International Accreditation Forum, Inc. User Advisory Committee UAC

Transcription

1 International Accreditation Forum, Inc. User Advisory Committee UAC UAC Position Paper UAC- N018 Users Expectations of Accreditation, of the Multilateral Recognition Arrangement (MLA) between Accreditation Bodies and of Accredited Certification This document has been developed and approved by the User Advisory Committee of the International Accreditation Forum (IAF/UAC). The task of the UAC is amongst others to provide advice and assistance to IAF for the development and implementation of strategies to ensure accredited certification is fulfilling end-user expectations, and to continually improve the value and effectiveness of accredited certification. The UAC members represent a wide spectrum of sectors and economies. They represent governmental agencies (military, healthcare, food safety), multinational industry (energy/oil, power/utilities, electro technology, machinery, aerospace/defence), international retailers, medical devices, and via three associations thousands of small & medium enterprises. Members come from Brazil, China, France, Germany, Italy, New Zealand, UK and the US. 1. Expectations of Accreditation 1.1. General expectations Besides its important role for trade and business, accreditation in many countries also has a specific regulatory role with regard to the safeguard of certain issues of public interest protection, such as legal metrology, environmental integrity and product safety. To be able to fulfil these roles, Accreditation must constitute the last level of conformity assessment (CA) from a technical point of view (no accreditation of accreditors ) to provide confidence in the entire CA system, to create added value (and not just additional costs), and to keep the infrastructure lean and efficient; Accreditation has to be a non profit activity, free from commercial interest. Commercial competition between accreditors should be discouraged as such competition may put undue non-technical pressure on bodies and lead to the devaluation of accreditation; Accreditation has to be an activity of public interest and should be recognised as a public authority activity. At least insofar as its role in support of regulatory CA is concerned, this authority needs to be derived from government. Activity of public interest means that private and commercial interests are not acceptable Support and facilitation of international trade World-wide equivalence of accreditation certificates and of accredited CA results Supply and procurement of products and services are becoming ever more international. Users must have confidence that an accredited conformity assessment body (CAB) will perform to a common expected or specified standard irrespective of where or by which accreditation body (AB) it has been accredited. IAF/UAC Position Paper N018 Page 1 (6)

2 To ensure world-wide equivalence of accreditation certificates and of accredited CA results to the same requirements, accreditation must assure a consistent level of high competence of accredited CABs, on the basis of the relevant international standards for CABs (formal aspects according to ISO/IEC standard PLUS technical competence according to accredited scope); deliver confidence in the integrity, impartiality and technical competence of conformity assessment operators and transparency of their operations; create a level playing field for CA operators and enable fair competition between them; ease the selection of competent CA operators by potential users and industry; be operated within regional and international MLAs to ensure ABs regularly undergo peer evaluation on the basis of the relevant international standard for accreditation bodies and the relevant competence criteria for the technical scope of their accreditation activity Rigorous and consistent assessment and surveillance of CABs Users must have confidence in the accreditation process and the result. They must be able to take for granted that: all the requirements contained in the relevant and specified normative documents for the accreditation scope (standards, regulations, application documents etc.) are thoroughly assessed on the basis of the no more, no less principle ; assessors are technically competent in the specific area of technology covered by the accreditation scope, and that they act impartially and independently; sufficient time is allowed for the assessment and the accreditation decision; accredited CABs regularly participate in proficiency testing and interlaboratory comparisons, as appropriate; leads are thoroughly followed; problem areas in thee CAB are uncovered and their removal monitored; negative decisions are properly enforced, including withdrawal or suspension of accreditation, if necessary Acceptance of CA results (test / inspection reports, certificates) Based on sound confidence in competence, accreditation should provide the basis for: acceptance of accredited CA results without re-assessment, especially by regulatory bodies; reciprocal acceptance of accredited CA results by regulatory bodies of foreign economies in the regulated area for market access of products and services; general acceptance of accredited CA results in business to business and contractual situations e.g. for procurement Increase of transparency Accreditation results must be visible easily and quickly. Many CABs operate internationally, some with national and others with world-wide or regional accreditation. Where one AB acts in a country, particularly with respect to withdrawal or suspension of accreditation, this must quickly be notified to users. Putting information on a single website would facilitate this. Where regulatory bodies are expected to utilize accredited CA activities to protect consumers (e.g. accredited CA activities for market access according to 1.2.3), accreditation activities should be developed to provide enforceable arrangements for regulatory bodies to communicate to, and monitor as necessary, the AB, CAB and users of certification. IAF/UAC Position Paper N018 Page 2 (6)

