September 2014

APLAC News Notes

The next issue will be published

in December 2014.

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 1
675 Victoria Street
Abbotsford VIC 3067
Australia
Telephone: +61 3 9274 8200
Fax: +61 3 9421 0887
Email: aplac@nata.com.au
This issue is published by:

3060 Saturn Street, Suite 100

Brea, California 92821-1732 U.S.A.
1-562-364-8201 | www.iasonline.org

Issue No. 120

In this ISSUE
From the Secretariat

Update from IAS

Update from PAC

Update from BAB

10

Update from CALA

12

Update from CNAS

13

Update from HKAS

14

Update from IAAC

19

Update from NATA

22

Feature: IAS Joins APLAC/PAC for Its

Inaugural Joint General Assembly
Feature: PAC and APLAC combine
successfully to host joint annual
meetings in Mexico
Feature: Bangladesh Prime Minister
Interested in BAB Activities
Ilac Chairs Address Adds to Success
of Cala Conference
Laboratory Accreditation Subcommittee
of the Mirror Technical Committee of
ISO/CASCO in China Established
Feature: HKAS Hosts APLAC Workshop
on Medical Laboratory Accreditation

Feature: NATA to provide assessments

for National Health Standards

From the Secretariat

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 Pathologist, 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.
Page 2

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 events

The 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.

September 2014 APLAC News Notes Issue No. 120

From the International Accreditation Service, Inc.

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
theInternational 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.

September 2014 APLAC News Notes Issue No. 120

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 andInternational 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.

Page 3

From the International Accreditation Service, Inc.

IAS Has Relocated Headquarters to Brea,

California

The 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.

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 Training

IAS 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.

Accreditation of Calibration Laboratories

Displayed at NCSLI Conference

IAS 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
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) 4274422 or e-mail info@iasonline.org.

September 2014 APLAC News Notes Issue No. 120

Page 4

From the International Accreditation Service, Inc.

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 October

IAS 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.

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.

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

Page 5

September 2014 APLAC News Notes Issue No. 120

From the International Accreditation Service, Inc.

IAS Accreditation Committee Approves

Criteria at L.A. Meeting

The IAS Accreditation Committee held a public hearing

10 February at the Sheraton Gateway Hotel Los Angeles. The purpose of
these regularly scheduled hearings is to establish or revise accreditation criteria pertaining
to IAS accreditation
programs and to inform
the public on IAS principles and major policies. The open hearing
process provides all interested parties with the
opportunity to contribute ideas or voice their opinions
on any item posted on the agenda. For more information, click here.

IAS Exhibits at 2014 Measurement

Science Conference

IAS 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.

Page 6

September 2014 APLAC News Notes Issue No. 120

From PAC

PAC and APLAC combine successfully to

host joint annual meetings in Mexico

The week of 23 27 June 2014 saw a further enhancement 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 Guadalajara, Mexico.
A training course in ISO/IEC 17065 was held for Accreditation 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 committee activities were held separately, with PAC working
groups for Product Certification, GHG and Energy Management, 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 Committee and the Technical Committee Chair is Mr. Fei Yang
(CNAS, PR China).

2014 Training Activities

PAC, 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 assessments against this standard, with two courses being held
Page 7

during
the year. This
will enable them to participate in the PAC MLA for Persons 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. Regional 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 Membership

PAC 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 Activities

We 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
September 2014 APLAC News Notes Issue No. 120

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 & Marketing

The 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 Bodies

The PAC Secretary attended the first APEC Senior

Officials Meeting (SOM l) in Ningbo, China, in

Page 8

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 pacsecr@email.com.

September 2014 APLAC News Notes Issue No. 120

From PAC

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

JAS-ANZ (Australia & New Zealand) 1, 2, 3, 4

BAB (Bangladesh) Associate Member

PSK (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 Russia

SAC (Singapore)

SLAB (Sri Lanka) 1, 2, 3, 4

1, 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 Member

ICL (NZ) Observer Member

TCL (India) Observer Member

BSB (Bhutan) Corresponding Member

Legend: 1 = QMS Signatory; 2 = EMS Signatory; 3 = Product Signatory; 4 = FSMS Signatory, 5 = GHG Signatory;
6 = ISMS Signatory

Page 9

September 2014 APLAC News Notes Issue No. 120

From BAB

Bangladesh Prime Minister

Interested in BAB Activities

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

Page 10

September 2014 APLAC News Notes Issue No. 120

From BAB

Information Session
Decision Makers

for Accreditation

In order to fulfill the requirements of ISO/IEC

17011:2004, BAB held a training session for the accreditation decision makers at the Centre for Advanced
Research in Sciences, University of Dhaka, where
nine Board members attended the information
session. The session
was conducted by BAB
Consultant Mr. Ned
Gravel. Apart from the
roles and responsibilities in the decision making process, the session
also covered the roles
and responsibilities of the appeals committee. The
session ended with a social gathering which was embellished by the kind presence of the Vice Chancellor of the University of Dhaka, Professor Dr. A.A.M.S.
Arefin Siddique.

Accreditation Decision
Makers in the
Information Session

BAB Organized Training on Root Cause

Analysis and Internal Calibration and
Proficiency Testing

BAB arranged two technical training sessions on

Root Cause Analysis
and Internal Calibration
and Proficiency Testing in June 2014 for
the testing and calibration laboratories in the
country. Mr. Ned Gravel,
Consultant of BAB, delivered the trainings for
a total of 36 participants.

