Date: Mon, 6 Dec 1999 21:43:42 -0500
From: Larry Gradin <[email protected]>
To: Greg Gogates <[email protected]>, [email protected]
Subject: Re: Origins of ISO/IEC Guide 25
The following was posted today by Tim Alcock:
> Subject: Origins of ISO/IEC Guide 25
>
> I read with some interest the debate/reactions on the origins of ISO 25..
> Europe, Australia, USA etc.
>
> I also recall that there was a request some time ago to post some listing
> of history on the forum.
>
> I know it is a somewhat acadamic debate, but would be interested if
> members could provide a little bit of history prior to the issuance of the
> Guide (without causing a nationalistic furore!)
>
> Tim
Response ----
This latest request for information and other discussions seem to be saying that Accreditation, ISO/IEC Guide 25, ISO 17025 is new and a foreign intrique imposed on test and calibration laboratories recently. This is not correct. The following is an excerpt of a more than 30 page report generated by Greg Gogates (this list's moderator) and myself when we led the retirement of IEEE 498 (the nuclear power industry calibration standard) to adopt ISO/IEC Guide 25 (and ANSI/NCSL Z540-1 in the US). The report was entitled, "Using the New US National Calibration Standard And Accreditation To Assure Quality and Competence In M&TE Calibration For Nuclear Safety" and clarifies history of Guide 25, Accreditation, and worldwide cooperation and US involvement for decades. I hope it helps provide the historical perspective.
Excerpt from Paper/Report
"Basis for Measurements and Test
Measurements and Tests are essential to all modern life. Whether one buys a gallon of gasoline, is concerned with a radiation exposure limit during a medical examination, depends upon an honest measure of a product from a grocery store, worries about the lead content in paint, requires an accurate measurement to launch a shuttle spacecraft, or assure the adequacy of measurements used in nuclear safety related equipment testing and assessment -- competency and quality in measurements are expected and necessary. Within the nuclear industry as well as the general quality community it is recognized that without measurements and the adequacy of such measurements, quality is simply not achievable.
For nuclear safety related system data derived from measurements and tests, the data integrity is critical for the facility, worker, purchaser, supplier, nation, international industry and in a worst case the world or regional environment.
Standards and Accuracy
Standards and accuracy in measurement have been an issue which man has attempted to address throughout recorded history. These issues are not new to the nuclear industry or modern technology. The pyramids of ancient Egypt would not have been built, or still be standing today, without proper attention to Measurement Accuracy. National and international conventions for the consistency of methods for determining measurements have special commercial and legal consequences. The importance of measurements, and their credibility to customers in foreign lands, in an era which is driven by a global economy continues to increase daily.
The typical means to assure the adequacy of a measurement or a test value is to use Calibrated Measurement and Test Equipment (M&TE) whose measurement are traceable in an unbroken chain of comparisons to accepted national or international standards of measurement. Calibration itself being the set of comparison operations, between the instrument being calibrated and a more accurate instrument, (standard or set of standard instruments) for the purpose of quantifying, reporting, and eliminating by adjustment, errors in the instrument being calibrated. Calibration to be effective must be performed under a definite, documented and controlled procedure, by competent individuals, in a repeatable manner, under controlled conditions, reported in a unambiguous manner, and meet the traceability requirements as previously defined. Even if the work is truly competent, the actual customer acceptability of the measurement or test data (or product claimed capability based on the test data) requires that the measurement or test be provided by a source considered credible to the customer.
"The key issue is not the quality of paperwork, but the accuracy, repeatability, traceability, acceptable methods used, technical competence, and quality of the data upon which critical decisions are made."
Early Third Party (Independent) Assessments
It has been recognized (both nationally and internationally) that special attention to the adequacy of Test Laboratories (which include Calibration Laboratories) was necessary for some time. Issues of safety led to independent third party (i.e. not the first party supplier or second party purchaser) testing, inspection, and stated certification of products such as explosive potential pressure boilers, gas pipelines, fire hazard, and electric shock potential equipment for the last 75 to 125 years. These efforts; however, were usually product specific or industry specific, or performed in a manner that was not easy to use beyond a single nation's borders.
