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| A2LA News: The Newsletter of the American Association for Laboratory Accreditation__January 2006, Number 91 | |||||||||||||||||||||||||||||||
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In This Issue....... |
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General Updates, Notices & Press Releases- A2LA 2006 Conclave Meeting Summaries- Entering Into The Veterinary Diagnostics World Updates on A2LA Operations & Policies- Calibration vs. Service International & Domestic Involvements- News from the Inter-American Accreditation Cooperation (IAAC) |
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A2LA 2006 ConclaveA2LA will be holding its 2006 Conclave March 7 – 13, 2006, at the Sheraton Columbia in Columbia, MD. Invitations were sent out in early January of 2006. Meetings on March 11 and 12 are open to interested parties and A2LA encourages laboratory representatives to attend. If you would like to attend the Conclave and/or participate in one of the advisory committees, or if you should have received an invitation but have not, please contact A2LA (301 644 3248) or your Laboratory Services Officer. | |||||||||||||||||||||||||||||||
Press Release: Product Certification Body Accreditation ProgramA2LA is expanding its services with the launch of its product certification body accreditation program. A2LA is currently accepting applications for accreditation from product certification bodies seeking to be accredited to ISO/IEC Guide 65:1996, General Requirements for Bodies Operating Product Certification Systems. We welcome applications for accreditation of all types of certifications. Examples of work for which accreditation may be sought can be found in the General Requirement of Accreditation for Product Certification Bodies.
Also, A2LA has applied to NIST for recognition as an accreditation body of telecommunication certification bodies (TCBs). NIST/NVCASE representatives will be conducting a technical evaluation of A2LA’s certification body accreditation program. Upon NIST approval, A2LA will be recognized to accredit TCBs in accordance with ISO/IEC Guide 65:1996, and the appropriate FCC rules along with Industry Canada (IC) and Singapore’s certification body requirements for telecom equipment. Applications for accreditation can be found on the A2LA web site or by contacting A2LA directly at 301 644 3248. If you would like additional information on the A2LA product certification body accreditation program, please contact Brad Moore by phone at 301 644 3226 or by email at bmoore@a2la.org. |
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Results of A2LA Board of Directors ElectionElections for officers and members of the 2006 A2LA Board of Directors were held recently among the A2LA membership. Trevor Boyce of Microbac Laboratories has been elected Chairman of the Board. William Harral was elected First Vice Chairman just prior to his unexpected death, so that position remains vacant at this time. James Galipeau of Plastics Technology Labs, Inc. has been elected Second Vice-Chairman and Nancy Foncannon of Quality Systems Consulting, Inc. has been elected Secretary. Newly elected members of the Board include George Robert Brammer, Edward Colbert, Arlene Fox, and Dilip Shah. Keith Bennett of Transcat Laboratories was welcomed to the Board in October 2005 to replace a resigning member. A2LA welcomes each of them to their elected positions and anticipates stimulating and productive interactions with the 2006 Board of Directors. |
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Remembering Joe Kane
Joe's younger brother, Dan, shared his memories of his older brother during the funeral services. As Dan pointed out, Joe was not the sort of person who wanted credit for his hard work or sought to be the center of attention. Joe's 15 minutes of fame never came and probably never would have even if he had lived to be 100. Instead, Joe was a steady presence in the lives of his family, close friends, neighbors, and co-workers. He was a loving and attentive father who never had to think about his priorities. He was a source of strength to Lisa during her father's illness and death and to his family during his sister's battle with cancer, which took her life the year before Joe died. Joe enjoyed participating in sports throughout his life including playing baseball for Good Council High School and later playing in adult softball and volleyball leagues. He also enjoyed fishing. He is buried next to Lisa's father in a cemetery that is within view of A2LA's offices in Frederick. Joe worked at A2LA as a Senior Laboratory Services Officer serving laboratories in the construction materials testing area. Prior to coming to A2LA, Joe worked for ten years as an inspector for the Cement and Concrete Reference Laboratories (CCRL) in Gaithersburg, MD. He is deeply missed by his friends and coworkers at A2LA. We will always remember Joe for his willingness to help others, his sense of humor, and his steadfast dedication to his family and friends. Memorial contributions may be made to: The Emily T. Kane and Jack D. Kane Trust, C/O Keith Sanders, First United Bank and Trust, 1990 Monocacy Blvd., Route 26, Frederick, MD 21701. |
