IECEx Workshop, GSO

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INTERNATIONAL ELECTROTECHNICAL COMMISSION

IECEx Workshop, GSOWhat is Certification and What is

being certified?

Chris AGIUS

IECEx Executive Secretary,

GSO Workshop, Riyadh

March 2015

Who is the IEC ?

International Electotechnical Commission

Founded in 1906 - Promote international co-operation on all questions of standardization and related matters in the fields of electrotechnology, including Conformity Assessment.

According to the IEC Masterplan:

Standardisation+

Conformity Assessment

The 2 Pillars of IEC

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83 Members 83 Affiliates (Offices in 5 Countries)

IEC Family: 166 countries – Global Reach

IEC Central Office – GenevaRegional Offices in Brazil, Singapore, Nth America and Australia

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Systems IECQIECEEIECExIECRE 5

Structure of the IEC

IEC Council

Council Board (CB)Executive Committee

(ExCo)Central Office

Management Advisory

Committees

Strategic Groups

Standardization Management

Board (SMB)

Conformity Assessment

Board (CAB)

Technical Committees

(TC)

Technical Advisory

Committees

SC PT MT WG

Market Strategy Board

(MSB)

Special Working Groups

New Conformity Assessment System dedicated to Renewable Energy Sectors

Special WGs

IECExSystem for Certification to Standards Relating to Equipment for use in Explosive Atmospheres

Ex Equipment

Ex Services

Ex Personnel

IECQQuality Assessment System for Electronic Components, assemblies, materials and related processes

Components + assemblies

Processes

HSPM

Avionics

IECRESystem for certification to Standards relating to equipment for use in renewable energy applications

Wind Energy

Marine Energy

PV Solar

IEC’s Conformity Assessment Systems

24 Member IEC Board on Conformity Assessment (CAB)

CB-FCS Scheme

IECEESystem of Conformity Assessment Schemes for Electrotechnical Equipment and Components

CB Scheme

PV Programme

E3 Energy Efficiency

Hazardous Substances

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Terminology/meaning can be Confusing ??

“CONFORMITY ASSESSMENT” -Accreditation-Certification-Testing-Audit-Attestation-Inspection-Approval-Declaration-Surveillance- First Party Conformity Assessment-Second Party Conformity Assessment-Third Party Conformity Assessment-Peer Assessment-Others

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Basic Terms ?????????

Standard

Testing

Approval

Certification

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STANDARDSTANDARD

ISO/IEC Guide 2 (Clause 3.2):-

Document established by consensus and approved by a recognised body, that provides for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

Note – Standards should be based on the consolidated results of science, technology and experience and aimed at the promotion of optimum community benefits

ISO/IEC Guide 2 (Clause 3.2):-

Document established by consensus and approved by a recognised body, that provides for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

Note – Standards should be based on the consolidated results of science, technology and experience and aimed at the promotion of optimum community benefits

IEC Standards Development Process

Proposal

NCs votes +comments

NCs votes +comments NCs votes

NCscomments

NCs votes

IEC TC/SC orExternalOrganization

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Testing

ISO/IEC 17000 (Clause 4.2):-

Testing:

determination of one or more characteristics of an object of conformity assessment, according to a procedure

NOTE “Testing” typically applies to materials, products or processes.

Physical Measurements Calibration Testing Endurance/Performance Testing Test Report ONLY refers to item tested No assurance of on-going compliance. Remember - Test Report can be issued to show failure

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Approval


Approval:Permission for a product, process or service to be marketed or used for stated purposes or under stated conditions

Approved by a Statutory Body to a RegulationGovernment Regulator grants permissionMay or may not require compliance with StandardsApproval Documents refer to the relevant regulation and generally not Standards.

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Certification


Certification:

Third-party attestation (5.2) related to products, processes, systems or persons

.

• Only issued when conformity has been established• Cannot be issued if there is failure • Relates to the capability of the supplier

Certification

Forms of Certification1st Party

Self Declaration (by supplier)

Commonly referred to as SDOC*

Rely on supplier

Test Facilities

Test Procedures

Pass/Fail Criteria

(*Suppliers Declaration of Conformity) Low admin cost Little oversight Lacks Consistency Low confidence Low risk areas

2nd Party

Purchaser Assmt.

Purchaser :-

Test Facilities

Test Procedures

Pass/Fail Criteria

Reliance on product knowledge and test methods by purchaser

Low admin cost Costs by purchaser Lacks consistency Low confidence

3rd Party

Independent

Test Lab + Certifier involved

No commercial influence

Traceability of results All suppliers treated

the same Portability of results Usually involves a

central registry

Admin costs incurred Provides consistency More Accountability Increased Confidence Value adding

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Conformity Assessment Terms

Testing

Only relates to the sample tested/assessed

NO Assurance of on-going compliance in production

May or may not cover all requirements of a Standard(s)

Approvals

Issued by a Statutory Body

May or may not include surveillance of manufacturing

Does NOT require full compliance with Standards

Certification

Covers capability of a manufacturer or supplier

May be 1st, 2nd, or 3rd Party

Applied in various forms

Requires compliance with Standard(s)

Type 5 System becoming the Standard (Testing+QAassessment+ Surveillance)

Activity Product Testing

Government Approvals

CertificationType Test

ISO Type 1

Certification Quality Based

ISO Type 5Select suitable specification

Develop Suitable Testing Plan

Conduct Testing on samples representative of production

Issue Test Report

Technical Review of Test Report

Assess Quality Control of manufacturer

Verify Implementation (audit)

Issue Certificate of Conformity or Approval

On-going assessment at manufacturer’s premises

Expiry Date - Revalidation -

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?

