Accreditation Standards: Recent Developments

Transcription

1 Accreditation Standards: Recent Developments Speaker/Author: Peter S. Unger American Association for Laboratory Accreditation (A2LA) 5301 Buckeystown Pike, Suite 350 Frederick, MD Phone: ; Fax: Abstract The process of determining whether products, processes, systems or people meet specified requirements has been given the name, conformity assessment. The term covers such activities as inspection, testing and certification. Certification should not be confused with accreditation. Accreditation is defined as a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. Certification is defined as a procedure by which a third party gives written assurance that a product, process, or service conforms to specified requirements. Accreditation bodies, in effect, supervise the proper implementation of standards by the conformity assessment bodies (e.g., certification bodies and laboratories) and identify their competence to perform specific tasks, such as testing, measurement, calibration, inspection and certification for given methods and product areas. The Committee on Conformity Assessment (CASCO) of the International Organization for Standardization (ISO) provides many of the accreditation and conformity assessment standards on this subject. The laboratory accreditation standards have recently been given much attention. ISO/IEC 17025:1999, General requirements for the competence of calibration and testing laboratories, [1] is being amended to align with the principles of ISO 9001:2000 [2]. ISO/IEC 17011, General requirements for bodies providing accreditation of conformity assessment bodies [3] is replacing ISO/IEC Guide 58, Calibration and testing laboratory accreditation systems General requirements for operation and recognition. [4] This paper provides an overview of recent activities of ISO CASCO, particularly the changes affecting the requirements, principles and practices of laboratory accreditation. 1 Introduction to ISO CASCO ISO, the International Organization for Standardization, promotes the international harmonization of conformity assessment activities and the worldwide acceptance of the results through ISO/CASCO, its general policy committee on conformity assessment. CASCO works both on the principles and the practice of conformity assessment. It develops documents that are published by ISO as International Standards or Guides. The voluntary criteria contained in these represent an international consensus on what constitutes best practice.

2 CASCO's objectives are to: Study means of assessing the conformity of products, processes, services and management systems to appropriate standards or other technical specifications; Prepare standards and guides relating to the practice of testing, inspection and certification of products, processes and services, and to the assessment of management systems, testing laboratories, inspection, certification and accreditation bodies, and their operation and acceptance Promote mutual recognition and acceptance of national and regional conformity assessment systems, and the appropriate use of International Standards for testing, inspection, certification, assessment and related purposes. CASCO Membership is open to all ISO member bodies as participating (P) or observer (O) members. P-members currently number 67 and O-members 21, with both developing and industrialized countries well represented. The committee has a strong liaison with ISO's standardization partner, the International Electrotechnical Commission (IEC). As well as being responsible for International Standards in the electrical, electronic and related areas, IEC operates a number of global certification schemes for products in its field. CASCO also has a number of external liaisons with international organizations such as International Laboratory Accreditation Cooperation (ILAC). The aim underlying many of these liaisons is to promote cross-border mutual recognition agreements (MRAs) between conformity assessment bodies, including accreditation bodies. MRAs establish user confidence in the competence and equivalence of bodies in different countries, reducing the need for multiple assessments and hence lowering technical barriers to trade. 2 What is Conformity Assessment? ISO and ISO/IEC Guides and, more recently, International Standards relating to conformity assessment activities such as testing, inspection and various forms of certification are prepared by working groups of the ISO Committee on conformity assessment (CASCO). Each group decides on any special terms and definitions to be included in each document. With several related projects being pursued simultaneously, by separate groups, at any time, duplication of work on terminology has sometimes resulted in unnecessary differences in the description of similar concepts. For many years, ISO/IEC Guide 2, last revised in 1996, [5] has included a core vocabulary for conformity assessment, built up from a small number of terms and definitions first compiled to facilitate communication and understanding about product certification based on standards for traditional manufactured goods.

