3rd Annual Regulatory Workshop

Conformity Assessment Structure in South Africa

Mr Tumelo Ledimo

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

CONFORMITY ASSESSMENT BODIES (CABs)(Inspection, Testing, Calibration & Certification)

Acc

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ion

Trac

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ility

Stan

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Reg

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ns

TECHNICAL INFRASTRUCTURE

SANAS’ Structure

ADVISORY FORUM

Company Secretary/Legal

Advisor

Minister: Trade & Industry

Board of Directors

HR & Remuneration

Committee

Audit and Risk Committee

CEO

PA

Senior Manager Certification, Testing, BEE

Senior ManagerCorporate Services

Senior ManagerMechanical &

Physical

Senior Manager Research &

Development

EXECUTIVE AUTHORITY

ACCOUNTING AUTHORITY

MEMBERS OF KEY MANAGEMENT

COMMITTEES OF THE BOARD

Chief Financial Officer

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

SANAS Growth

0

50

100

150

200

250

300

350

235

91

311

22

52

152

219

197

5

183

2 6 2 5

33

Total No. of Accredited Facilities: 1515 31/03/2015

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 17011

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.

WHAT MAKES SANAS ACCEPTABLE

THE INTERNATIONAL PICTURE

EA European co-operation for Accreditation

APLAC Asia Pacific Laboratory Accreditation Cooperation

IAAC Inter-American Accreditation Cooperation

SADCA Southern African Accreditation Cooperation

AFRAC African Accreditation Cooperation

ILAC/IAF

EA APLAC

IAACSADCA

SANAS Don’t and Do

Don’t Do

We do not develop or draft standards We support SANSWe verify compliance to relevant national and international standards

We do not regulate Support regulators

We do not legislate We provide input to legislation when required

We do not prosecute We provide support to prosecutors

We do not provide conformity assessment services e.g. testing, inspection certification

We accredit conformity assessment bodies

Accreditation Bodies

CertificationBody

InspectionBody

TestLab

CalLab

Product/service

Suppliers

PurchasersRegulators

Trade Organizations

and Authorities

Conformity assessment bodies

Conforming

product/service

Requirements

Demands for

competent

conformity

assessment

Demands for

facilitating

trade

Conformity Assessment Service

Accreditation service

Market

Supervision in the Market

Impact of Accreditation

• 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

Facilitate Trade (Fair trade, International Trade)

• 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

Support Regulations

• Reliable medical (diagnostic and treatment) and testing

• OHS measurements: For example noise exposure levels, light, testing & inspection etc.

• Protects against inferior imports (dumping)

Improve Quality of Life (Health, Safety, Environment; Law

enforcement, etc.)

• 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

Helps to meet social needs

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.

TECHNICAL COMPETENCE

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 www.sanas.co.za),

This directory contains :

An organisation’s contact details and

information on their specific capabilities.

HOW CAN WE TELL IF AN ORGANISATION IS ACCREDITED

007

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

17065 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 .

ACCREDITATION of CONFORMITY ASSESSMENT

• IAF MD 8 – IAF Mandatory Document for the application of ISO/IEC

17011 in Medical Device Quality Management Systems. Issued 15 July

2011

• IAF MD 8 – IAF Mandatory Document for the application of ISO/IEC

17021 in Medical Device Quality Management Systems. Issued 15 July

2011

IAF Mandatory Documents

• The objective of the IAF MD8 document is to enable accreditation

bodies to harmonise their application of ISO/IEC 17011 for the

accreditation of bodies providing audit and certification to ISO/IEC

13485 by including:

• Annexure 1: Scopes of accreditation.

• Annexure 2: Required types of knowledge and skills for

personnel involved with the ISO 13485 activities.

IAF Mandatory Documents

• The objective of the IAF MD9 document is to enable consistence

application of ISO/IEC 17021 by Conformity Assessment Bodies.

• Annexure A: Medical Devices Technical Area.

• Annexure B: Types of knowledge and skills for personnel

involved with the ISO 13485 activities.

• Annexure C: Auditor qualification, training and experience.

• Annexure D: Auditing Duration.

IAF Mandatory Documents

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.

BENEFITS OF BECOMING ACCREDITED

• Getting global acceptance Providing medical device industry

with one ISO 13485 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.

ACCREDITATION

THANK YOU