3 2. Expectations of the Multi lateral Recognition Arrangement (MLA) between Accreditation Bodies 2.1. General expectations The MLA should not be another level of accreditation ( Hyper Accreditation ). MLAs must be based on partnership and cooperation between peers and on peer evaluation; ensure a consistent and high level of integrity, transparency, impartiality and technical competence of all MLA signatories, enforced by efficient sanctions; discourage any multiple accreditation for the same scope; make the scopes of the different MLAs transparent and clear in order to enable and support mutual acceptance. Too broad scopes may reduce confidence in the equivalence of accreditations; ensure common understanding, interpretation and application of common accreditation requirements and processes; ensure high level of competence, consistent over all peer evaluation actors and technology specific enough to enable technical insight in the evaluated sector (important especially accreditation of CBs for products, laboratories and inspection bodies); provide database of MLA signatories and accredited CABs or links to databases of individual ABs. Accreditation bodies must demonstrate in a transparent way the governance and processes they employ to ensure they continually maintain the competence to approve conformity assessment bodies. The peer evaluation processes of the MLA have to focus on that competence Support and facilitation of international trade MLAs for accreditation should seek to become the basis for international governmental arrangements/regimes for general acceptance of CA results issued under the regime (e.g. Multilateral Recognition Agreements (MRAs) concluded between the European Union and a number of third countries; or as practiced on a regional scale in the European Union, APEC,.). The MLA should be promoted to governments and inter-governmental bodies like WTO-TBT, OECD, APEC, EU, as a nucleus for a future world-wide acceptance system of CA results. 3. Expectations of accredited certification 3.1. General expectations Besides compliance with all the requirements placed on Certification Bodies arising from relevant standards, accredited certification should meet the following user expectations: Voluntary certification schemes, whether MS or product certification, are a commercial activity offered (mostly) by private companies as a voluntary service. Therefore, sound and transparent competition between CBs is necessary to ensure market relevance, cost efficiency and added value of the services offered. Accreditation should provide a sound base for assuring sound competence of involved CBs but stay neutral in application of the certification schemes, i.e. ABs should not actively promote their use. CBs should ensure that all applicable requirements in the normative documents (standards, regulations, other application documents, etc.) used for the different certification schemes are thoroughly and consistently assessed. Accreditation should ensure that CBs perform their assessments with the necessary level of rigor and consistency, taking due account of the size of the certified organization or of the sector in which it operates where this is required by the scheme. IAF/UAC Position Paper N018 Page 3 (6)

4 CBs should accept without challenge test/inspection reports issued by accredited manufacturers in-house testing laboratories / inspection bodies. Any unnecessary duplication of assessments should be strictly avoided. CBs should not contest the objective of accreditation by refusing acceptance of accredited CA results but enhance efficiency of certification and avoid duplication of CA activities. CBs should join, promote and further expand the relevant international arrangements on the mutual recognition and acceptance of test reports and certificates, such as the IECEE CB-Scheme and the IECEE CB-Full Certification Scheme in the electro-technical field, based on the use of international standards. Accreditation should develop a practical solution to interface with such mutual recognition agreements based on peer assessment Management System Certification Certification must deliver reliable results to ensure global acceptance by regulators in cases where system audits/certifications are mandatory for market access (e.g. QMS, factory inspections); by other certification bodies (e.g. product certifiers) where system audits are required for product certification (e.g. QMS, factory inspection); by industry, purchasers and end users and thus reduce the number of second party audits. World-wide equivalence of accredited certificates: As supply chains become more international and so more certification bodies become involved, the certification user must be able to assume that wherever certifications are conducted in the world they are conducted to the same high standards. Responsibility of the end product manufacturer: The importance of assuring quality in the supply chain is becoming more important as it becomes longer and international. Product quality can now depend on actions taken many levels down in the supply chain. Users in those cases may come to expect that certification activities have investigated how supply chain quality is assured. This does not mean that the entire supply chain has to be certified. Added Value: The overall process of accredited certification is to provide an added value for the organizations as well as for their customers. Creation of wrong expectations/misconceptions must be avoided. MS certification must assure effectiveness of the implemented process, i.e. consistency of the output/performance as a result of the MS as implemented. However, MS certification cannot in itself lead to higher/other levels of output/performance than those set out in the relevant specifications; stakeholder surveillance reduction / reduction of customers audits: Certified organizations expect that the amount of surveillance conducted by certified organisation s stakeholders can be reduced since areas requiring attention will have been identified by the certification process; certified organisations stakeholders have the same expectation; the certification / audit process must be adapted to the maturity level of the organization (besides other aspects like complexity of the organization and risk of its products); Mature and effective internal audit systems must reduce external audit efforts. Means to achieve this: Certification assessments that go deep enough to test the effect of the MS on the results of the organization (e.g. products, environmental footprint), focusing on understanding and meeting user requirements, rather than simply testing to see that the MS is compliant with the standard. Users place contracts with suppliers with accredited certification to purchase products; they do not place contracts for Management Systems. Rigorous assessment: Where a company displays evidence of holding accredited certification, users expect that the process undergone to achieve the certification has been rigorous; namely holding accredited certification means a good company that is likely to deliver good results, e.g. a product meeting all specifications. To achieve this users expect the certification bodies have: IAF/UAC Position Paper N018 Page 4 (6)

