SIST EN ISO/IEC 17020:2004

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.General criteria for the operation of various types of bodies performing inspection (ISO/IEC 17020:1998)Criteres généraux pour le fonctionnement de différents types d'organismes procédant a l'inspection (ISO/IEC 17020:1998)Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen durchführen (ISO/IEC 17020:1998)Ta slovenski standard je istoveten z:EN ISO/IEC 17020:2004SIST EN ISO/IEC 17020:2004en03.120.20ICS:SIST EN 45004:19971DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO/IEC 17020:200401-december-2004







EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO/IEC 17020
September 2004 ICS 03.120.20 Supersedes EN 45004:1995English version
General criteria for the operation of various types of bodies performing inspection (ISO/IEC 17020:1998)
Critères généraux pour le fonctionnement de différents types d'organismes procédant à l'inspection (ISO/IEC 17020:1998)
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen durchführen (ISO/IEC 17020:1998) This European Standard was approved by CEN and CENELEC on 15 July 2004.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:rue de Stassart, 36
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B-1050 Brussels© 2004 CEN/CENELEC All rights of exploitation in any form and by any means reservedworldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17020:2004 E



EN ISO/IEC 17020:2004 (E)
2
Foreword
The text of ISO/IEC 17020:1998 has been prepared by Technical Committee ISO/CASCO "Committee on conformity assessment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO/IEC 17020:2004 by Technical Committee CEN/CLC/TC 1 "Criteria for conformity assessment bodies", the secretariat of which is held by SN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2005, and conflicting national standards shall be withdrawn at the latest by March 2005.
This document supersedes EN 45004:1995.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO/IEC 17020:1998 has been approved by CEN and CENELEC as EN ISO/IEC 17020:2004 without any modifications.



B CReference numberISO/IEC 17020:1998(E)INTERNATIONALSTANDARDISO/IEC17020First edition1998-11-15General criteria for the operation of varioustypes of bodies performing inspectionCritères généraux pour le fonctionnement de différents types d'organismesprocédant à l'inspection



ISO/IEC 17020:1998(E)©
ISO/IEC 1998All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronicor mechanical, including photocopying and microfilm, without permission in writing from the publisher.ISO/IEC Copyright OfficeCase postale 56 · CH-1211 Genève 20 · SwitzerlandPrinted in SwitzerlandiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.International Standard ISO 17020 was prepared by the European Committee for Standardization (CEN) and theEuropean Committee for Electrotechnical Standardization (CENELEC) as EN 45004, and was adopted, under aspecial “fast-track procedure”, by the ISO Committee on Conformity Assessment (ISO/CASCO) in parallel with itsapproval by the ISO member bodies and the IEC National Committees.The ISO Committee on Conformity Assessment (ISO/CASCO), now mandated to produce International Standards,chose EN 45004 to meet a perceived market need for an international consensus-based normative document onrequirements for inspection bodies, replacing ISO/IEC Guide 39:1988, General requirements for the acceptance ofinspection bodies, and ISO/IEC Guide 57:1991, Guidelines for the presentation of inspection results.Throughout the text of this standard, read ‘‘. this European Standard .’’ to mean ‘‘. this InternationalStandard .’’.Annexes A to C form an integral part of this International Standard. Annexes D and ZZ are for information only.Annex ZZ provides a list of corresponding International and European Standards for which equivalents are not givenin the text.



© ISO/IECISO/IEC 17020:1998(E)iiiForewordThis European Standard has been drawn up by CEN/CENELEC/TC 1 “Criteria for conformity assessment bodies”,whose secretariat is held by the CEN Central Secretariat.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 1995, and conflicting national standards shall be withdrawn at the latestby September 1995.According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement thisEuropean Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.



ISO/IEC 17020:1998(E)© ISO/IECivIntroductionThis European Standard has been drawn up with the objective of promoting confidence in those bodies performinginspection which conform to it.It has been drawn up in the light of experience of European bodies performing inspections taking into accountrequirements and recommendations of European and international documents such as the ISO 9000 (EN/ISO 9000)series of standards and ISO/IEC Guide 39.Inspection bodies have carried out assessments on behalf of private clients, their parent organizations, and/orofficial authorities with the objective of providing information to those parties relative to conformity with regulations,standards, or specifications. Inspection parameters may include matters of quantity, quality, safety, fitness for use,and continued safety compliance of plant or systems in operation. The general criteria, with which these bodies arerequired to comply in order that their services be accepted by clients and by supervisory authorities, need to beharmonized in a European standard.This standard, therefore, covers the functions of bodies whose work may include the examination of materials,products, installations, plant, processes, work procedures, or services, and the determination of their conformity,with requirements, and the subsequent reporting of results of these activities to clients and, when required, tosupervisory authorities. Inspection of a product an installation or plant may concern all stages during the lifetime ofthese items, including the design stage. Such work normally requires the exercise of professional judgement inproviding the service, in particular when assessing conformity.The requirement for the independence of inspection bodies varies according to legislation and market needs. Thisstandard therefore includes, in annexes A, B and C, criteria for independence.This standard has also been produced to support the introduction of the conformity assessment proceduresspecified in the EC Council decision concerning the modules for the various phases of the conformity assessmentprocedures which are intended to be used in the technical harmonization directives.The relevant requirements of the EN/ISO 9000 series of standards applying to the quality systems for inspectionbodies are incorporated in this standard.This standard forms part of the following series of standards covering testing, inspection, certification andaccreditation:¾ EN 45001, General criteria for the operation of testing laboratories¾ EN 45002, General criteria for the assessment of testing laboratories¾ EN 45003, General criteria for the laboratory accreditation bodies¾ EN 45004, General criteria for the operation of bodies performing inspection¾ EN xxxx1), General criteria for the accreditation of various types of bodies performing inspection¾ EN 45011, General criteria for certification bodies operating product certification¾ EN 45012, General criteria for certification bodies operating quality system certification¾ EN 45013, General criteria for certification bodies operating certification of personnel¾ EN 45014, General criteria for suppliers' declaration of conformity¾ EN 45020, General terms and their definitions concerning standardisation and related activities
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INTERNATIONAL STANDARD
© ISO/IECISO/IEC 17020:1998(E)1General criteria for the operation of various types of bodiesperforming inspection1 Scope1.1
This European standard specifies general criteria for the competence of impartial bodies performing inspectionirrespective of the sector involved. It also specifies independence criteria.1.2
This standard is intended for the use of inspection bodies and their accreditation bodies as well as other bodiesconcerned with recognizing the competence of inspection bodies.1.3
This set of criteria may have to be interpreted when applied to particular sectors, or to in-service inspection.1.4
This standard does not cover testing laboratories, certification bodies or the suppliers' declaration ofconformity, the criteria for which are contained in other European Standards of the EN 45000 series.2 DefinitionsFor the purpose of this standard the following definitions apply.2.1 InspectionExamination of a product design, product, service, process or plant, and determination of their conformity withspecific requirements or, on the basis of professional judgement, general requirements.NOTE 1Inspection of processes includes personnel, facilities, technology and methodology.NOTE 2The results of inspection may be used to support certification.2.2 Inspection bodyBody, that performs inspection.NOTE
A body can be an organization, or part of an organization.For other definitions those given in EN 45020:1993 are applicable.3 Administrative requirement3.1
The inspection body, or the organization of which it forms a part, shall be legally identifiable.3.2
An inspection body that is part of an organization involved in functions other than inspection shall beidentifiable within that organization.



