www.aeconformity.com

Introduction to Conformity

Assessment and ISO/CASCO Tool

Box Alex Ezrakhovich

Co-convener of APG & AAPG

Sydney, Australia

5th International Conference on Quality Management

October 2016

Tehran, Iran

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Introduction

Structure of CASCO

Introduction to conformity assessment

CASCO Toolbox

Development of CASCO standards

Conclusions

Content

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The ISO/CASCO structure and

Toolbox

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Definition of conformity assessment

the demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.

Or more simply…

Is all the activities we complete to determine if a product or service meets specific requirements (usually contained in a standard)

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Conformity assessment activities

Testing determination of one or more characteristics of an object of conformity

assessment

Certification

Examination of a product design, product, process or installation and

determination of its conformity with specific requirements or, on the basis of

professional judgement, with general requirements.

Inspection

third party assurance that: product (services), process, personnel,

organization or management system conforms to specific requirements

Supplier's

declaration of

conformity

Mutual

recognition &

Peer

assessment

Accreditation

first-party attestation

third-party attestation related to a conformity assessment body conveying

formal demonstration of its competence

Arrangement whereby more than two parties recognize or accept one another’s

conformity assessment results

Assessment of a body against specified requirements by representatives of other bodies

in, or candidates for, an agreement

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Conformity assessment claims

Certificate

Contract

SDoC (Self Declaration

of Conformity)

Object Test done by: Attestation type

+ Requirements

1st party

(the manufacturer,

service provider)

2nd party

(the purchaser,

the client)

3rd party - independent

(certification body, laboratory,

inspection body...)

3rd party bodies can be accredited.

Accreditation bodies are assessed by their pairs

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ISO* CASCO “TOOlbOx”

CA & Standards

17007, Guide 23

Vocabulary

17000

17027

CA Code/Principles

Guide 60, PAS 17001-5

CA Results Guide 68, 17022

Marks

Guide 27, 17030

Supplier’s Declaration

17050 – 1 & 2

Accreditation & CA Bodies

17011

17020, 17021-1 thru 7 (8)

17024, 17025

17040, 17043, 17065

Product Certification

17065, 17067,

17026 (Example of a

scheme)

* predominantly co-published with IEC Full list of standards available here

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ISO and conformity assessment

Non-acceptance of test reports and certificates is 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.

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Accepted everywhere

1 Test

1 Conformity Assessment

1 Standard

The 1-1-1 dream of conformity

assessment

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132 ISO members

(96 participating members and 36 observers).

22 international organizations are liaison (includes

IEC)

POLICY and TECHNICAL work

continual improvement and

feedback cycle

COMMITTEE ON CONFORMITY ASSESSMENT

ISO/CASCO membership and

structure

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CASCO membership as of August 2016

Participating members (96)= Blue

Observing members (36) = Orange

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Structure of ISO/CASCO

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CASCO is the only policy committee in ISO that develops standards and is based in ISO.

CPC gives recognition to the policy role of CASCO and oversees the internal coordination of the CASCO subgroups.

CPC studies conformity assessment issues.

CPC sets priorities for current and future CASCO work items.

CPC creates possible recommendations for endorsement by CASCO on conformity assessment.

CPC – Chairman’s policy and coordination group

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The STAR is responsible to oversee the CASCO communication strategy by:

• Providing a mechanism for industry sectors and intergovernmental regulators to interact with CASCO;

• Providing a forum to discuss conformity assessment concerns of industry sectors and regulators;

• Giving CASCO advice on how to enhance and develop relationships with intergovernmental organizations and economic sectors;

• Promoting the CASCO toolbox to international agencies (regulators) and industry/economic sectors and other interested groups;

• Another major effort is the promotion of the CASCO toolbox to developing economies. CASCO does it in conjunction with the ISO committee on developing country matters (DEVCO).

STAR - Strategic alliance and regulatory group

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• A harmonized approach by all TCs to conformity assessment;

• CASCO conformity assessment policies are understood and adhered to where relevant

• The provision of advice internally in ISO on conformity assessment;

• The provision of advice to TCs on the design and development of sector specific schemes where justified.

Focused on the

technical relationship

between CASCO

and ISO/TCs to

ensure:

TIG – Technical interface group

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Overview of the ISO/CASCO Toolbox

ISO/CASCO Toolbox addresses each of the following activities:

ISO/CASCO Toolbox refers to 27 International Standards and Guides on each conformity assessment activity.

