Aplac News Notes 120

September 2014 APLAC News Notes Issue No. 120

APLAC is an organization of accreditation bodies in the Asia Pacific area that have expressed a desire to cooperate in fostering the development of competent laboratories, inspection bodies, proficiency testing providers, and reference material producers in member economies.

Cooperation is to include: Exchange of information Joint training programs Proficiency testing Harmonisation of requirements Mutual recognition of systems meeting harmonised

requirements

APLAC NEWS NOTES is published four times a year to facilitate the exchange of information among members and interested parties. It is not copyrighted and may be reproduced in full. Excerpts should reference APLAC News Notes specifically. Wide copying and distribution are encouraged. APLAC also maintains a website at www.aplac.org.

Secretariat for APLAC:National Association of Testing Authorities (NATA)Level 1675 Victoria StreetAbbotsford VIC 3067AustraliaTelephone: +61 3 9274 8200Fax: +61 3 9421 0887Email: [email protected]

This issue is published by:

3060 Saturn Street, Suite 100Brea, California 92821-1732 U.S.A.1-562-364-8201 | www.iasonline.org

The next issue will be published in December 2014.

In thIs IssUEFrom the secretariat 2Update from IAs 3

Feature: IAS Joins APLAC/PAC for Its Inaugural Joint General Assembly

Update from PAC 7Feature: PAC and APLAC combine successfully to host joint annual meetings in Mexico

Update from BAB 10Feature: Bangladesh Prime Minister Interested in BAB Activities

Update from CALA 12ILAC Chairs Address Adds to Success of Cala Conference

Update from CnAs 13Laboratory Accreditation Subcommittee of the Mirror Technical Committee of ISO/CASCO in China Established

Update from hKAs 14Feature: HKAS Hosts APLAC Workshop on Medical Laboratory Accreditation

Update from IAAC 19Update from nAtA 22

Feature: NATA to provide assessments for National Health Standards

APLAC training Courses A successful training course for nominated evaluators was held in Ottawa, Canada, from 21 to 23 July 2014, hosted by CALA.

We thank our presenters for their time and efforts in conducting the training:

Mr. JEJ (Ned) Gravel, A-S-B, United States of America

Ms. Colleen Cotter, CALA, Canada Ms. Roxanne Robinson, A2LA, United States of

America

We also thank Ms. Maria Koslowski for her fine efforts in organising and assisting participants in the training course.

We have now trained a further 19 provisional evaluators: 3 for PTP; 4 for RMP; 4 for Inspection; 2 for medical; 5 for calibration and 14 for testing. Many of the provisional evaluators have competencies in multiple disciplines.

A successful workshop on Medical Laboratory Accreditation was held in Hong Kong, China, from 3 to 5 September, hosted by HKAS.

We thank our presenters for their time and efforts in facilitating the workshop:

Dr. Graham White, Chief Clinical Biochemist, Flinders Medical Centre, SA Pathology, South Australia

Dr. Anthony Shek, Consultant Chemical Patholo-gist, Queen Elizabeth Hospital, Hong Kong, China

Ms. Linda Crawford, QMP-LS, Canada Dr. Sook-Kyung Kim, Korea Research Institute of

Standards and Science (KRISS), Korea Representatives from various accreditation bodies

(CNAS, TAF, JAB, HKAS)

We also thank Dr. Lillian Chow, HKAS, the rapporteur for this workshop and Ms. Bella Ho, HKAS, for her fine efforts in organising and assisting participants in the training course.

A workshop on the best practices of implementing ISO/IEC 17011 will be hosted by SAC, Singapore, from 18 to 20 November 2014. Invitations have been sent to members and all members are encouraged to return their registration forms before Friday, 10 October 2014.

A lead evaluator training course, to train lead evaluators on changes to ILAC documents and accreditation standards, will be held in Hong Kong, China, on 6 and 7 January 2015. This course will be held in conjunction with the mid-term meetings.

APLAC Cooperation with APMP Mr. Nigel Jou and Mr. Michael Fraser will meet with Dr. Peter Fisk and Ms. Noleen Grogan at the 2014 APMP General Assembly and related meetings in Daejeon, South Korea, on Tuesday, 23 September. Nigel is also invited to give a presentation at the APMP Symposium on the Cooperation between Metrology and Accreditation in the Asia Pacific Region.

The first meeting of the APMP-APLAC Joint PT Working Group will be held on Sunday, 21 September 2014 and Dr. Koichi Nara and Mr. Yoshinobu Uematsu will be representing APLAC.

Future APLAC eventsThe next MRA Council meeting will be held in Hong Kong, China, from 8 to 9 January 2015.

The next Joint APLAC General Assembly/PAC Plenary will be held in Colombo, Sri Lanka, from 13 to 20 June 2015.

From the secretariat

Page 2 September 2014 APLAC News Notes Issue No. 120

IAs Joins APLAC/PAC for Its Inaugural Joint General Assembly

The first-ever Joint General Assembly meeting of the Pacific Accreditation Cooperation (PAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC) was attended by IAS Vice President/Chief Technical Officer Pat McCullen, IAS Vice President of Operations Raj Nathan and IAS Quality Manager Mohan Sabaratnam from 21-26 June in Guadalajara, Mexico. This was an especially important event for APLAC and PAC to establish a more cooperative role in the conformity assessment arena. Our participation in the Joint General Assembly and its technical meetings is also of strategic importance for IAS as we will undergo a full re-evaluation by PAC for continuation of our signatory status with PAC and the International Accreditation Forum (IAF) for our Product Certification Body accreditation program. We will also be seeking to expand IAS scope of recognition with PAC and IAF for the accreditation of Personnel and Management System Certification Bodies. The evaluation slated for late 2014 and successful completion of the evaluation will expand IAS national and international reach.

