Example ISO 17025 Quality Manual wanted

A

Al Dyer

#11
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...
 
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A

Al Dyer

#13
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...
 
R

Ryan Wilde

#14
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
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#15
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.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
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! ;)
 
S

sunilgaidhani

#17
Re: Seeking a copy of a quality manual geared towards ISO 17025

Really good one to list down all the policies and procedures, I m also the beginer and will try this.



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
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
Example manuals here: There are only a couple, they can serve as beginning examples to give you ideas.

The manual does not have to be organized along the structure of the standard.

Does anyone here have an example manual they can share to add to the collection?

Example ISO 17025 Manuals

Also see these related existing discussion threads: ISO 17025 Manuals
 
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