3 In 2000, CASCO decided to take conformity assessment terminology (clauses 12 to 17) out of Guide 2:1996, Standardization and related activities General vocabulary [5] and provide instead a self-contained vocabulary more readily applicable within the planned ISO/IEC series of standards and in the drafting or revision of related guides. CASCO Working Group 5, Definitions, has accordingly prepared a Draft International Standard (DIS) in consultation with other active CASCO working groups intending to adopt it through normative reference in their publications and to use it for guidance in their choice of vocabulary in cases where extra terms need to be agreed for related, more specific concepts. On February 20, 2003, the ISO/IEC DIS [6] was issued for comment and eventually a vote under the title Conformity assessment General vocabulary which revises practically the whole body of terms in this field. This Draft International Standard specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A functional description of conformity assessment is included as an informative annex, as a further aid to mutual understanding, in both voluntary and regulatory environments, among users of conformity assessment, conformity assessment bodies and their accreditation bodies. Conformity assessment is now defined as an activity that provides demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. It covers such activities as calibration, testing, inspection and certification, as well as the accreditation of conformity assessment bodies. As a common basis for the preparation and maintenance of the ISO/IEC series of standards in particular, and other guides relating to conformity assessment activities, this International Standard will offer a consistent framework within which more specific concepts may be defined appropriately and denoted by the most appropriate terms. A distinction is being made between conformity assessment bodies and accreditation bodies. A conformity assessment body is a body that performs conformity assessment services and that can be the object of accreditation. Examples are laboratories, inspection bodies, product certification bodies, management system certification bodies and personnel certification bodies. An accreditation body for conformity assessment is being defined as an authoritative body that performs accreditation The authority of an accreditation body is typically derived from government either government administered or government authorized by its designation as a non-profit, public service or public benefit organization.. Certification is defined as a third-party attestation related to products, processes, systems or persons. Certification is applicable to all objects of conformity assessment except for conformity assessment bodies themselves, to which accreditation is applicable. Accreditation of conformity assessment bodies is being defined as a third-party attestation that a conformity assessment body fulfils specified requirements and is competent to carry out specific conformity assessment tasks. Thus, formal recognition of the conformity assessment body s competence is provided by an accreditation body

4 Designation of conformity assessment bodies or accreditation bodies is a governmental authorization of a conformity assessment body or accreditation bodies to perform specified conformity assessment activities under legislation or regulations Designating authority is a body established within government or empowered by government to designate conformity assessment bodies or accreditation bodies, suspend or withdraw their designation or remove their suspension from designation 3 Principles of Conformity Assessment 3.1 The functional approach Conformity assessment is a series of three functions that satisfy a need, or demand, for demonstration that specified requirements are fulfilled. Such demonstration can add substance or credibility to claims that specified requirements are fulfilled, giving users greater confidence in accepting such claims. Standards are often used as the specified requirements since they represent a broad consensus of what is wanted in a given situation. As a result, conformity assessment is often viewed as a standards-related activity. Conformity assessment can be applied to products (defined to include services), processes, systems and persons, and also to those bodies that perform conformity assessment services. For convenience within this standard, the expression object of conformity assessment is used to refer collectively to any or all of these entities. Each of the various kinds of users of conformity assessment has its own specific needs. As a result there is much variety in the different types of conformity assessment performed. However, all types of conformity assessment follow the same general approach as shown in Figure 1. It is convenient, and common practice, to refer to any single instance of a sequence of the three conformity assessment functions shown in Figure 1 simply as an assessment. There may be a single assessment; alternatively an initial assessment can be followed by systematically repeated assessments, which are collectively referred to as surveillance.

5 NEED TO DEMONSTRATE FULFILMENT OF SPECIFIED REQUIREMENTS Selection Information on selected items Determination Information on fulfilment of specified requirements Review and attestation Fulfilment of specified requirements demonstrated Yes Surveillance needed No END Figure 1 A functional approach to conformity assessment The following shape in Figure 1 represents a conformity assessment function. The specific activities in each function can vary from one type of conformity assessment to another, based on the needs of users, the nature of the specified requirements and the object of conformity assessment involved. The following shape in Figure 1 represents output from a function and is also the input to the next function. The nature of the output varies, depending on the specific activities that have been undertaken. The solid arrows in Figure 1 link the conformity assessment functions and their outputs/inputs. The broken arrows express the possible needs or demands for conformity assessment.