APLAC and PAC are regional cooperation bodies that are associations of accreditation bodies and interested stakeholders, facilitating trade and commerce among economies in the Asia Pacific region. These regional groups in turn serve the global markets through the framework established under the International Accreditation Forum and International Laboratory Accreditation Cooperation (ILAC). ILAC/APLAC specializes in the fields of laboratory, reference material producers and inspection accreditation, while IAF/PAC specializes in the field of certification. However, both ILAC and IAF work together to enhance and harmonize accreditation and conformity assessment activities worldwide. The primary means by which IAF/ILAC achieve international acceptance of accreditations granted by its accreditation body members is based on the equivalence of their accreditation programs through the establishment of multilateral agreements. These agreements provide for worldwide recognition of reports and certificates by accredited conformity assessment bodies and their accredited-certified clients.

From the International Accreditation service, Inc.

September 2014 APLAC News Notes Issue No. 120 Page 3

IAs has Relocated headquarters to Brea, CaliforniaThe International Accreditation Service has moved its West Coast operations to 3060 Saturn Street in Brea. Consistent with IAS commitment to efficiency and environmental responsibility, the new facility meets or exceeds the CALGreen standards adopted by the State of California and features updated technologies and on-site training facilities.

Accreditation of Calibration Laboratories Displayed at nCsLI ConferenceIAS exhibited at the 2014 NCSLI Annual Conference in Orlando, Fla., to provide information for attendees about IAS accreditation of calibration and testing laboratories and related organizations in the calibration field. The conference brought together calibration

professionals from around the world to present tutorials, papers, panels, plenary sessions and workshops, and to discuss shared problems and solutions in sessions and informal settings at all levels of instruction. NCSL International was formed in 1961 to promote cooperative efforts for solving the common problems faced by measurement laboratories. Today, NCSL International has over 1,000 member organizations from academic, scientific, industrial, commercial and government facilities around the world.

IAs Offers IsO/IEC standard 17020 and 17025 trainingIAS is offering ISO/IEC 17020 (Inspection Agency) Training and ISO/IEC 17025 (Laboratory) Training 17-21 November in Upper Marlboro, Md. Knowledge of these standards is beneficial for conformity assessment bodies involved in inspection, testing, calibration and product certification that wish to become accredited.

If you are considering accreditation, contact IAS for more information on training schedules, custom curricula, training at your facility, special requests or more information at (866) 427-4422 or e-mail [email protected].


September 2014 APLAC News Notes Issue No. 120 Page 4

IsO/IEC 17024 and IsO 19011 training

On 29-30 September, IAS administered a training program on ISO/IEC 17024 and ISO 19011. This class trained internal auditors and new IAS assessors on IAS and ISO requirements for accreditation of Personnel Certification Bodies. The class was administered at the ICC Midwestern Office in Country Club Hills, Illinois, and was taught by IAS International Representative Dr. George J. Anastasopoulos and by Dr. David S. Nelson, DirectorWork Force Qualification Programs. The participants included representatives of seven national certification boards as well as psychometricians in training for service as IAS assessors.

IsO/IEC 17025 Measurement Uncertainty training Program Coming in OctoberIAS will be sponsoring a training program for Calibration of Dimensional Measuring Equipment & Evaluation of Uncertainty in Measurements on Thursday and Friday, 23-24 October, in Brea, California.

This IAS training program is designed to provide a complete overview of the ISO/IEC 17025 requirements concerning Measurement Uncertainty (MU) as applied to calibration of dimensional measuring equipment. The program offers its participants an initial step to understanding the accreditation requirements of

ISO/IEC 17025 as applicable to MU calculations, with hands-on practical application. Also covered in the program are measurement processes and the concepts of effectively estimating and controlling MU. While the program material is largely derivative of case studies and examples, the statistical component is emphasized through practical examples. The program includes numerous discussions and exercises and requires an understanding of basic mathematical concepts. Laboratory managers, metrology managers, quality managers, process,

product, design and test engineers, calibration personnel, test personnel, and those who wish to gain an understanding of calculating measurement uncertainty will find this program beneficial and an invaluable tool to decision making. Those attending the course and completing all course work will receive a certificate of attendance and credit for 12 Professional Development Hours (PDHs). Those also completing and passing the optional written exam will receive a certificate of completion referencing the standard.



IAs Accreditation Committee Approves Criteria at L.A. MeetingThe IAS Accreditation Committee held a public hearing 10 February at the Sheraton Gateway Hotel Los An-geles. The purpose of these regularly sched-uled hearings is to es-tablish or revise accred-itation criteria pertaining to IAS accreditation programs and to inform the public on IAS prin-ciples and major poli-cies. The open hearing process provides all in-terested parties with the opportunity to contribute ideas or voice their opinions on any item posted on the agenda. For more informa-tion, click here.

IAs Exhibits at 2014 Measurement science ConferenceIAS exhibited information about its accreditation programs for calibration laboratories, testing laboratories, inspection agencies and related disciplines at the 2014 Measurement Science Conference, 10-14 March, at the Long Beach Convention Center in California. The Measurement Science Conference is a full week of activities focused on education and training through the offering of seminars and tutorials that cover a myriad of technical topics. The event also features an exhibit area where approximately 120 companies provide exhibit booths that display the latest in technology. The Measurement Science Conference typically has about 1,200 attendees where over 200 companies, governmental agencies and academia participate each year.



