Conformity Assessment Facilitates Trades Development

Transcription

1 Conformity Assessment Facilitates Trades Development SIRIM QAS International Bahrain Branch Office Basori Hj Selamat 30 th March 2017

2 Presentation Outline Challenges to facilitates trade Quality Infrastructure Conformity Assessment Benefits of Conformity Assessment Value of Certification

3 Challenges to facilitates trade Customers confidence that their need and expectations will be met. non-acceptance of conformity mark, certificates of conformity and test reports costly multiple re-testing and/or certification non-acceptance of foreign standards and conformity assessment results

4 Quality Infrastructure BIPM Metrology OIML Technology Conformity Assessment Society Standard Accreditation ISO IAF IEC ITU-T Trade ILAC IQNet

5 Conformity Assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled ISO 17000:2004 any procedure used, directly or indirect, to determine that relevant requirements in technical regulations or standards are fulfilled Annex 1 WTO/TBT Agreement Specified requirements may be stated in normative documents such as regulations, standards and technical specifications

6 Conformity Assessment what does it cover? Conformity Assessment includes the following activities: Testing - most widely used Inspection System certification Product certification Accreditation Most common

7 What is a standard? A document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics for products and their related processes or production methods, Compliance is not mandatory unless requested by authorities Often used as specified requirements since they represent a broad consensus of what is wanted in a given situation.

8 What is a technical regulation? A document which lays down product characteristics or their related process or production methods, including administrative provisions, with which compliance is mandatory. It may also cover terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method. WTO/TBT Agreement

9 metrology is the technology or science of measurement. availability of a national measurement system to ensure that measurements are made with appropriate accuracy and reliability and can be related to other measurements made domestically or internationally. Subdivided into Metrology a. scientific metrology (highest level of measurement standards), b. legal metrology (ensure the correctness of measurements that affect the transparency of trade, law enforcement, health and safety) c. industrial metrology (satisfactory functioning of measurement instruments used in industry)

10 Who will benefit consumers and other members of the public. clients of certification, inspection bodies, test labs Conformity Assessment beneficiaries customers of organizations whose products, processes or services are certified; nongovernmental organizations; governmental authorities;

11 Principles of Conformity Assessment Need to fulfilment of specified requirements Selection Information and selected items Determination Review and attestation Information on fulfilment of specified requirements fulfilment of specified requirements demonstrated Yes Surveillance needed END No

12 Selection Involves planning and preparation activities to collect or produce all information and input needed for subsequent determination activities. May be a large number of identical items: on-going production, continuous process or system, or numerous locations - consideration needs to be given to sampling or sample selection. A single individual product may be the object of conformity assessment - even in such cases, sampling may be necessary to select a part that is representative of the whole.

13 Determination Undertaken to develop complete information regarding fulfillment of specified requirements. Typical determination activities are : auditing inspection testing There are other determination activities with no specific name or designation. Output is combination of information created through determination activity and input to determination function - structured to facilitate review and attestation.

14 Review and attestation Review - final stage of checking before taking decision that the object of conformity assessment has been reliably demonstrated to fulfill the specified requirements. Attestation results in a statement in a form that most readily reaches all potential users; could be in the form of a : certificate license statement of conformity. Note: Attestation issue of a statement, based on a decision following review, that fulfilment of specified requirements has been demonstrated

15 Basic conformity assessment process Object Test Attestation + Declaration (1st. Party) Contract (2 nd Party) Certificate (3rd. Party) Enabling Regulators to meet the WTO T B T and requirements for conformity assessment Requirements (Technical Regulations and/or Standards) Accreditation Peer assessment

16 Conformity Assessment Bodies and Standards Certification bodies ISO/IEC for certification of Management Systems, ISO/IEC for products, processes or services ISO/IEC for persons Inspection bodies ISO/IEC requirements for inspection of various items etc Laboratories ISO/IEC requirements for competence of labs (Testing and Calibration)

17 Management System Certification Management system is set of interrelated or interacting elements of an organization to establish policies and objectives and processes to achieve those objectives Management system includes among others: ISO 9001 Quality ISO Environment ISO Energy efficiency, ISO Assets ISO Information security ISO Food safety,.