Developing Consistent International Accreditation Guidelines
The first broad based Laboratory Accreditation Program was established in Australia as the National Association of Testing Authorities (NATA) in 1947. The second such program was the Testing Laboratory Registration Council (TELARC) of New Zealand some fifteen years later. By the late 1970s similar programs were established in the United States, United Kingdom, Denmark, France, Germany, Sweden, Canada, and several other nations.
Concern for the technical competence and quality of test and calibration laboratories and the inherent barrier to free trade when measurements are in doubt, led to the first International Laboratory Accreditation Conference (ILAC) in 1977 (sponsored by the Lab Accreditation Systems of the United States, Denmark, New Zealand, and Australia). ILAC provided input to the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) which represent worldwide standards development organizations (supported by the US and essentially every industrial nation). ISO and IEC (with US representation) produced a joint document, designated as ISO/IEC Guide 25-1982 , "General Requirements for the Competence of Testing Laboratories" in 1982. The 1990 version of the standard specifically included calibration laboratories and, "the relevant requirements of the ISO 9000 series of standards..." in ISO/IEC Guide 25-1990, "General Requirements for the Competence of Calibration and Testing Laboratories".
Use, Adequacy, and Validating The Accreditation Bodies
Additional issues relating to the validity or acceptability of the Accreditation Bodies themselves also needed to be addressed before technical trade barriers, such as the non-acceptance of foreign test data in the nation importing a product, required resolution. For example within the United States. by 1991 we had approximately 100 "Formal Accreditation" systems; the majority sponsored by government (federal, state, local), approximately a third by profession and trade associations, plus a myriad of private accreditation systems#.
The world laboratory community and the various US professional or standards development organizations have been active to develop a consistent means to assure both laboratory competence and the adequacy of the accreditation system used to determine that competence. As reported in a review of the Past, Present, and Future activities by the chairman of the American Society for Testing and Materials (ASTM) Committee E-36 (Peter Unger), Laboratory Accreditation (formerly Laboratory and Inspection Agency Evaluation and Accreditation), the ASTM has been in the forefront of the early establishment of both the first standard for accreditation as well as the first standard for laboratory accreditation systems. ASTM charted the E-36 committee in 1972 with the original mission, "To develop a generic standard for the evaluation of the qualifications of laboratories regardless of their disciplines", which led to ASTM E548-76, "Practice for Generic Criteria for Evaluation of Testing and Inspection Agencies". ASTM E548-76 was the first published standard of its kind, it formed the basis of the US input to the first ILAC conference in 1977 and the first issue of ISO/IEC Guide 25. The current version of ASTM E548-91 is in harmony with ISO/IEC 25-1990.
Similar ASTM activity (beginning in a 1978 task force report) led to the 1984 ASTM E994 - 84, standard "Standard Guide for Laboratory Systems", which was the model for the eventual international standard to assure impartiality and acceptability of the Accrediting Body itself. Current ISO/IEC Guide 58 with assessment validation is the standard means to assure all parties of impartiality and consistency of an Accreditation Body. Today there are more than fifty National Laboratory Accreditation systems worldwide. Included is the recent establishment of such a system in Mexico, spurred on by the North American Free Trade Association agreement. The only two Accreditation bodies based on US soil who are known to meet the international requirements, are A2LA and NVLAP. As explained above, the international requirements are not foreign requirements imposed on us, but the evolution of prudent US standards development activities, which have included leadership roles of both A2LA and NVLAP staff
The significance of this is found in the standards and their implementation. For example the Mutual Recognition Agreements (MRAs) established between the world's oldest broad based Laboratory Accreditation scheme of NATA and our US based NVLAP and A2LA (no other US organizations are so recognized) include rigorous requirements and procedures harmonized with ISO/IEC 58 to include mutual appraisal for competence in the accreditation process, confidence in accredited labs, competence of assessors, and formal assessment activities, published criteria, documented quality programs, and other requirements."