Testing

Inspection

Certification Management system Personnel Product

Accreditation

Mutual recognition & Peer

assessment

Supplier's declaration of

conformity

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ISO/CASCO TOOLBOX

The ISO/CASCO Toolbox is the

set of conformity assessment

standard developed by

ISO CASCO for the operation of

conformity assessment

bodies (laboratories, certification bodies and inspection

bodies)

accreditation bodies

for peer evaluation and other associated

activities

ISO/CASCO has more than 29 published

standards and guides

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ISO/CASCO TOOLBOX

The Toolbox is a collection of ISO/CASCO standards,

covering all conformity assessment activities.

The broad geographical reach and development with a

multi-stakeholder environment means it is widely

supported and used.

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The ISO/CASCO toolbox provides specific standards

and guides on each conformity assessment activity

1

9

The decision to use one type of conformity assessment, depends on the customer's requirements,

the level of risk associated with the product/service

and regulatory requirements

Testing

Inspection

Certification Management system Personnel Product

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration

of conformity

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Mechanisms for performing CA - Testing

Definition from ISO/IEC 17000 (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.

2

0

Testing

Inspection

Certification

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration of

conformity

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Mechanisms for performing CA - Testing

Common form of conformity assessment

Provides the basis for other types of conformity

assessment like inspection and product certification

Product is tested against a specified set of

criteria

Used to make decisions on the performance of

the product

Depending on specific requirements from

customers and the risk associated with the product,

the testing laboratory may choose to be accredited

2

1

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Mechanisms for performing CA - Inspection

Definition - Inspection

– Examination of a product design, product, process or

installation and determination of its conformity with specific

requirements or, on the basis of professional judgement, with

general requirements

– NOTE Inspection of a process may include inspection of

persons, facilities, technology and methodology

2

2

Testing

Inspection

Certification

Accreditation

Mutual recognition & Peer

assessment

Supplier's declaration of

conformity

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Mechanisms for performing CA - Inspection

Inspection bodies

Examine

– a huge range of products, materials,

installations, plants, processes, work procedures

and services, in the private as well as the public

sector, and report on such parameters as quality,

fitness for use and continuing safety in operation

Overall aim

– to reduce risk to the buyer, owner, user or

consumer of the item being inspected

2

3

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Mechanisms for performing CA - Certification

Definition from ISO/IEC 17000 (5.5) - Certification

− Third party attestation related to products, processes, systems or

persons”

– NOTE 1 Certification of a management system is sometimes also

called registration

– NOTE 2 Certification is applicable to all objects of conformity

assessment except for conformity assessment bodies themselves, to

which accreditation is applicable

Definition of Attestation from ISO/IEC 17000 (5.2)

– Issue of a statement based on a decision following review that fulfillment

of specified requirements have been demonstrated

2

4

Testing

Inspection

Certification

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration of

conformity

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Mechanisms for performing CA - Accreditation

Definition in ISO/IEC 17000 (5.6) - Accreditation

− Third-party attestation related to a conformity assessment

body conveying formal demonstration of its competence to

carry out specific conformity assessment tasks

2

5

Testing

Inspection

Certification

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration of

conformity

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Mechanisms for performing CA - Accreditation

Accreditation is the procedure by which an

authoritative body gives formal recognition that a

body or person is competent to carry out specific

tasks

Accreditation of testing laboratories, product

certification and inspection bodies is independent

verification that they are competent to perform the

activities for which they are accredited

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6

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Mechanisms for performing CA - Mutual

Recognition Agreements (MRA's) and peer

assessment

Definition from ISO/IEC 17000 (7.9) for multilateral arrangement

– arrangement whereby more than two parties recognize or accept

one another’s conformity assessment results

Definition from 17000 (4.5) for peer assessment

– assessment of a body against specified requirements by

representatives of other bodies in, or candidates for, an agreement

group

Definition from 17000 (7.10) for agreement group

– bodies that are signatories to which an arrangement is based

2

7

Testing

Inspection

Certification

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration of

conformity

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Mechanisms for performing CA - Mutual

Recognition Agreements (MRA's)

Through cross-border cooperation among conformity

assessment bodies and also among accreditation bodies the

parties involved agree to recognize the results of each other's

testing, inspection, certification or accreditation

MRA’s can

– Reduce the multiple conformity assessment that products,

services, systems, processes and materials may need to

undergo, especially when they are traded across borders

– Contribute to the efficiency of the international trading

system by facilitating the acceptance of goods and services

everywhere on the basis of a single assessment in one

country,

– Benefit suppliers and customers alike 2

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Mechanisms for performing CA – Peer assessment

