ISO 9001:2000 and ISO 17025 combined Quality Manual needed

P

pong35

#1
Hi, I am much exposed to 9000:2000, but not at 17025. When I read the Introduction of ISO 17025 manual, it said that the company also should be also using ISO 9001:2000 but don't need to be certified. My question is, do we need a copy of ISO 9001:2000 Quality standard as part of our Quality records aside from having one ISO 17025 quality standard?

And do I understand that the Quality Manual for ISO 9000 is different from the Quality manual for ISO 17025, thus having different Quality Policy Statement (Mission, Vision statement)?

Thank you for all your help
 
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B

Benjamin28

#2
Re: ISO 9000:2000 manual needed together with ISO 17025

I believe you are interpreting the ISO 17025 document incorrectly here. It states that "Testing and calibration laboratories that comply with this international standard will therefore also operate in accordance with ISO9001"

This is not meant to say you must adopt ISO 9001 into your operations, only that the applicable portions of 9001 are included in 17025 and therefore those portions will be in accord with each other.

You are not required to have the ISO 9001 document as part of your quality records, the ISO 17025 document is sufficient.

However, I would like to ask your specific situation, as you state you will have two quality manuals, I assume you are operating a ISO 17025 accreditted laboratory within an ISO 9001 certified company? If this is the case, yes it is typical for both to use different quality manuals...I will, however, leave this for elaboration by other covers which may be more qualified to answer in regards to operating both standards in one business entity.

Oh, and welcome to the Cove!
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: ISO 9001:2000 manual needed together with ISO 17025

As Benjamin28 points out, an accreditation to ISO/IEC 17025 means that the lab is also in compliance with the applicable portions of ISO 9001.....

However, many customers of the lab may require registration to ISO 9001 along with accreditation to ISO/IEC 17025, for reasons of their own.....

One manual can in fact take care of both, and if well written, you should only need one manual.

The easy thing to do is to structure the manual per the Clauses of ISO/IEC 17025, and include a matrix that points out - in the manual - where the ISO 9001 requirements and the ISO/IEC 17025 requirements are met.

Hope this helps.

Hershal
 
P

pong35

#4
Re: ISO 9001:2000 manual needed together with ISO 17025

Thank you Benjamin and Hershal, it did helped and clearned some questions.

Thank you.
 

qusys

Trusted Information Resource
#7
Re: Combined ISO 9001:2000 and ISO 17025 Quality Manual needed

Hi Jennifer,
interesting links to have ideas and knowledbe about other organization.
This is a good example of quality culture sharing!:applause:
 

spacey

Involved In Discussions
#8
Wow, thank you everyone who has contributed to this thread

Seeing as the company I work for is not yet 9001 certified but the lab is used for design and development reasons and now we are looking to get this accredited to ISO 17025 for final product testing reasons, rather than out of house testing.

firstly to save money but also time, I believe this is possible

I will look to intergrate the two into one manual over the coming months
 
M

Maven

#9
Re: Combined ISO 9001:2000 and ISO 17025 Quality Manual needed

I like the 4 pager. Simple, easy to understand. You don't have to re-write the whole standard in your quality manual!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
Re: Combined ISO 9001:2000 and ISO 17025 Quality Manual needed

I like the 4 pager. Simple, easy to understand. You don't have to re-write the whole standard in your quality manual!
I liked it too. And I think a lot of others here would too, because most of us certainly don't support regurgitating the standards in quality manuals.:agree1:
 
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