PAC and APLAC combine successfully to host joint annual meetings in MexicoThe week of 23 27 June 2014 saw a further enhance-ment of the relationship between PAC and APLAC, when they joined forces to host their first joint annual meetings. The meetings were graciously hosted by entidad mexicana de acreditacin (ema) in Guadala-jara, Mexico.

A training course in ISO/IEC 17065 was held for Ac-creditation Body staff and assessors on the weekend before the official meetings commenced. Several of the committees met jointly, including the Executives, MLA/MRA and Promotions Committees. Technical commit-tee activities were held separately, with PAC working groups for Product Certification, GHG and Energy Man-agement, Organics and Halal Certification meeting and making good progress. The week culminated in a Joint General Assembly and technical visit.

Two new Executive Committee members were elected during the Plenary, with the current Executive being: Chair Mr. Brett Abraham (JAS-ANZ, Australia & New Zealand), Vice-Chair Mr. Ekanit Romyanon (NSC Thailand), Members: Ms. Chang Kwei Fern (SAC Singapore), Ms. Susan Law (IIOC UK), Mr. Bruce Li (TAF Chinese Taipei) and Mr. Vu Xuan Thuy (BOA Vietnam), with Mr. Mohan Sabaratnam (IAS, USA) as Quality Manager. Ms. Azusa Nakagawa (JAB Japan) is Chair of the MLA Group and Management Commit-tee and the Technical Committee Chair is Mr. Fei Yang (CNAS, PR China).

2014 training ActivitiesPAC, in conjunction with KAN Indonesia, was successful in obtaining APEC funding to hold two workshops in 2014 to provide training to Accreditation and Certification body staff on ISO/IEC 17024:2012. The projects main purpose is to build the capacity of certification and accreditation bodies in APEC member economies to carry out assess-ments against this standard, with two courses being held

during the year. This will enable them to par-ticipate in the PAC MLA for Per-sons Certification Bodies, which was launched at the beginning of 2014.

The MLA will contribute to strengthen the quality of regional economies workforces by aligning standards on person certification with the international standard and harmonizing person standards of competence amongst accreditation and certification bodies. Re-gional acceptance of certificates of competence for persons, through the PAC MLA, will also increase the mobility and job opportunities for people in the region.

A further four training courses, for training in ISO 50001, Energy Management systems will be held in 2014. This project is also receiving APEC funding and will facilitate development of a new PAC MLA in this scope.

PAC MembershipPAC welcomed new Full Member, National Institute of Environmental Research (NIER) of Korea, during the annual meetings. The International Organic Accreditation Service (IOAS) also upgraded its membership from Associate to Full Member status during the meetings. For further membership information, please contact the PAC Secretariat.

PAC MLA ActivitiesWe are delighted to advise that the PAC MLA for Food Safety Management Systems (FSMS) became fully operational in Mexico, with PR China (CNAS), Japan (JAB), Australia and New Zealand (JAS-ANZ), Mexico (ema), Singapore (SAC), Chinese Taipei (TAF), Vietnam (BOA), India (NABCB) and Sri Lanka (SLAB) joining Indonesia (KAN) as signatories.

Four members also signed the MLA for Greenhouse Gases: Japan (JAB), Mexico (ema), Chinese Taipei

From PAC


(TAF) and the USA (ANSI).

PAC launched an MLA for Information Security Management Systems in 2013 and has one signatory to date: Japan (JAB). Two further applications are currently being processed and it is expected that the MLA will become fully operation at the 2015 annual meetings.

As of 1 January 2014 PAC has announced that it is accepting applications for its latest MLA program for certification of Persons (ISO 17024).

A full list of PAC members including their MLA status is included on the following page.

Communications & MarketingThe PAC newsletter is published electronically twice per year. The most recent issue (September 2014) provided more comprehensive information on the outcomes of World Accreditation Day and the PAC Annual Meetings as well as general member news. Interested parties are welcome to contact the PAC Secretary to be added to the newsletter distribution list.

Cooperation with APEC, the sRBs and IAF Regional BodiesThe PAC Secretary attended the first APEC Senior Officials Meeting (SOM l) in Ningbo, China, in

February, and the SOM lll meetings in Beijing, PR, China, in August.

PAC wishes to thank PASC for its assistance with our request to have Category A liaison status with ISO/TC 207/SC 7 by circulating the request to PASC members seeking their support to vote positively on this ballot.

PAC and APLAC are jointly participating in a further three-year PTB project to build capacity in developing economies outside the APEC area (e.g. Myanmar, Cambodia). The PAC and APLAC secretaries travelled to Nepal immediately after the SCSC meetings in Ningbo to meet with Nepal Standards Bureau personnel and other government officials as part of this project.

PAC continues to play a major role within the IAF with the Vice Chair, MLA Group Chair, Technical Committee Chair, and Development Support Chair coming from PAC members and with its active participation in many other working groups and sub-committees.

The PAC Secretary attended the IAAC annual meetings in Guatemala in August 2014 and will also attend the IAF annual meetings in Vancouver in October.

Further information on PAC and PAC activities is available at www.apec-pac.org or by contacting the PAC Secretary, Ms. Belinda Mort, at Ph +612 6345 5828 or email [email protected].

