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 AbrahamPAC 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.

K AN 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.

D AC, D UBAI ACCREDITATION DEPARTMENT HOSTED THE 3 RD 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 MemberPSK (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 MemberINDECOPI (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 MemberICL (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.