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From the National Arena

NABCB to support Ministry of Commerce programme on Geographical IndicatorsThe Ministry of Commerce & Industry has launched an elaborate promotional programme for the Geographical Indication (GI) products of India with an objective of boosting their market and supplementing the income of producers like farmers, artisans etc. The logo and tagline under this initiative were launched on 16 Aug 2018. QCI has been assigned the task of developing a system of verification of authenticity and certification for quality for GI products to enhance trust in them. The Department of Industrial Policy and Promotion has identified 17 GI products including Banarasi saris, Nasik wine, Nagpur oranges, Hyderabadi haleem etc initially for developing such a system.

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FSSAI prescribes NABCB accreditation for Food safety audit agencies FSSAI in a gazette notification No. 328, published on 07th Sep 2018 has prescribed that for the purpose of carrying food safety audits, it would grant recognition to auditing agencies that hold a valid accreditation for ISO/IEC 17020 or ISO/IEC 17021 or ISO/TS 22003 from the National Accreditation Board for Certification Bodies (NABCB) for the required food categories specified by the Food Authority. The regulation also states that in case there are no NABCB accredited agencies available for a food product, Food Authority may consider auditing agencies which are accredited by any other accreditation body which is a signatory to the International Accreditation Forum Multilateral Recognition Arrangements (IAF MRA) for Management System Certification provisionally subject to the condition that they shall apply for NABCB accreditation.

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NABCB conducts sensitization programme for officials of Nagaland Government:

A one day sensitization programme on Standards, Technical Regulations, Conformity Assessment and Accreditation was held at the Directorate of Industries and Commerce in Kohima for Nagaland industries officials on 25 September 2018. The programme was organized by the Directorate of Industries and Commerce, Nagaland in collaboration with NABCB and had over thirty participants.

NABCB NEWSOctober 2018 | Vol. 05 | Issue 03

National Accreditation Board forCertification Bodies,Quality Council of India, Institution of Engineers Building,2, Bahadur Shah Zafar Marg, New Delhi - 110002, IndiaTel: +91-11-2337 8056/57,2337 8837/38Fax: 91-11-2337 8678.Email: nabcb@qcin.org

From the National Arena

NABCB to support Ministry of Commerce programme on Geographical Indicators

FSSAI prescribes NABCB accreditation for Food safety audit agencies

NABCB conducts sensitization programme for officials of Nagaland Government:

IBSC forges global partnership with AAMI to certify biomedical engineering professionals

NABCB conducts Appreciation Programmes on ISO 45001:2018

NABCB participates in GeM Workshop on Quality Framework

3rd Annual Medical Device Regulatory and Quality Summit 2018

NABCB participates in ASSOCHAM conference on Food

NABCB attends 2nd Pipeline Integrity Management System (PIMS) Conference

From the International Arena

NABCB outreach to Industry and Consumers

Industry Awareness Programmes

Consumer Awareness Programmes

NABCB attends National Convention of Consumer Confederation of India

News from QCI

QCI organizes Regional Quality Conclave in Varanasi

Interactive session on AYUSH Premium Mark and Standard Mark Scheme

ASSOCHAM organizes session on Swachchta in Food Processing Sector

NABCB accreditation at a Glance

New Accreditations

New Applications

NABCB Accreditations (as on 30 September 2018)

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Inaugurating the programme, the Commissioner and Secretary of Industries and Commerce, Nagaland, Ms Lithrongla G Chishi, underscored the importance of standards, regulations and certification in the modern competitive world. She particularly encouraged the agri and allied, bamboo, handloom and bio-resources departments to make the best use of the training as they would be the forerunners in creating awareness and imparting training to other departments in the future.

Mr. Anil Jauhri, CEO, NABCB explained the basic concepts and the importance of standards, technical regulations and conformity assessment in the WTO regime. He apprised the participants about the existing regulatory regime in the country and the role of State Governments in ensuring implementation of regulations effectively even if there was little industry in the state.

The participants were made aware about the rampant unauthentic and even fraudulent certificates available in the market and how accreditation is the only recognized means of ensuring genuine certificates. Mr. S. Krishnamurthy, Lead assessor, NABCB explained about accreditation and conformity assessment infrastructure and its role in the ecosystem.

Prof. Murali Kallummal of the Centre for WTO Studies, who was deputed by the Department of Commerce, spoke about WTO TBT and SPS Agreements.

