ISO 17025 Quality Manual - How elaborate does the quality manual have to be?

S

shawnann

#1
I'm going to post this here because we are in the process of getting ISO 17025 certified, but I guess the question could go for any certifications that require a quality manual.

We all know that a quality manual is required, as it states in the instructions for the application for accreditation that you need to "Create and implement a Quality Manual and Management System policies and procedures that meet the ISO/IEC 17025:2005 and A2LA requirements."

So my question is, how elaborate does the quality manual have to be? When we got our ISO 9001 certification, we for the most part typed word for word the international standard, with the exception of creating a couple pages at the beginning and this was acceptable. We were also told we could combine the quality manual to our procedures manual and eliminate the part of the quality manual that was word for word of the international standard. Can we just create those "extra pages" and use the international standard (as is) as our quality manual? This would save a lot of time typing something that is already in print and paper that really isn't needed to be printed on.

In other words, create a quality policy (or quality pages), that lists the scope of the laboratory/company, the organizational overview-mission (who we are, etc) and then refer to the international standard for the actual quality manual.
 
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Coury Ferguson

Moderator here to help
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#2
Re: Quality Manual

I'm going to post this here because we are in the process of getting ISO 17025 certified, but I guess the question could go for any certifications that require a quality manual.

We all know that a quality manual is required, as it states in the instructions for the application for accreditation that you need to "Create and implement a Quality Manual and Managment System policies and procedures that meet the ISO/IEC 17025:2005 and A2LA requirements."

So my question is, how elaborate does the quality manual have to be? When we got our ISO 9001 certification, we for the most part typed word for word the international standard, with the exception of creating a couple pages at the beginning and this was exceptable. We were also told we could combine the quality manual to our procedures manual and eliminate the part of the quality manual that was word for word of the international standard. Can we just create those "extra pages" and use the international stadard (as is) as our quality manual? This would save a lot of time typing something that is already in print and paper that really isn't needed to be printed on.

In other words, create a quality policy (or quality pages), that lists the scope of the laboratory/company, the organizational overview-mission (who we are, etc) and then refer to the international standard for the actual quality manual.
Does your current manual meet the requirement of 17025? That is what you need to be concerned about.

It appears that you have all the necessary information an established Quality Manual and System.

I am not an expert in the 17025 Standard. So I maybe way of base.
 
Q

qualityboi

#3
I'm going to post this here because we are in the process of getting ISO 17025 certified, but I guess the question could go for any certifications that require a quality manual.

We all know that a quality manual is required, as it states in the instructions for the application for accreditation that you need to "Create and implement a Quality Manual and Management System policies and procedures that meet the ISO/IEC 17025:2005 and A2LA requirements."

So my question is, how elaborate does the quality manual have to be? When we got our ISO 9001 certification, we for the most part typed word for word the international standard, with the exception of creating a couple pages at the beginning and this was acceptable. We were also told we could combine the quality manual to our procedures manual and eliminate the part of the quality manual that was word for word of the international standard. Can we just create those "extra pages" and use the international standard (as is) as our quality manual? This would save a lot of time typing something that is already in print and paper that really isn't needed to be printed on.

In other words, create a quality policy (or quality pages), that lists the scope of the laboratory/company, the organizational overview-mission (who we are, etc) and then refer to the international standard for the actual quality manual.
First of all your certification body did not do you justice if you merely parroted the Standard. Your quality manual should describe your company's quality system. Some companies write their quality manual to show how their quality system meets the standard, key word is "how", but that, in my opinion, is a less mature way of documenting the quality system as it is aimed more at passing an audit than describing what the company does. The intent of the standard is to set minimum requirements for a quality system or in your case laboratory and aid in the path of continual improvement resulting in greater customer satisfaction. The intent of the manual is to describe the system so managment and personnel have a common understanding of how the company works. Then they have a baseline to improve upon.
 
#4
I'm going to post this here because we are in the process of getting ISO 17025 certified, but I guess the question could go for any certifications that require a quality manual.

We all know that a quality manual is required, as it states in the instructions for the application for accreditation that you need to "Create and implement a Quality Manual and Management System policies and procedures that meet the ISO/IEC 17025:2005 and A2LA requirements."

So my question is, how elaborate does the quality manual have to be? When we got our ISO 9001 certification, we for the most part typed word for word the international standard, with the exception of creating a couple pages at the beginning and this was acceptable. We were also told we could combine the quality manual to our procedures manual and eliminate the part of the quality manual that was word for word of the international standard. Can we just create those "extra pages" and use the international standard (as is) as our quality manual? This would save a lot of time typing something that is already in print and paper that really isn't needed to be printed on.

In other words, create a quality policy (or quality pages), that lists the scope of the laboratory/company, the organizational overview-mission (who we are, etc) and then refer to the international standard for the actual quality manual.
That's an interesting question! It has to be as elaborate as your lab operations demand it to be!

Please, please don't do what you did for ISO 9001! All you've done is please a third party CB auditor. Copying the standard word for word is a recipe for a useless document that your management will never use and, as a result, no one else will. Besides, no-one speaks that 'ISO language' in there. (Oh, BTW - you don't get 17025 registered or certified, it's accredited - a simple but important difference).

Shawann - there are loads of posts around here about the contents of manuals. It's not a stretch to do a good one for 17025. It's not so different. The lab std gives you some ideas as to what might be in there - like an org. chart which shows the lab related to the 'parent' company. Also, who's the QM and the deputies of the lab tech mgr etc. ALso, work in those specific accreditation Body 'tweaks' they prefer, like the correction of data, when there's an error (double cross through, in ink, initialed, etc.)

But, please don't just do that old, waste of time, cut and paste the standard cr*p - your A2LA assessor might not accept it anyways.....
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#5
There are two things going on here based on the original post.....

First, the ANS/ISO/IEC 17025:2005 requirements, and second the requirements for the chosen AB.....

Your manual needs to address both.....needs to address them in terms of what you ACTUALLY do TODAY.....

Now, the manual may not need to be elaborate if the AB accepts that.....

But almost certainly can't simply be a regurgatation of the Standard.....

Hope this helps......
 
P

Peter West

#6
Do you use your manual? That is to say do you actually intend to be a company who achieve certification/accreditation (subject to the ISO) with the full intent of using what they have learnt and discovered to improve business/operations?

No offence intended but i sort of get the feeling that the efforts are for the external surveillance only, in which case work efficiency would dictate you do the bare minimum to achieve the ISO and then continue as you always did (I question this - especially do not endorse this approach).

If you are not going to reap any operational benefits of gaining this ISO (i.e. improvement in procedures) is it worth getting it???
 
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