18 Management System Certification An independent demonstration that the organization s management system a) conforms to specified requirements, b) capable of consistently achieving its stated policy and objectives, and c) effectively and efficiently implemented Motivation to the organization s employees Provides the organization with marketing opportunities to potential customers Serves as a foundation for facilitating the organization in the international trade

19 Product Certification Provides consumers with sufficient information (product safety and quality) to make decisions Facilitates suppliers to achieve market acceptance and penetration. A recognized Certification Mark can increase confidence; Assists manufactures in selecting components or services incorporated into their own products; Traders/retailers have high trust in the products they are selling Plays a significant role for enforcement of regulated products(subject to technical regulations)

20 Product Certification Type testing : full tests of a sample product against standard and/or regulation; Factory assessment of the quality system; Followed up by testing of samples taken from factory and/or the open market; Factory surveillance assessment and/or confirmatory testing; Market surveillance.

21 Product Certification Selection of type of product certification scheme Refer to ISO/IEC for guidance Consideration on the level of risk of products or services to consumers Low risk product- may choose a once-off type test; Medium risk product may use batch certification High risk product - may use a scheme which has type testing, management system with regular product testing from the factory and/or from the market.

22 Certification of Persons Recognizes the competence of individuals to perform specific tasks. Person competence is not based on academic qualification alone. A person can be well qualified but be incompetent Typically assessment is based on individuals ability to apply knowledge and skills to achieve intended results.

23 Certification of Persons Provides a consistent framework and set of requirements to allow recognition of competence Provides employers with confidence in their certified employees and clearly identifies the competencies required for different categories of professions and jobs Competencies can be up graded and maintained as technologies change Allows for mobility of certified persons

24 Inspection Provides objective evidence that an inspected item/material meets the specified requirements and needs of a customer (purchaser, manufacturer or regulator). Heavily relies on professional judgment of an inspector whose competence is crucial to make a right decision.

25 Inspection Many plants and installations use inspection to ensure that equipment and plant facilities continue to operate safely and correctly. Usually performed on site and allow for the clients to be informed immediately. Conducted before shipping or confirmation with the order to prevent shipment of wrong items/materials. Commonly used prior shipment of building materials and heavy machineries.

26 Testing and Calibration Testing is the determination of a product s characteristics against the requirements of the standard or specification testing depends on the support of competent calibration calibration is also a foundation for confidence in various industries where decisions are based on measurement accreditation to ISO/IEC compliance to the generic standard requirements and also to any field specific requirements and to the laboratories

27 Testing and Calibration the scope is supported by the specific test methods the laboratory uses for testing and specific measurements; and associated uncertainty for calibration laboratories. the scope allows the laboratory to identify competent people to do the work within their scope of activity. the scope allows the customers to identify a suitable laboratory for their purposes and have confidence in the tests and measurements made by the laboratory.

28 Accreditation third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific assessment tasks Confidence in competence, integrity and impartiality of accredited conformity assessment bodies the accreditation function cannot be carried out by an organization that also provides conformity assessment services

29 Accreditation Accreditation Certification Inspection Testing body body laboratory System/Product/ Service Producer Consumer Regions + Government Requirements Demands for accreditation Market Conformity assessment Conformity Assessment - Accreditation

30 International Accreditation In response to Standards Code negotiations If countries are expected to accept foreign test data, they must be able to have confidence in the competence of foreign laboratories Accreditation offered a good solution The concept of mutual recognition between accreditation bodies was born Accreditation and Mutual Recognition Agreements

31 Mutual Recognition Agreements (MRA s) Internationally traded goods and services are subject to repeated conformity assessment controls Mainly because of lack of confidence by consumers of conformity assessment in one country in the competence of conformity assessment bodies in another country Confidence achieved through cross-border cooperation among conformity assessment bodies and accreditation bodies - formalized in MRA s. Accreditation and Mutual Recognition Agreements