6 Conformity assessment activities can be characterized as first-party, second-party or thirdparty. Generally, for each of these categories: the conformity assessment activities are under the control or direction of the type of individual or body stated in the definition; and the critical decision on which attestation is based is made by the type of individual or body stated in the definition. 3.2 Selection Selection involves planning and preparation activities in order to collect or produce all the information and input needed for the subsequent determination function. Selection activities vary widely in number and complexity. In some instances, very little selection activity may be needed. Some consideration may need to be given to selection of the object of conformity assessment. Frequently, the object may be a large number of identical items; ongoing production; a continuous process or a system; or involve numerous locations. In such cases, consideration may need to be given to sampling, or selection of specimens to be used for determination activities. For example, the sampling plan for river water related to a demonstration that pollution requirements are fulfilled would be an example of a sizeable and significant sampling activity. However, occasionally the object may be the whole population, for instance when a single, individual product is the object of conformity assessment. Even in such cases sampling may be necessary to select a part of the entire object, which is representative of the whole (e.g. selection of critical parts of a bridge for a determination of material fatigue). Consideration may also need to be given to the specified requirements. In many cases, a standard, or other pre-existing requirements exist. However, some consideration may need to be given when applying the pre-existing requirements to the specific object of conformity assessment. For example, consideration might be needed for applying a standard written for metal pipes to plastic pipes. In some cases, only a very general set of requirements may exist which must be expanded for assessment to be meaningful or acceptable to the users. For example, a government regulator may require that products pose no unacceptable safety risks (the general requirement) and expect a certification body to establish specific requirements for individual certified products or types of products. Or, general management system requirements may need to be more focused when the management system must address fulfillment of specific service requirements. Selection may also include consideration of the most appropriate procedures (for example, testing methods or inspection methods) to be used for determination activities. It is not uncommon that new or modified methods must be developed to conduct determination activities. Consideration of procedures may include selecting the proper locations and the proper conditions, or the individuals to perform them.

7 Finally, additional information may be needed for determination activities to be properly performed so that the demonstration of fulfillment of specified requirements will be effective. For example, the scope of testing to be covered by laboratory accreditation must be identified before appropriate determination activities can be performed. Or, a description of a service may be needed to perform appropriate determination activities. Also, a determination activity may be a review of information alone, and that information must be identified and collected. For example, a copy of a product s use instructions or warning markings may be needed. In Figure 1, all the information, samples (if sampling is used), decisions and other output from the selection function is represented as information on selected items. 3.3 Determination Determination activities are undertaken to develop complete information regarding fulfillment of the specified requirements by the object of conformity assessment or its sample. The terms, testing, inspection, audit, and peer assessment, which are defined as types of determination activities only, can be used with system or scheme to describe conformity assessment systems or schemes that include the type of determination activity indicated. Thus, a peer assessment system is a conformity assessment system that includes peer assessment as the determination activity. Various determination activities have no specific name or designation. An example is the examination or analysis of a design, or other descriptive information, in relation to specified requirements. Individual sub-fields of conformity assessment (e.g., testing, certification, accreditation, etc.) may have terms defined for determination activities that are unique to that sub-field. There is no generic term used in this standard or in practice to represent all determination activities. Care should be taken to understand clearly the determination activities characterized as testing or inspection. In figure 1, all the output from the determination function is represented as information on fulfillment of specified requirements. The output is a combination of all the information created through determination activity as well as all the input to the determination function. The output is usually structured to facilitate review and attestation activities. 3.4 Review and attestation Review constitutes the final stage of checking before taking the important decision whether or not the object of conformity assessment has been reliably demonstrated to fulfill the specified requirements. If so, attestation results in a statement in a form that most readily reaches all of the potential users. Statement of conformity is a generic expression used to include all means of communicating that fulfillment of specified requirements has been demonstrated. If fulfillment of the specified requirements has not been demonstrated, the finding of nonconformity can be reported.