Peers Assessments are useful

– To demonstrate competence

– To ensure quality

– To create and keep mutual confidence

Peer assessment process

– Carried out by peers or by agreement groups of

accreditation bodies or conformity assessment bodies

– Other certification bodies, other laboratories, etc

– Parties with similar experiences, training, competence

2

9

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Mechanisms for performing CA - Supplier's

Declaration of conformity (SDoC)

Most widely used claim of conformity in the market

ISO/IEC 17050-1:2004, Conformity assessment -- Supplier's

declaration of conformity -- Part 1: General requirements

ISO/IEC 17050-2:2004, Conformity assessment -- Supplier's

declaration of conformity -- Part 2: Supporting documentation

3

0

Testing

Inspection

Certification

Accreditation

Mutual recognition &

Peer assessment

Supplier's declaration of conformity

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Complete list of CASCO standards is available here.

Terms and definitions– ISO/IEC 17000

Conformity

assessment

for

suppliers

Self

Declaration

ISO/IEC

17050-1

ISO/IEC

17050-2

Requirements for accreditation bodies– ISO/IEC 17011

Pe

er

As

se

ss

me

nt

ISO

/IE

C 1

70

40

Requirements for Certification bodies

Management

Systems

ISO/IEC

17021 -1

+ Parts

2,3,4,5,6,7…

Requirements for

Testing/Calibration

Testing

&calibration

laboratories

ISO/IEC 17025

Proficiency

testing

ISO/IEC 17043

Requirements

for Inspection

bodies

ISO/IEC17020

Products

ISO/IEC

17065

(17067,

17026)

Persons

ISO/IEC

17024

Mu

tual

Rec

og

nit

ion

Gu

ide

68

Продолжительность аудита ISO/IEC 17023

Conformity assessment

hierarchy

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CASCO documents published in last 2 years

• ISO/IEC 17021-1:2015 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements

• ISO/IEC TS 17021-5:2014 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 5: Competence requirements for auditing and certification of asset management systems

• ISO/IEC TS 17021-6:2014 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 6: Competence requirements for auditing and certification of business continuity management systems

• ISO/IEC TS 17021-7:2014 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 7: Competence requirements for auditing and certification of road traffic safety management systems

• ISO/IEC TR 17026:2015 Conformity assessment -- Example of a certification scheme for tangible products

• ISO/IEC TS 17027:2014 Conformity assessment -- Vocabulary related to competence of persons used for certification of persons

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CASCO documents in development • ISO/IEC DIS 17011

Conformity assessment -- Requirements for accreditation bodies accrediting conformity assessment bodies (WG42)

• ISO/IEC DIS 17021-2 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 2: Competence requirements for auditing and certification of environmental management systems (WG34)

• SO/IEC DIS 17021-3 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 3: Competence requirements for auditing and certification of quality management systems (WG35)

• ISO/IEC DTS 17021-9 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 9: Competence requirements for auditing and certification of anti-bribery management systems (WG47)

• ISO/IEC NP 17021-10 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 10: Competence requirements for auditing and certification of occupational health and safety management systems

• ISO/IEC CD 2 17025 General requirements for the competence of testing and calibration laboratories (WG44)

• ISO/IEC NP TR 17028 Conformity assessment -- Example of a certification scheme for services (WG45)

• ISO/FDIS 17034 General requirements for the competence of reference material producers(WG43)

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ISO/CASCO and key standards’ principles

Transparency *

Openness *

Consensus and impartiality *

Market relevance and effectiveness *

Coherence *

Development dimension *

Stakeholder engagement

Due process

National implementation/adoption

* explicit principles for the

“development of international

standards, guides and

recommendations with relation to

articles 2, 5 and Annex 3 of the

WTO/TBT agreement”

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Conformity assessment standards generation

ISO Standard

A normative document, developed according to consensus procedures, which has been approved by the ISO membership and P-members of the responsible committee in accordance with Part 1 of the ISO/IEC Directives as a draft International Standard and/or as a final draft International Standard and which has been published by the ISO Central Secretariat.

ISO/PAS Publicly available specification

A normative document representing the consensus within a working group.

ISO/TS Technical specification

A normative document representing the technical consensus within an ISO committee.

ISO/TR Technical report

An informative document containing information of a different kind from that normally published in a normative document.