From PAC


PAC Membership list (and MLA signatory status of Full Members):

JAS-ANZ (Australia & New Zealand) 1, 2, 3, 4 BAB (Bangladesh) Associate MemberPSK (Brunei Darussalam) Associate Member CNAS (PR China) 1, 2, 3,4

DAC (Dubai) 1, 2 HKAS (Hong Kong, China) 1, 2, 3

NABCB (India) 1, 2, 3,4 KAN (Indonesia) 1, 2, 3, 4

NACI (Iran) IA Japan (Japan) 3

JAB (Japan) 1, 2, 3,4, 5, 6 JASC (Japan)JIPDEC (Japan) NCA (Kazakhstan) 3

KAB (Korea) 1, 2 KAS (Korea) 3

NIER (Korea) KCA (Kyrgyzstan)STANDARDS MALAYSIA (Malaysia) 1, 2, 3 ema (Mexico) 1, 2, 3, 4, 5

MASM (Mongolia) PNAC (Pakistan) 1, 2

PNGLAS Associate Member INDECOPI (Peru)PAO (Philippines) 1, 2 STC-IS RussiaSAC (Singapore) 1, 3, 4 SLAB (Sri Lanka) 1, 2, 3, 4

TAF (Chinese Taipei) 1, 2, 3, 4, 5 NSC (Thailand) 1, 2, 3

ANSI (USA) 3, 5 IAS (USA) 3

IOAS (USA) BoA (Vietnam) 1, 3, 4

IIOC Associate MemberICL (NZ) Observer Member TCL (India) Observer MemberBSB (Bhutan) Corresponding Member xLegend: 1 = QMS Signatory; 2 = EMS Signatory; 3 = Product Signatory; 4 = FSMS Signatory, 5 = GHG Signatory; 6 = ISMS Signatory

From PAC


Bangladesh Prime Minister Interested in BAB Activities

In a meeting with the senior officials of the Ministry of Industries on 24 August 2014, The Honorable Prime Minister of the Government of Bangladesh Sheikh Hasina showed keen interest about the ongoing activities of the Bangladesh Accreditation Board (BAB). She also enquired about the future plans and activities of BAB.

Emphasizing the necessity and importance of accreditation, the Prime Minister said industrial development is very crucial to make Bangladesh a developed nation in South Asia by 2041. Minister for Industries Amir Hossain Amu, MP, and Industries Secretary Mohammad Moinuddin Abdullah also spoke on the occasion. Director General of BAB Md. Abu Abdullah gave a brief presentation on the activities of BAB.

From BAB

Prime Minister Sheikh Hasina addresses officials of the Ministry of Industries and BAB while visiting the ministry on 24 August 2014


Information session for Accreditation Decision MakersIn order to fulfill the requirements of ISO/IEC 17011:2004, BAB held a training session for the ac-creditation decision makers at the Centre for Advanced Research in Sciences, University of Dhaka, where nine Board members at-tended the information session. The session was conducted by BAB Consultant Mr. Ned Gravel. Apart from the roles and responsibili-ties in the decision mak-ing process, the session also covered the roles and responsibilities of the appeals committee. The session ended with a social gathering which was em-bellished by the kind presence of the Vice Chancel-lor of the University of Dhaka, Professor Dr. A.A.M.S. Arefin Siddique.

BAB Organized training on Root Cause Analysis and Internal Calibration and Proficiency TestingBAB arranged two technical training sessions on Root Cause Analysis and Internal Calibration and Proficiency Test-ing in June 2014 for the testing and calibra-tion laboratories in the country. Mr. Ned Gravel, Consultant of BAB, de-livered the trainings for a total of 36 participants.

From BAB

Accreditation Decision Makers in the Information Session

Root Cause Analysis training


ILAC Chairs Address Adds to success of CALA Conference

As part of its 25th Anniversary celebrations, CALA hosted its inaugural professional development conference and trade showthe CALA Catalyst Conference (or C3) from June 2-4, 2014, in Toronto.

Based on the evaluations submitted by participants, they were very pleased with the overall conference and, in particular, with the keynote speakers CALA had lined up to both engage and motivate participants.

The highest overall rating for keynote addresses delivered at the conference was given to Mr. Peter Unger, the A2LA President & CEO and current Chair

of ILAC (the International Laboratory Accreditation Cooperation).

Mr. Ungers address was titled Laboratory Accreditation: Future Challenges and it received many positive accolades both for its quality as well as its relevance to the participants attending the conference.

CALA wishes to publicly thank Pete Unger for bringing his value-added message on accredi-tation to the CALA conference. To see a copy of Mr. Ungers presentation slides please go to: www.cala.ca/pr_c3_2014_p_unger.pdf

From CALA

Pete Unger, ILAC Chair making his Keynote presentation at the CALA Conference in Toronto on Tuesday June 3, 2014.


Laboratory Accreditation subcommittee of the Mirror technical Committee of IsO/CAsCO in China Established

Subcommittee 1 on Laboratory Accreditation of National Technical Committee 261 on Certification and Accreditation of Standardization Administration of China (SAC/TC261/SC1) was established under the approval of the Standardization Administration of the Peoples Republic of China (SAC). National Technical Committee 261 on Certification and Accreditation (TC261) is the mirror technical committee of ISO/CASCO in China. SAC/TC261/SC1 is the first subcommittee of TC261.

SAC/TC261/SC1 is composed of 35 members from government departments, scientific research institutes, China National Accreditation Service for Conformity Assessment (CNAS), certification bodies and laboratories. Dr. Song Guilan, Deputy Chief

Executive of CNAS, is Director of SAC/TC261/SC1. Dr. Lv Jing, Deputy Director of CNAS Technical Department, is Secretary General of SAC/TC261/SC1 Secretariat. CNAS is designated to undertake the activities of SAC/TC261/SC1 Secretariat.

