A2LA News: The Newsletter of the American Association for Laboratory Accreditation__ July, Number 85
 
 

In This Issue.......

   
 

GENERAL UPDATES, NOTICES AND PRESS RELEASES:

- Remembering Jim Munnerlyn
- Remembering Phil Stein
- Fall 2004 Training Course Schedule
- Labs Gaining GE Acceptance
- Inspection Body Program Update
- 2003 Annual Report Available

MEETING SUMMARIES:

- Recent Meetings in the Area of Life Sciences
- 2004 Quality Expo
- NCSLI Conference

UPDATES ON A2LA OPERATIONS & POLICIES:

- New and Updated Documents
- Use of the A2LA Logo

ACCREDITATION REQUIREMENTS, INTERPRETATIONS & EXPLANATIONS:

- Recalibration Intervals on Calibration Certificates and Other Problems
- A2LA's New Uncertainty Policy
- Lab Accreditation Work of CASCO

 

 
   
   
   
         
 
   

Remembering Jim Munnerlyn

It is with great sadness that A2LA marks the passing of Jim Munnerlyn due to complications of cancer on June 17, 2004, in Salt Lake City, Utah. Jim was born in Lonoke, Arkansas, received his higher education at Portland State College and the University of Oregon, and served in the U.S. Army during the Korean War. His professional life as a civil engineer spanned over 40 years with Pittsburgh Testing Laboratory and Professional Services Industries, retiring in 1999. Jim then became an A2LA Construction Materials and Geotechnical assessor with his expertise in the testing areas of concrete, aggregate, cement, soil, bituminous, masonry, roofing, steel, brick, nondestructive testing, mortar, soil cement and rock. Jim also served as an A2LA Accreditation Council member and was on the board of the American Welding Society. Jim was an avid athlete, who played basketball, semi-pro baseball and golf. He is survived by his wife, 6 children, 30 grandchildren, and 4 great-grandchildren.

 
       
     
       
   

Remembering Philip G. Stein

Philip G. Stein died June 24, 2004, at University Medical Center at Princeton at the age of 62. Born in Washington, D.C., he grew up in Brooklyn, NY as the son of the late Annie and Arthur Stein. His wife, Carole Armel Stein; children Daniel Katz-Stein, Jonah Stein, Jac, Jeff and Paul Hagerhorst, and Jeannine Trewhella; sister Eleanor Stein; and five grandchildren survive him. His interests included gourmet food, Bordeaux and Sauterne wines, fine chocolate, music, fencing and games.

He received a bachelor's degree in physics from Columbia College and a master's degree in measurement science from George Washington University.  As a measurement scientist, he worked at the National Bureau of Standards for 15 years before joining the David Sarnoff Research Center in West Windsor. For 40 years he researched diverse, state-of-the-art systems problems in which measurement was the central issue. The primary purpose of his consulting practice, P. G. Stein Consultants, was to bring the techniques of quality assurance, measurement assurance, quality software, and statistical control of measurements from the standards lab to the business world. He worked extensively as a standards writer for and assessor to international and national laboratory accreditation standards (ISO/IEC 17025 and Guide 25, and ANSI Z-540-1), as well as for quality system standards such as ISO 9000, QS-9000, and the Malcolm Baldrige award.

Mr. Stein served as an assessor and technical advisor for the Measurement Advisory Committee with A2LA for several years. He was internationally known as an expert in measurement uncertainty determination, calculations and standards, and statistical evaluation and control of measurement systems. He was a technical expert in measurements in many fields, including video, audio, DC-to-RF electronics, dimensional, temperature and heat, mass, pressure, force and torque as well as in color, light and optics.

He was a fellow member of the American Society for Quality and a member of its board of directors; a senior examiner for the Baldrige-based New Jersey Quality Achievement Award, was certified as a quality manager, quality auditor, quality engineer, software quality engineer, reliability engineer, quality technician, and mechanical inspector, and taught all of those subjects regularly. He was a member of the AMSE B89 standards committee on dimensional metrology and past chair of the Measurement Quality Division and of the Princeton Section, ASQ. Mr. Stein was a longtime member of the board of advisors of Legacy International, a nonprofit educational and training organization. Recently, he was a contributor to standards on electronic voting being developed by the Association for Computing Machinery Committee on Computers and Public Policy.