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IBSC forges global partnership with AAMI to certify biomedical engineering professionalsThe Indian Bio-medical Skill Consortium (IBSC), in which QCI is a partner, signed an MoU with the Association for the Ad-vancement of Medical Instrumentation (AAMI) on 24 Aug, 2018 to help biomedical engineering professionals get certifi-cations and international acceptance. This is a significant development as AAMI has certified more than 7,000 biomedical engineering professionals in over 100 countries.

The MoU was signed by Dr. Jitendar Sharma, MD & CEO, Andhra Pradesh Med Tech Zone (AMTZ) and Dr. Brad Schoener, Vice Presi-dent, Innovation, AAMI in the presence of Dr. Renu Swaroop, Sec-retary, Department of Biotechnology (DBT), Government of India, Ms. Sunita Sanghi, Director General, National Skill Development Agency (NSDA) under the Ministry of Skill Development, Mr. Shyam Sunder Bang, Chairman, National Accreditation Board for Certifica-tion Bodies (NABCB), Mr. Rajiv Nath, Forum Coordinator, Associa-tion of India Medical Devices Manufacturers (AiMed) and Mr. Anil Jauhri, CEO, NABCB.

This is intended to benefit 2 lakh biomedical engineers and technicians in the country across hospitals, manufacturing units, sales and marketing divisions, installation and servicing units and R & D laboratories. The assessment for certification and skill development will be conducted across the country through pan India assessment centres.

IBSC is a pioneering initiative of AMTZ done in collaboration with the NABCB - Quality Council of India (QCI) and Association of Indian Medical Devices Industry (AiMeD) to establish an institutional mechanism for certification and skill development. IBSC proposes to develop an equivalence system of value-based assessment covering educational training, work experience and competency possessed by practitioners of biomedical engineering skills.

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NABCB conducts Appreciation Programmes on ISO 45001:2018NABCB organized a series of one-day appreciation programmes on ISO 45001:2018 on Occupational Health and Safety Management System (OH&SMS) on 15 September 2018 at Chennai; 22 September 2018 at Delhi and 29 September 2018 at Mumbai. The purpose of organising these programmes was to give a head start to organizations who wish to migrate to ISO 45001 from OHSAS 18001 or implement ISO 45001.

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NABCB NEWS OCTOBER 2018

The programme helped the consultants, certification bodies and industry personnel to understand the changes in the new ISO 45001: 2018 vis-à-vis OHSAS 18001 and to identify the actions which an organisation needs to take in order to imple-ment or migrate to ISO 45001:2018.

Mumbai had the maximum number of participant count with a total of 71 followed by 42 participants in Delhi and 30 in Chennai.

Mr Abhay Pathak, Lead Assessor, NABCB was the expert resource for the programme. He was member of the Indian group in BIS which was involved in the development of ISO 45001. He had also undergone training on ISO 45001 from Pacific Accreditation Cooperation (PAC) imparted by Mr. Leonardo Omodeo Zorini, who was an active member of the ISO/PC 283 Committee for the ISO 45001 development. Mr Abhay Pathak works with Tata Motors Ltd, Pune as Head, Sustainability.

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NABCB participates in GeM Workshop on Quality FrameworkNABCB was actively involved in guiding the participants in a Workshop on Quality Framework organised by GeM (Government E-market place) on 28 Sept 2018 at Delhi. The workshop was attended by 120 plus participants. Mr Anil Jauhri, CEO, NABCB explained to participants about the need for Quality during procurement. He informed the participants that it was essential that authenticity of certificates be reviewed in the market during procurement and only certificates issued by accredited cer-tification bodies should be relied upon.

There was a session on “Role of Accreditation/Certification in GeM Procurement and its Integration” and during this session talks were delivered by Ms Sashi Rekha, Director NABCB and Dr Aparna Dhawan, Joint Director, NABCB. They informed the participants about accreditation, its benefits and the need to use only services of accredited conformity assessment bodies during procurement. Ms Shobha Hegde, Lead Assessor, NABCB provided an overview on inspection services and methodol-ogy during the session.

