PAC NEWS
PAC Chair’s Wish for the Success of PAC-APLAC Joint Meeting in Mexico
Dear PAC members and friends,
On behalf of the PAC Executive Committee, I would like
to welcome you to the 21st PAC Plenary meetings,
which will take place from 23 to 27 June, 2014 in
Guadalajara, Mexico.
The meetings will be held concurrently with the General
Assembly of the Asia Pacific Laboratory Accreditation
Cooperation (APLAC). This is the first time that PAC
and APLAC have met together and we are grateful to
entidad mexicana de acreditación, a.c. (ema) for hosting
these historic meetings.
A two-day training course in ISO/IEC 17065 for
Accreditation Body staff and assessors will be held on
21 – 22 June, directly before the official program
commences.
Several of the meetings will be joint activities, enabling
the meeting duration to be the same as in previous years. It will also encourage
members of both organisations to get to know each other better and to learn more about
each other’s operations and areas of mutual cooperation. There will also be a join
technical visit on Saturday 28 June.
We are delighted to advise that PAC will have at least three accreditation bodies that will
have successfully completed the rigorous peer evaluation activities required to become
eligible to sign the PAC Food Safety Management Systems (FSMS) Multi-Lateral
recognition Arrangement (MLA). The PAC FSMS MLA will be ratified during a signing
ceremony at the Gala Dinner on Thursday 26 June.
Ratification of the PAC MLA for FSMS establishes a regional MLA that that will underpin
FSMS capability building within our region. It will also enable certification bodies that are
accredited by signatories to the PAC FSMS MLA to be recognized internationally. That is
“certified once, accepted everywhere”.
I look forward to welcoming you to Mexico and to your active participation in the meetings.
Brett Abraham
PAC Chairman
IAAC EXECUTIVE COMMITTEE MEETING WAS HELD AT EMA MAR 17 TO 20.
EMA
hosted
the
Executive
Committee Meeting of IAAC, the
Inter-American
Accreditation
Cooperation.
Representatives from Argentina and
New Zealand gave well received
presentations
regarding
Good
Laboratory
Practices
in
their
respective countries.
Delegates had the opportunity to
meet
with
and
exchange
experiences with each other prior to
the meetings at the Welcome
function.
During the Welcome function, Fabián
Hernández,
Certification
Bodies
Manager was recognised for his
participation as President of the
IAAC MRA Committee from 2004 to
2008.
Finally, IAAC would like to welcome the National Body of Accreditation of Colombia
(ONAC), the newest MLA signatory in the scope of Testing and Calibration Laboratories.
TRAINING WORKSHOP FOR PAC PEER EVALUATORS HELD IN BANGKOK ON 3 – 4
MARCH, 2014
Ms. Manizheh Tahmasebi Afshar, Deputy
Director of NACI, reported on the training
workshop for Peer Evaluators, that was
held in Bangkok, Thailand, on 3 – 4 March
this year.
The training course was well prepared and
the participants acknowledged NSC staff,
supported by the PAC Secretariat, for
providing appropriate information and
venue planning. NSC was also thanked for
their excellent hospitality during the training
course.
The trainers, Ms. Azusa Nakagawa of JAB
Japan and Mr. Ekanit Romyanon of NSC
Thailand, were very active and happy to
answer the trainees’ questions. They had
excellent knowledge and experience related
to ISO Standards and IAF and PAC documents and rules. They covered all the training
course contents within the time allocated for the course.
Several case studies were undertaken to ensure that the trainees understand the
requirements of ISO/IEC 1701. The case studies also encouraged participants to think and
find the right solution and decision as qualified peer evaluators. All participants found the
training course very useful and the trainees all expressed their desire to participate in
further training in the future.
Prior to the course, the Secretariat requested feedback from all members regarding their
needs for future training, many ABs including NACI answered. We look forward to future
PAC training courses covering the required programmes for members.
KAN LAUNCHES ACCREDITATION SCHEME FOR MEDICAL DEVICES QUALITY
MANAGEMENTS SYSTEM (ISO 13485)
Transparency of international
economic development has been
encouraging
the
region
to
strengthen its regional market. In
response to the development of
trade regionalization, ASEAN
member countries have agreed to
establish the ASEAN Economic
Community (AEC) in 2015 to
create a flow of goods and
services flowing freely in the
ASEAN
region
with
the
expectation of improving the
economy
of
the
member
countries of the ASEAN sector.
One of the ASEAN integration sector priorities is medical equipment, which in the context
of ASEAN's AEC will be arranged in the Medical Devices Directive (AMDD). The medical
equipment sector has an important role in the diagnosis, prevention, monitoring, and
treatment of disease and in improving quality of life.
