Quality Systems Manual Ideas - Moving from QS-9000 / TE Supplement to ISO 9001:2000

[Oriondad]

Howdy yall,,,,

Our company is moving from a QS-9000 / TE Supplement implementation to a ISO9001:2000 implementation. I am tasked with getting the documentation updated. I am beginning with the manual.

In looking at the standard, could you not just substitute your companies name where the standard refers to the term "Organization" and just go from there, provided of course that you can do what you say!!!!

as always, your input is appreciated

[Mike S.]

That's a loaded question! There are many threads discussing quality manuals, advantages and disadvantages of different types, etc. here in the Cove. There are even examples of registrar-approved manuals.

Have a peek here ISO 9001 Quality Manual Organization and Structure including Numbering and here QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do?.

After that, if you have a question c'mon back and fire away!

[Oriondad]

That helps. Thanks,

I must ask though, why is it a loaded question. My background is making the product, not managing a quality system, so please forgive my ignorance. I only took this on as we began this process 3 years ago and it died. We made some changes and now here we are again.

I feel our QS manual was fine, but with the change in format, I now need to basically start from scratch.

We have our procedures done, and don't anticipate much of a change there. I only need to renumber the procedures and tie them to the sections in ISO. The manual however is a different matter. I want it to marry up to the standard so it is easy for our auditor, and also so it's in a format that our employees can understand and tie back to the structure of the ISO standard.

So many questions, and not enough overtime hours available!!!!

[CarolX]

Originally Posted by Oriondad

That helps. Thanks,

I must ask though, why is it a loaded question.

Hello Oriondad and Welcome to the Cove.

We have had many lively discusions about this very topic. And opinions run on both sides of the fence. Some would say for the Quality (Policy) manual it is ok to regurgitate the standard. Other argue that you must accurately describe your system.

Myself...I think you could do it.

Have a great day!

[Greg B]

Originally Posted by Oriondad

That helps. Thanks,

I must ask though, why is it a loaded question. My background is making the product, not managing a quality system, so please forgive my ignorance. I only took this on as we began this process 3 years ago and it died. We made some changes and now here we are again.

I feel our QS manual was fine, but with the change in format, I now need to basically start from scratch.

We have our procedures done, and don't anticipate much of a change there. I only need to renumber the procedures and tie them to the sections in ISO. The manual however is a different matter. I want it to marry up to the standard so it is easy for our auditor, and also so it's in a format that our employees can understand and tie back to the structure of the ISO standard.

So many questions, and not enough overtime hours available!!!!

Welcome to the Cove Orion,

IMHO you have started with the wrong mindset. The Quality Manual SHOULD NOT be written to make it easy for the AUDITOR to understand but rather it should be written for YOUR company to use and unsderstand.
The QM should express how YOU do YOUR business..... let the auditor work it out for themselves, if your company complies or not (they work for you).
The manual is not to be a regurgitation of the standard otherwise we all may as well just use the standard. As Mike & Carol have stated, there are many threads on this topic and you will find a lot of information (maybe too much). The standard does not say that you must identify each of the clauses within the manual. Clause 4.2.2 states 'The organisation shall establish and maintain a Quality Manual that includes:

1. the scope of the quality management system, including details of and justification for any exclusions (see 1.2)
2. the documented procedures established for the quality management system, or reference to them, and
3. a description of the interaction between the processes of the quality management system

You could get away with as little as, this is our system, these are our procedures and here is our process maps.IMHO you should start simple. Good luck.

[Claes Gefvenberg]

Originally Posted by Greg B

away with as little as, this is our system, these are our procedures and here is our process maps.IMHO you should start simple. Good luck.

The advice given thus far is good and the links provided by Mike S. are very relevant.

Personally I'm a proponet of a lean QMS, providing your staff with what they need and/or what the standard requires. I also agree with Greg, and strongly advice against writing a system for the auditors. They should be competent enough to be able to tell if a system written for the users is adequate or not.

/Claes

[Oriondad]

Thanks for the valuable feedback.

Hate to ask this, but,,,,,,,,,,,,,,,,,,,,

Based on all of your vast experience, is it then possible to revamp my current QS9000 manual slightly, and just use that.

I guess I was always under the belief that the manual should be numbered in the same format as the standard. Hence we have 20 elements in our current QS manual and my thoughts were we need to reduce it to 5 for ISO.

[Claes Gefvenberg]

Originally Posted by Oriondad

is it then possible to revamp my current QS9000 manual slightly, and just use that.

It must certainly be possible. I don't want to tell you what to do but if your current manual is a biggie, you may want to consider the option to write a new one from scratch? It could prove to be less an easier job than rewriting the old one.

/Claes