do about 7.4 purchasing, 7.5.4 customer property?

Again, sorry about the confusion. I will try to improve my communications the next time I post.