IECEx

Forms of 3rd Party Certification, ISO/IEC Guide 67

Certificate number on Product

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IECEx certificate of Conformity requires Testing + Factory Inspections

Independent Testing of Samples according to IEC 60079 series

Initial Factory audit + on-going factory auditingAccording to ISO/IEC 80079-34

IECEx Certificate of Conformity, with Cert. Number on the product label. Certificates live on-Line

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Elements of 3rd Party Product Certification ISO/IEC Guide 67

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Certificate of Conformity versus Test Report

Test Report:- What Information is being conveyed by a Test

Report? Who is the legal owner of the Test Report? Should an End User have free access to a Test

Report, how? How long is a test report Valid, after its issue?

Certificate of Conformity (third Party according to ISO/IEC Guide 67)What Information is being conveyed by a

Certificate?Who is the legal owner of the Certificate?Should an End User have free access to a

Certificate, how?How long is a Certificate Valid, after its issue?

IECEx Compared to ATEX

ATEX:- “EC Type Examination Certificate Compliance with Standards NOT Mandatory Role- Enable sale in EU – Market Access Covers Mechanical + Electrical Zone 2 Equipment not require 3rd Party

Testing, SDOC Does not cover Services nor Persons No dedicated Secretariat but an ATEX Consultant

IECEx:-“IECEx Certificate of Conformity”Compliance with Standards Mandatory all casesCovers Electrical + Mechanical (subject to Standards

available)All Issued IECEx Certificates, on-line in one location!Covers Services and PersonsCentral Dedicated Technical Secretariat

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ISO 9001 Certification alone?Situation 1: A manufacturer of Ex Equipment holds ISO 9001 Certification alone.

Situation 2:An Ex Repairer holds ISO 9001 Certification alone.

Question:Does this provide confidence that Ex equipment meets IEC 60079 series Standards?? Y/N

Question:Does this provide confidence that Ex equipment repairs comply with IEC 60079-19?? Y/N

ISO 9001 and Ex

4.2.4 Control of recordsRecords established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

Records shall remain legible, readily identifiable and retrievable

ISO 9001 Control of Records – requirement:

ISO 9001 and Ex

Under IECEx, the types of records to be retained and for how long are specified and checked during IECEx factory audits.

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IECEx Overview

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Standard Procedures + Rules

Standard Reporting formats

Logo + Mark

All IECEx Certificates available “On-Line” –Full Transparency

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Schemes within the IECEx System

IECEx System www.iecex.com

IECEx Conformity Mark License Scheme

IECEx Services SchemeCertification of Ex Service Providers, eg Repair and overhaul workshops + Install.

IECEx Certified Persons Scheme (CoPC)Competency to work in Ex field (New)

IECEx Equipment SchemeCertification of Ex EquipmentIECEx Equipment SchemeCertification of Ex Equipment

IECEx “Certificate of Conformity”

IECEx “Unit Verification” Cert.

3 Types:

IECEx “Component Certificate”

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Examples of errors due to lack of competence

Outline of IECEx History - Timeline

1996

1997-99

1999

2000

2002

2003

2007

2009

2010

1992 Concept of IEC International Scheme for Ex Considered by IEC TC 31 + Agreed

1st Meeting of the New Management Committee (Comprising TC 31 Experts)

Develop Initial Structure + CB/ExTL qualification requirements

Commence Initial Phase (Transitional Arrangements)

Exchange of Ex Test Reports Commence (no IEC Certificate)

Decision to move to next stage (issue IECEx Certificates)

1st IECEx Certificate issued via “On-Line” System

New Ex Scheme for Services/Repairs Commenced + IECEx Mark Of Conformity Introduced

UN Formal Endorsement of IECEx, via UNECE

New Ex Certified Persons Scheme Launched

2014 > 40’000 Reports and Certificates issued

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United Nations Endorsement of IECEx

New United Nations Publication, March 2011 endorsing IEC TC 31 Standards + IECEx as “world’s best practice”.

Full Text http://www.unece.org/press/pr2011/11trade_p03e.htm

Closing Remarks

• IECEx System and its separate Certification Schemes covering• Equipment• Services to Ex industries• Competence of Persons

Has been developed over many years and provides the complete Conformity Assessment solution for Ex Equipment and Services

• With al IECEx Certificates publicly available in real time, no need to develop national or regional regimes

• IECEx is managed by the IECEx Management Committee with currently 33 Countries having a seat and membership of the IECEx Management Committee with UAE as one of the recent member countries to join and welcomes others from this region.

• IEC and the IECEx thanks His Excellency Nabil A Molla and GSO for the initiative of this workshop and support them in their effects for harmonisation of Standards and Conformity Assessment

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The End

THANK YOU

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IECEx Workshop, GSO

Documents

Transcript of IECEx Workshop, GSO