Hope this is helpful -- no need for "nationalistic furore" as expressed by Tim Alcock. The standards and accreditation is the product of many nations and decades of effort which deserves commendation. In the last five years significant national and regional activity has occurred that has included essentially the entire world recognition of ISO/IEC Guide 25 as a foundation for agreements relating to acceptance of test and calibration data.
Larry Gradin
***************************************************************
* Larry Gradin, PE, QMS-LA
* Email: [email protected] & [email protected]
* Integrity Solutions Group, Inc.
* 6419 Bridgewood Terrace
* Boca Raton, FL 33433
* Phone 561-289-9137
* Efax: 978-285-6589
* Email to Mobile Phone: [email protected]
* Web Page http//www.Integrity-Solutions.Org
_______________________________________________________
Remember - Quality depends on Integrity, Attention To Detail,
Cost-Effective Action, and Commitment -- not buzzwords.
*****************************************************************
From: Mark Mathewson <[email protected]>
To: "'[email protected]'" <[email protected]>
Subject: Origins of ISO/IEC Guide 25
Date: Wed, 8 Dec 1999 06:46:10 -0500
MIME-Version: 1.0
X-Mailer: Internet Mail Service (5.5.2232.9)
Content-Type: text/plain;
charset="iso-8859-1"
Hello All,
To continue on with the history, I just received a transcript from the Official Journal of the European Communities, (1999/C 347/03), "Implementing Arrangement between the National Institute of Standards and Technology of the Department of Commerce of the United States of America and the Commission of the European Communities for Cooperation in the Fields of Metrology and Measurement Standards". This document lays the foundation for a MRA between the EU and NIST. This document was signed on October 5, 1999 and will be in force for 5 years. This measure will help unify the standards used by the different nations in free trade, including the establishment of mutual traceability. Even though not directly applicable to Guide 25, it certainly affects the underlying concepts, and for the betterment of all.
Mark Mathewson
From: Larry Gradin <[email protected]>
To: Greg Gogates <[email protected]>, [email protected]
Subject: Re: Origins of ISO/IEC Guide 25
The following was posted today by Tim Alcock:
> Subject: Origins of ISO/IEC Guide 25
>
> I read with some interest the debate/reactions on the origins of ISO 25..
> Europe, Australia, USA etc.
>
> I also recall that there was a request some time ago to post some listing
> of history on the forum.
>
> I know it is a somewhat acadamic debate, but would be interested if
> members could provide a little bit of history prior to the issuance of the
> Guide (without causing a nationalistic furore!)
>
> Tim
Response ----
This latest request for information and other discussions seem to be saying that Accreditation, ISO/IEC Guide 25, ISO 17025 is new and a foreign intrique imposed on test and calibration laboratories recently. This is not correct. The following is an excerpt of a more than 30 page report generated by Greg Gogates (this list's moderator) and myself when we led the retirement of IEEE 498 (the nuclear power industry calibration standard) to adopt ISO/IEC Guide 25 (and ANSI/NCSL Z540-1 in the US). The report was entitled, "Using the New US National Calibration Standard And Accreditation To Assure Quality and Competence In M&TE Calibration For Nuclear Safety" and clarifies history of Guide 25, Accreditation, and worldwide cooperation and US involvement for decades. I hope it helps provide the historical perspective.
Excerpt from Paper/Report
"Basis for Measurements and Test
Measurements and Tests are essential to all modern life. Whether one buys a gallon of gasoline, is concerned with a radiation exposure limit during a medical examination, depends upon an honest measure of a product from a grocery store, worries about the lead content in paint, requires an accurate measurement to launch a shuttle spacecraft, or assure the adequacy of measurements used in nuclear safety related equipment testing and assessment -- competency and quality in measurements are expected and necessary. Within the nuclear industry as well as the general quality community it is recognized that without measurements and the adequacy of such measurements, quality is simply not achievable.