Working towards implementation of the ASEAN Economic Community by 2015 and the
implementation of the Medical Devices Directive ASEAN documents in January 2015, KAN,
with the Ministry of Health are working together to facilitate the stakeholders in the
implementation of quality management system standard ISO 13485, medical equipment
accreditation and certification schemes, through the National Accreditation Committee of
Indonesia (KAN). The Indonesia Quality Expo (IQE) opening ceremony saw the launch of
the accreditation schemes and quality management system Certification of Medical
Devices. The series of activities for IQE 2013 began on October 17, 2013. IQE was
officially opened by the Coordinating Minister for Economic Affairs DR.( HC ).Ir. Hatta
Radjasa . This event was attended by 800 participants that represent all stakeholders
from industries, conformity assessment bodies, government institutions, universities and
other relevant agencies.
BSN and KAN has facilitated the stakeholders to develop accreditation schemes and
quality management system certification of medical devices based on ISO 13485 , Medical
devices - Quality management systems - Requirements for regulatory purpose . This
scheme is expected to create consistent quality of medical devices, and to improve the
competitiveness of these products in the domestic, ASEAN, and international markets. A
KAN accreditation and certification scheme for Medical Device Quality Management
System requires business to provide medical devices and related services consistently,
and to meet customer requirements and applicable regulations. Certification for
conformance of this standard becomes a liability for the business to ensure the quality
assurance of the medical devices product as stated in the AMDD. The benefits of the
implementation of the quality management system of medical devices , among others,
increase the quality assurance of medical devices , minimize and manage risks ,
demonstrate compliance with legal and regulatory requirements , saving time and costs
and to support government in market surveillance.
This accreditation scheme will facilitate the business in proving compliance with relevant
customer requirements and regulations consistently, which ultimately could increase the
competitiveness of national products. For certification body this situation is a business
opportunity to become competent conformity assessment bodies in carrying out
certification to support global trade. Certification body located in Indonesia may start to
apply the accreditation for this scheme and visit KAN website www.kan.or.id. for further
information of application requirements .
KAN has also published its poster to celebrate the World Accreditation Day, which is June
9, 2014.
DAC, DUBAI ACCREDITATION DEPARTMENT HOSTED THE 3RD MEETINGS OF
HALAL ACCREDITATION COMMITTEE OF SMIIC
Dubai Accreditation Department
(DAC) hosted the 3rd meetings of
Halal Accreditation Committee of
The Standards and Metrology
Institute for Islamic Countries
(SMIIC). The meetings were held on
15 to 17 November 2013 in Dubai.
Delegates from Turkey, UAE, Iran,
Bosnia & Herzegovina and SMIIC
secretariat attended the meeting.
Ms. Amina Ahmed Mohammed,
Director of DAC, welcomed the
delegates. The scope of the Accreditation Committee (AC) is to establish a Halal
accreditation scheme among member states of Organization of Islamic Cooperation (OIC).
During meetings the Accreditation committee discussed the progress regarding
establishing the Halal accreditation system. Five working groups for documentation,
human resources, test methods for certification, peer evaluation and cooperation were
established. Meetings of working groups for documentation and human resources were
also held. Mr. Salih Yuksal, Chair of the committee thanked Dubai Accreditation
Department for hosting the committee meetings in Dubai.
DAC ARRANGED SYMPOSIUM ON HALAL ACCREDITATION
During the 7th Dubai Food Safety Conference, DAC arranged a symposium on Halal
accreditation and certification systems. Engineer Salem Bin Mohammad Mesmar,
assistant Director General of Dubai Municipality delivered the opening speech by focusing
on Dubai government’s vision regarding placing Dubai as a capital of Islamic economy. Ms.
Amina Ahmed, director of DAC gave a presentation on DAC’s upcoming Halal
accreditation scheme. Mr. Saleh Yuksal representative of Standards and Metrology
Institute for Islamic Countries (SMIIC) gave a presentation on unifying Halal standards
among Islamic countries. Dr. Tony Wigg, Australian Department of Agriculture, gave a
presentation on the Australian Government Authorised Halal Program (AGAHP). A large
number of representatives of food manufacturers and conformity assessment bodies
attended the symposium.
TSE DELEGATION VISITED DUBAI ACCREDITATION DEPARTMENT
A delegation from the Turkish
Standards Institution (TSE) visited
Dubai Accreditation Department on 5th
March 2014. The delegation was led by
the President of TSE, Mr. Hulusi
Senturk.
Various areas of mutual interest were
discussed. Ms. Amina Ahmed Director
of DAC briefed the visiting delegation
about upcoming accreditation schemes
of DAC.
She informed that in line with the vision of the Dubai Government, DAC is going to launch
an accreditation scheme for certification bodies providing Halal certifications.