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Remembering Bill HarralWilliam M. Harral passed away on January 23, 2006, at the age of 65. Bill was CEO of Arch Associates LLC, a Northville, MI, environmental and quality management systems consulting and training firm. He founded Arch Associates in 1983 after twenty years in engineering, manufacturing, testing, and quality management positions at Ford Motor Co. Arch has served the business community for the past twenty years utilizing the outstanding professionalism of Bill and many of his friends and associates in industry. He held a MBA from The University of Michigan and obtained his BS in industrial and systems engineering in an honors program as a Sloan Scholar at Ohio State University. He held multiple professional certifications (ASQ: CQA, CQE, CQMgr, CRE, and QS-LA; PEIT-Ohio). Laboratory experiences range from part-time lab technician during college to designing, training, and implementing Guide 25 and ISO/ IEC 17025 systems for clients. Bill was a very active professional volunteer and began duties with the A2LA Board of Directors in 2000 on which he served as 2003 – 2005 secretary and the 2005 2nd vice-chair. Previously, he served at local chair, regional director, and national officer levels with American Society for Quality (ASQ) and was named as an ASQ Senior in 1987 and then an ASQ Fellow in 1992. He was ASQ Auto Division Certification Chair/Standards alternate and ASQ Detroit Healthcare Chair. Other volunteer activities included: participating (voting) member of U.S. Technical Advisory Group to ISO Technical Committee 176; American National Standards Institute (ANSI) Z1 committee voting member; Steering Committee of Truck and Heavy Equipment Group (THEG) of the Automotive Industry Action Group (AIAG); and member of THEG reliability and quality committees. Mr. Harral was a frequent meeting/conference speaker, contributor of articles to professional journals and contributing or co-author of books, e.g. The ISO 9000 Handbook, Edition 1 and Edition 2, The QFD Handbook, ASQ Advance Quality Planning, ASQ Greater Detroit Certified Quality Engineer Refresher Manual, ASQ Greater Detroit Certified Quality Auditor Refresher Manual, ASQ Auditor Handbook – Third Edition (2005), AIAG Truck and Heavy Equipment Reliability Guide (2004). In addition to manufacturing, Mr. Harral worked in non-manufacturing environments of agriculture, research/calibration/testing laboratories, logistics & warehouses, business services, construction and air/land application of herbicides & pesticides. Focus ranged from shop floor/line activities to corporate executive staffs. Organizations varied from few person firms to global fifty corporations/consortiums. In lieu of flowers the family requests that donations be made to the charity of your choice in Bill's name, if so you desire. Condolences can be sent to Michael Harral at Michael.Harral@mann-hummel.com or info@archassociates.com. |
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Remembering Howard FormanDr. Howard I. Forman, 88, a lawyer and advocate for inventor’s rights in the United States and abroad, died of heart failure Monday December 5, 2005. From 1974 to 1981, Dr. Forman was a deputy assistant secretary in the U.S. Commerce Department directing the department’s Office of Product Standards (OPS). He spearheaded the department’s efforts to persuade foreign business communities to stop infringing on U.S. patents and accept U.S. developed laboratory product data. Howard was a founder of the International Laboratory Accreditation Conference (now the International Laboratory Accreditation Cooperation (ILAC)) and the National Inventors Hall of Fame. He was a member of the boards of ANSI, ASTM and A2LA. He wrote more than 200 articles about patent law and authored four books. During World War II, he helped develop weapons at the Frankfort Arsenal and eventually became chief of patents there. At nights he attended Temple law school and received a law degree and later a master’s degree and doctorate from the Wharton School. In 1956, he joined the legal department of Rohm & Haas Corp. and was chief of the international and Asian trademarks division when he left in 1974. He also wrote and produced a play, The Birth of the American Patent System, which was performed and filmed in Independence Hall in 1976 as part of the Bicentennial. After retiring from government service, he was a standards and international laboratory accreditation consultant and also served as an arbitrator for civil cases until his mid-80s. |
