SIST EN ISO/IEC 17021:2011
(Main)Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
This International Standard contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to this International Standard need not offer all types of management system certification. Certification of management systems (named in this International Standard “certification”) is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party conformity assessment bodies (named in this International Standard “certification body/bodies”).
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011)
Diese Internationale Norm enthält Grundsätze für und Anforderungen an die Kompetenz, Folgerichtigkeit und
Unparteilichkeit von Audits und Zertifizierungen von Managementsystemen jeglicher Art (z. B. Qualitätsmanagementsystemen
oder Umweltmanagementsystemen) und für Stellen, die diese Tätigkeiten ausführen. Zertifizierungsstellen,
die nach dieser Internationalen Norm arbeiten, müssen nicht alle Arten von Managementsystem-
Zertifizierungen anbieten.
Zertifizierung von Managementsystemen (in dieser Internationalen Norm als „Zertifizierung“ bezeichnet) ist
eine Konformitätsbewertungstätigkeit durch eine dritte Seite (siehe ISO/IEC 17000:2004, 5.5). Stellen, die
diese Tätigkeit anbieten, sind daher Konformitätsbewertungsstellen und werden in dieser Internationalen
Norm verkürzt als „Zertifizierungsstellen“ bezeichnet.
ANMERKUNG 1 Diese Anmerkung gilt nur für den englischen Text.
ANMERKUNG 2 Eine Zertifizierungsstelle kann nichtstaatlich oder staatlich sein (mit oder ohne regelsetzender Kompetenz).
ANMERKUNG 3 Diese Internationale Norm kann als Vorgabe für die Akkreditierung oder Begutachtung unter Gleichrangigen
bzw. für andere Auditprozesse genutzt werden.
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management (ISO/IEC 17021:2011)
L'ISO 17021:2011 spécifie les principes et les exigences relatifs à la compétence, à la cohérence et à l'impartialité lors des audits et lors de la certification de systèmes de management de tous types (par exemple systèmes de management de la qualité ou systèmes de management environnemental) et relatives aux organismes fournissant cette activité. Les organismes de certification conformes à l'ISO 17021:2011 ne sont pas tenus de proposer tous les types de certification de système de management.
La certification de systèmes de management est une activité d'évaluation de la conformité par tierce partie. Les organismes exerçant cette activité sont par conséquent des organismes d'évaluation de la conformité par tierce partie.
Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja (ISO/IEC 17021:2011)
Ta mednarodni standard vsebuje principe in zahteve po pristojnosti, konsistenci in nepristranskosti za presojo in certifikacijo vseh vrst sistemov vodenja (npr. sistemi vodenja kakovosti ali sistemi vodenja okolja) in za organe, ki zagotavljajo te dejavnosti. Organom za certifikacijo, ki delujejo po tem mednarodnem standardu, ni treba ponujati vseh vrst certifikacij sistemov vodenja. Certifikacija sistemov vodenja (imenovana v tem mednarodnem standardu »certifikacija«) je dejavnost ugotavljanja skladnosti, ki jo izvaja tretja oseba (glej ISO/IEC 17000:2004, točko 5.5). Organi, ki izvajajo to dejavnost, so potemtakem organi za ugotavljanje skladnosti tretje osebe (v tem mednarodnem standardu imenovani »certifikacijski organi«).
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ugotavljanje skladnosti - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja (ISO/IEC 17021:2011)Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011)Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management (ISO/IEC 17021:2011)Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)03.120.20Certificiranje proizvodov in podjetij. Ugotavljanje skladnostiProduct and company certification. Conformity assessmentICS:Ta slovenski standard je istoveten z:EN ISO/IEC 17021:2011SIST EN ISO/IEC 17021:2011en01-april-2011SIST EN ISO/IEC 17021:2011SLOVENSKI
STANDARDSIST EN ISO/IEC 17021:20061DGRPHãþD
SIST EN ISO/IEC 17021:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO/IEC 17021
February 2011 ICS 03.120.20 Supersedes EN ISO/IEC 17021:2006
English version
Conformity assessment - Requirements for bodies providing audit and certification of management systems (ISO/IEC 17021:2011)
Évaluation de la conformité - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management (ISO/IEC 17021:2011)
Konformitätsbewertung - Anforderungen an Stellen, die Managementsysteme auditieren und zertifizieren (ISO/IEC 17021:2011) This European Standard was approved by CEN on 17 January 2011.
