is anyone able to direct me to a copy of a quality manual geared towards iso 17025 certification?

I don't know of any available, maybe in the FTP site.

A shot in the dark but you could contact the various testing labs (ie Detroit Testing) and maybe get some ideas.

ASD...

mph 407,
The NIST has quality manual templates and procedures for ISO 17025. Go to
http//ts.nist.gov/ts/htdocs/230/235qualtemp.htm

You can download from there.

DICKIE - I'm having no joy with the link you you wrote - any suggestions?

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ditto
ASD...

[This message has been edited by Al Dyer (edited 22 March 2001).]

Sorry about that it was a typo. I do not know how to import links to anything. The correct address is http://ts.nist.gov/ts/htdocs/230/235/qualtemp.htm I just tried it and it still works.
Dickie

Thanks for the update, I just did a cursory hit but it looks good.

ASD...

I am currently preparing to organize a quality manual fitting iso 17025 standards. However, I am concerned about proper wording and documentation as far as the quality manual itself is concerned. If anyone could give me some adivice I would greatly appreciate it.
Thank you ahead of time.

I don't know that I can be of great help. But my first thought is to check from of the applicable registrar websites. My second thought is to tell you what I do. I write my quality policies with the applicable standards (i.e.: ISO 17025 (formerly Guide 25, etc..) open and in front of me as I write. I take each paragraph or sentence from the standard and do a self-evaluation as I write, and ask myself if I have a particular sentence or requirement in my policy to conform with the standard. Another useful technique (if you haven't written policies to conform with standards, is to organize your policy in similar order to the standard. My final advice is to have some other knowledgeable people review your work (quality manager for your site, or someone with that type background) while you are still in the initial editing and writing stage.

You don't have to write your policy any certain way. You only have to write it so as to conform to the applicable requirements of the standard.

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Lynn,

Here is a tip that really helped me out (and I've been through a few of these). Make a copy of 17025 that you would not mind writing all over (mark it as "Reference", "Uncontrolled") and read each clause. With a highlighter, highlight EVERY "shall have procedures" and every "shall have policies". Then go through and index them.

Example:
Clause----Requires-----------Description---------Accomplished
4.10.1----Policy/Procedure---Corrective Action---[checkbox]

From this index of the entire standard(it will be fairly long) you will know what you need to write and to what level.

Unless your assessor is very different than those I've encountered, if it says to have a procedure, you had better have a separate procedure for it. If it says to have a policy, it had better be written as a policy. Many of the clauses only require addressing, probably only at the quality manual level, and I've found it best to keep those very short and simple.

Just my opinion...

Ryan

[This message has been edited by Ryan Wilde (edited 08 July 2001).]

[This message has been edited by Ryan Wilde (edited 08 July 2001).]

Lynn,

Call some registrars and discuss the situation and see if they will give you a copy of what they "particularly" will look for in a desk audit.

This might help you define the levels of documentation that you want to proceed with.

You are the customer, and as such I am sure you are already looking at Registrars. Tell them you will not consider them until you get a copy of their expectations!

MHO!

ASD...

Hi!
Can manufacturer's inserts be used instead of documenting the test method ?

Originally posted by lily:
Hi!
Can manufacturer's inserts be used instead of documenting the test method ?


Sure they can, but think of the following:

- The situation will need to be addressed in your document control procedure.

- What would be the methodology to ensure current revision levels and updates to the document?

- How much time would it take to just transcribe the instructions into your own (Word) document and control it under the current method?

Just a couple of items to consider.

ASD...

Originally posted by Al Dyer:

Sure they can, but think of the following:

- The situation will need to be addressed in your document control procedure.

- What would be the methodology to ensure current revision levels and updates to the document?

- How much time would it take to just transcribe the instructions into your own (Word) document and control it under the current method?

Just a couple of items to consider.

ASD...

I'll throw in a strong reason for using manufacturer's procedures under a 17025 system. Two words - Method Validation. The manufacturer (should) know how to properly test the device. But, in the instance that you have only a few procedures to deal with (<100) I would write my own and document that the method is from the manufacturer, as Al stated.

Document control of manufacturer procedures is a nightmare in most cases, as most manufacturers do not tell you when the procedure has been updated, and most often you must pay for the new procedure. My company uses literally thousands of procedures, and to pay $40 each every few years would be financial suicide.

Another problem with manufacturer's procedures is the equipment that it calls out for use. No lab has everything that every mfr procedure calls out, and substitution on the fly requires quite a time investment in researching what you have, what its uncertainty is, possibly several items to perform the function of one, and so on. The ability to make proper, informed decisions on this substitution is quite often out of the realm of the standard technician, and again, the substitution must be validated. You would save time in the long run by importing the document and tailoring it to your exact capabilities.

In other words - What Al said.

Ryan

I have to agree with Ryan. In addition to everything else, I don't see this as a revision sensitive issue. Or, when so, extremely rarely. They're generally relatively streight forward and 'aimed' at teches who do such work.

As far as addressing it in one's procedures, I would include the explaination as a simple statement.

This should be looked at in the context of how you're handling control of equipment manuals (manufacturing, M&TE, whatever). A lot of companies do Preventive Maintenance according to the manufacturers manual(s) as opposed to originating an in-house maintenance procedure.

Don't over document. Never repeat that which is already written elsewhere.

Originally posted by lily:
Hi!
Can manufacturer's inserts be used instead of documenting the test method ? The comments on this have been good, but this is really off the original topic,

-> I am currently preparing to organize a quality manual

me thinks. Remember folks - it's easy to start a New Topic! http://16949.com/ubb/wink.gif