DAC
CONDUCTED
VARIOUS
TRAINING
COURSES
FOR
CONFORMITY
ASSESSMENT BODIES
DAC conducted various training courses for conformity assessment bodies on various
accreditation related subjects, including awareness training on the new version of ISO
17020, ISO 15189 and ISO 17024 standards. Training on methods validation and
uncertainty measurements have also been included in the DAC training program for
laboratories.
DAC ARRANGED 3RD BRAINSTORMING SESSION
DAC arranged the 3rd annual
brainstorming session for DAC staff
in a local hotel in Dubai. DAC staff
presented various ideas on the
operations of DAC and related
conformity assessment issues.
DAC uses various formal means to
gather feedback from DAC staff
including an electronic suggestion
system and annual brainstorming
sessions.
During the session, appreciation certificates were awarded to the best performing sections
within DAC, who achieved the annual targets & key performance indicators.
NABCB SIGNS MOU WITH NBSM
The National Accreditation Board for Certification Bodies (NABCB) has been actively
promoting accreditation within the South Asian Association for Regional Cooperation
(SAARC) region. To further promote technical cooperation within the region, NABCB
signed a Memorandum of Understanding (MoU) with the Nepal Bureau of Standards and
Metrology (NBSM) in Kathmandu on 22 Jan 2014. This activity was part of the “National
Awareness Programme on Accreditation” to build capacity of the National Accreditation
Focal Point (NAFP) being set up in NBSM with support from Physikalisch-Technische
Bundesanstalt (PTB).
The MoU was signed by Mr. Anil
Jauhri Chief Executive Officer, NABCB
and Mr. Ram Adhar Sah, Director
General, NBSM, in the presence of Mr.
Mr. Krishna Gyawali, Secretary,
Ministry of Industry, Govt of Nepal.
Also present on the occasion was Mr.
B. Venkataram, Secretary General,
Quality Council of India and Vice Chair
of PAC.
The purpose of the MoU is to provide
NABCB accreditation services to
Certification Bodies and Inspection
Bodies in Nepal and to establish a NAFP in Nepal, with technical cooperation and
assistance from NABCB.
PAC PE TRAINING CONDUCTED BY NABCB
NABCB hosted a training programme for PAC Peer Evaluators covering ISO 17011, in
Delhi on 27 - 28 Feb 2014.
The training was attended by six assessors
from India (NABCB), three from Pakistan
(PNAC), two from Sri Lanka (SLAB) and
one from South Korea (KAB). There were
also two observers from India.
PAC nominated Mr. Phua Kim Chua from
SAC Singapore) and Mr. Anil Jauhri from
NABCB as trainers.
The venue cost and training fees were
sponsored by PAC, with NABCB and the
PAC Secretariat providing logistical
support to participants.
The peer evaluation process, mandatory documents of IAF/ PAC etc. were covered in
addition to ISO 17011.
REPORT ON 2ND SOUTH ASIAN ASSOCIATION FOR REGIONAL COOPERATION
(SAARC) EXPERT GROUP ON ACCREDITATION (SEGA) MEETING
At the invitation of the Government of Nepal, the Second Meeting of South Asian
Association for Regional Cooperation (SAARC) Expert Group on Accreditation (SEGA)
was held in Kathmandu on 20-21 January 2014.
The Meeting was inaugurated by Hon. Mr. Shankar Prasad Koirala, Minister of Finance,
Commerce, Industries and Supplies, Government of Nepal. In his inaugural address, the
Hon. Ministers underlined the importance of cooperation in the field of accreditation and
stated that “regional economic integration among SAARC countries can be enhanced
through co-operation in the field of accreditation of conformity assessment bodies”.
In his address, Mr. Madhav P. Regmi, Secretary, Ministry of Commerce and Supplies,
Government of Nepal informed that Nepal is in the process of establishing its own national
accreditation body. He also urged that it is important to reduce technical barriers to trade
for facilitating and enhancing intra-SAARC trade. In this context, it is imperative to promote
mutual cooperation in the field of conformity assessment in the SAARC region, he added.
Ms. L. Savithri, Director, Economic, Trade and Finance, SAARC Secretariat, Kathmandu;
Mr. Ram Adhar Sah, Director-General, Nepal Bureau of Standards and Metrology, Mr. B.
Venkataram, Secretary General, Quality Council of India; and Mr. Ajay Pradhananga,
representative of Federation of Nepalese Chambers of Commerce and Industry also spoke
in the inaugural session.. All speakers emphasised the importance of promoting
cooperation in the field of accreditation among the SAARC Member Countries. They noted
with appreciation the continuous financial and technical assistance being provided by PTB
in this regard.
Ms. Julia Micklinghoff, Project Coordinator, National Metrology Institute (PTB) of the
Federal Republic of Germany, also spoke in the Inaugural Session and reiterated the
commitment of PTB in helping SAARC Member States in promoting cooperation in the
field of quality infrastructure.
