T
TheOtherMe
Date: Tue, 4 May 1999 11:07:47 -0400
From: Jack Gale <[email protected]>
To: 'Greg Gogates' <[email protected]>
Subject: RE: News Article/ISO 10012 Vs ISO 17025
John and Leslie,
This is great that somebody may clear up the differences between ISO 10012-1 and ISO Guide 25/17025/Z540. Our customers are confused and it is hard to put them at ease when auditors and consultants put out things like "you must be accredited to ISO 10012-1" when it can't be done.
Section 1.3 of ISO 10012-1 states "This part of ISO 10012 is applicable to measuring equipment used in the demonstration of compliance with a specification: it does not apply to other items of measuring equipment." This part of ISO 10012 does not deal exclusively with other elements that may affect measurement results such as methods of measurement, competence of personnel etc.; these are dealt with more specifically in other International Standards, such as those referred to in 1.4." (Note : 1.4 mentions those labs operating under ISO/IEC Guide 25.)
This seems to backup the ISO 9001 statement that this may be used as guidance in addition to other standards that may more completely cover the entire topic. ISO 9001, Note 18 states:" The metrological confirmation system for measuring equipment given in ISO 10012 may be used for guidance." ISO9001 and ISO 10012-1 together would not be inclusive of all the requirements contained in G25/Z540. Add all these up and 10012-1 should not be used for cal labs:
1) It recognizes that it does not cover all the requirements for a cal lab that is done by ISO G25;
2) The use of "may" and "guidance" in the ISO9001 wording give it no clout;
3) Most practioners of metrology recognize G25/Z540 as the more complete document;
4) I do not know of any current third party auditor that will do ISO 10012-1; I have not heard of any major company placing that requirement ALONE (without G25) on an external cal lab;
5) and, lastly, ISO 10012-1 applies to "measuring equipment used in the demonstration of compliance with a specification;" I believe that calibration is beyond the scope of this statement.
We should let ISO 10012-1 be guidance for the users of measuring equipment and let ISO G25/17025/Z540 be for the calibration labs. This distinction would clear up many questions for customers. It may also be used by the AIAG to define what a customer has to meet for an internal cal lab, since this has not been defined some four months after QS9000 rev 3 (4.11.2.b.1) went into effect. A team has been assembled to see how to answer this one. This would also please the segment in our group that believe that ISO 9000 is insufficient for metrology and shouldn't be allowed.
A position statement from the NCSL would be an useful tool for the industry:
Example:
" ISO 10012-1 is to be used by suppliers administering their own calibration program and ISO/IEC Guide 25/ISO 17025 shall be the primary reference for independent calibration facilities or those required to meet ISO/IEC Guide 25/ISO 17025 requirements. Accreditation to ISO/IEC Guide 25/ISO 17025 by a competent auditor (ISO Guide 58) shall be considered equivalent to ISO 10012-1."
We could even further define the word "competent" above to get the "let's do Guide 25 audits" registrars out of the picture and leave it to the few truly qualified firms.
NIST is limited by their own rules from determining such things. NCSL could go a long way in filling this gap. I look forward to seeing the article.
Jack
Jack Gale
ASQ-CQE
Essco Cal Lab
[email protected]
From: Jack Gale <[email protected]>
To: 'Greg Gogates' <[email protected]>
Subject: RE: News Article/ISO 10012 Vs ISO 17025
John and Leslie,
This is great that somebody may clear up the differences between ISO 10012-1 and ISO Guide 25/17025/Z540. Our customers are confused and it is hard to put them at ease when auditors and consultants put out things like "you must be accredited to ISO 10012-1" when it can't be done.
Section 1.3 of ISO 10012-1 states "This part of ISO 10012 is applicable to measuring equipment used in the demonstration of compliance with a specification: it does not apply to other items of measuring equipment." This part of ISO 10012 does not deal exclusively with other elements that may affect measurement results such as methods of measurement, competence of personnel etc.; these are dealt with more specifically in other International Standards, such as those referred to in 1.4." (Note : 1.4 mentions those labs operating under ISO/IEC Guide 25.)
This seems to backup the ISO 9001 statement that this may be used as guidance in addition to other standards that may more completely cover the entire topic. ISO 9001, Note 18 states:" The metrological confirmation system for measuring equipment given in ISO 10012 may be used for guidance." ISO9001 and ISO 10012-1 together would not be inclusive of all the requirements contained in G25/Z540. Add all these up and 10012-1 should not be used for cal labs:
1) It recognizes that it does not cover all the requirements for a cal lab that is done by ISO G25;
2) The use of "may" and "guidance" in the ISO9001 wording give it no clout;
3) Most practioners of metrology recognize G25/Z540 as the more complete document;
4) I do not know of any current third party auditor that will do ISO 10012-1; I have not heard of any major company placing that requirement ALONE (without G25) on an external cal lab;
5) and, lastly, ISO 10012-1 applies to "measuring equipment used in the demonstration of compliance with a specification;" I believe that calibration is beyond the scope of this statement.
We should let ISO 10012-1 be guidance for the users of measuring equipment and let ISO G25/17025/Z540 be for the calibration labs. This distinction would clear up many questions for customers. It may also be used by the AIAG to define what a customer has to meet for an internal cal lab, since this has not been defined some four months after QS9000 rev 3 (4.11.2.b.1) went into effect. A team has been assembled to see how to answer this one. This would also please the segment in our group that believe that ISO 9000 is insufficient for metrology and shouldn't be allowed.
A position statement from the NCSL would be an useful tool for the industry:
Example:
" ISO 10012-1 is to be used by suppliers administering their own calibration program and ISO/IEC Guide 25/ISO 17025 shall be the primary reference for independent calibration facilities or those required to meet ISO/IEC Guide 25/ISO 17025 requirements. Accreditation to ISO/IEC Guide 25/ISO 17025 by a competent auditor (ISO Guide 58) shall be considered equivalent to ISO 10012-1."
We could even further define the word "competent" above to get the "let's do Guide 25 audits" registrars out of the picture and leave it to the few truly qualified firms.
NIST is limited by their own rules from determining such things. NCSL could go a long way in filling this gap. I look forward to seeing the article.
Jack
Jack Gale
ASQ-CQE
Essco Cal Lab
[email protected]