SAC/TC261/SC1 is responsible for organizing and coordinating the development and revision of basic standards, management standards, competence assurance standards and other national standards relevant to laboratory accreditation.

The establishment of SAC/TC261/SC1 is an important event in the development process of certification and accreditation standardization which will greatly strengthen the work of laboratory accreditation standardization in China.

From CnAs


hKAs hosts APLAC Workshop on Medical Laboratory Accreditation

Over 30 representatives from APLAC members gathered in Hong Kong on 3-5 September 2014 to discuss various accreditation issues, with emphasis on measurement uncertainty and other topics.

Following the successful training course on the over-view of ISO 15189:2012 in Thailand last year, this workshop was designed to enable participants to bet-ter understand some key elements of the new stan-dardmethod validation/verification, measurement uncertainty, metrological traceability, risk assessment and laboratory information managementwhich are challenging and evolving.

Measurement Uncertainty (MU)Prof. Graham White, Chief Clinical Biochemist, Flinders Medical Centre, SA Pathology, South Australia is a leading expert in the medical community advocating the importance of MU. MU is a quality

tool for the laboratory to evaluate the reliability of test results, emphasized Prof. White. In this workshop, he introduced the concept of top-down and bottom-up approaches and the value of realizing the MU. Having quality control materials in medical testing makes the estimation of MU in medical laboratories easier and more manageable. Using examples in different disciplines, Prof White illustrated the calculation of MU step by step. Ms. Linda Crawford, Director, QMP-LS/OLA, Canada, and Chair, ILAC PT WG, strengthened participants understanding by leading group exercises on case scenarios.

Metrological traceabilityUnlike other physical measurements, testing in medical laboratories often lacks traceability to SI units. In this session, Prof. White reviewed metrological traceability and its significance in a routine medical

From hKAs

Mr Nigel Jou, APLAC Chair (second from left, front row) and Mr Wong Wang-wah, Executive Administrator, HKAS (centre, front row) welcoming all participants to the workshop


laboratory. Equivalent test results, regardless of procedure and location, are desirable but not easily achieved. Metrologically traceable reference materials are critical for standardization. Dr. Sook-Kyung Kim, Head/Principal Research Scientist, Center for Bioanalysis, Korea Research Institute of Standards and Science (KRISS) representing the Asia Pacific Metrology Programme showed the participants how measurement standards and reference materials for medical testing are produced in KRISS.

Verification and Validation of Testing MethodValidation and verification are always a debatable area in assessments. What studies should be included and to what extent the studies go depend on different factors such as the purpose of the test, cost, risk and customers needs. Dr. Anthony Shek, Consultant Chemical Pathologist, Queen Elizabeth Hospital, Hong Kong, went through some key parameters of a proper validation. Dr. Shek pointed out that a universal protocol for validation and verification was impossible. A laboratory is responsible for choosing the most suitable procedure. Keeping thorough documentation and regular checking of the method are also important.

Risk management and Laboratory Information ManagementIn this session, while Ms. Crawford gave an overview of the information management requirements of ISO 15189:2012, Ms. Mandy Chiu, Taiwan Accreditation Foundation, gave practical tips on how to assess a medical laboratory by different approaches. Risk management for patient safety is a new concept to most medical laboratories. Mr. Kao Chih-Hsiung, Laboratory Director, St. Martin De Porres Hospital of Taiwan, who has implemented risk management in his laboratory for three years, introduced risk management and its application using vivid examples.

An interesting session on reporting critical results showed the vast variability in the terms used to describe critical results. Prof White advocated harmonized terminology and having laboratories develop policies and procedures for establishing and reporting those results. Other sessions in the seminar included CNAS comprehensive field-specific requirements on quality control, sharing on the use of ISO 15189

From hKAs

Dr Graham White giving a general introduction on measurement uncertainty

Mr Kao Chih-Hsiung describing the integration of risk management into an effective management system


by different accreditation bodies for accrediting point-of-care testing, anatomical pathology laboratories and physiological laboratories.

In and out of the seminar, participants openly and actively exchanged ideas and shared their views in accreditation practice. Most participants found this training workshop very fruitful and practical. The knowledge gained in this seminar would greatly improve their accreditation programs.

tripartite seminar on Accreditation of Medical testing Laboratories

Hong Kong Accreditation Service (HKAS), China National Accreditation Service for Conformity Assessment (CNAS) and Taiwan Accreditation Foundation (TAF) meet every year to discuss various matters in accrediting medical testing laboratories. HKAS hosted the last seminar in Hong Kong on 1-2 September 2014. Renowned experts in the field were invited to share their experiences in specific topics in ISO 15189:2012, aiming to enhance colleagues understanding of new requirements and harmonizing accreditation requirements.

Since the publication of ISO 15189:2012 in November 2012, the three accreditation bodies have been putting quite an effort into the transition exercise. In this edition of ISO 15189, medical laboratories are required to manage risk for patient safety and laboratory information. On top of that, estimation of measurement uncertainty is no longer restricted to tests with measured

From hKAs

Participants actively discussing case scenarios

2014 Tripartite Seminar on Accreditation of Medical Testing Laboratories


quantity values; medical laboratories also need to estimate MU around the cut-off for those examinations which they report a qualitative result derived from a measured quantity value.