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3rd Annual Medical Device Regulatory and Quality Summit 2018Ms Sashi Rekha, Director NABCB participated in a panel discussion in the third Annual Medical Device Regulatory and Quality Summit held in New Delhi on 9-10 Aug 2018. She was a panellist for a discussion on “Perspective on Notified Bodies: Prepar-ing for MDR implementation and expectations from industry”. The panel consisted of representatives from Atomic Energy Regulatory Board (AERB), Tuv Rheinland and Quality and Accreditation Institute (QAI) and the panel discussions were moder-ated by Mr. Sudhakar Mairpadi, Director - Quality & Regulatory, Philips India Limited. Over 100 participants representing the medical devices manufacturers attended the programme. The panel discussions were focussed around the following:

Status of preparation and implementation

Understanding the impact on Notified Bodies

Clarifying expectations for how industry should be preparing

Director, NABCB explained the role of NABCB accredited notified bodies in MDR 2017. She stated that NABCB has already accredited 7 Notified Bodies for MDQMS and eight more applications are being processed by NABCB, the details of which are available on the NABCB website. She also explained that the accredited notified bodies had to register with CDSCO in order to be notified by them and many of these bodies are hesitating to do so as the volume of business does not seem large to them since only a one time audit of the manufacturing site of Class A and B medical devices by these notified bodies is stipulated in MDR 2017.

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NABCB participates in ASSOCHAM conference on Food Ms Vani Bhambri Arora, Deputy Director, NABCB delivered a talk on “Food safety schemes & Initiatives of QCI and fraud certification” at ASSOCHAM’s Conference on “Food Value Chain Partnerships - End to End Approach” on 28 September 2018 held at New Delhi. The Food Value Chain Partnerships - End to End Approach is intended to bring together key stake-holders (Value Chain Experts, Food Entrepreneurs, Central & State Government Dignitaries, National program managers, innovators, technical experts, policy-makers, Research orga-nizations, Global agencies, Innovation institutions, and mul-tilateral agencies) to initiate developments on optimizing the value chain in Food & Allied Sectors in India. It was attended by around 200 participants.

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NABCB attends 2nd Pipeline Integrity Management System (PIMS) Conference The 2nd Pipeline Integrity Management System (PIMS) Conference was held from 23-24 August 2018 in New Delhi. It covered a well-diversified participation from the regulatory bodies, Oil Marketing Companies (OMCs), pipeline operators, line pipe manufacturers, vendors and other experts. The conference had attendance of 125 persons. The focus of the conference was to discuss key technical issues like Pipeline Cathodic Protection, Intelligent Pigging, Patrolling & Security; Pipeline O&M-key is-sues; Direct Assessment Tools; Bank protection and Regulatory perspectives- PIMS and Emergency Response & Disaster Management Plan (ERDMP)

Mr Anil Jauhri, CEO, NABCB delivered a talk on ‘Policy and Regulatory Perspectives’. The conference was also attended by assessors and staff of NABCB which included Mr. C.M. Sharma, Assessor; Mr. S.N. Mathur, Assessor and Mr. Ajay Sharma, Joint Director. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

From the International Arena

17 countries meet in India for Codex online tools workshopA two-day training workshop was conducted in Delhi on 5-6 September 2018 to enhance the ability of 17 Asian countries to operate successfully in the Codex Alimentarius international standard-setting environment. Led by the Codex Alimentarius Secretariat, the sessions were focussed on the electronic systems and tools including: the new Codex website; Online Commenting System (OCS); Digital platform for Electronic Working Groups (EWG) and other web-based tools, such as the platform to collect information on Member countries’ food safety control systems. NABCB was invited by FSSAI which is the National Codex Point of India to

attend this workshop as it is actively participating in two of the codex committees, Codex Committee on Food Hygiene (CCFH) and Codex Committee on Food Import and Export Certification and Inspection (CCFICS). Ms Vani Bhambri Arora, Deputy Director, NABCB attended the meeting on behalf of NABCB.

The countries which participated in this workshop were Bangladesh, Bhutan, Cambodia, China, India, Indonesia, Japan, Lao PDR, Republic of Korea, Malaysia, Maldives, Mongolia, Nepal, Philippines, Singapore, Sri Lanka and Thailand. This training activity supports the Codex Strategic Plan (2014-19), in particular, strategic goal 3 which is about facilitating the effective participation of all Codex Members.

The workshop was inaugurated by Shri Pawan Agarwal, Chief Executive Officer of Food Safety and Standards Authority of India (FSSAI). During the course of the meeting, participants also had an opportunity to discuss about the Regional Coordinating Committee meeting scheduled for 2019

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NABCB outreach to Industry and Consumers

Industry Awareness ProgrammesNABCB conducted an Industry Awareness Programme on the theme ‘International Equivalence of Accreditation & its Benefits to Industry’ on 10 August 2018 in Nashik. The programme was jointly conducted with EEPC.The Inaugural address was given by the Chief Guest Mr. Rajaram Mane, Divisional Commissioner, Nashik. The gathering was also addressed by Mr. H.S. Banerjee, President, NIMA (Nashik Industries Manufacturers Association). The programme had participation from almost 45 industry representatives from various industries such as electronics, automobile, chemical, heavy fabrication and electrical switchgear. Presentations on Challenges of Standards and Conformity Assessment, Accreditation and its benefits and Guidance on selecting Certification Bodies were made by the NABCB team comprising of Ms. Shobha Hegde, Lead Assessor, NABCB and Mr. Ajay Sharma, Joint Director, NABCB. This was followed by an open house discussion in which participants had an extensive interaction with NABCB.