32 Mutual Recognition Agreements (MRA s) Accreditation of Certification Bodies International Accreditation Forum (IAF) Pacific Accreditation Cooperation (PAC) Accreditation of Labs. And Insp. Bodies International Laboratory Accreditation Cooperation (ILAC) Asia Pacific Laboratory Accreditation Cooperation (APLAC)

33 International Accreditation Forum (IAF) Established in 1992 as an informal co-operation and incorporated in the US in 1998 Objectives: achieve and maintain confidence in the accreditation programmes operated by its members Links with ILAC, international standardization bodies and trade organizations IAF Multilateral Recognition Arrangement (MLA) in the areas of Management system & Product certification with the objective of certified once, accepted everywhere.

34 International Accreditation Forum (IAF) Admission to the MLA after stringent evaluation of operations by a peer evaluation team to evaluate compliance with international standards (ISO/IEC 17011) and IAF requirements IAF MLA signatories: IAF QMS MLA IAF EMS MLA IAF Product MLA 3 regional accreditation groups and 46 Abs 2 regional accreditation groups and 41 Abs 3 regional accreditation groups and 38 ABs Accreditation and Mutual Recognition Agreements

35 Aims and objectives of ILAC International forum for the development of laboratory accreditation practices and procedures Harmonisation of accreditation procedures and practices to remove technical barriers to trade Advice and assistance to countries developing their own laboratory accreditation systems facilitating trade by promotion of the acceptance of accredited test and calibration results product tested once, accepted everywhere

36 Accreditation Acceptance of certificates can be strengthened: At National Level Accreditation Across borders Mutual Recognition between Certifiers National Accreditation + Mutual Recognition between Accreditors Accreditation and Mutual Recognition Agreements

37 Mark of conformity indicates that an object of conformity assessment (product, process, person, system or body) is in conformity with specified requirements can be on products (product certification), license, certificates and publications materials convey useful information about a product, or indicate particular characteristics of a product such as its safety, quality, performance, reliability or impact on the environment. - ISO/IEC 17030

38 Conformity Assessment Model Voluntary Sectors Regulated Sectors Risk-based (Source:Building trust The Conformity Assessment Toolbox, 2010 ) 38

39 Benefits of Conformity Assessment For Business Greater acceptance of products and services - greater market access Avoid high costs associated with multiple certifications and testing Reduces time to market new products and services. Minimize wastage of material and non-conforming products during production. Gain access to the growing number of tenders which specify accredited certification

40 Benefits of Conformity Assessment For Society Enhance confidence in products and services, despite complex global marketplace Protected from procuring sub standard products and services in the markets Minimises product failures or recalls from the marketplace Preservation of environment

41 Benefits of Conformity Assessment For Government Facilitator of an international trade Increase international cooperation An efficient tools for enforcement / monitoring An effective mechanism to enhance public awareness on the compliance to regulation

42 Actions when a certified product fails? Accredited Conformity Assessment Bodies must have procedures in place to handle, record and report: Certified products that are found to be failure against standard or technical regulation Misuse of a certification mark Actions Product containment Public advisories Product recall Revocation of certificates of conformity & use of marks

43 Drivers for Seeking Certification The main driver for seeking certification is internal business improvement (47%), customer requirement (32%), and to meet regulatory requirements (13%). (Source: IAF survey report - published 2012)

44 The value of certification 83% of respondents agreed or strongly agreed that certification had added value to their organisation. (Source: IAF survey report - published 2012)

45 The value of certification 79% of respondents confirmed that certification helped to meet the requirements of regulators. (Source: IAF survey report - published 2012)

46 Conclusion Achieving accreditation is not an option. Without accreditation, certificates issued by a CAB in a developing economy have very little chance of being accepted in developed markets Conformity Assessment is a catalyst for improving the quality of products/services, competitiveness and access to global market. Conformity Assessment is proven to be an effective mechanism to ensure that public interest requirements, such as health, safety and environmental, are being met.

47 Thank You SIRIM QAS International Sdn Bhd Block 8, Persiaran Dato' Menteri Section 2, Shah Alam, MALAYSIA Tel: , Fax :