For nuclear safety related system data derived from measurements and tests, the data integrity is critical for the facility, worker, purchaser, supplier, nation, international industry and in a worst case the world or regional environment.
Standards and Accuracy
Standards and accuracy in measurement have been an issue which man has attempted to address throughout recorded history. These issues are not new to the nuclear industry or modern technology. The pyramids of ancient Egypt would not have been built, or still be standing today, without proper attention to Measurement Accuracy. National and international conventions for the consistency of methods for determining measurements have special commercial and legal consequences. The importance of measurements, and their credibility to customers in foreign lands, in an era which is driven by a global economy continues to increase daily.
The typical means to assure the adequacy of a measurement or a test value is to use Calibrated Measurement and Test Equipment (M&TE) whose measurement are traceable in an unbroken chain of comparisons to accepted national or international standards of measurement. Calibration itself being the set of comparison operations, between the instrument being calibrated and a more accurate instrument, (standard or set of standard instruments) for the purpose of quantifying, reporting, and eliminating by adjustment, errors in the instrument being calibrated. Calibration to be effective must be performed under a definite, documented and controlled procedure, by competent individuals, in a repeatable manner, under controlled conditions, reported in a unambiguous manner, and meet the traceability requirements as previously defined. Even if the work is truly competent, the actual customer acceptability of the measurement or test data (or product claimed capability based on the test data) requires that the measurement or test be provided by a source considered credible to the customer.
"The key issue is not the quality of paperwork, but the accuracy, repeatability, traceability, acceptable methods used, technical competence, and quality of the data upon which critical decisions are made."
Early Third Party (Independent) Assessments
It has been recognized (both nationally and internationally) that special attention to the adequacy of Test Laboratories (which include Calibration Laboratories) was necessary for some time. Issues of safety led to independent third party (i.e. not the first party supplier or second party purchaser) testing, inspection, and stated certification of products such as explosive potential pressure boilers, gas pipelines, fire hazard, and electric shock potential equipment for the last 75 to 125 years. These efforts; however, were usually product specific or industry specific, or performed in a manner that was not easy to use beyond a single nation's borders.
Developing Consistent International Accreditation Guidelines
The first broad based Laboratory Accreditation Program was established in Australia as the National Association of Testing Authorities (NATA) in 1947. The second such program was the Testing Laboratory Registration Council (TELARC) of New Zealand some fifteen years later. By the late 1970s similar programs were established in the United States, United Kingdom, Denmark, France, Germany, Sweden, Canada, and several other nations.
Concern for the technical competence and quality of test and calibration laboratories and the inherent barrier to free trade when measurements are in doubt, led to the first International Laboratory Accreditation Conference (ILAC) in 1977 (sponsored by the Lab Accreditation Systems of the United States, Denmark, New Zealand, and Australia). ILAC provided input to the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) which represent worldwide standards development organizations (supported by the US and essentially every industrial nation). ISO and IEC (with US representation) produced a joint document, designated as ISO/IEC Guide 25-1982 , "General Requirements for the Competence of Testing Laboratories" in 1982. The 1990 version of the standard specifically included calibration laboratories and, "the relevant requirements of the ISO 9000 series of standards..." in ISO/IEC Guide 25-1990, "General Requirements for the Competence of Calibration and Testing Laboratories".
Use, Adequacy, and Validating The Accreditation Bodies
Additional issues relating to the validity or acceptability of the Accreditation Bodies themselves also needed to be addressed before technical trade barriers, such as the non-acceptance of foreign test data in the nation importing a product, required resolution. For example within the United States. by 1991 we had approximately 100 "Formal Accreditation" systems; the majority sponsored by government (federal, state, local), approximately a third by profession and trade associations, plus a myriad of private accreditation systems#.