8 The terms, declaration, certification and accreditation, which are defined as types of attestation only, can be used with system or scheme to describe conformity assessment systems or schemes that include the type of attestation activity indicated as the final step. Thus, a certification system is a conformity assessment system that includes selection, determination, review and finally certification as the attestation activity. In figure 1, all the output from the review and attestation function is represented as fulfillment of specified requirements demonstrated. 3.5 The need for surveillance Conformity assessment can end when attestation is performed. However, in some cases systematic iteration of the functions in figure 1 may be needed to maintain the validity of the statement resulting from attestation. The needs of users drive such activities. For example, an object of conformity assessment may change over time, which could affect its continuing fulfillment of specified requirements. Or, users may demand ongoing demonstration that specified requirements are fulfilled; for example, when a product is produced continuously. The activities undertaken in surveillance are planned in order to satisfy the need to maintain the validity of an existing statement resulting from attestation. A complete repeat of the initial assessment is usually not necessary in every iteration of surveillance to satisfy this need. Thus, the activities in each function in figure 1 during surveillance may be abbreviated, or different from, the activities undertaken in the initial assessment. Selection activities take place in both the initial assessment and in surveillance. However, entirely different choices might be made in surveillance. For example, a test for a product may have been selected in the initial assessment. In surveillance, an inspection might be selected to determine that a sample of the product is the same as the sample originally tested. In fact, the choices in selection may change from time to time, based on information from previous iterations of surveillance and other inputs. Ongoing risk analysis or consideration of market feedback regarding actual fulfillment of specified requirements may be part of selection activities in surveillance. Choices about the specified requirements may be different as well. For example, only a subset of the specified requirements might be selected in any given iteration of surveillance. Or, similarly, only a portion of the object of conformity assessment may be selected for determination activities in surveillance; for example, only a portion of an accredited certification body may be audited during surveillance. As noted above, the different choices in selection can lead to different determination activities for surveillance purposes. However, in both initial assessment and surveillance, the output from selection defines the determination activities and how they will be carried out. The review and attestation function is also used in both initial assessment and surveillance. In surveillance a review of all the inputs and outputs in figure 1 leads to a decision whether the statement resulting from attestation continues to be valid. In many cases, no special action is

9 taken if the statement continues to be valid. In other cases, for example, if the scope of attestation has been extended, a new statement of conformity can be issued. If the decision is that the statement of conformity is no longer valid, appropriate activities are necessary to advise users, for example, that the scope of attestation has been reduced or that the statement has been suspended or withdrawn. 4 Laboratory Accreditation Criteria In 2001, CASCO established a working group (WG 25) to align ISO/IEC 17025:1999 with ISO 9001:2000. WG 25 agreed to propose a draft amendment to ISO/IEC which would have the absolute minimum number of changes to the text to ensure that the claim of alignment to the principles of ISO 9001 was valid. 4.1 General changes The following changes presented in Table 1 have taken place throughout the document where the term appears, unless otherwise described. Table 1. Current word(s) New word(s) or reference(s) or reference(s) quality system The term quality system has been changed to either management system or quality management system client The term client has been changed to customer. nonconformances The term nonconformances has been changed to nonconformities and and conformance conformance to conformity ISO 9001:1994 References to ISO 9001:1994 and ISO 9001:1994 have been changed to ISO 9004:1994 references to ISO 9001:2000 ISO 8402 [7] References to ISO 8402 have been changed in references to ISO 9000:2000 chief executive The term top management is introduced as a substitute for chief executive. This term, top management, is also used in four new paragraphs (4.1.6, 4.2.3, and 4.2.7). 4.2 Specific changes The following table summarizes the specific changes not already covered above. Where a new sub-clause is introduced, the following sub-clauses have been renumbered in ISO/IEC WD [7] This renumbering is included below and presented in Table 2.

10 Table 2. Original clause or sub-clause in the New sub-clause in ISO/IEC WD published ISO/IEC 17025:1999 Introduction New text included to explain the reason for the amendment 1.4 New sentence added to the end of the clause. 1.6 If testing and calibration laboratories comply with the requirements of this International Standard they will operate a quality system for their testing and calibration activities that also meets the requirements of ISO 9001 when they engage in the design/development of new methods, and/or develop test programs combining standard and non-standard test and calibration methods, and ISO 9002 when they only use standard methods. 2. Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9001 :1994, Quality systems Model for quality assurance in design, development, production, installation and servicing. ISO 9002 :1994, Quality systems Model for quality assurance in production, installation and servicing. This international standard is not to be used for the purposes of certification of the quality management system. Replaced by: 1.6 If testing and calibration laboratories comply with the requirements of this International Standard they will operate a management system for their testing and calibration activities that also meets the principles of ISO 9001:2000 Replaced by The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2000, Quality management systems - - Fundamentals and vocabulary ISO 9001:2000, Quality Management Systems - Requirements

11 4.1.5 The laboratory shall Replaced by: a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also 5.2) ; a) have managerial and technical personnel, who irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also 5.2); New sub-clause inserted k) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. New sub-clause inserted The laboratory's quality system policies and objectives, shall be defined in a quality manual (however named). The overall objectives shall be documented in a quality policy statement Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. Replaced by The laboratory's management system policies, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established and reviewed during management review... New sub-clause inserted Top management shall provide evidence of commitment to the continual improvement of the management system. New sub-clause inserted Top management shall communicate to the organization the importance of meeting customer as well as statutory and regulatory requirements

