-
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
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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
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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].
From the International Accreditation service, Inc.
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.
From the International Accreditation service, Inc.
Page 5 September 2014 APLAC News Notes Issue No. 120
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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.
From the International Accreditation service, Inc.
Page 6 September 2014 APLAC News Notes Issue No. 120
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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
Page 7 September 2014 APLAC News Notes Issue No. 120
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(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
Page 8 September 2014 APLAC News Notes Issue No. 120
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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
Page 9 September 2014 APLAC News Notes Issue No. 120
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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
Page 10 September 2014 APLAC News Notes Issue No. 120
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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
Page 11 September 2014 APLAC News Notes Issue No. 120
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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.
Page 12 September 2014 APLAC News Notes Issue No. 120
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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
Page 13 September 2014 APLAC News Notes Issue No. 120
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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
Page 14 September 2014 APLAC News Notes Issue No. 120
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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
Page 15 September 2014 APLAC News Notes Issue No. 120
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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
Page 16 September 2014 APLAC News Notes Issue No. 120
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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.
Page 17 September 2014 APLAC News Notes Issue No. 120
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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.
Page 18 September 2014 APLAC News Notes Issue No. 120
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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.
Page 19 September 2014 APLAC News Notes Issue No. 120
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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
Page 20 September 2014 APLAC News Notes Issue No. 120
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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
Page 21 September 2014 APLAC News Notes Issue No. 120
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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
Page 22 September 2014 APLAC News Notes Issue No. 120
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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)
Page 23 September 2014 APLAC News Notes Issue No. 120
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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
Page 24 September 2014 APLAC News Notes Issue No. 120
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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
Page 25 September 2014 APLAC News Notes Issue No. 120
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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
Page 26 September 2014 APLAC News Notes Issue No. 120