The world laboratory community and the various US professional or standards development organizations have been active to develop a consistent means to assure both laboratory competence and the adequacy of the accreditation system used to determine that competence. As reported in a review of the Past, Present, and Future activities by the chairman of the American Society for Testing and Materials (ASTM) Committee E-36 (Peter Unger), Laboratory Accreditation (formerly Laboratory and Inspection Agency Evaluation and Accreditation), the ASTM has been in the forefront of the early establishment of both the first standard for accreditation as well as the first standard for laboratory accreditation systems. ASTM charted the E-36 committee in 1972 with the original mission, "To develop a generic standard for the evaluation of the qualifications of laboratories regardless of their disciplines", which led to ASTM E548-76, "Practice for Generic Criteria for Evaluation of Testing and Inspection Agencies". ASTM E548-76 was the first published standard of its kind, it formed the basis of the US input to the first ILAC conference in 1977 and the first issue of ISO/IEC Guide 25. The current version of ASTM E548-91 is in harmony with ISO/IEC 25-1990.
Similar ASTM activity (beginning in a 1978 task force report) led to the 1984 ASTM E994 - 84, standard "Standard Guide for Laboratory Systems", which was the model for the eventual international standard to assure impartiality and acceptability of the Accrediting Body itself. Current ISO/IEC Guide 58 with assessment validation is the standard means to assure all parties of impartiality and consistency of an Accreditation Body. Today there are more than fifty National Laboratory Accreditation systems worldwide. Included is the recent establishment of such a system in Mexico, spurred on by the North American Free Trade Association agreement. The only two Accreditation bodies based on US soil who are known to meet the international requirements, are A2LA and NVLAP. As explained above, the international requirements are not foreign requirements imposed on us, but the evolution of prudent US standards development activities, which have included leadership roles of both A2LA and NVLAP staff
The significance of this is found in the standards and their implementation. For example the Mutual Recognition Agreements (MRAs) established between the world's oldest broad based Laboratory Accreditation scheme of NATA and our US based NVLAP and A2LA (no other US organizations are so recognized) include rigorous requirements and procedures harmonized with ISO/IEC 58 to include mutual appraisal for competence in the accreditation process, confidence in accredited labs, competence of assessors, and formal assessment activities, published criteria, documented quality programs, and other requirements."
Hope this is helpful -- no need for "nationalistic furore" as expressed by Tim Alcock. The standards and accreditation is the product of many nations and decades of effort which deserves commendation. In the last five years significant national and regional activity has occurred that has included essentially the entire world recognition of ISO/IEC Guide 25 as a foundation for agreements relating to acceptance of test and calibration data.
Larry Gradin
***************************************************************
* Larry Gradin, PE, QMS-LA
* Email: [email protected] & [email protected]
* Integrity Solutions Group, Inc.
* 6419 Bridgewood Terrace
* Boca Raton, FL 33433
* Phone 561-289-9137
* Efax: 978-285-6589
* Email to Mobile Phone: [email protected]
* Web Page http//www.Integrity-Solutions.Org
_______________________________________________________
Remember - Quality depends on Integrity, Attention To Detail,
Cost-Effective Action, and Commitment -- not buzzwords.
*****************************************************************
From: Mark Mathewson <[email protected]>
To: "'[email protected]'" <[email protected]>
Subject: Origins of ISO/IEC Guide 25
Date: Wed, 8 Dec 1999 06:46:10 -0500
MIME-Version: 1.0
X-Mailer: Internet Mail Service (5.5.2232.9)
Content-Type: text/plain;
charset="iso-8859-1"
Hello All,
To continue on with the history, I just received a transcript from the Official Journal of the European Communities, (1999/C 347/03), "Implementing Arrangement between the National Institute of Standards and Technology of the Department of Commerce of the United States of America and the Commission of the European Communities for Cooperation in the Fields of Metrology and Measurement Standards". This document lays the foundation for a MRA between the EU and NIST. This document was signed on October 5, 1999 and will be in force for 5 years. This measure will help unify the standards used by the different nations in free trade, including the establishment of mutual traceability. Even though not directly applicable to Guide 25, it certainly affects the underlying concepts, and for the betterment of all.
Mark Mathewson