Memorial contributions may be made to The Philip Stein Metrology Education Fund, c/o Waxman & Associates, P.O. Box 89, Princeton Junction, NJ 08550 or Legacy International, 1020 Legacy Drive, Bedford, VA 24523.
       
     
       
   

Fall 2004 Training Course Schedule

Title: Introduction to Measurement Uncertainty

  • September 13-15, 2004 – St. Paul, MN
  • October 25-27, 2004 – Los Angeles, CA

Title: Measurement Uncertainty Workshop

  • September 16, 2004 – St. Paul, MN
  • October 28, 2004 – Los Angeles, CA

Title: ISO/IEC 17025 and Accreditation

  • September 16-17, 2004 – St. Paul, MN
  • October 28-29, 2004 – Los Angeles, CA

Title: Assessment of Laboratory Competence

  • November 15-19, 2004 – Charleston, SC
For additional information, please contact Ms. Julie Stevens, A2LA Training Coordinator, at 301 644 3235 or jstevens@a2la.org.
 
         
       
         
   

Labs Gaining GE Acceptance

A2LA has received positive evidence that accredited materials testing laboratories are actively enjoying the recognition A2LA has obtained from General Electric Aircraft Engines (GEAE). Once these laboratories obtain initial approval from GEAE, they are able to achieve re-certification for GEAE work by obtaining and maintaining A2LA accreditation.

Laboratories interested in making use of this recognition should clearly indicate so within their application or renewal paperwork.

A2LA is aggressively working with the rest of the aerospace primes to gain their acceptance of A2LA accreditation and/or acceptance of the ILAC MRA. Updates and announcements will be posted on the A2LA website and within A2LA News.

   
         
       
         
   

Inspection Body Accreditation Program Update

In an effort to promote uniformity in the application of ISO/IEC 17020-1998, General Criteria for the Operation of Various Types of Bodies Performing Inspection, the International Laboratory Accreditation Cooperation/International Accreditation Forum (ILAC/IAF) Joint Working Group on Inspection (JWGI) has submitted the document titled ISO/IEC 17020 Guidance Document for publication as a P-Series (Procedural Series) document. Although the document is called a "guidance document", it is intended to form the requirements, together with ISO/IEC 17020, of the ILAC/IAF Multi-Lateral Mutual Recognition Arrangement (MLMRA). All accreditors of inspection bodies (IBs) who wish to become signatories to the ILAC/IAF MLMRA will require their accredited inspection bodies to comply with the requirements included in this document.  The final draft was distributed to all ILAC full members for a 60-day voting period.

   
         
       
       
   

2003 Annual Report Available

The 2003 A2LA Annual Report is now available online. The Annual Report outlines A2LA’s staff and membership, activities pertaining to accreditation of laboratories, proficiency testing providers and reference material producers, and participation in national and international activities and recognition arrangements throughout 2003. Also contained within the Annual Report is a summary of financial activities for the past year.

If you would like to receive a hardcopy of the Annual Report, please contact Teresa Barnett, A2LA Quality Manager, at 301 644 3202 or tbarnett@a2la.org.
         
       
         
   

Recent Meetings in the Area of Life Sciences

On March 18-19, 2004, Ada Hensley and Roger Brauninger attended, as exhibitors, the Food Safety Summit Exhibition at the DC Convention Center in Washington, DC. They spoke with personnel from several current and potentially accredited laboratories regarding A2LA accreditation. The sentiment received from the laboratories already accredited was overwhelmingly positive in terms of the level of service they have been receiving to this point from A2LA. In addition, they had occasion to speak with some parties that are very interested in seeking accreditation. Overall, booth traffic was good over the two days of the show.