International Workshop Agreement (IWA)

An IWA is an ISO document produced through workshop meeting(s) and not through the technical committee process.

ISO Guide

Guides provide guidance to technical committees for the preparation of standards, often on broad fields or topics.

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3 months by default

2 months possible

2 months by default

optional; 3 or 4 months possible

2 month translation

(all ISO) 3 month

ballot

2 month ballot

NP

CD

DIS Publication

Opt out

Opt in

FDIS

WD

Main development stages

optional

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Double layer of consensus for ISO standards

At the level of delegates/experts who participate in technical

committees, sub-committees, working groups, i.e. industry

specialists, technologists, users, consumers, etc.

Then, at the level of countries through their national standards

bodies (NSBs), involving all stakeholders in national mirror

committees.

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At the Member Body (MB)

level it is important for the MB to

have a balanced national mirror

committee (NMC) to:

• get a double level of consensus (MB

and stakeholders);

• provide mechanisms for stakeholders,

industry, national consumers, national

regulators and other interested

parties;

• balance interests so no one interest

dominates;

• generate a national consensus

position.

National mirror committees (NMCs)

ISO/CASCO WGs

Members

NMBs

Liaisons

Experts

Industry

Government

Others

NMCs

Mirror exactly the work of

ISO/CASCO WGs and have a

national composition with the

same category of members

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Impartiality

Confidentiality

Complaints and appeals

Disclosure of information

Use of management systems

ISO/CASCO document common structure PAS

elements

All ISO/CASCO standards contain

core requirements which are the

same irrespective of standard, using identical wording

and facilitating their implementation.

core set of requirements given in PAS documents

covering:

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Informative

preliminary

Title page

Table of contents

Foreword

Introduction (including relationship to other standards)

Normative

General

Title

Scope

Normative references

Normative

Technical

Terms and definitions

Requirements

Structural requirements

Resource requirements (including human resources)

Process requirements (including operational functions)

Management system requirements

Normative annexes

Informative

supplementary

Any further explanations that are not part of the normative

process

Informative annexes

Bibliography

Indexes

CASCO Common structure

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1. Principles (optional)

2. General requirements

• Legal and contractual matters

• Management of impartiality

• Liability and financing

3. Structural requirements

• Organizational structure and top management

• Committee for safe guarding impartiality

4. Resource requirements

• Competence of management and personnel

• Personnel involved in the certification activities

• Use of individual external auditors and external technical experts

• Personnel record

• Outsourcing

5. Information requirements

• Publicly accessible information

• Certification documents

• Directory of certified clients

• Reference to certification and use of marks

• Confidentiality

• Information exchange between a certification body and its clients.

Typical content of ISO/CASCO standard (1)

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6. Process requirements

• General requirements

• Initial audit and certification

• Surveillance activities

• Recertification

• Special audits

• Suspending withdrawing or reducing the scope of certification

• Appeals

• Complaints

• Records of applicants and clients

7. Management system requirements

• Options

• Option B Management system requirements in accordance with ISO 9001

• Option A General management system requirements

Typical content of ISO/CASCO standard (2)

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The TBT Agreement:

recognizes the important contribution that international

standards and conformity assessment systems can make

to improving efficiency of production and facilitating

international trade.

aims at the harmonization of standards on as wide a basis

as possible, encouraging all standardizing bodies to play

as full a part as resources allow in the preparation of

international standards by the relevant international body,

including the ISO and IEC.

THE CONTRIBUTION OF INTERNATIONAL

STANDARDS AND CONFORMITY ASSESSMENT

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Conformity assessment involves a set of processes that show your

product, service or system meets the requirements of a standard.

Undergoing the conformity assessment process has a number of

benefits:

It provides consumers and other stakeholders with added confidence.

It gives your company a competitive edge.

It helps regulators ensure that health, safety or environmental

conditions are met.

ISO CASCO develops high quality voluntary International

Standards which:

facilitate international exchange of goods and services,

support sustainable and equitable economic growth,

promote innovation and

protect health, safety and the environment

Conclusion

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A global framework for conformity assessment will increase consumer and regulator confidence by: Providing a common interpretation of test

results Providing a mechanism for acceptance of

certificates and reports Achieving consistency and building confidence

in products and services Applying to International Standards a principle

of neutrality Defining good practices for market

surveillance

Conclusion

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Thank you !متشکرم

SALAM! Auditing Practices Group

&

Accreditation Auditing Practices Group