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Consumer Awareness Programmes NABCB conducted a Consumer awareness programme on Quality in Products and Services in collaboration with the Consumer Coordination Council (CCC) at Jodhpur, Rajasthan on 31 Aug 2018. The programme was attended by social and consumer activists representing Consumer organizations from Jodhpur

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NABCB NEWS OCTOBER 2018

and nearby cities. Ms. Sashi Rekha, Director, NABCB briefed the participants about the significance of Voluntary Standards and Technical Regulations, Role of Accreditation and Product and Systems Certification. Mr. Ajay Jaidka, Assistant Director, NABCB explained about the Complaint Handling Process and the measures to be taken into consideration while lodging consumer complaints The programme was attended by over 100 participants. NABCB plans to conduct more such programmes across the country jointly with the Consumer Coordination Council.

NABCB attends National Convention of Consumer Confederation of India Ms. Sashi Rekha, Director, NABCB, attended the 3rd National Convention of Consumer Activists of India organized by the Consumer Confederation of India (CCI) at Jaipur on 30 September 2018. The focus of the Convention was on Consumer Laws, Consumers Charter of India and Consumer Agenda for next decade. Director, NABCB spoke about how India is hugely under regulated and how the lack of regulations puts consumers at risk and therefore the need for consumer organizations to join hands and build pressure on the Government to bring in more regulations for better consumer protection. She added that Market Surveillance in India is very weak and consumer organizations should offer to assist the Government in this activity which enables to verify if products are safe thus ensuring consumer protection.

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News from QCI

QCI organizes Regional Quality Conclave in Varanasi A 3-day Regional Quality Conclave was organized by QCI at Banaras Hindu University (BHU), Varanasi from 8-10 August 2018. The theme of the Conclave was “Universal Health Coverage under Ayushman Bharat : Assisting Implementation”. The Conclave was attended by over 500 people, comprising of experts on the subject along with service providers (public & private), trade & industry associations and patient organizations.

The following subjects related to healthcare were included in the Conclave : (i) Making Ayushman Bharat Quality Centric (ii) Strengthening primary health care & Health Wellness

Centres (iii) Role of Health Insurance vs Assurance, and (iv) Information, Education and Communication Activities & Robust Patient Feedback Mechanism.

Mr Anil Jauhri, CEO, NABCB, delivered a talk during the workshop on the risk of unauthentic and fraudulent certifications in healthcare. He emphasized the need to review the certificates which were being used by different organisations to ensure quality etc. like ISO 9001, ISO 14001, ISO 22000 as there are rampant malpractices even in the healthcare sector. There are certificates for WHO GMP, CE Marking, ISO 13485 and ISO 9001 being provided by unscrupulous certification bodies with unknown credentials. He stressed that internationally accreditation is the only recognized means of authenticating a certification body and there is a need to use the services of accredited certification bodies for this purpose.

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Interactive session on AYUSH Premium Mark and Standard Mark SchemeDr. Deepika Gunawant, NABCB & QCI Expert, delivered a talk on AYUSH Mark Scheme of QCI in the “Interactive Session on Strategy for Implementation of Premium Mark and Standard Mark on Ayurveda Products” organised by the PHD Chamber of Commerce and Industry at New Delhi on 20 Aug 2018. The session was attended by almost 100 participants representing stakeholders from industry, government, research organizations, regulatory bodies and professional service providers. The AYUSH Premium Mark is a part of the Ministry of AYUSH – QCI Voluntary Certification Scheme designed to ensure efficacy of herbal products based on the Indian systems of healthcare including Ayurveda, Unani, Siddha as well as Homeopathy.

Shri P.N. Ranjit Kumar, Joint Secretary, Ministry of AYUSH, Government of India was the Chief Guest for the Interactive Session.