On May 18, 2004, Roger attended the American National Standards Institute Homeland Security Standards Panel (ANSI-HSSP) Workshop on Biological and Chemical Threat Agents hosted by AOAC International in Gaithersburg, MD. The objective of this workshop was to begin to identify existing standards, standards under development, and gap areas in biological and chemical threat agent standardization, as well as to identify any existing or required conformity assessment programs.  The workshop also sought to prioritize work that is currently underway or that is needed. More work is needed, and there will be another meeting in early Fall 2004.

On May 23, 2004, A2LA participated in the American Society for Microbiology’s (ASM) Workshop, Verification, Validation and Accreditation for Microbiology Laboratories, held at the Morel Convention Center, New Orleans, Louisiana. For the accreditation portion of the workshop, the speakers included Roger Brauninger talking on So You Want to Become Accredited and Michelle Smoot of Silliker Laboratories speaking on Practical Approaches to Meeting Managerial and Technical Requirements to ISO Standard 17025 for Laboratory Accreditation. Method validation was covered by Darryl Sullivan of Covance Laboratories who spoke on the AOAC Approach to Method Validation by Single lab, Multi Lab and Collaborative Study, and Tom Hammack of the FDA’s Division of Microbiological Studies who presented Verification, Validation and Accreditation. The method verification topic was covered by Molly Mills of rTech Laboratories in her talk entitled ISO 17025: Method Selection and Verification: Fit-for-Purpose Concept - A Food Lab’s Perspective, Steve Benson of the USDA’s Food Safety Inspection Service who presented Method Selection and Verification Requirements of Accredited Regulatory Laboratories, and Arlene Fox of AOAC International who spoke on The Use of Proficiency Testing For Method Verification. The session was ably rounded out by the moderator of the workshop, Michael Brodsky of Brodsky Consultants who spoke on A Simple Microbiologists View on Estimation of Uncertainty of Measurement Approach.

The session was well attended by a diverse audience that included a significant number of those associated with testing laboratories as well as those with a more clinical laboratory background. A number of good questions were asked of the panel at the end of the session. This workshop (in a slightly “trimmer” format) will be repeated at the upcoming AOAC International’s annual meeting in St. Louis in September 2004.

 
         
       
       
   

2004 Quality Expo, Novi, MI

Once again A2LA attended the Quality Expo held in Novi, MI., which ran from June 9-10, 2004, at the Novi Convention Center. Steve Medellin and Brad Moore represented A2LA throughout the show. This year’s Expo provided a platform for a large number of manufacturers and industries to be on center stage and showcase their newest technologies for quality improvement.   Thanks to all who took the time to stop by the A2LA exhibit to inquire about the A2LA accreditation programs and how accreditation can be used to separate your laboratory from the competition.

For any inquiries or questions regarding the accreditation programs offered by A2LA, please contact A2LA at 301 664 3248 or visit us on the web at, www.A2LA.org.

Stop by and visit next year at our new-look exhibit at the 2005 Quality Expo, April 19-21 2005, at the Donald E. Steven Convention Center in Rosemont, IL. We look forward to seeing you there.

 
       
     
       
   

A2LA Exhibits at the 2004 NCSL International Workshop and Symposium in Salt Lake City, UT

The National Conference of Standards Laboratories (NCSL) International held its 2004 Workshop and Symposium July 11 through 15, 2004, at the Salt Palace in Salt Lake City, UT. A2LA presented two tutorials regarding laboratory accreditation and exhibited at the Symposium with Roxanne Robinson, Dana Leaman, and Tim Osborne representing the Association. Also exhibiting were a number of A2LA accredited test and calibration laboratories, including:

Air Force Primary Standards Laboratory, The Bionetics Corporation – Charlie Mays

Army Primary Standards Laboratory – Wesley England

Artel – Robert Pineau

Davis Inotek Instruments – Stewart Hopkins

DHI Instruments, Inc. – Mike Bair

Dynamic Technology, Inc. – Adam Webb

ESSCO Calibration – Manny Causland

Exelon Powerlabs – Thomas Pessa and Steven Scully

Guildline Calibration Services – Mike Frisz, Tony Anderson, and Bob Gangawer

ICL Calibration Laboratories, Inc. – Jeff Kelly

Interface, Inc. – Keith Skidmore

JJ Calibrations – Jan Johansen

Laco Technologies – Paul Chamberlain and Rogelio Gutierrez

Lockheed Martin – Mark Hayes

Process Instruments, Inc – Jay Klevens

Quametec Corporation – Karen Moor , Jim Jenkins, and Jeff Gust

Richard J. Bagan, Inc. – Randy Long and Dick Bagan

Simco Electronics – Dennis Taylor and Tom Hettenhouser

Sypris Test & Measurement – Sammy Isbell

Tegam – Michael Eckart

Transcat – Keith Hadley

Vaisala – Bruce McDuffee and Ricky Henderson

Veriteq – Kevin Bull

We enjoyed speaking with all who took time to stop by our exhibit. If you have any questions or concerns regarding A2LA accreditation, please contact Dana Leaman or Tim Osborne at A2LA Headquarters.

Please stop and see us at the 2005 Workshop and Symposium August 7 th through 11 th in Washington, D.C.

 
       
     
       
   

New and Updated Documents

  • On June 15, 2004, A2LA issued a current Good Manufacturer’s Practices (cGMP) checklist. The criteria contained in this checklist are to be used in evaluating a laboratory to US FDA cGMP requirements as specified in 21 CFR Parts 210 and 211. These criteria primarily address those lab activities dealing with drug production, containers, closures, etc. but may have relevance with other aspects of drug manufacturing as well. Any laboratories wishing to be assessed to these criteria are now able to include it within their A2LA accreditation. Please call your Laboratory Services Officer if you are interested in pursuing this option further.
  • On June 15, 2004, A2LA issued a combined ISO/IEC 17025/AOAC Food Criteria checklist and, on June 25, 2004, issued a combined ISO/IEC 17025 Animal Drug Testing checklist. Each of these checklists contains the full text of ISO/IEC 17025 in addition to the specific program criteria for the AOAC Food Program or the Animal Drug Testing program. Laboratories will be given the option of receiving and completing the combined checklist in lieu of the ISO/IEC 17025 checklist alone during their renewal or initial application process. However, since they do contain the full text of the standard, new applicants to these programs must sign an affidavit attesting to their ownership of the standard and, in the case of the food-testing program, ownership of the AOAC Food Criteria.
  • The transition period from the Interim Policy on Measurement Uncertainty for Testing Laboratories to the Measurement Uncertainty Policy for Testing Laboratories (dated 3/8/04) was completed. The Interim Policy has been removed from circulation and all laboratories are now expected to comply with the 3/8/04 version, which is available on the A2LA website.
  • In July 2004, the A2LA Wyoming Storage Tank Remediation (STR) Program Requirements officially replaced the former Wyoming Remediation of Leaking Aboveground and Underground Storage Tank (LAUST) Program Requirements. The revision was made to update the program’s name and also to update the associated test methods.
       
     
       
   

Use of the “A2LA Accredited” Logo

A2LA-accredited laboratories are strongly encouraged to promote their A2LA accreditation by using the “A2LA Accredited” mark. However, there are requirements pertaining to the way in which this may be promoted. A2LA has issued its Laboratory Reference to A2LA Accredited Status – A2LA Advertising Policy document to assist laboratories in developing clear and appropriate means of utilizing the “A2LA Accredited” mark.

Over the years, there has arisen some confusion over the distinction between the “A2LA Accredited” mark:

and the “A2LA” logo:

Although the current Advertising Policy appears to allow the use of either by an accredited laboratory, the original intent was for laboratories to use only the “A2LA Accredited” mark. Use of the “A2LA” logo is restricted for use by A2LA itself.

At its October 2004 meeting, the Board of Directors will decide on a revision to the current Advertising Policy. This revision will make clear the distinction between the two marks and will make clear that laboratories may only use the “A2LA Accredited” mark. Upon acceptance of this revision, laboratories will no longer be able to use the “A2LA” logo and simply include a statement of accreditation with it.

