Quality Infrastructure and implementing EnMS UNIDO’s approach to NQI development Müge DOLUN UNIDO Trade Capacity Building Branch 08/04/2014

Quality Infrastructure (QI) Technical regulations, standards, metrology, accreditation, inspection, testing and certification are utilized by societies to address issues related to the optimization of production, safety and health, consumer protection, environmental control as well as to manage risks and market failures. Their sound development and effective implementation enable sustainable development, build welfare and facilitate trade.

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Building blocks of Quality Infrastructure Standards Specific technical requirements for product, process or service

Conformity Assessment Proof that technical requirements are met: Testing Inspection Certification

Metrology

Accreditation

Measurement standards underpin testing and calibration

Assures competence

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Legal Framework

Metrology

Accreditation

Standards

Institutions

Metrology Institute

Accreditation Board

Standards Body

Source: UNIDO

Inspection

Certification Personnel

Processes

Products

Competent Authorities

Inspection Bodies

Etc.

Testing Services

Pesticide Residues

Chemical

Etc.

Microbiological

Testing Calibration Services

Mass

Volume

Temperature

Calibration Services

Public and/or Private

Public

International Governance

Quality Assurance Infrastructure

Value Chain: Producers / Exporters / Consumers

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ISO and conformity assessment • Non acceptance of test reports and certificates one of the biggest obstacles to trade • International recognition and acceptance to be based on confidence and good practices • The way forward: implementing the ISO/IEC Standards and Guides, with a double level of consensus, amongst countries and across stakeholders

SMA /CASCO

The ISO/CASCO Toolbox – 5

The ISO/CASCO Toolbox The CASCO toolbox consists of 27 documents covering: Vocabulary, principles and common elements of conformity assessment ISO/PASs 17001-17005 (Impartiality, Confidentiality, Complaints and Appeals, Disclosure of Information, Management Systems of CABs) under revision Code of good practice ISO/IEC Guide 60:2004, Conformity assessment --Code of good practice under systematic review Product, system, and persons certification Testing, calibration, inspection, marks of conformity Supplier’s declaration of conformity, accreditation, peer assessment, and mutual recognition arrangements

SMA /CASCO

The ISO/CASCO Toolbox – 6

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Conformity assessment Hierarchy RECONFIRMED 2013

Under revision

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2012

ISO/IEC 17022:2012 Audit Reports ISO/IEC 17023 : 2013 Audit Duration

Accreditation and international cooperation: International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) Global networks of conformity assessment accreditation bodies ensure: • Recognition of competent conformity assessment activities through global multi-lateral mutual recognition arrangements • Harmonization of conformity assessment practices • Promotion of accredited conformity assessment as an effective mechanism for providing confidence in goods and services

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The IAF MLA Main Scopes-provide confidence that conformity assessment bodies are equally reliable • Product certification – AB conforms to ISO/IEC 17011 + CB conforms to ISO/IEC 17065

• Management systems certification – AB conforms to ISO/IEC 17011 + CB conforms to ISO/IEC 17021

• Certification of persons – AB conforms to ISO/IEC 17011 + CB conforms to ISO/IEC 17024

Structure of the IAF MLA Level 1

ISO/IEC 17011

Level 2

Product Certification

Management Systems Certification

Certification of Persons

Level 3

ISO/IEC 17065

ISO/IEC 17021

ISO/IEC 17024

Level 4

ISO/TS 22003

Level 5

ISO 22000

ISO/IEC ISO 50003 27006

ISO ISO 9001 14001

ISO 50001

ISO 27001

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The IAF MLA Mark • MLA signatories with sub-scopes can license CBs to use the MLA mark in conjunction with their own accreditation body logo • The certification body must include an indication of the MLA sub-scope for which the accredited certification is related. • MLA signatories can use the MLA mark on accreditation certificates • Businesses seeking certification will be able to see at a glance if the certification body issuing the certificate is accredited by an accreditation body that is a signatory to the IAF MLA.

Management system auditors- competency ISO/IEC TS 17021-x, Conformity assessment --Requirements for bodies providing audit and certification of management systems --Part 2: Competence requirements for auditing and certification of –Part 2:2012 Environmental management systems –Part 3:2013 Quality management systems –Part 4:2013 Event sustainability management systems –Part 5:201x Asset management systems –Part 6:201x Road traffic safety management systems –Part 7:201x Business continuity management systems

ISO/IEC17027:2014, Conformity assessment --Vocabulary related to competence of persons used for certification of persons

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MS experts and auditors- competency II Some examples of auditor “trainings” - The International Register of Certificated Auditors (IRCA) : “certified” or “approved” training” 90 IRCA approved training organisations operating in over 100 countries, IRCA certified auditor based on generic “Requirements for certification as an IRCA auditor” (including EnMS)- not based on 17024 - Exemplar Global (formerly RABQSA) accredited to ISO 17024: 2003 by JASANZ lead auditor 9001, 14001, OHSAS and food safety, also certifies training providers - Professional Evaluation and Certification Board (PECB, Canada): has thirty one (31) certification schemes accredited by ANSI ISO/IEC 17024

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Joint UNIDO-ISO-IAF project: Implementation of ISO 9001 Quality Management System in Asian developing countries: Survey covering system development, certification, accreditation and impact Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, Indonesia, Malaysia, Philippines, Thailand, Vietnam

Objective: To assess ISO 9001 certification process in SAARC and South East Asian countries through an impact assessment study and to build synergy in certification process and to facilitate improvements in accreditation scheme of certification bodies.

Project Outcomes: •

Improved empirical evidence on economic impact of management system certification in industries in SAARC & South East Asian countries

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Best practices and policy guidelines for improvement of functioning of management system certification bodies and accreditation boards. No.14

Survey report launched at ILAC/IAF General Assembly Shanghai, 25 October 2010

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Concerns for developing country NQI Weaknesses in national capacity for conformity assessment: In order to benefit from possible opportunities countries have to access rather high-cost conformity assessment service providers (e.g. certification bodies and testing laboratories) from abroad. Also system-wide weaknesses need to be addressed such as: • Need for awareness creation- on NQP, NQI and Accreditation • Building traceable calibration • Addressing human capacity upgrading • Ensuring Staff Motivation and Retention • Supporting Service Promotion, Marketing and Sustainability

Thank you.

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