12 New sub-clause inserted Note 3 Laboratories are encouraged to obtain other feedback, both positive and negative, from their customers (e.g. customer surveys). The feedback should be used to improve the quality system, testing and calibration activities and customer service Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented. Deleted New sub-clause inserted The laboratory shall obtain feedback, both positive and negative, from its direct customers (e.g. through customer satisfaction surveys). The feedback should be used and analyzed to improve the quality management system, testing and calibration activities and customer service. New sub-clause inserted 4.10 Improvement The laboratory shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. New list item added in after the 9th entry: recommendations for improvement New sentence added at the end of sub-clause The effectiveness of the training actions taken shall be evaluated. New list item added as as f) regular checking of equipment for stability and integrity.

13 New sub-clause added Quality control data shall be analyzed and where it is found to be outside pre-defined action criteria, the defined actions shall be taken to correct the problem and to prevent incorrect results from being reported. Annex A has been replaced in its entirety giving a new set of cross references between the new versions of ISO 9001 and There are no changes to Annex B. The Bibliography has been updated to reflect revisions and replacements of the documents that were originally listed. 5 Accreditation Body Requirements The proposed ISO/IEC Final Draft International Standard (FDIS) 17011, General requirements for accreditation bodies accrediting conformity assessment bodies, dated 1 April 2003, should be circulated (once the French version is available) for a 60-day yes-no vote. ISO/IEC should be available by the end of General changes Table 3 presents proposed changes from Guide 58 to the proposed new ISO/IEC Table 3. Current word quality system laboratory nonconformances and conformance or compliance ISO/IEC Guide 2:1991 ISO/IEC Guide 25:1999 ISO 8402 ISO :1990[9] & - 2:1991 [10] senior executive New word(s) The term quality system has been changed to management system The term applicant has been changed to conformity assessment body so that all types of conformity assessment bodies are covered The term nonconformances has been changed to nonconformities and conformance or compliance to conformity Reference to ISO/IEC Guide 2 has been changed to reference to ISO/IEC 17000:20xx Reference to ISO/IEC Guide 25 has been removed by simply referring to the relevant ISO/IEC standards for all general requirements for competence of conformity assessment bodies References to ISO 8402 have been changed in references to ISO 9000:2000 References to ISO :1990 and ISO :1991 have been replaced by reference to ISO 19011:2002 [11] The term top management is introduced as a substitute for senior executive. This term, top management, is used in seven new paragraphs (4.2.4, 4.2.5, 4.3.7, 5.2.1, 5.2.3, and 8.1.2)

14 Table 4 summarizes the more specific changes and new requirements not already covered in Table 3. Table 4. New clauses or subclause topics New text or requirements in ISO/IEC FDIS Introduction New text is included to provide background on the role of accreditation in the regulatory sector and in the voluntary sector. The role of accreditation in trade on equal terms is explained by reference to the World Trade Organisation (WTO) principles. The importance of accreditation to inform the purchaser, regulator and the public about the competence of conformity assessment bodies (CABs) to do their task. For these reasons, there is an increasing demand for impartial checking of their competence. Such checks are done by accreditation bodies, which are impartial in relation to both the CABs and their clients, and which normally operate in a non-profit distributing manner. A system to accredit CABs' conformity assessment services should provide confidence to the purchaser and regulator. Such a system should facilitate cross-border trade, as pursued by trade authorities and organizations. The ultimate goal is to achieve one-stop accreditation and one-stop conformity assessment. A cross border trade facilitating system can work well if accreditation bodies and CABs all operate to globally accepted requirements in an equivalent manner and take into account the interests of all parties concerned. It is noted that peer evaluation mechanisms have been created at regional and international level, through which assurance is provided that accreditation bodies are operating to this International Standard. Those who have passed such an evaluation can become members of mutual recognition arrangements. Through regular re-evaluations the continued adherence to the International Standard is assured. These mutual recognition arrangement members facilitate the one-stop process, through recognition, promotion and acceptance of each other s accredited conformity assessments. This means that a CAB in an economy should not need to be accredited more than once for the same scope by different accreditation bodies