 

 

For example, below is an appropriate reference to a laboratory’s accreditation status:

CERTIFICATE #9999.99

However, the following is not appropriate:

ACCREDITED LABORATORY
CERTIFICATE #9999.99

Although a reasonable implementation timeframe will be given, laboratories are encouraged to review their current use of the “A2LA Accredited” mark and/or “A2LA” logo to ensure it is in keeping with the above clarification. In addition, ILAC will shortly be issuing rules for use of the ILAC MRA mark conjoined to the A2LA logo and to the A2LA-accredited mark. We expect our revised Advertising Policy to include these rules so that A2LA-accredited laboratories can make use of this mark of international recognition and acceptance.

As always, A2LA staff is happy to review any current or proposed reference to A2LA on advertisements, letterhead, reports, etc. for compliance with the Advertising Policy. We expect the revision to the Advertising Policy to be ready for distribution by the end of 2004 and all laboratories will be notified at that time.
 
       
     
       
   

Recalibration Intervals on Calibration Certificates and Other Problems…

During a laboratory's on-site assessment, A2LA assessors look closely at relevant calibration certificates.  For testing laboratories, the assessors examine certificates related to the equipment and reference standards used, looking specifically to see that the calibration certificates received by the testing laboratory are in compliance with the A2LA Policy on Measurement Traceability and the laboratory's own purchasing procedure and vendor approval practices.  For calibration laboratories, the assessors also examine the certificates they issue to their clients, looking specifically to see that appropriate contract review procedures were adhered to and that appropriate information was presented in the certificates per ISO/IEC 17025 and the A2LA Calibration Program Requirements.  If problems are noted with certificates in any of these cases, the assessors bring them to A2LA's attention and cite deficiencies as appropriate.

One of the most common, recurring problems that we see is that of recalibration intervals stated on a certificate of calibration without obtaining prior agreement from the client.  The responsibility for ensuring that this problem does not occur is borne by both the laboratory that receives the calibration certificates and the calibration laboratory that issues them.

Testing and Calibration Laboratories Receiving Calibration Certificates from External Sources:

Section 4.6.2 of ISO/IEC 17025 requires laboratories to use services and supplies that comply with specified requirements.  In the case of external calibration services, the 'specified requirements' are those outlined in the A2LA Policy on Measurement Traceability and ISO/IEC 17025 Section 5.10.  As part of their procedure for purchasing services and supplies, laboratories should very clearly communicate with their calibration service provider what is expected of the product received (i.e., the calibration certificate).  For example, they should make it very clear if they want:  an 'accredited' calibration, a calibration certificate with the accrediting body's logo, a statement of uncertainty, a statement of any requested recalibration interval, etc.  This final item is only to be included on a calibration certificate with prior agreement.  If a lab receives a certificate that contains a recalibration interval that was not requested or agreed to, then it is the lab’s responsibility (per ISO/IEC 17025 Section 4.6.2) to contact the calibration service provider for an amended certificate.  If this is not done, an A2LA assessor will cite a deficiency because the lab did not ensure that the calibration certificate received was in keeping with what had been requested from the calibration service provider.

Calibration Laboratories Issuing Calibration Certificates:

Section 4.4.1 of ISO/IEC 17025 requires laboratories to have a procedure for contract review that ensures the requirements of the contract/request for service are adequately defined, documented and understood.  Section 5.10.4.4 of ISO/IEC 17025 requires that calibration laboratories not include on their calibration certificates any recommendation on the calibration interval except where this has been agreed with the client.  If a calibration provider issues a calibration certificate that contains a recalibration interval, but there is no evidence that this was included only in agreement with the client to whom it was issued (e.g., through implementation of the contract review procedure), the A2LA assessor will cite a deficiency.

It is equally important that all laboratories (whether they are the ones receiving these certificates or the ones issuing them) understand the part they play and the responsibility they bear.  A2LA assessors will continue to cite deficiencies if the above problems are noted, but it is our hope that communication between laboratories and their calibration service providers will improve and instances of these problems will be lessened as a result of this reminder.

If you have any questions, please feel free to contact your A2LA Laboratory Services Officer.

