Conformity Assessment Structure in South Africa

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1 3 rd Annual Regulatory Workshop Conformity Assessment Structure in South Africa Mr Tumelo Ledimo

2 Status of SANAS SANAS is recognized as the sole national accreditation body responsible for carrying out accreditation in respect of conformity assessment, which includes: Calibration, testing and verification laboratories; Medical laboratories; Certification Bodies; Inspection Bodies; B-BBEE Rating agencies; and Monitoring of GLP compliance with principles adopted by the OECD. The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 19 of 2006

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4 Accreditation Traceability Standards Regulations TECHNICAL INFRASTRUCTURE CONFORMITY ASSESSMENT BODIES (CABs) (Inspection, Testing, Calibration & Certification)

5 SANAS Structure Minister: Trade & Industry EXECUTIVE AUTHORITY Board of Directors ACCOUNTING AUTHORITY ADVISORY FORUM Audit and Risk Committee HR & Remuneration Committee COMMITTEES OF THE BOARD CEO MEMBERS OF KEY MANAGEMENT Company Secretary/Legal Advisor PA Chief Financial Officer Senior Manager Mechanical & Physical Senior Manager Certification, Testing, BEE Senior Manager Corporate Services Senior Manager Research & Development

6 SANAS Growth Between 1994 and 2015 the internationally recognised network of accredited conformity assessment bodies available in South Africa grew from 139 to 1515; This network services industries such as metals fabrication, aerospace, automotive, green industries, agro-processing, clothing and textiles, biofuels, pharmaceuticals and chemicals. This network is also used to protect the health and safety of the public and the environment

7 SANAS Growth Total No. of Accredited Facilities: /03/

8 WHAT MAKES SANAS ACCEPTABLE We have to comply with international criteria (includes Quality Management system criteria and demonstration of our technical competence with regard to the various sectors we accredit in). ISO/IEC SANAS has a formal documented complaints procedure for both its own activities as well as those with whom it has formal mutual recognition arrangements. Constant international interaction and benchmarking.

9 THE INTERNATIONAL PICTURE ILAC/IAF EA APLAC SADCA IAAC EA APLAC IAAC SADCA AFRAC European co-operation for Accreditation Asia Pacific Laboratory Accreditation Cooperation Inter-American Accreditation Cooperation Southern African Accreditation Cooperation African Accreditation Cooperation

10 SANAS Don t and Do Don t We do not develop or draft standards We do not regulate We do not legislate We do not prosecute We do not provide conformity assessment services e.g. testing, inspection certification Do We support SANS We verify compliance to relevant national and international standards Support regulators We provide input to legislation when required We provide support to prosecutors We accredit conformity assessment bodies

11 Supervision in the Market Accreditation Bodies Accreditation service Conformity assessment bodies Certification Body Inspection Body Test Lab Cal Lab Conformity Assessment Service Product/ service Market Conforming product/service Requirements Purchasers Regulators Demands for competent conformity assessment Suppliers Trade Organizations and Authorities Demands for facilitating trade

12 Impact of Accreditation Facilitate Trade (Fair trade, International Trade) Support Regulations Ensure compliance to international standards Underpin the acceptance of South African produced goods and services Negate technical barriers to trade (TBTs) Crucial for locking out bad quality and unsafe imports and locking in export markets Use as a prerequisite by some regulators to approve private entities to perform work within the regulatory domain e.g. Department of Labour- Inspection, National Regulator for Compulsory Specifications (NRCS)- Trade Metrology Improve Quality of Life (Health, Safety, Environment; Law enforcement, etc.) Reliable medical (diagnostic and treatment) and testing OHS measurements: For example noise exposure levels, light, testing & inspection etc. Protects against inferior imports (dumping) Helps to meet social needs New energy sources, biofuels, liquefied natural gas, etc. Increased reliable energy efficiency and green house gas emission measurements, usage and claims (accurate consumption measures etc.) Contribute to safe water & food testing

13 TECHNICAL COMPETENCE Accreditation bodies such as SANAS assess factors relevant to an organisation s ability to produce precise, accurate test, calibration and inspection data, including the: - technical competency of staff; - validity and appropriateness of methods; - traceability of measurements to national standards; - suitability, calibration and maintenance of equipment; - suitable environmental conditions; - handling of test / inspection items; - quality assurance processes.

14 HOW CAN WE TELL IF AN ORGANISATION IS ACCREDITED Accredited organisations issue test or calibration reports bearing the SANAS symbol indicating their accreditation. A potential customer can also check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This is specified in their Scope of Accreditation, which should be supplied by the laboratory upon request. SANAS has a published directory of the facilities they have accredited (see This directory contains : An organisation s contact details and information on their specific capabilities. 007

15 ACCREDITATION of CONFORMITY ASSESSMENT IAF MLA Structure Level 1: ISO/IEC 17011; Level 2: Accreditation Activities, currently including management system certification, product certification and certification of persons; Level 3: Generic accreditation standards, e.g. ISO/IEC 17021, ISO/IEC and ISO/IEC 17024; Level 4: Sector specific CAB standards, e.g. ISO/TS 22003, ISO/IEC 27006; Level 5: Conformity assessment standards, e.g. ISO 9001, ISO 14001, ISO 22000, ISO/IEC 27001, ISO13485.

16 IAF Mandatory Documents IAF MD 8 IAF Mandatory Document for the application of ISO/IEC in Medical Device Quality Management Systems. Issued 15 July 2011 IAF MD 8 IAF Mandatory Document for the application of ISO/IEC in Medical Device Quality Management Systems. Issued 15 July 2011

17 IAF Mandatory Documents The objective of the IAF MD8 document is to enable accreditation bodies to harmonise their application of ISO/IEC for the accreditation of bodies providing audit and certification to ISO/IEC by including: Annexure 1: Scopes of accreditation. Annexure 2: Required types of knowledge and skills for personnel involved with the ISO activities.

18 IAF Mandatory Documents The objective of the IAF MD9 document is to enable consistence application of ISO/IEC by Conformity Assessment Bodies. Annexure A: Medical Devices Technical Area. Annexure B: Types of knowledge and skills for personnel involved with the ISO activities. Annexure C: Auditor qualification, training and experience. Annexure D: Auditing Duration.

19 BENEFITS OF BECOMING ACCREDITED Impartial feedback from independent examinations by experts against a defined scope of activity. Comparisons of technical ability against similar facilities. Customer has access to independent complaint mechanism. National and International recognition of competence. International benchmarking.

20 ACCREDITATION Getting global acceptance Providing medical device industry with one ISO certificate that could be ACCEPTED EVERYWHERE, while also meeting the importing countries demand for safe and effective medical devices. An organisation with certification to a specific standard or scheme that is accredited by an IAF MLA signatory AB can be recognised worldwide thereby facilitating international trade.

21 THANK YOU

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