15 3. Definitions Several definitions have been added including, accreditation body logo, accreditation certificate, accreditation body symbol, appeal, assessment, assessor, complaint, consultancy, expert, interested parties, lead assessor, scope of accreditation, surveillance, and witnessing. 4. Accreditation Body 4.2 Structure A description of legal status is now required. Top management authority and responsibilities are more clearly identified for the following: (1) policies on operation, (2) supervision of the implementation of policies and procedures, (3) supervision of the finances, (4) decisions on accreditation, (5) contractual arrangements, and (6) delegation of authority to committees or individuals, as required, to undertake defined activities on behalf of top management Participants in committees involved in the accreditation process shall be identified. 4.3 Impartiality A full page is devoted to the requirements related to impartiality. This is probably the most significant change. For safeguarding impartiality and for developing and maintaining the principles and major policies of operation of its accreditation system, the accreditation body shall have documented and implemented a structure to provide opportunity for effective involvement by interested parties. The accreditation body shall ensure a balanced representation of interested parties with no single party predominating. The accreditation body shall ensure that each decision on accreditation is taken by competent person(s) or committee(s) different from those who carried out the assessment. The accreditation body shall not offer or provide any service that affects its impartiality such as: those conformity assessment services that CABs perform. Exception to this rule is permissible if the accreditation body can demonstrate, with the participation of interested parties, that there is a need for a particular conformity assessment service that is not otherwise available. When any CAB is able to provide such a service, this exception shall no longer apply;

16 consultancy. The accreditation body s activities shall not be presented as linked with consultancy. Nothing shall be said or implied that would suggest that accreditation would be simpler, easier, faster or less expensive if any specified person(s) or consultancy were used. The accreditation body shall ensure that activities of its related bodies do not compromise the confidentiality, objectivity and impartiality of its accreditations. A related body may, however, offer or provide those conformity assessment services the accreditation body accredits when the related body has (with respect to the accreditation body): different top management for the activities, personnel different from those involved in the decision-making processes of accreditation, no possibility to influence the outcome of an assessment for accreditation, and distinctly different name, logos and symbols. The accreditation body, with the participation of the interested parties shall identify, analyze and document the relationship with related bodies to determine the potential for conflict of interest, whether they arise from within the accreditation body or from the activities of the related bodies. Where conflicts are identified, appropriate action shall be taken. A related body is a separate legal entity that is linked by common ownership or contractual arrangements to the accreditation body. A separate part of the government, outside the governmental accreditation body, is considered as a related body The accreditation body shall establish procedures for extending its activities and to react to demands of interested parties. 5 Management In general, the management system requirements now better align with ISO 9001:2000 requirements. 5.3 Document control has become a major section instead of one sentence. 5.5 Nonconformities and corrective actions are more in line with ISO 9001 practice.

17 5.6 A section on preventive action has been added. 5.9 The concept of disputes has been deleted in favor of disputes being treated as one of several types of complaints. 6.1 Personnel The re is much more detail with regard to sufficiency and competence of all types of personnel associated with the accreditation body. The accreditation body shall require all its personnel to commit themselves by a signature or equivalent to comply with the rules of the accreditation body including those related to confidentiality and to independence and conflicts of interest. 6.2 The required qualifications, experience and competence for all persons involved in the accreditation process, not just assessors, now needs to be specified The accreditation shall establish procedures for selecting, training and formally approving assessors and experts used in the assessment process The accreditation body shall identify the specific scopes in which each assessor and expert has demonstrated competence to assess. 6.3 The accreditation body now has to monitor the performance of all personnel involved in the assessment and decision making process, not just assessors. 7.3 There is now a requirement to perform a resource review of the accreditation body s ability to carry out the assessment of each applicant in a timely manner A preliminary visit or pre-assessment is explicitly an option with agreement of the applicant. 7.6 Document and record review before initiating an on-site assessment is explicitly required The assessment team shall witness the performance of a representative number of staff of the CAB to provide assurance of the competence of the CAB across the scope of accreditation. 7.8 The analysis of findings and assessment report are more prescriptive but generally follow common practice The information provided to the accreditation decisionmaker(s) is prescribed in 11 bullets The reassessment and surveillance section is more prescriptive. It allows two approaches: (1) full reassessment at maximum intervals of every two years, or (2) a combination of surveillance and reassessment with reassessment intervals not to exceed 5 years and on-site assessments not to exceed 2 years There is a special section on proficiency testing and other comparisons for laboratories.