       
     
       
   

A2LA’s New Uncertainty Policy

A2LA issued a Policy on Estimating Measurement Uncertainty for Testing Laboratories on March 8, 2004. This policy replaces the A2LA Interim Policy on Measurement Uncertainty for Testing Laboratories. There are two significant changes in the new policy which will affect both labs and assessors.

Sampling of Uncertainty Budgets

The first difference involves the assessment of measurement uncertainty budgets. Prior to performing the assessment, the assessor will review the lab’s Scope of Accreditation for testing that requires uncertainty budgets (categories III, IV, and V). Of these, the assessor will select 15% (or a minimum of one) for review and notify the lab of those selected. Any new testing requested to be added to the Scope will be considered as part of this 15%. The lab is then expected to supply the uncertainty budgets for these tests to the assessor for review “by the time of the assessment.” In subsequent assessments assessors will select a different 15% for review until all testing has been reviewed and the cycle will start again.

There are two exceptions to this 15% sampling rule. The first is for testing requiring the reporting of the estimated best measurement uncertainty on the Scope (e.g. dimensional testing). All uncertainty calculations for these test methods must be reviewed in addition to the 15% mentioned above. Additionally, assessors may ask to review specific uncertainty budgets either before or during the assessment for uncertainties included on test reports. Again, this is in addition to the 15% reviewed as part of the normal assessment and not dependent upon whether the budgets were reviewed in a previous assessment. Assessors may write a deficiency if uncertainties are being reported in test reports that have been improperly calculated.

Category III Uncertainties

First, let us clarify a few “types.” Category III and IV refers to measurement uncertainty classifications as defined in the A2LA uncertainty policies. Type A and B refers to measurement uncertainty components in determining an expanded uncertainty. Type A components are based on random and systematic errors and are commonly evaluated by performing repeatability and reproducibility studies and the resultant standard deviation. Type B components are evaluated using standard deviations of assumed probability distributions, such as uncertainties of calibrations and reference standards commonly reported on certificates, environmental conditions, etc. Type A and B components are often combined in a root-sum-square method to obtain a combined uncertainty.

There is a subtle difference in the definition of category III uncertainties in the current policy that may affect chemical, environmental, and/or biological labs. The Interim Policy classified category III uncertainties as chemical, environmental, or biological test methods based on published regulatory or consensus standards for which the uncertainty is not defined in the test method. In this case, the estimated uncertainty is based solely on the standard deviation (Type A components) of laboratory control samples.

In the new policy the uncertainty of chemical, environmental, or biological test methods based on published regulatory or consensus standards for which the uncertainty is not defined in the test method (the same wording as in the Interim Policy) must be evaluated using appropriate guidance documents, such as, the ISO Guide to the Expression of Uncertainty in Measurement (the GUM), CITAC Guide 1, ISO5725, etc. These documents require an analysis of both Type A components and Type B components. It is no longer sufficient to automatically assume Type A components are the sole (or major) contributing factors to the uncertainty. Labs must evaluate both Type A and B components and calculate a combined uncertainty if there are multiple, significant contributing factors. The last sentence in the definition of category III tests goes on to say that there may be some methods which have no significant Type B uncertainty contributors. In this case it is sufficient to base the uncertainty solely on the Type A component.

Essentially, the new definition creates two classes of category III testing. Category IIIa requires an analysis of both Type A and B contributors to measurement uncertainty. This is similar to category IV tests as defined in the both of the A2LA measurement uncertainty documents. Category IIIb tests are those which have only a Type A component (random error). How do you know if you have a category IIIb test? Perform the uncertainty analysis as if it were a category IIIa. If the Type B components are negligible, then it is category IIIb.

 
       
     
       
   

Laboratory Accreditation Work of the ISO Committee on Conformity Assessment (CASCO)

The ISO Committee on Conformity Assessment has undertaken a major revision of most of its documents, converting those specifying requirements from guides to standards and renumbering them (the 17000 series). Three of those standards (17025, 17011 and 17000) directly address laboratory accreditation practice.