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-CENELEC Management Centre or to any CEN and 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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels© 2011 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17021:2011 E SIST EN ISO/IEC 17021:2011
EN ISO/IEC 17021:2011 (E) 2 Contents Page Foreword .3 SIST EN ISO/IEC 17021:2011
EN ISO/IEC 17021:2011 (E) 3 Foreword This document (EN ISO/IEC 17021:2011) has been prepared by the Committee on conformity assessment in collaboration with Technical Committee CEN/CENELEC/TC 1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI. 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 August 2011, and conflicting national standards shall be withdrawn at the latest by August 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO/IEC 17021:2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEC 17021:2011 has been approved by CEN as a EN ISO/IEC 17021:2011 without any modification.
SIST EN ISO/IEC 17021:2011
SIST EN ISO/IEC 17021:2011
Reference numberISO/IEC 17021:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO/IEC17021Second edition2011-02-01Conformity assessment — Requirements for bodies providing audit and certification of management systems Évaluation de la conformité — Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management
SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Principles.3 4.1 General.3 4.2 Impartiality.3 4.3 Competence.4 4.4 Responsibility.4 4.5 Openness.4 4.6 Confidentiality.4 4.7 Responsiveness to complaints.4 5 General requirements.5 5.1 Legal and contractual matters.5 5.2 Management of impartiality.5 5.3 Liability and financing.6 6 Structural requirements.7 6.1 Organizational structure and top management.7 6.2 Committee for safeguarding impartiality.7 7 Resource requirements.8 7.1 Competence of management and personnel.8 7.2 Personnel involved in the certification activities.9 7.3 Use of individual external auditors and external technical experts.10 7.4 Personnel records.10 7.5 Outsourcing.10 8 Information requirements.11 8.1 Publicly accessible information.11 8.2 Certification documents.11 8.3 Directory of certified clients.12 8.4 Reference to certification and use of marks.12 8.5 Confidentiality.13 8.6 Information exchange between a certification body and its clients.13 9 Process requirements.14 9.1 General requirements.14 9.2 Initial audit and certification.22 9.3 Surveillance activities.25 9.4 Recertification.26 9.5 Special audits.27 9.6 Suspending, withdrawing or reducing the scope of certification.27 9.7 Appeals.28 9.8 Complaints.28 9.9 Records of applicants and clients.29 10 Management system requirements for certification bodies.30 10.1 Options.30 10.2 Option 1: Management system requirements in accordance with ISO 9001.30 10.3 Option 2: General management system requirements.30 SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) iv © ISO 2011 — All rights reserved Annex A (normative)
Required knowledge and skills.34 Annex B (informative)
Possible evaluation methods.35 Annex C (informative)
Example of a process flow for determining and maintaining competence.37 Annex D (informative)
Desired personal behaviours.39 Annex E (informative)
Third-party audit and certification process.40 Annex F (informative)
Considerations for the audit programme, scope or plan.42 Bibliography.44
SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved v Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft International Standards 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/IEC 17021 was prepared by the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This second edition cancels and replaces the first edition (ISO/IEC 17021:2006), which has been revised to expand the scope. The first edition is provisionally retained for a period of one year until the systematic review of this second edition. This International Standard has also been published in an unofficial, marked version indicating changes from the previous edition. SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) vi © ISO 2011 — All rights reserved Introduction Certification of a management system, such as a quality or environmental management system of an organization, is one means of providing assurance that the organization has implemented a system for the management of the relevant aspects of its activities, in line with its policy. This International Standard specifies requirements for certification bodies. Observance of these requirements is intended to ensure that certification bodies operate management system certification in a competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and the acceptance of their certifications on a national and international basis. This International Standard serves as a foundation for facilitating the recognition of management system certification in the interests of international trade. Certification of a management system provides independent demonstration that the management system of the organization a) conforms to specified requirements, b) is capable of consistently achieving its stated policy and objectives, and c) is effectively implemented. Conformity assessment such as certification of a management system thereby provides value to the organization, its customers and interested parties. In this International Standard, Clause 4 describes the principles on which