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Remembering Erskine Bronson (Bud) Mayo, Jr.Mr. Mayo, 88, of Matthews, NC, died December 18, 2005. He was born on October 17, 1917, in Jersey City, NJ, the son of the late Erskine Bronson Mayo and Sara Alberts Mayo. Mr. Mayo was raised in Westfield, NJ, where he graduated from Westfield Sr. High School. He then attended Colgate University where he received his AB degree and was a member of the Phi Kappa Tau fraternity. He served in the South Pacific during World War II and was a retired Commander, SC, US Naval Reserve. Upon leaving college, he first worked with Wright Aeronautical Corporation, then with Lucius Pitkin, Inc. from 1946 to 1982. While at Lucius Pitkin, Inc., he served as Secretary, Treasurer, and Sampling Director. Among his numerous contributions, Mr. Mayo was:
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New & Updated Documents
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A2LA VP to Speak at February 2006 ASQ MeetingInterested in learning more about what’s hot and what’s happening in the world of ISO/IEC 17025 and laboratory accreditation in general? Roxanne Robinson, A2LA Vice-President, will be the featured speaker at the February 16, 2006, dinner meeting of the Akron-Canton Section of the American Society for Quality (ASQ). Ms. Robinson will present a technical clinic on the changes to ISO/IEC 17025 that were promulgated in Akron-Canton Section 810 meetings begin with a technical clinic at 5:30 PM followed by dinner and a speaker concluding around 8:30. Meetings are open to the public at a cost of $20 for dinner, and reservations can be made on line. |
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Opportunities for Test Labs to Participate in NCSLIThe National Conference of Standards Laboratories International (NCSLI) has expanded its mission to include meeting the needs and interests of testing laboratories. Historically, NCSLI had focused its energies on the needs and interests of the calibration world and there is a robust NCSLI membership of knowledgeable calibration organizations and calibration professionals that actively participates in standards writing, committee work, presentations and tutorials for NCSLI. Now testing laboratories are invited to become active within NCSLI and take advantage of many opportunities to interact with these calibration professionals about issues such as estimation of measurement uncertainty, traceability, and maintenance of measuring and testing equipment. Also, current NCSLI committees are looking for testing laboratory professionals who can contribute their input and knowledge of testing issues to the scopes of work of these committees. There is an NCSLI committee (158 Industrial Programs: Testing Laboratories Committee) specifically created for testing laboratories to discuss issues of importance to them and to serve as the point of contact for interaction with other more calibration-related committees. For further information about joining this Testing Laboratories Committee, please contact the committee chair, Ms. Marlene Moore, at 302 368 1211 or mmoore@advancedsys.com. There is also a 171 Laboratory Evaluation Resources Committee whose members are tasked with writing a handbook providing guidance on the application of ISO/IEC 17025:2005. ISO/IEC 17025 is the international standard for both testing and calibration laboratories, so it is important that this committee include appropriate representation from the testing community. For further information about joining this committee, please contact the committee chair, Mr. Chester Franklin, at 951 313 3866 or cfranklin@cscnorco.com. NCSLI is a 501c3 membership organization, but one does not have to be an NCSLI member to serve on its committees. For further information about NCSLI, please visit the web site (www.ncsli.org) or contact Roxanne Robinson, NCSLI Vice President of Industrial Programs, at rrobinson@a2la.org. |
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Manufacturing & Measurement Conference & WorkshopA2LA is pleased to announce that we will be exhibiting at the Manufacturing & Measurement Conference & Workshop (MMCW) formerly IDW. Now in its 8th year, the MMCW announces new & expanded topics in 2006 covering both dimensional measurement issues and strategies, as well as measurement in manufacturing situations. Session topics include:
And much more. For more information on the conference, workshops and registration visit http://conferences.bnpmedia.com/QTY/MMCW