Prof. Graham White, Chief Clinical Biochemist, Flinders Medical Centre, SA Pathology, South Australia, is a leading expert in measurement uncertainty in the medical community. Prof. White was invited to be the key presenter for an APLAC workshop on medical testing in the same week as the tripartite meeting. HKAS made use of this golden opportunity to invite Prof. White to deliver a one-day seminar on measurement uncertainty to the assessors of these three accreditation bodies. In his presentation on the first day, he emphasized the application of MU in result interpretation and its role as a quality tool to evaluate the reliability of laboratory test results. He further explained why the bottom-up approach described in the Guide to Uncertainty of Measurement was not suitable for medical testing and briefly went through the top-down and bottom-up approaches. Medical testing laboratories enjoy a clear advantage of having quality control materials run routinely which makes estimating MU easier and more manageable. Participants learned how to calculate MU step-by-step through Prof. Whites worked examples in different disciplines.

Careful and thorough planning of the laboratory setting is crucial to the development of molecular diagnosis for infectious disease. Dr. Yam Wing Cheong, Clinical Bacteriologist, Department of Microbiology, Queen Mary Hospital, University of Hong Kong, shared his experience in setting up such a laboratory cost effectively. As nucleic acid contamination is always a challenge in molecular diagnostic laboratories, Dr. Yam emphasized the need to pay attention to details and gave some practical tips on how to minimize the problem. Method validation is another key to successful test development. Dr. Yam pointed out a simple rule: a laboratory test should produce accurate, precise and reproducible results with rapid turnaround

time and clinical utility. He then showed participants how this could be achieved.

Mr. Zhai Peijun, Director of the Fourth Accreditation Division, CNAS, shared some interesting findings of a recent survey on the application of ISO 15189 in the accreditation of other medical testing fields among ILAC Accreditation Issues Committee members. He drew members attention to the use of different ISO standards for accrediting other medical disciplines (e.g., medical imaging, medical physics, etc.). From the survey, he noted that accreditation bodies have developed supplementary requirements/guidelines to be used in conjunction with ISO 15189.

Risk management for patient safety is a new concept to many medical laboratories but not to Mr. Kao Chih-Hsiung, Laboratory Di-rector, Laboratory, St. Martin De Por-res Hospital of Taiwan, who has been studying this subject for ten years and has put

From hKAs

Participants listening attentively to Dr Yams presentation on the environmental setting of a molecular diagnostic laboratory for infectious diseases.


theory into practice in the last three years in his labo-ratory. In this workshop, he introduced risk manage-ment and its application using vivid examples and his own experience.

The seminar ended with an interactive discussion on some case scenarios in which the participat-ing accreditation bodies came up with different views. This exercise was meant to highlight how, despite the implementa-tion of the same accredi-tation standard, there is a need to harmonize the interpretation of different requirements. This inter-esting exercise and active discussion brought bet-ter understanding about the accreditation practice and government policies for medical testing in the three economies.

From hKAs

Mr Kao Chih-Hsiung explaining what an effective risk management should look like.


IAAC Membership IAAC currently has a total of 46 members, 23 of which are full members, 7 are associate members and 16 are stakeholders. IAAC welcomed ODAC of the Dominican Republic as an Associate member, and ASOCOLAB of Colombia, an association of laboratories, as an IAAC Stakeholder member, as of May 2014.

IAAC MLA signatoriesDuring its recent meeting in August 2014, ONA of Nicaragua and OSA of El Salvador were accepted into the IAAC MLA, both for the scope of Testing Laboratories. In March 2014, the IAAC MLA Group accepted ONAC of Colombia as a signatory to the IAAC MLA for Calibration and Testing Laboratories. IAAC now has a total of 21 MLA signatory members. 21 signatories for the scope of Testing Laboratories, 14 for the scope of Calibration Laboratories, 10 for Quality Management Systems Certification Bodies, 8 for Environmental Management Systems Certification Bodies, 9 for Product Certification Bodies, and 10 for Inspection Bodies.

IAAC Re-evaluation process by ILAC-IAF IAAC is a Regional Cooperation Body whose MLA is recognized by ILAC for the scopes of Calibration and Testing Laboratories including Medical Laboratories; and for Inspection Bodies. The IAAC MLA is also recognized by IAF for the scopes of QMS, EMS, and Product Certification Bodies.

IAF and ILAC are in the process of re-evaluating IAAC to verify compliance with international requirements as a recognized Regional Cooperation. The IAF-ILAC peer evaluation team carried out an evaluation of the IAAC Secretariat and the MLA Group and also carried out four witnesses of IAAC peer evaluations, the last of which concluded in February 2014. IAAC is proud to report that it received zero Non Conformities, although some

concerns and comments were raised. IAAC has implemented corrective actions as part of the process to address these findings. IAAC expresses its appreciation to the IAF and ILAC evaluation team for their hard work and professionalism to successfully carry out this evaluation.

Extensions of the IAAC MLAIAAC is currently operating the following MLA scopes:

Persons Certification Bodies according to the ISO/IEC 17024

Food Safety Management Systems (FSMS), ac-cording to ISO/IEC 17021, ISO/TS 22003, and ISO 22000.

Information Security Management Systems (ISMS), according to ISO/IEC 17021, ISO 27006 and ISO 27001.

Medical Devices Management Systems MLA (ISO 13485).

Green House Gas Emissions, according to ISO 14065.

Proficiency Testing Providers, according to ISO/IEC 17043.

Reference Material producers, according to ISO/IEC Guide 34.

The MLA Committee is encouraging members to propose qualified peer evaluators for these scopes.

