TL 9000 8.4.V.1 Quality Manual in a Service Company

qmanager2012 · Oct 8, 2014

HELP, Please...:truce:
I am the Quality Manager for a contract manufacturer. We do not have any products but offer services to our clients such as packaging, testing, logistics, fulfillment, distribution etc. We were misguided during the stage 1 TL audit and were told (based on our business type) that we could exclude 8.4.V.1 from our Quality Manual/QMS. However, during the stage 2 audit, the same auditor identified the fact that he misguided us and asked us to update our Quality Manual to include 8.4.V.1. The problem I am having is trying to figure out what to write into our manual for this element since we do not have our own products. Can I say that we utilize our corrective action system for the collection and analysis of data in order to foster continual improvement? Am I reading too much into this and not really understanding the requirement, yes, I'm sure I am :bonk:

Any information or better yet, an excerpt out of section 8.4.V.1 from someone's quality manual would be very helpful. Thanks!

AndyN · Oct 8, 2014

Re: TL 9000 8.4.V.1 Quality Manual

qmanager2012 said:
HELP, Please...:truce:
I am the Quality Manager for a contract manufacturer. We do not have any products but offer services to our clients such as packaging, testing, logistics, fulfillment, distribution etc. We were misguided during the stage 1 TL audit and were told (based on our business type) that we could exclude 8.4.V.1 from our Quality Manual/QMS. However, during the stage 2 audit, the same auditor identified the fact that he misguided us and asked us to update our Quality Manual to include 8.4.V.1. The problem I am having is trying to figure out what to write into our manual for this element since we do not have our own products. Can I say that we utilize our corrective action system for the collection and analysis of data in order to foster continual improvement? Am I reading too much into this and not really understanding the requirement, yes, I'm sure I am
Any information or better yet, an excerpt out of section 8.4.V.1 from someone's quality manual would be very helpful. Thanks!

Here's what I'd do. Firstly, based on the inconsistent comments, I'd go back to your CB's management and ask them to clarify WHY their auditor is wavering on a requirement which he/she should be competent in. Tell them that as a result of this inconsistent auditor, you've been put to an amount of work, which is wasted and you'll be deducting that cost from your bill.

Then, ask them which is correct - exclusion or not? And why.

Finally, ask for the next audit to be done by someone who is competent in YOUR services.

qmanager2012 · Oct 8, 2014

Thank you but, in defense of the CB auditor, I should have known better (If I had understood the requirements and did more homework

) that you cannot exclude any elements/clauses except for those in 7.
With that being said, I still am in the predicament of not knowing what to write into our QM. If anyone can shed some light on this and provide me some guidance, I would greatly appreciate it. :deadhorse:

AndyN · Oct 8, 2014

If the auditor had been awake, they would have written a concern at the stage 1 as to why you hadn't correctly addressed the requirements of 8.4.v.1.

Instead, they offered a consulting comment - exclude it. So they are 2 for 2, IMHO. Instead of doing their job, and reporting on something which can't be excluded (they didn't KNOW?) and thereby bringing it to your attention for action (if you can't exclude it, you gotta do something), the auditor offered and action. You run a risk, now, that follow-on audits are going to have you doing similar things.

TL 9000 8.4.V.1 Quality Manual in a Service Company

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