Mr. Bishwa Babu Pudasaini, Deputy Director General, Nepal Bureau of Standards and
Metrology, proposed vote of thanks.
For the technical meeting, the members selected Ms.Romi Manandhar, Deputy Director
General, Nepal Bureau of Standards and Metrology as Chairperson following the tradition
of chairperson being from the host country.
Mr. B. Venkataram, Secretary General, Quality Council of India, invited the attention of the
Meeting towards Article 6.1.1 of TBT Agreement under WTO which relates to the
importance of accreditation. Mr. Venkataram also informed that the importance of
accreditation has also been indicated in the South Asian Free Trade Area (SAFTA)
Agreement under Article 8. In view of the above, he underlined that it is necessary for the
SAARC Expert Group on Accreditation to chart out a plan of action for 2014 and beyond
for collaboration among SAARC Member States in the field of accreditation of conformity
assessment bodies. In his capacity as the Vice Chair of Pacific Accreditation Cooperation
(PAC), Mr. Venkataram also made a presentation on the activities of PAC.
SAARC countries including Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri
Lanka were represented by delegates from their national accreditation bodies, where they
exist, or national accreditation focal points or the national standards bodies. Mr. Anil Jauhri
and Ms. Vani Bhambri Arora represented NABCB.
A presentation was made by all heads of delegations on the status of national
accreditation bodies and update on new developments on regional (APLAC; PAC) and
international (ILAC, IAF) level; and on the events (e.g. trainings) hosted or attended since
the last SEGA Meeting held in Maldives in Sept, 2012, including how knowledge was used
and transferred within the country.
A discussion on future regional activities to address the topic of Food Safety in SAARC
was also held. Ms. Vani Bhambri Arora, the delegate from NABCB, India presented a
Concept Note on Food Safety trainings in SAARC.
The Group discussed the matter relating to Food Safety in SAARC and possible action at
the regional level in the food sector for facilitating export of food products within and
outside the SAARC region. For enhancing capacity of the Member States in food safety,
the Group recommended 4 training programs on food safety with the financial assistance
of PTB for which technical inputs and resource persons would be provided by NABCB.
These include trainings in revised ISO 22003, GMP/GHP/HACCP implementation, Auditing
of GMP/GHP/HACCP and Indian food regulations.
The Group also discussed adoption of CASCO standards as regional standards and it was
decided that standards which are used as accreditation criteria in the first instance may be
adopted as SAARC Standards. For this purpose, South Asian Regional Standards
Organisation (SARSO) may initiate a dialogue with ISO/IEC. NABCB agreed to prepare a
list of CASCO standards which can be immediately adopted by the Sectoral Technical
Committee on Conformity Assessment under SARSO.
The Meeting welcomed the offer of Pakistan to host the Third Meeting of the SAARC
Expert Group on Accreditation in the first week of September 2014 as per the terms of
reference of SEGA with the financial and technical assistance of PTB, Berlin.
CURRENT PAC MEMBERSHIP LIST - INCLUDING MLA SIGNATORY STATUS OF
FULL MEMBERS
JAS-ANZ (Australia & New Zealand) 1, 2, 3
BAB (Bangladesh) - Associate Member
PSK (Brunei Darussalam) – Associate Member
CNAS (PR China) 1, 2, 3
DAC (Dubai)
HKAS (Hong Kong, China) 1,2,3
NABCB (India) 1, 2
KAN (Indonesia) 1, 2, 3, 4
NACI (Iran)
IA Japan (Japan)
JAB (Japan)
1, 2, 3
JASC (Japan)
JIPDEC (Japan)
NCA (Kazakhstan) 3
KAB (Korea) 1, 2
KAS (Korea) 3
KCA (Kyrgyzstan)
STANDARDS MALAYSIA (Malaysia) 1, 2, 3
ema (Mexico) 1, 2, 3
MASM (Mongolia)
PNAC (Pakistan)
PNGLAS - Associate Member
INDECOPI (Peru)
PAO (Philippines) 1, 2
STC-IS Russia
SAC (Singapore) 1, 3
SLAB (Sri Lanka)
TAF (Chinese Taipei) 1, 2, 3
NSC (Thailand) 1, 2, 3
ANSI (USA) 3
IAS (USA) 3
BoA (Vietnam) 1,3
IOAS – Associate Member
IIOC – Associate Member
ICL (New Zealand) – Observer Member
TCL (India) – Observer Member
BSB (Bhutan) – Corresponding Member
Legend: 1 = QMS Signatory; 2 = EMS Signatory; 3 = Product Signatory; 4 = FSMS Signatory
Further information on PAC and PAC activities is available at www.apec-pac.org or by
contacting the PAC Secretariat by email pacsecr@email.com .
The PAC newsletter is published electronically twice per year. Interested parties are
welcome to contact the Secretariat, to be added to the newsletter distribution list.