In-house Laboratory Manual Requirements - ISO9001
- Thread starter ozziegood
- Start date
D
D.Scott
ozziegood said:
ISO 9001:2000 does not directly address internal labs. You may be thinking of the old QS-9000 section on internal labs or the ISO 16949 requirements in 7.6.3.1.
If you are setting up a lab to ISO 17025 there are specific requirements to conform to that standard.
Has someone told you a lab manual is needed? Have I missed the intent of your question?
Dave
D
D.Scott
Try the search feature in the blue bar above these posts and type in 17025 lab manual.
There are many discussions listed there on the subject. The manuals found there will probably be long out of date but they might give you an idea.
I am still in the dark as to why you need a lab manual for ISO 9001:2000.
Dave
There are many discussions listed there on the subject. The manuals found there will probably be long out of date but they might give you an idea.
I am still in the dark as to why you need a lab manual for ISO 9001:2000.
Dave
Hi ozziegoodozziegood said:
Who just told you that?
Best approach:
If your parent organization is already registered to QS or TS 16949 or 9K, then the lab manual only needs to address the additional extra requirements of ISO/IEC 17025.....don't reinvent the wheel.
However, some things to watch for, ESPECIALLY if you seek accreditation under 17025.....
Management review - regardless of any other topics or whether it is combined with the parent's review - MUST include the prescriptive requirements of Clause 4.14.1.....Internal audits MUST SPECIFICALLY address the internal lab, even if combined with the parent's internal audits.....any information published by the internal lab, even if only going to the parent MUST meet requirements of Clause 5.10 (sub-sections as applicable).....watch the calibration and traceability parts, your calibration provider including sub-contracted cal or testing must be able to support your accreditation, which means they must meet the same requirements, whether accredited or not.....and if not, then you take the 17025 checklist and a technical person with the background in what the vendor/sub is doing for you and perform what amounts to an accreditation assesment on them.....
This is not easy, however we have seen that labs that meet these requirements often have a higher level of performance and a lower level of issues.
Hope this helps.
Hershal
If your parent organization is already registered to QS or TS 16949 or 9K, then the lab manual only needs to address the additional extra requirements of ISO/IEC 17025.....don't reinvent the wheel.
However, some things to watch for, ESPECIALLY if you seek accreditation under 17025.....
Management review - regardless of any other topics or whether it is combined with the parent's review - MUST include the prescriptive requirements of Clause 4.14.1.....Internal audits MUST SPECIFICALLY address the internal lab, even if combined with the parent's internal audits.....any information published by the internal lab, even if only going to the parent MUST meet requirements of Clause 5.10 (sub-sections as applicable).....watch the calibration and traceability parts, your calibration provider including sub-contracted cal or testing must be able to support your accreditation, which means they must meet the same requirements, whether accredited or not.....and if not, then you take the 17025 checklist and a technical person with the background in what the vendor/sub is doing for you and perform what amounts to an accreditation assesment on them.....
This is not easy, however we have seen that labs that meet these requirements often have a higher level of performance and a lower level of issues.
Hope this helps.
Hershal
C
corollax
Before we were accredited to 17025, our company was using ISO10012 "Measurement management systems - Requirements for measurement processes and measuring equipment" as one of the guidelines for our in-house cal lab. Thks.
G
Graeme
Iso 10012:2003
One of the few I have heard of who actually use that standard ...
I can see where the principles of ISO 10012 can be applied within an internal lab, and I assume that you are still using it even after 17025 registration. But the intent of the standard is for it to be used in the entire organization to ensure that all measuring instruments are appropriate for the intended use and that all measurement systems are validated as meeting the measurement requirements of the product. Calibration of inspection, test and measuring equipment is very important, but it is only one (fairly small) part of what is covered in 10012.
Probably the biggest benefit to a cal lab of their company having a measurement management system such as 10012 describes it that the perrenial question "does this [thing] need to be calibrated?" has already been answered by the system's documentation.
Late addition: another thread has a document I have been working on for a while that addresses some of the questions and misconceptions about the standard. I did not have it available when I first replied.
corollax said:
One of the few I have heard of who actually use that standard ...
I can see where the principles of ISO 10012 can be applied within an internal lab, and I assume that you are still using it even after 17025 registration. But the intent of the standard is for it to be used in the entire organization to ensure that all measuring instruments are appropriate for the intended use and that all measurement systems are validated as meeting the measurement requirements of the product. Calibration of inspection, test and measuring equipment is very important, but it is only one (fairly small) part of what is covered in 10012.
Probably the biggest benefit to a cal lab of their company having a measurement management system such as 10012 describes it that the perrenial question "does this [thing] need to be calibrated?" has already been answered by the system's documentation.
Late addition: another thread has a document I have been working on for a while that addresses some of the questions and misconceptions about the standard. I did not have it available when I first replied.
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