ISO/IEC 17020:1998(E)© ISO/IEC23.3
The inspection body shall have documentation which describes its functions and the technical scope of activityfor which it is competent.The precise scope of an inspection will be determined by the terms of the individual contract or work order.3.4
The inspection body shall have adequate liability insurance unless its liability is assumed by the State inaccordance with national laws or by the organization of which it forms a part.3.5
The inspection body shall have documentation describing the conditions on which it does business unless it ispart of an organization and provides inspection services only to that organization.3.6
The inspection body, or the organization of which it forms a part, shall have independently audited accounts.4 Independence, impartiality and integrity4.1 GeneralThe personnel of the inspection body shall be free from any commercial, financial and other pressures which mightaffect their judgement. Procedures shall be implemented to ensure that persons or organizations external to theinspection body, cannot influence the results of inspections carried out.4.2 IndependenceThe inspection body shall be independent to the extent that is required with regard to the conditions under which itperforms its services.Depending on these conditions it shall meet the minimum criteria stipulated in one of the normative annexes A, Bor C.4.2.1 Type A inspection bodyThe inspection body providing “third party” services shall meet the criteria of annex A (normative).4.2.2 Type B inspection bodyThe inspection body which forms a separate and identifiable part of an organization involved in the design,manufacture, supply, installation, use or maintenance of the items it inspects and has been established to supplyinspection services to its parent organization shall meet the criteria of annex B (normative).4.2.3 Type C inspection bodyThe inspection body which is involved in the design, manufacture, supply, installation, use or maintenance of theitems it inspects or of similar competitive items and may supply inspection services to other parties not being itsparent organization shall meet the criteria of annex C (normative).5 ConfidentialityThe inspection body shall ensure confidentiality of information obtained in the course of its inspection activities.Proprietary rights shall be protected.6 Organization and management6.1
The inspection body shall have an organization that enables it to maintain the capability to perform its technicalfunctions satisfactorily.



© ISO/IECISO/IEC 17020:1998(E)36.2
The inspection body shall define and document the responsibilities and reporting structure of the organization.Where the inspection body also supplies certification and/or testing services, the relationship between its functionsmust be clearly defined.6.3
The inspection body shall have a technical manager however named, who is qualified and experienced in theoperation of the inspection body and who has overall responsibility that the inspection activities are carried out inaccordance with this standard. He shall be a permanent employee.NOTE
Where an inspection body consists of several divisions with different scopes of activity, there may be one technicalmanager per division.6.4
The inspection body shall provide effective supervision by persons familiar with the inspection methods andprocedures, the objectives of the inspection and the assessment of the examination results.6.5
The inspection body shall have named persons who will deputize in the absence of any manager, howevernamed, responsible for inspection services.6.6
Each position category affecting the quality of the inspection services shall be described. These jobdescriptions shall include the requirements for education, training, technical knowledge and experience.7 Quality system7.1
The inspection body's management shall define and document its policy and objectives for, and commitment toquality, and shall ensure that this policy is understood, implemented and maintained at all levels in the organization.7.2
The inspection body shall operate an effective quality system appropriate to the type, range and volume ofwork performed.7.3
The quality system shall be fully documented. There shall be a Quality Manual, which shall contain theinformation required by this standard and as listed in annex D (informative).7.4
The management of the inspection body shall designate a person who, irrespective of other duties, shall havedefined authority and responsibility for quality assurance within the inspection body. This person shall have directaccess to top management.7.5
The quality system shall be maintained relevant and current under the responsibility of the same person.7.6
The inspection body shall maintain a system for control of all documentation relating to its activities. It shallensure that:a) the current issues of the appropriate documentation are available at all relevant locations and to all relevantstaff;b) all changes of documents or amendments to documents are covered by the correct authorization andprocessed in a manner which will ensure timely availability at the appropriate location;c) superseded documents are removed from use throughout the organization, but one copy is filed for adetermined period;d) other parties, as
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