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Entering into the Veterinary Diagnostic WorldIn November 2005, A2LA introduced our new Veterinary Diagnostic Program Requirements. In order to begin marketing this new program, we attended the American Association of Veterinary Laboratory Diagnosticians (AAVLD) conference in November 2005 and exhibited at the American Society for Veterinary Clinical Pathologists (ASVCP) conference in December 2005. While at the AAVLD conference in November, A2LA attended a number of the technical and quality meetings and spent time introducing ourselves to the exhibitors at the show. This opportunity allowed us to meet a number of prominent individuals in the field in order to foster future relationships. In December at the ASVCP conference, A2LA exhibited and participated in an ISO/IEC 17025 discussion led by Dr. Lester from Central Laboratory for Veterinarians, LTD. The show gave A2LA the opportunity to present ourselves in a positive way and to speak one-on-one with the laboratories in an effort to expand A2LA into this new area of interest. While the show was a wonderful opportunity, the discussion led by Dr. Lester helped to promote the importance of ISO/IEC 17025 and our ILAC partnership. Dr. Lester and her colleagues went into great depth on applying the standard and achieving the maximum benefits that it is capable of giving. Over the next year, A2LA looks forward to advancing into the veterinary diagnostic field through further discussions and exhibits. If you are interested in this field of testing or have any questions, please contact Ada Hensley, Sr. Laboratory Services Officer, at 301 644 3234 or via email at ahensley@a2la.org. |
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A2LA Technical Assessors Meet to Discuss NELAC PTPA/PTOB ProgramA2LA hosted several of our life science technical assessors for a weekend session at A2LA headquarters in Frederick, MD, on October 29th and 30th. The objective of the meetings was to help foster consistency in the interpretation and application of the requirements used to support the National Environmental Laboratory Accreditation Program’s Proficiency Testing Provider Accreditor/Proficiency Testing Oversight Body (NELAC PTPA/PTOB) Accreditation Program. Randy Querry provided the assessors with an overview on the background of the requirements and the roles and responsibilities of A2LA as a PTPA/PTOB. The group then immersed itself into each of the standards being employed in the accreditation program to identify redundancies in the requirements as well as to discuss the application and practical implementation of the standards as an assessment tool. Assessors in attendance included Ms. Marlene Moore, Ms. Mitzi Miller, Ms. Dawn Mettler, Mr. Dan Tholen, Mr. Kenneth Stoub, and Dr. William Mills. A2LA was recognized by NELAP as a PTPA/PTOB in August 2005 following an evaluation of A2LA comprised of a review of the implementation of our policies and procedures, interviews with staff, and the review of records as well as an evaluation of an assessment team assessing a proficiency testing provider. The NELAP standards require that the proficiency testing providers meet the requirements of ISO Guide 43, ISO Guide 34, ISO/IEC 17025, NELAC Chapter 2 and relevant sections of NELAC Chapter 5. A2LA will use assessment teams comprised, at a minimum, of a technical assessor and a statistician; however, the number of assessors will be determined by the extent of proficiency testing schemes offered and the size of the organization. A2LA is scheduling on-site assessments of proficiency testing providers to occur in the first quarter of 2006 with the goal of naming the first class of A2LA NELAC proficiency testing providers in July 2006. Inquiries may be directed to Randall Querry, Program Manager, at 301 644-3221 or via email at rquerry@A2LA.org. |
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Calibration vs. ServiceWhat is a calibration? As a testing lab, what do you expect when you call an A2LA accredited calibration provider and ask to get your brand-new, budget-busting piece of high-tech equipment calibrated? The ISO International Vocabulary of Basic and General Terms in Metrology (VIM), a normative reference for ISO/IEC 17025, basically defines a calibration as a comparison between a reference standard and the indications of a measuring system. There is nothing in the definition about adjusting or servicing. A2LA accredits laboratories to ISO/IEC 17025 as being competent to perform the calibrations listed on their Scopes of Accreditation. We do not assess nor accredit for competence in servicing of equipment. This is becoming more of a concern as measuring systems become more complicated and dependent on proprietary software. You may contract an accredited calibration provider to calibrate a coordinate measuring machine (CMM). The provider will put some type of reference standard on the machine, run it through its paces, and issue a calibration certificate. It may even contain a statement of in or out of tolerance. That is where the A2LA accreditation ends. If some aspect is out of tolerance, the calibration technician may or may not be able to adjust the device. He may cause sparks to fly and smoke to pour forth in the process. Unless the calibration provider in some way falsely implied that service of the device falls within the A2LA accreditation, this is not an issue we can do much about. There are some calibrations where minor servicing is part of the calibration procedure to allow the equipment being calibrated to function at its best. Gage blocks are commonly wiped with a