credible certification is based. These principles help the reader to understand the essential nature of certification and they are a necessary prelude to Clauses 5 to 10. These principles underpin all the requirements in this International Standard, but such principles are not auditable requirements in their own right. Clause 10 describes two alternative ways of supporting and demonstrating the consistent achievement of the requirements in this International Standard through the establishment of a management system by the certification body. This International Standard is intended for use by bodies that carry out audit and certification of management systems. It gives generic requirements for such certification bodies performing audit and certification in the field of quality, environmental and other forms of management systems. Such bodies are referred to as certification bodies. This wording should not be an obstacle to the use of this International Standard by bodies with other designations that undertake activities covered by the scope of this document. Certification activities involve the audit of an organization's management system. The form of attestation of conformity of an organization's management system to a specific management system standard or other normative requirements is normally a certification document or a certificate. The publication of this International Standard includes the text of ISO/IEC 17021:2006, including amendments to delete relevant references to ISO 19011, with new text adding specific requirements for third-party certification auditing and the management of competence of personnel involved in certification. Specific market needs have already been identified, resulting from a lack of specific and recognized requirements for third-party auditors of management systems, such as quality management systems, environmental management systems or food safety management systems. The lack of requirements for auditor competence and the way in which these auditors are managed and deployed has been identified by key interested parties, including industry interested parties, as being a drawback. This International Standard provides a set of requirements for management systems auditing at a generic level, aimed at providing a reliable determination of conformity to the applicable requirements for certification, conducted by a competent audit team, with adequate resources and following a consistent process, with the results reported in a consistent manner. SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved vii This International Standard is applicable to the auditing and certification of any type of management system. It is recognized that some of the requirements, and in particular those related to auditor competence, can be supplemented with additional criteria in order to achieve the expectations of the interested parties. In this International Standard, the word “shall” indicates a requirement and the word “should” a recommendation.
SIST EN ISO/IEC 17021:2011
SIST EN ISO/IEC 17021:2011
INTERNATIONAL STANDARD ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved 1 Conformity assessment — Requirements for bodies providing audit and certification of management systems 1 Scope This International Standard contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to this International Standard need not offer all types of management system certification. Certification of management systems (named in this International Standard “certification”) is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party conformity assessment bodies (named in this International Standard “certification body/bodies”). NOTE 1 Certification of a management system is sometimes also called “registration”, and certification bodies are sometimes called “registrars”. NOTE 2 A certification body can be non-governmental or governmental (with or without regulatory authority). NOTE 3 This International Standard can be used as a criteria document for accreditation or peer assessment or other audit processes. 2 Normative references 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 9000:2005, Quality management systems — Fundamentals and vocabulary ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000 and the following apply. 3.1 certified client organization whose management system has been certified 3.2 impartiality actual and perceived presence of objectivity NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so as not to adversely influence subsequent activities of the certification body. SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) 2 © ISO 2011 — All rights reserved NOTE 2 Other terms that are useful in conveying the element of impartiality are: objectivity, independence, freedom from conflict of interests, freedom from bias, lack of prejudice, neutrality, fairness, open-mindedness, even-handedness, detachment, balance. 3.3 management system consultancy participation in designing, implementing or maintaining a management system EXAMPLES a) preparing or producing manuals or procedures, and b) giving specific advice, instructions or solutions towards the development and implementation of a management system. NOTE Arranging training and participating as a trainer is not considered consultancy, provided that, where the course relates to management systems or auditing, it is confined to the provision of generic information that is freely available in the public domain; i.e. the trainer should not provide company-specific solutions. 