Questions About Exclusions in ISO 9001 - Clause 7.5 Production and Service provision

[qualitygoddess]

Here's one I haven't run across before. In 7.5, Production and Service provision, does a company specifically have to state that it excludes "service", if the management team says that they do not service the product they sell? They typically replace it, but will occasionally repair it. The repair is done at the manufacturing site. There is a document that defines the repair activity.

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

--QG

[DannyK]

Hi,

We have to differentiate the words "servicing" and "service". Servicing as in the 1994 standard clause 4.19 is not the same as what is covered in 7.5.1. The only link is in 7.5.1 f) for post delivery activities. I believe that this element should not be excluded since this clause includes all the services that you may provide, such as design, repair, etc...

With regards to process validation, soldering or painting should be validated if it has to be performed to specific requirements. If you are painting and it is just for aesthetic purposes, validation does not apply.


Danny K

[Bob Ablondi]

You cna only exclude 7.3 in TS16949.

Bob Ablond1

[Howard Atkins]

Originally Posted by qualitygoddess

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

--QG

We have recently discussed this issue here
http://elsmar.com/Forums/showthread.php?t=11268 and the general comnclusion is yes, you can exclude and there are companies that have.

[RCBeyette]

Originally Posted by qualitygoddess

Here's one I haven't run across before. In 7.5, Production and Service provision, does a company specifically have to state that it excludes "service", if the management team says that they do not service the product they sell? They typically replace it, but will occasionally repair it. The repair is done at the manufacturing site. There is a document that defines the repair activity.

We make a specific statement to the effect that we exclude the "service" aspect of 7.5 and that doing so does not adverserly impact our ability to meet the needs of our Customers. The concepts of replacing it or fixing it are dealt with under Customer satisfaction and nonconforming product (for us).

Originally Posted by qualitygoddess

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

As was already said, if the painting process is for looks only, I'm not sure how validation comes into play - unless colour matching is vital. But for some organizations (e.g., I used to work for a manufacturer of city transit buses), the painting process includes verifying/validating the thickness of the paintcoat.

[MarilynJ6354]

Our scope of "Processing of orders for new equipment" was approved by our registrar. However, the auditor says we have to include the service side of our business, which we planned to add to our scope next year, because we do service after the sale. So here I am wondering why the registrar approved the scope, knowing about our plans for the future. Any ideas? Oh yeah our audits are this week!

[Helmut Jilling]

Originally Posted by MarilynJ6354

Our scope of "Processing of orders for new equipment" was approved by our registrar. However, the auditor says we have to include the service side of our business, which we planned to add to our scope next year, because we do service after the sale. So here I am wondering why the registrar approved the scope, knowing about our plans for the future. Any ideas? Oh yeah our audits are this week!

In ISO 9001, you do not have to include all aspects of your business. There can be certain types that can be excluded, but it must be clear in the scope. IE: we certify the manufacturing business, but not the distribution division.

In TS, this is not an option, unless the excluded divisions are non-automotive.