Amendment of ISO/IEC 17025:1999

The working group (WG 25) met for the fifth time to review the voting results and comments received on ISO/IEC DAM 17025 (DAM = draft amendment). The effort to amend ISO/IEC 17025:1999, General Requirements for the Competence of Testing and Calibration Laboratories began in 2002. The DAM received a very high (92%) level of approval from ISO members and 91% approval from IEC national committees. After making some minor changes to the amendment, WG 25 agreed that the revised text be released for the approval stage ballot as the final draft amendment (FDAM).

The scope of the standard is being revised to make it clear that ISO/IEC 17025 is not to be used by certification/registration bodies to certify a laboratory's conformity with the requirements of 17025.  Effectively, ISO/IEC 17025 is reserved for accreditation of laboratories or as the basis of peer assessment, but not certification/registration.

Next Steps and Timeframes for the New ISO/IEC 17025

The FDAM text will now be sent for the necessary translations and to the ISO Central Secretariat for final editing. The FDAM should be available for approval stage balloting by October 2004. The approval stage ballot period is 2 months. Assuming a positive vote by ISO member bodies and IEC national committees on the FDAM, the new edition of ISO/IEC 17025:2005 incorporating the approved FDAM is expected to be available by the end of March 2005.

Transition Period to ISO/IEC 17025:2005

The International Laboratory Accreditation Cooperation (ILAC) is expected to decide, in consultation with ISO CASCO, the effective date for implementation of the 2005 version of 17025. Enforcement of new requirements is not expected any earlier than 2006.

Final Draft International Standard 17011 for Accreditation Bodies

Another CASCO working group (WG 18) has worked for the last four years to consolidate three guides for accreditation bodies into one standard, ISO/IEC 17011. ISO/IEC FDIS 17011 has been approved. WG18 met on July 29, 2004, to advise the CASCO Secretariat on how to handle two sets of requested corrections in relation to calibration and the definition of conformity assessment body. The only task at the WG18 meeting was to provide the Secretary with specific advice on the two sets of requested corrections. Based on the advice received, the Secretary will make his final recommendations to the office of the ISO CEO for specific corrections to be made to ISO/IEC FDIS 17011 prior to its publication. 

Corrections to the introduction and scope of ISO/IEC 17011 were requested to reflect Resolution 11 of the 22nd General Conference on Weights and Measures (CGPM) that noted calibration is not a conformity assessment activity. Changes may be made to accommodate the CGPM’s resolution without changing the intent to have calibration laboratories be accredited by accreditation bodies that fulfill the requirements of ISO/IEC FDIS 17011. If this is not the case, then pursuant to ISO rules, the changes cannot be included.

The second set of requested corrections highlighted the need for ISO/IEC FDIS 17011 to have terms and definitions that are the same, or are not in conflict with, those set out in ISO/IEC FDIS 17000, Conformity Assessment – General Vocabulary. This has been an ongoing issue given the parallel development of both international standards. 

There are numerous changes and improvements over the current requirements contained in ISO/IEC Guide 58 for laboratory accreditation bodies. Most of the new requirements reflect current practice in A2LA, so A2LA is well positioned and does not foresee any significant changes that would affect its accredited laboratories.

Transition Period to ISO/IEC 17011:2005

The ILAC is expected to decide in consultation with ISO CASCO and the International Accreditation Forum (IAF) the effective date for implementation of ISO/IEC 17011:2004. Enforcement of the new requirements during future peer evaluations by ILAC and its recognized regions is not expected to begin until 2006.

Definition of AccreditationCASCO WG 5 on terms and definitions met on July 28 to complete the final text of ISO/IEC FDIS 17000 for a 60-day voting period. The definition of accreditation as proposed in the DIS is, “Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks.” “Laboratory accreditation” would no longer be separately defined in ISO/IEC 17000. While this new broader definition is more abstract, one can easily deduce what “laboratory accreditation” is by melding the old definition with the new one to get, “Third-party attestation related to a laboratory conveying formal demonstration of its competence to carry out specific tests or calibrations.”

A2LA will keep you apprised as these three standards, 17025, 17011, and 17000, are published and made available in 2005.

 
 
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