Page 11

Root Cause
Analysis
training

September 2014 APLAC News Notes Issue No. 120

From Cala

Ilac Chairs Address Adds to Success

of Cala Conference

Pete Unger, ILAC Chair

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

Page 12

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 accreditation 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

September 2014 APLAC News Notes Issue No. 120

From CNAS

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

Page 13

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.
September 2014 APLAC News Notes Issue No. 120

From HKAS

HKAS Hosts APLAC Workshop on

Medical Laboratory Accreditation

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
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 overview of ISO 15189:2012 in Thailand last year, this
workshop was designed to enable participants to better understand some key elements of the new standardmethod 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
Page 14

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 Traceability
Unlike 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
September 2014 APLAC News Notes Issue No. 120

From HKAS

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.

Risk management and Laboratory Information

Management
In 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.

Dr Graham White giving a general introduction on

measurement uncertainty
Verification and Validation of Testing Method
Validation 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.

Page 15

Mr Kao Chih-Hsiung describing the integration of risk

management into an effective management system
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

September 2014 APLAC News Notes Issue No. 120

From HKAS

by different accreditation bodies for accrediting pointof-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.
Participants actively discussing case scenarios

Tripartite Seminar on Accreditation of

Medical Testing Laboratories

2014 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.

Page 16

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

September 2014 APLAC News Notes Issue No. 120

From HKAS

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

Page 17

time and clinical utility. He then showed participants

how this could be achieved.

Participants listening attentively to Dr Yams

presentation on the environmental setting of a
molecular diagnostic laboratory for infectious
diseases.

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 Director, Laboratory, St. Martin De Porres Hospital of Taiwan, who has
been studying this subject
for ten years and
has
put

September 2014 APLAC News Notes Issue No. 120

From HKAS

theory into practice in the last three years in his laboratory. In this workshop, he introduced risk management and its application
using vivid examples and
his own experience.
The seminar ended with
an interactive discussion
on some case scenarios
in which the participating accreditation bodies
came up with different
views. This exercise was
meant to highlight how,
despite the implementation of the same accreditation standard, there is
a need to harmonize the
interpretation of different
requirements. This interesting exercise and active
discussion brought better understanding about
the accreditation practice
and government policies
for medical testing in the
three economies.

Page 18

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

September 2014 APLAC News Notes Issue No. 120

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

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 Signatories

During 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
Page 19

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 MLA

IAAC is currently operating the following MLA scopes:

Persons Certification Bodies according to the ISO/
IEC 17024
Food Safety Management Systems (FSMS), according 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 subSeptember 2014 APLAC News Notes Issue No. 120

From IAAC

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 participants from the region.
A Workshop on Traceability of Measurement Results, 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 Refrigerators
IAAC 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.

Page 20

IAAC C003 Proficiency Test on Type K

Thermocouples Calibration (2nd round) 2012
This 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 Projects

Projects with the Physikalisch Technische
Bundesanstalt (PTB)
Renewable Energies and Energy Efficiency Project
IAAC 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 Project
IAAC together with COPANT and SIM, the
regional organizations for standards
and metrology, held their first planning meeting in August 2013
to define the areas of
potential interest and

September 2014 APLAC News Notes Issue No. 120

From IAAC

the scope of the draft project regarding the strengthening of quality infrastructure in programs related to
biodiversity and climate change. Sponsor organizations include PTB of Germany and the OAS. So far,
two IAAC members have expressed interest in participating in this project with a proposal to develop a national 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 Laboratories 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 Victor 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 evaluations 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.

Page 21

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 Technical Cooperation in Guatemala City in August
2014.
IAAC regularly invites AFRAC and SADCA members to participate in its proficiency testing programs.
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).

September 2014 APLAC News Notes Issue No. 120

From NATA

NATA to provide assessments for National

Health Standards

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

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

Page 22

8. Preventing and Managing Pressure Injuries

9. Recognising and Responding to
Deterioration in Acute Health Care

Clinical

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.

September 2014 APLAC News Notes Issue No. 120

From NATA

New accreditation scheme facilitates

Australian meat exports

A new accreditation scheme will facilitate the ongoing

acceptance of Australian
meat exports to the
European Union.
NATA and the Australian Department of Agriculture are entering into
a Deed of Agreement
which will facilitate the
necessary exchange of
information regarding applicant and accredited inspection bodies and the
annual surveillance arrangements required by
the Scheme rules.

The new Scheme may be

adopted for other markets
to improve access for
Australian meat and meat
products. (Photo: daff.
gov.au)

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.

Page 23

September 2014 APLAC News Notes Issue No. 120

From NATA

NATA conducts training in Indonesia

Helen May and Edita Rokov with the second group of

participants

The course was well-received by participants

Edita and Helen with some of the first group of

trainees

Helen May and Edita Rokov with the second group of

participants

Page 24

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 provided to the Indonesian Ministry of Agriculture,
with the first

September 2014 APLAC News Notes Issue No. 120

From NATA

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

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, inturn, facilitates greater accuracy in modelling
potential future changes and adds gravitas to
conclusions reached.

Authorised Representatives and invites them to submit

an entry describing how they feel accreditation relates
to the World Accreditation Day theme. This year the

Page 25

Furthermore, as next generation

energy provision technologies
are more widely implemented, the use
of quality

September 2014 APLAC News Notes Issue No. 120

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

Page 26

September 2014 APLAC News Notes Issue No. 120