solvent. Optical comparitors and microscopes may have surfaces and lenses cleaned. These are part of the calibration process and should be defined in a calibration procedure. It is important for both parties to be clear in the contract review process (Sections 4.4 and 4.6) before the calibration takes place. After the client lab asks if the provider can perform an accredited calibration, the next question may be, “What kind of service can you provide if the equipment is out of tolerance?” Calibration providers should document the expectation of service and be clear it is not covered under the A2LA accreditation. A2LA is not trying to avoid responsibility. We have a complaint process in place at our web site or complaints can be discussed with Teresa Barnett, the Quality Manager (301-644-3202). But many problems can be avoided by asking the right questions up-front and using and documenting the contract review process. |
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Domestic Traceability Issues(Reprinted from a 1/20/06 memorandum to A2LA accredited and enrolled laboratories and A2LA assessors from Peter Unger, A2LA President) In December 2004, A2LA withdrew from the NACLA MRA for various reasons that we have reported in our A2LA newsletter and on the A2LA website. Prior to the decision to withdraw from the MRA, A2LA took part in the Acceptance Panel discussion and subsequent decision of the NACLA acceptance of L-A-B – albeit with a reduced scope of recognition. However, with A2LA departing from the MRA soon after L-A-B’s acceptance, A2LA made a good faith business decision to extend a bilateral agreement with L-A-B to enable A2LA test and calibration laboratories to obtain traceability through an L-A-B accredited calibration laboratory. In October 2005, the A2LA Board of Directors made the decision to sever all ties with NACLA, including membership, due to lack of enforcement of the MRA obligations of signatory accreditation bodies (ABs) and operational missteps by NACLA. A2LA can no longer place any confidence in NACLA for the formation of bilateral arrangements. As such, A2LA will rely solely on international MRAs to establish and maintain mutual recognition among ABs and will sever all bilateral arrangements that have been established. Therefore, beginning January 1, 2006, A2LA will only accept traceability via the use of calibration laboratories accredited by an AB that is a signatory to the APLAC, EA, IAAC, or ILAC MRA. Currently in the United States, only A2LA, International Accreditation Services (IAS) and the National Voluntary Laboratory Accreditation Program(NVLAP) meet the A2LA Policy on Measurement Traceability. Please note that if you are currently using a calibration provider that does not meet the A2LA Traceability Policy, you do not need to immediately re-calibrate the equipment in question, however, you must use an acceptable source of calibration for the next regularly scheduled calibration cycle. A list of A2LA accredited calibration laboratories can be located on our web site. If you have any questions or need any further information, please contact A2LA or your Laboratory Services Officer. |
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The Purpose of Traceability StudiesA2LA recently received a call from a corporate technical manager of a large chain of calibration providers. He mentioned that his labs have been contacted by A2LA accredited laboratories asking for evidence of traceability. For A2LA and other recognized accrediting bodies (ABs), the AB’s symbol or reference to accreditation by the AB on the calibration certificate is the evidence of traceability. No other evidence is required. If a lab desires a traceable calibration from an accredited calibration provider, then it must request an accredited calibration certificate, that is, one with the AB’s symbol on it or reference to accredited status. If a lab is cited for not having a traceable calibration certificate from an accredited provider, the remedy is to get an accredited certificate. A traceability study is not acceptable and A2LA does not expect accredited calibration providers to provide this to their clients in such cases. One of the purposes of the accreditation process is to avoid having to provide traceability studies to all clients. The only purpose of a traceability study is to provide evidence that a non-accredited calibration provider or a provider accredited by a non-recognized AB can trace the calibration provided to a national metrology institute (NMI) when an accredited calibration provider cannot be found or used for a legitimate reason. For more details on the use of non-accredited or non-recognized calibration providers, see “Exceptions to the A2LA Traceability Policy” in the February 2002 A2LA News. A2LA cannot dictate the requirements of other assessing or auditing bodies; however, accredited calibration providers receiving requests for traceability studies should contact A2LA with all pertinent information. We will do what we can to alleviate these requests. |