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QCI participates in the 5th Annual Food Quality and Safety CongressMr Vishnu Chandra Srivastava, Deputy Advisor, QCI delivered a talk on ‘Food safety schemes & Initiatives of QCI’ covering IndGAP, IndiaGHP and IndiaHACCP, Q Mark, Safe Food Tasty Food, and Food Safety Professional Certification schemes of QCI at the 5th Annual Food Quality and Safety Congress, organised

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by Inventicon Business Intelligence Pvt. Ltd. on 9-10 August 2018 at New Delhi. Mr. Udai Kumar Saxena, NABCB assessor, also delivered a talk on Role of Conformity Assessment in the food industry The session was attended by about 150 participants representing stakeholders from Food industry, government, research & regulatory bodies and professional service providers. The objective was to bring together regulators, F&B manufacturers, analytical services and testing companies, to share best practices in aligning food quality and safety systems with FSSAI regulations.

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ASSOCHAM organizes session on Swachchta in Food Processing SectorTo discuss and promote health & hygienic practices, nutritional value, food safety & standards and operational efficiency at various levels in food industry and to accomplish Swacchata Action Plan, ASSOCHAM with support from the Ministry of Food Processing Industries, organized an Interactive Session on “Swachchta in Food Processing Sector” on Wednesday, September 19, 2018, in Gurugram. Mr Vishnu Chandra Srivastava, Deputy Advisor, QCI delivered a talk on “Food safety schemes & Initiatives of QCI’ covering IndGAP, IndiaGHP and IndiaHACCP, Q Mark and Safe Food Tasty Food certification schemes. The session was attended by a conglomeration of stakeholders from food industry, government, research & regulatory bodies and professional service providers on one platform to take concrete steps towards having an industry sector that is driven to deliver clean and hygienic food by following best and healthy practices.

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NABCB accreditation at a Glance

New AccreditationsDuring the quarter July – Sept 2018, NABCB has granted accreditations in Inspection (2) as follows:

Shashank Mehendale Consultants Pvt. Ltd. as Type-A inspection body since July 2018

Bureau Veritas International Doha L.L.C as Type-A inspection body since July 2018

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New ApplicationsDuring the quarter Jul - Sept2018, NABCB has received applications for NABCB accreditation in Management Systems (6), Product Certification (3), Inspection (4) and Personnel Certification (1) as follows:

Prime Certification & Inspection L.L.C for QMS as per ISO/IEC 17021-1

Deutsch Quality Systems (India) Pvt. Ltd. for QMS as per ISO/IEC 17021-1

Prime Certification & Inspection L.L.C for EMS as per ISO/IEC 17021-1

Prime Certification & Inspection LLC for FSMS as per ISO/IEC 17021-1

Bureau of Indian Standards for FSMS as per ISO/IEC 17021-1

Nepal Bureau of Standards and Metrology for FSMS as per ISO/IEC 17021-1

Prime Certification & Inspection LLC for Product Certification as per ISO/IEC 17065

IRCLASS Systems and Solutions Pvt. Ltd. (Operating certification services through its Division Indian Register Quality Systems) for Product Certification as per ISO/IEC 17065

Equalitas Systemcert Pvt. Ltd. for Product Certification as per ISO/IEC 17065

Astron Certification India Pvt Ltd. for Inspection as per ISO/IEC 17020

PVN Associates Pvt. Ltd. for Inspection as per ISO/IEC 17020

Maverick Quality Advisory Services Pvt. Ltd. for Inspection as per ISO/IEC 17020

TUV InterCert Saar India Pvt. Ltd. for Inspection as per ISO/IEC 17020

Bureau Veritas (India) Pvt. Ltd. for Personnel Certification as per ISO/IEC 17024

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NABCB NEWS OCTOBER 2018

NABCB Accreditations (as on 30 September 2018)

Scheme Accreditations Applications

Quality Management Systems (QMS) 36 10

Environmental Management Systems (EMS) 09 04

Inspection Bodies (IB) 46 20

Food Safety Management Systems (FSMS) 14 08

Occupational Health and Safety Management Systems (OHSMS) 06 02

Product Certification (PCB) 11 06

Information Security Management Systems (ISMS) 05 -

Energy Management Systems (EnMS) 05 -

Information Technology Service Management Systems (ITSMS) 01 -

Personnel Certification (PrCB) 01 04

Road Traffic Safety Management Systems (RTSMS) - -

Trustworthy Digital Repositories Management Systems (TDRMS) 01 -

Medical Devices QMS (MDQMS) 07 10

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Media Coverage for NABCB and its activitiesNABCB appeared in the various media coverage for its different activities. The following media clippings are available on the NABCB website at the web link: http://nabcb.qci.org.in/media-coverage.php