18 The accreditation body shall ensure that its accredited laboratories participate in proficiency testing and other comparison programs where available and appropriate and that corrective actions are carried out when necessary. The minimum amount of proficiency testing and the frequency of participation shall be specified in cooperation with interested parties and be appropriate in relation to other surveillance activities. Accreditation body Assess competence Conformity assessment bodies Accreditation bodies assess the competence of CABs. They can facilitate trade by promoting global acceptance of conformity assessment results issued by accredited CABs. This is strengthened if they are peer-evaluated and are members of mutual recognition arrangements among the accreditation bodies. CABs assess conformity of products/services and suppliers to specifications/requirements. Assess conformity products/ services supplier Purchasers acquire products/services that conform to specifications or buy from suppliers that conform to specific requirements. Regulators may set requirements on products and suppliers. Note: the word supplier is used as provider of products/services. Figure 2. A diagram depicting the roles of accreditation bodies and those conformity assessment bodies that they accredit. 6 Rules for Mutual Recognition Arrangements (MRAs or MLAs) ISO CASCO has recently embarked upon development of a new standard to address the peer evaluation (or assessment) process of mutual recognition agreement groups. ISO/IEC CD , General requirements for peer assessment of conformity assessment bodies [12] has been drafted and is out for comment. The next meeting of the working group is June 16, 2003.

19 The respective contributions of accreditation and peer assessment needed to be understood better, because they are important tools in increasing confidence and preparing for mutual recognition and trade facilitation. The concept of accreditation and on its use in the designation of conformity assessment bodies should continue, including in the WTO Committee on Technical Barriers to Trade, where it had already been on the agenda of the previous Triennial Review of the agreement. The one-stop approach, in relation to evidence of conformity as a basis for reaching the widest possible market, is still has a long way to go, but that there was still no better tool than mutual recognition, which to a certain extent favors the convergence of the systems. Mutual recognition agreements in the voluntary sector deliver specific, practical and rapid results. MRAs in the mandatory sector have been more difficult and less fruitful. Conformity Assessment Accreditation Hierarchy Cooperation ILAC MRA Government & Industry Acceptance Cooperation IAF MLA Mutual Recognitions EA, APLAC, IAAC ISO/IEC Mutual Recognitions EA, PAC, IAAC ISO/IEC Accreditation Bodies accredit labs & inspection bodies ISO/IEC Guide 58, future ISO/IEC Accreditation Bodies accredit certification bodies ISO/IEC Guide 61 future ISO/IEC Laboratories test, products, materials ISO/IEC Inspection Bodies inspect products, items, structures ISO/IEC Certification Bodies certify products ISO/IEC Guide 65 Certification Bodies certify management systems ISO/IEC Suppliers ISO/IEC 17049/50 Confidence regarding compliance with requirements Second Parties Figure 3. A diagram depicting the standards and relationships among the parties of conformity assessment bodies and accreditation bodies and their agreement groups (MRAs or MLAs). 7 References 1. ISO/IEC17025:1999, General requirements for the competence of testing and calibration laboratories. 2. ISO 9001:2000, Quality management systems requirements 3. Draft ISO/IEC FDIS 17011, General requirements for accreditation bodies accrediting conformity assessment bodies, April 1, 2003.

20 4. ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems General requirements for operation and recognition. 5. ISO/IEC Guide 2: 1996, Standardization and related activities General vocabulary. 6. Draft ISO/IEC DIS 17000, Conformity assessment General vocabulary. 7. ISO 8402:1994, Quality management and quality assurance Vocabulary 8. Draft ISO/IEC WD 2 DAM 17025, General requirements for the competence of calibration and testing laboratories, 9. ISO :1990, Guidelines for auditing quality systems Part 1: Auditing 10. ISO :1991, Guidelines for auditing quality systems Part 2: Qualification criteria for quality systems auditors. 11. ISO19011:2002, Guidelines for quality and/or environmental management systems auditing. 12. ISO/IEC CD , General requirements for peer assessment of conformity assessment bodies From Figure 3 (not numbered in the figure): 13. ISO/IEC TR 17010:1998, General requirements for bodies providing accreditation of inspection bodies. 14. ISO/IEC Guide 61:1998, General requirements for bodies providing accreditation of certification bodies 15. ISO/IEC 17020:1998, General criteria for the operation of various types of bodies performing inspection. 16. ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems 17. ISO/IEC CD 17021, General requirements for bodies operating management system certification systems. 18. ISO/IEC DIS 17049/50, General requirements for supplier s declaration of conformity