Improvements to the IAAC MLA process:The IAAC MD 002 Policies and Procedures for a Multilateral Recognition Arrangement among Accreditation Bodies, Annex 7, will be changed to clarify that an assessment witnessing is required for an extension application of the IAAC MLA before the scheduled re-evaluation deadline for the following sub-

From IAAC

This report includes IAAC activities from October 2013 to September 2014.


scopes: Food Safety Management Systems (FSMS), Medical Devices Management Systems (MDMS), and Information Security Management Systems (ISMS).

The IAAC PR 004 Procedure for Selection, Training, Qualification and Monitoring the Performance of IAAC Peer Evaluators was changed to include a category for trainee lead peer evaluator.

IAAC and APLAC are developing a procedure for joint evaluations. IAAC will also develop a procedure for joint evaluations with PAC.

training Activities:IAAC is continuously training its peer evaluator resources and held the following workshops in 2014:

A workshop for experienced peer evaluators in Guatemala City, in August 2014, with 31 partici-pants from the region.

A Workshop on Traceability of Measurement Re-sults, held in August 2014, in Guatemala City, with 31 participants from the region.

IAAC Proficiency Testing programs

IAAC T009 Proficiency Test on Energy Efficiency in RefrigeratorsIAAC is carrying out a regional Proficiency Testing (PT) program on Energy Efficiency in Refrigerators. The accreditation body that is coordinating this PT is EMA of Mexico, with ANCE of Mexico participating as the proficiency testing provider. This PT program receives funding from a project with PTB. A preliminary workshop took place to present the PT protocol to participating laboratories. Ten laboratories from six countries in the region and one lab from Germany are participating in this PT which began in January 2014. In July the samples were distributed to the participating labs, the tests were carried out in August, and the final report is scheduled to be available by the end of October of this year.

IAAC C003 Proficiency Test on Type K thermocouples Calibration (2nd round) 2012This PT was organized by NVLAP of USA and coordinated by NIST of the USA. The first round was cancelled in 2009 due to logistical issues, a second round was organized and four accredited laboratories participated in this PT program. The final report was issued on May 2014.

technical Cooperation ProjectsProjects with the Physikalisch technische Bundesanstalt (PtB) Renewable Energies and Energy Efficiency ProjectIAAC is implementing a technical cooperation project titled Quality Infrastructure Services for Renewable Energies and Energy Efficiency (R3E) in Latin America and the Caribbean, together with the Regional organizations for standards and metrology COPANT and SIM. Sponsor organizations include PTB of Germany and the Organization of American States (OAS). The objective of this project is to strengthen the capabilities of the regional quality infrastructure organizations SIM, COPANT and IAAC and of their national members in providing services for the fields of energy efficiency and renewable energy sources as well as to promote mutual coordination in order to support the implementation of the respective national energy policies.

The activities carried out under this project include technical seminars, workshops and a proficiency testing program.

Biodiversity and Climate Change ProjectIAAC together with COPANT and SIM, the regional organizations for standards and metrology, held their first plan-ning meeting in August 2013 to define the areas of potential inter-est and

From IAAC


the scope of the draft project regarding the strength-ening of quality infrastructure in programs related to biodiversity and climate change. Sponsor organiza-tions include PTB of Germany and the OAS. So far, two IAAC members have expressed interest in partici-pating in this project with a proposal to develop a na-tional Ecolabel program which includes accreditation services.

Cooperation with International and Regional Organizations Relations with IAF and ILAC

Peter Unger, ILAC Chair, and Randy Dougherty, IAF Chair, attended the IAAC General Assembly meetings held in Guatemala City in August 2014. Peter also attended the beginning-of-the-year meetings in Mexico in March 2014.

Cooperation with APLAC and PAC: Barry Ashcroft of APLAC attended the IAAC Labo-

ratories Subcommittee meeting held in Mexico in March 2014.

Three IAAC representatives attended the APLAC workshop on Reference Materials Producers held in Tokyo in November 2013.

Belinda Mort, PAC Secretary, and Martha Meja, APLAC representative, were a regular presence at the IAAC General Assembly meetings, the last one of which was held in Guatemala City in August 2014.

Johanna Acua, IAAC MLAC Vice-Chair, and Vic-tor Gandy, IAAC Secretary, attended the APLAC and PAC Joint General Assemblies meetings held in Guadalajara, Mexico, in June 2014.

IAAC and APLAC carried out two joint peer evalu-ations in 2013 and one in 2014. IAAC and PAC carried out one joint peer evaluation in 2014.

IAAC and APLAC invited members to participate in each others proficie1ncy testing programs.

Cooperation with EA: Ileana Martinez, IAAC Chair, regularly attends EA

General Assemblies. The EA Chair plans to attend the IAAC General Assembly every two years, the next one in 2015.

Cooperation with the African Accreditation Cooperation, (AFRAC) and sADCA

AFRAC and IAAC signed a Memorandum of Tech-nical Cooperation in Guatemala City in August 2014.

IAAC regularly invites AFRAC and SADCA mem-bers to participate in its proficiency testing pro-grams.

Cooperation with the Arab Accreditation Cooperation, (ARAC):

IAAC exchanges information with ARAC regarding best practices in MLA management.

next IAAC meetings The IAAC Executive Committee, MLA Group, MLA Committee, and Laboratories Subcommittee will meet in March 2015 in Asuncion, Paraguay.

The next IAAC General Assembly meetings will be held in August 2015 in Punta Cana, Dominican Republic, and will be hosted by the Organismo Dominicano de Acreditacin (ODAC).