5 Competent auditors and audits: o external auditors must be impartial, independent and competent and have sector specific technical knowledge, experience and understanding of the organization s processes; o allowed sufficient time for the assessment; o followed leads thoroughly; o uncovered problem areas. o checked whether frequent assessments of management review, management commitment and continual improvement are made Product certification The area of different applications of product certification is very broad. Users expectations vary dramatically depending on the perspective and the area of application. Therefore some distinction seems necessary Mandatory product certification for market access. Mandatory product certification should be limited to really high risk products. Where certification is deemed necessary, it should be based on international standards with minimized national deviations. The Declaration of Conformity should be the preferred option for regulatory market access. Mandatory certification regimes must not be used as technical barriers to trade or put undue burden on manufacturers. Existing CA results (test / inspection reports, certificates) issued by competent and accredited CABs should be accepted. If used for mandatory market access, product certification schemes should make use of international MLAs for accreditation of CBs, laboratories and inspection bodies to enable global acceptance of CA results and avoid duplication Voluntary product certification Voluntary certification is a service offered on the market place according to the usual rules of demand and supply, which is why such certification schemes (as symbolized by the related product marks) are subject to competition among themselves. It should be left entirely to the market, without encouragement by either the public authorities or accreditors, to decide whether or not to make use of a specific certification scheme, which will depend on its added value. Any such added value requires the scheme to be tailored to the specific needs of the relevant market segment or targeted customer group. Also, added value may be derived from voluntary product certification in those cases, where its use facilitates access to the markets of certain countries. This role of certification will continue to be of relevance as long and insofar as the requirements for access to these national markets have not been fully harmonized; is relevant for reasons of insurance coverage or in the context of product liability. The globalization of supply and procurement will increase the need for efficient conditions for worldwide market access. Users will therefore expect accredited CBs offering voluntary certification to enter into agreements on the mutual recognition and acceptance of certificates, based on the use of the relevant international standards. Also, in a number of countries with mandatory certification requirements, such as China, Russia, South Africa and others, the submission of third-party test reports and/or certificates based on compliance with the relevant international standards facilitates access to their markets. Certification programs should not be self expanding by requiring a product to be certified to contain components certified under the same program. Other forms of attestation like test reports from accredited laboratories, certificates from other accredited CBs should be of equal value. Certificates almost always represent only a small fraction of the comprehensive quality requirements expected by customers. Most certificates are restricted to safety and do not cover other essential IAF/UAC Position Paper N018 Page 5 (6)

6 aspects like functionality, reliability / failure rates, reaction time for service, guaranteed spare part supply. Certification must not provoke unrealistic expectations regarding the contents of certification. Therefore certification programs should clearly define and make public what product characteristics are the basis for certification. Nevertheless, any voluntary certification scheme should make use of international recognition arrangements for accreditation of CBs, inspection bodies and laboratories to avoid duplication of CA activities. IAF/UAC Position Paper N018 Page 6 (6)