Introduction to Conformity Assessment and ISO/CASCO Tool Box

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

Content Introduction Structure of CASCO Introduction to conformity assessment CASCO Toolbox Development of CASCO standards Conclusions

The ISO/CASCO structure and Toolbox

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)

Conformity assessment activities Testing Certification Inspection Supplier's declaration of conformity Accreditation Mutual recognition & Peer assessment determination of one or more characteristics of an object of conformity assessment third party assurance that: product (services), process, personnel, organization or management system conforms to specific requirements 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. 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 bodie in, or candidates for, an agreement

Conformity assessment claims Object + Requirements Test done by: 1st party (the manufacturer, service provider) 2nd party (the purchaser, the client) Attestation type SDoC (Self Declaration of Conformity) Contract 3rd party - independent (certification body, laboratory, inspection body...) Certificate 3rd party bodies can be accredited. Accreditation bodies are assessed by their pairs

ISO * CASCO TOOlbOx CA & Standards 17007, Guide 23 CA Code/Principles Guide 60, PAS 17001-5 CA Results Guide 68, 17022 Full list of standards available here Vocabulary 17000 17027 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

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.

The 1-1-1 dream of conformity assessment 1 Standard Accepted everywhere 1 Test 1 Conformity Assessment

ISO/CASCO membership and structure 132 ISO members (96 participating members and 36 observers). COMMITTEE ON CONFORMITY ASSESSMENT 22 international organizations are liaison (includes IEC) POLICY and TECHNICAL work continual improvement and feedback cycle

CASCO membership as of August 2016 Participating members (96)= Blue Observing members (36) = Orange

Structure of ISO/CASCO

CPC Chairman s policy and coordination group 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.

STAR - Strategic alliance and regulatory group 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).

TIG Technical interface group Focused on the technical relationship between CASCO and ISO/TCs to ensure: 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.

Overview of the ISO/CASCO Toolbox ISO/CASCO Toolbox addresses each of the following activities: Testing Mutual recognition & Peer assessment Inspection Accreditation Certification Management system Personnel Product Supplier's declaration of conformity ISO/CASCO Toolbox refers to 27 International Standards and Guides on each conformity assessment activity.

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

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.

The ISO/CASCO toolbox provides specific 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 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 1 9

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. Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity 2 0

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

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 Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity 2 2

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

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 Testing Inspection Certification Accreditation Mutual recognition & Peer assessment 2 4 Supplier's declaration of conformity

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 Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity 2 5

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 2 6

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

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 2 8 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

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

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 Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity 3 0

Peer Assessment ISO/IEC 17040 Mutual Recognition Guide 68 Conformity assessment hierarchy Terms and definitions ISO/IEC 17000 Requirements for accreditation bodies ISO/IEC 17011 Requirements for Testing/Calibration Testing &calibration laboratories ISO/IEC 17025 Proficiency testing ISO/IEC 17043 Requirements for Inspection bodies ISO/IEC17020 Requirements for Certification bodies Management Systems ISO/IEC 17021-1 + Parts 2,3,4,5,6,7 Persons ISO/IEC 17024 Products ISO/IEC 17065 (17067, 17026) Conformity assessment for suppliers Self Declaration ISO/IEC 17050-1 ISO/IEC 17050-2 Продолжительность аудита ISO/IEC 17023 Complete list of CASCO standards is available here.

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

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 antibribery 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)

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

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.

Main development stages 3 months by default 2 months possible NP optional 2 months by default optional; 3 or 4 months possible 2 month translation (all ISO) 3 month ballot DIS Publication WD CD Opt in Opt out FDIS 2 month ballot

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.

National mirror committees (NMCs) 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. 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

ISO/CASCO document common structure PAS elements Impartiality 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: Confidentiality Complaints and appeals Disclosure of information Use of management systems

CASCO Common structure Informative preliminary Normative General Normative Technical Informative supplementary Title page Table of contents Foreword Introduction (including relationship to other standards) Title Scope Normative references Terms and definitions Requirements Structural requirements Resource requirements (including human resources) Process requirements (including operational functions) Management system requirements Normative annexes Any further explanations that are not part of the normative process Informative annexes Bibliography Indexes

Typical content of ISO/CASCO standard (1) 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 (2) 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

THE CONTRIBUTION OF INTERNATIONAL STANDARDS AND CONFORMITY ASSESSMENT 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.

Conclusion 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 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

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