From IAAC


nAtA to provide assessments for national health standards

NATA has been granted approval by the Australian Commission on Safety and Quality in Healthcare (ACSQHC) to provide assessments to the National Safety and Quality Health Service (NSQHS) Standards. NATA began offering assessments against the Standards on 1 July 2014.

The ACSQHC developed the NSQHS Standards to improve the quality of health service provision in Australia. The Standards provide a nationally consistent statement of the level of care consumers should be able to expect from health services.

There are 10 NSQHS Standards focusing on areas that are essential to drive the implementation and use of safety and quality systems:

1. Governance for Safety and Quality in Health Service Organisations

2. Partnering with Consumers

3. Preventing and Controlling Healthcare Associated Infections

4. Medication Safety

5. Patient Identification and Procedure Matching

6. Clinical Handover

7. Blood and Blood Products

8. Preventing and Managing Pressure Injuries

9. Recognising and Responding to Clinical Deterioration in Acute Health Care

10. Preventing Falls and Harm from Falls

NATA is offering accreditation to the NSQHS Standards to complement our current health accreditation activities, including pathology laboratories and their associated collection services, medical and diagnostic imaging services and sleep disorders services. Assessments will be coordinated with current NATA assessment visits and will operate on a four yearly cycle for assessment.

The NSQHS Standards and additional information and resources on the NSQHS Standards are available directly from the ACSQHC website www.safetyandquality.gov.au.

From nAtA


new accreditation scheme facilitates Australian meat exportsA new accreditation scheme will facilitate the ongoing acceptance of Australian meat exports to the European Union.

NATA and the Austra-lian Department of Agri-culture are entering into a Deed of Agreement which will facilitate the necessary exchange of information regarding ap-plicant and accredited in-spection bodies and the annual surveillance ar-rangements required by the Scheme rules.

The Independent Employer of AAOs Accreditation Scheme has been developed by the Department of Agriculture to provide for the employment of Australian Government Authorised Officers (AAOs) by independent employment providers.

The employment of AAOs by independent agencies rather than by the slaughtering establishment provides additional confidence in the inspections performed.

The scheme applies to inspectors undertaking on-line post mortem inspection in Australian export slaughter establishments exporting to EU markets. The scheme will require accreditation against ISO/IEC 17020:2012 by Australian National Accreditation Bodies to evaluate independent employers of Australian Government Authorised Officers (AAOs).

For slaughtering facilities supplying the EU market, AAOs must be employed by an independent AAO employer approved by the department to supply AAOs.

The Scheme may also be adopted for other markets to improve access for Australian meat and meat products.

From nAtA

The new Scheme may be adopted for other markets to improve access for Australian meat and meat products. (Photo: daff.gov.au)


From nAtA

nAtA conducts training in Indonesia

Edita Rokov and Helen May from NATAs Training Services Group presented the Refresher Auditor Training Course on 21-26 April 2014 at the Holiday Inn in Bandung, Indonesia.

Thirty staff from the Indonesian Ministry of Agriculture attended the three-day course. Fourteen participants were in the first training that was conducted on 21-23 April; and 16 participants were in the second group on 24-26 April 2014.

This course was a refresher for those who attended the Auditor Training conducted for the Indonesian Ministry of Agriculture in Tanjung Pandan, Belitung, Indonesia, from 25 February 1 March 2013. This was the second round of Auditor Training provid-ed to the Indonesian Min-istry of Agriculture, with the first

Edita and Helen with some of the first group of trainees

Helen May and Edita Rokov with the second group of participants

Helen May and Edita Rokov with the second group of participants

The course was well-received by participants


being held in Jakarta on 1st-5th October 2012.

The Refresher Auditor Training Course was well received by the participants with 89 per cent of the participants rating the five-day course Very Good to Excellent.

World Accreditation Day Competition winners talk about energy and accreditation Each year NATA holds a competition for all members

Authorised Representatives and invites them to submit an entry describing how they feel accreditation relates to the World Accreditation Day theme. This year the

theme was how accreditation relates to having our confidence in the provision of the energy we too often take for granted.

As always, the entries were of a high standard and judges had a hard time choosing the finalists. Eventually, three winners were named. The winners of NATAs 2014 World Accreditation Day competition were:

The provision of energy doesnt come without risk. To reduce that risk, Accreditation provides a level of assurance that companies providing services to the energy industry are performing their services correctly, as required.

This in turn supports the continuity of supply to meet our worlds continual growing demand for energy.

Mark Daniel Regional Quality Manager Applus RTD Asia Pacific

Energy provision in Australia currently finds itself centre-stage in the public spotlight. Rapidly spiralling costs coupled with cynical blame-games, played out at both business and political levels, have left consumers confused and disenchanted.

Accreditation in Australia has a vital role to play in providing the platforms necessary to help address these issues. For example, through ensuring the collection of quality data, any environmental changes can be measured more accurately which, in-turn, facilitates greater accuracy in modelling potential future changes and adds gravitas to conclusions reached.

Furthermore, as next generation energy provision technologies are more widely imple-mented, the use of quality

From nAtA


materials will ensure their benefits are fully harnessed.

Australias future energy policies and provision must be based on quality science and accreditation lies at its foundation.

Simon Lake Quality Assurance Manager CIPDD / TetraQ The University of Queensland

Accreditation supports the provision of energy by ensuring that organisations maintain homogeneity in good practice and auditing, thus minimising breakdowns.

Furthermore, the monitoring and reporting of new technologies supports the evolution of services in Australia and ensures sustainable practice.

Samantha Damiani Administration Earth Testing Services

From nAtA


Aplac News Notes 120

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Transcript of Aplac News Notes 120