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New Applications of ISO/IEC 17025 RequirementsOn January 5, 2006, the A2LA Criteria Council voted to approve two new applications of ISO/IEC 17025: 2005 requirements. These and other explanations may be found on the A2LA website, Understanding ISO/IEC 17025. ~~~~~~~~~~~~~~~~~~~~~~~ Section 4.14.1 (ISO/IEC 17025:2005) - Does this section require that an internal auditor have specific training on ISO/IEC 17025? ~~~~~~~~~~~~~~~~~~~~~~~~ If you have questions about these or any other applications of the ISO/IEC 17025 requirements, please contact A2LA. |
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News from the Inter-American Accreditation Cooperation (IAAC)The Inter-American Accreditation Cooperation (IAAC) held a series of meetings in Rio de Janeiro late in 2005. Included was a three-day workshop with 30 peer evaluators and candidates (in Spanish and Portuguese). This followed up two workshops held in October (English only). This effort to develop 17011 expertise with the peer evaluators from the Latin American countries was very successfully carried out under the leadership of Fabian Hernandez, EMA, Bertha Munguia, A2LA, and Mauricio Soares, Heliane Fonseca, and Suzana Saboia de Moura, INMETRO. The IAAC Technical Committee approved inter-laboratory comparisons for measurements of volume and water. The artifacts will be circulated throughout the Americas with several A2LA-accredited laboratories participating. At the IAAC Multi-Lateral Agreement (MLA) Committee meeting, Mexican Accreditation Entity (EMA), Mexico, was approved for calibration and testing lab accreditation. Various other peer evaluations for new signatories are in progress. The review of each IAAC MLA signatory’s conformity with the new requirements of ISO/IEC 17011 was assigned to the team member most familiar with the language of the accrediting body. The results will be reviewed at the August 2006 General Assembly meeting in Buenos Aires. Departing NVLAP chief Warren Merkel’s resignation as Vice-Chair of the IAAC MLA Committee was noted. Peter Unger agreed to replace him until the August 2006 meeting. At the IAAC Executive Committee Meeting, the status of several members was discussed. A new organization from Bolivia, Instituto Boliviano de Metrología (IBMETRO), has been accepted. The US-based American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) was recommended for General Assembly ballot approval as a full member of IAAC. IAAC is solvent. The cash flow is positive according to Keith Greenaway, the IAAC Treasurer. The IAAC Secretariat is being ably administered by Victor Gandy, IAAC Secretary, who is equally fluent in English and Spanish. The next meeting of the IAAC Executive Committee is April 5-7, 2006, in Santiago, Chile. Additional meetings are scheduled to coincide with the ILAC/IAF General Assembly meeting in Cancun scheduled for November 2006. |
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News from the Asia Pacific Laboratory Accreditation Cooperation (APLAC)The annual general meeting of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) took place in Chang Mai, Thailand, 14-18 November 2005. A2LA was represented by Peter Unger, Roxanne Robinson, Trace McInturff, and Dan Tholen. Three more signatories were added to the APLAC MRA: Canadian Association For Environmental Analytical Laboratories (CAEAL), Canada, for testing; Bureau of Product Standards Laboratory Accreditation Scheme (BPSLAS), Philippines, for testing and calibration; and Mexican Accreditation Entity (EMA), Mexico, for testing, calibration and inspection. The goal of recognizing at least one accreditation body before the end of 2005 which is both a member of APLAC and from a member economy of the Asia Pacific Economic Cooperation (APEC) has been successfully accomplished. The APLAC MRA Council also met in Chang Mai, Thailand. Some of the items presented were: several initial evaluation and re-evaluation reports were considered; MRA peer evaluation training on ISO/IEC 17011 was held in April 2005 with 42 lead evaluators and other APLAC members in attendance; the key changes and transition plan for ISO/IEC 17011:2004 for accreditation bodies were agreed; there are twenty-three signatories to the APLAC MRA (23 for testing; 20 for calibration; and 10 for inspection accreditation); the Asia Pacific Economic Cooperation (APEC) has funded 6 calibration and 15 testing proficiency testing programs to be run over 3 years. Joanne Dupont was elected to the Board of Management replacing Jeffrey Horlick. The following officers will serve on the APLAC Board of Management for 2006:
The APLAC committee chairs are:
APLAC documents and membership lists are available as PDF files at the APLAC web site. APLAC News Notes, published bi-monthly, is available only by electronic distribution (as a PDF) and via the APLAC web site. |
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