3.4 third-party certification audit audit carried out by an auditing organization independent of the client and the user, for the purpose of certifying the client's management system NOTE 1 In the definitions which follow, the term “audit” has been used for simplicity to refer to third-party certification audit. NOTE 2 Third-party certification audits include initial, surveillance, re-certification audits, and can also include special audits. NOTE 3 Third-party certification audits are typically conducted by audit teams of those bodies providing certification of conformity to the requirements of management system standards. NOTE 4 A joint audit is when two or more auditing organizations cooperate to audit a single client. NOTE 5
A combined audit is when a client is being audited against the requirements of two or more management systems standards together. NOTE 6 An integrated audit is when a client has integrated the application of requirements of two or more management systems standards into a single management system and is being audited against more than one standard. 3.5 client organization whose management system is being audited for certification purposes 3.6 auditor person who conducts an audit 3.7 competence ability to apply knowledge and skills to achieve intended results 3.8 guide person appointed by the client to assist the audit team 3.9 observer person who accompanies the audit team but does not audit SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) © ISO 2011 — All rights reserved 3 3.10 technical area area characterized by commonalities of processes relevant to a specific type of management system 4 Principles 4.1 General 4.1.1 These principles are the basis for the subsequent specific performance and descriptive requirements in this International Standard. This International Standard does not give specific requirements for all situations that can occur. These principles should be applied as guidance for the decisions that may need to be made for unanticipated situations. Principles are not requirements. 4.1.2 The overall aim of certification is to give confidence to all parties that a management system fulfils specified requirements. The value of certification is the degree of public confidence and trust that is established by an impartial and competent assessment by a third-party. Parties that have an interest in certification include, but are not limited to a) the clients of the certification bodies, b) the customers of the organizations whose management systems are certified, c) governmental authorities, d) non-governmental organizations, and e) consumers and other members of the public. 4.1.3 Principles for inspiring confidence include ⎯ impartiality, ⎯ competence, ⎯ responsibility, ⎯ openness, ⎯ confidentiality, and ⎯ responsiveness to complaints. 4.2 Impartiality 4.2.1 Being impartial, and being perceived to be impartial, is necessary for a certification body to deliver certification that provides confidence. 4.2.2 It is recognized that the source of revenue for a certification body is its client paying for certification, and that this is a potential threat to impartiality. 4.2.3 To obtain and maintain confidence, it is essential that a certification body's decisions be based on objective evidence of conformity (or nonconformity) obtained by the certification body, and that its decisions are not influenced by other interests or by other parties. SIST EN ISO/IEC 17021:2011
ISO/IEC 17021:2011(E) 4 © ISO 2011 — All rights reserved 4.2.4 Threats to impartiality include the following. a) Self-interest threats: threats that arise from a person or body acting in their own interest. A concern related to certification, as a threat to impartiality, is financial self-interest. b) Self-review threats: threats that arise from a person or body reviewing the work done by themselves. Auditing the management systems of a client to whom the certification body provided management systems consultancy would be a self-review threat. c) Familiarity (or trust) threats: threats that arise from a person or body being too familiar with or trusting of another person instead of seeking audit evidence. d) Intimidation threats: threats that arise from a person or body having a perception of being coerced openly or secretively, such as a threat to be replaced or reported to a supervisor. 4.3 Competence Competence of the personnel supported by the management system of the certification body is necessary to deliver certification that provides confidence. 4.4 Responsibility 4.4.1 The client organization, not the certification body, has the responsibility for conformity with the requirements for certification. 4.4.2 The certification body has the responsibility to assess sufficient objective evidence upon which to base a certification decision. Based on audit conclusions, it makes a decision to grant certification if there is sufficient evidence of conformity, or not to grant certification if there is not sufficient evidence of conformity. NOTE Any audit is based on sampling within an organization's management system and therefore is not a guarantee of 100 % conformity with requirements. 4.5 Openness 4.5.1 A certification body needs to provide public access to, or disclosure of, appropriate and timely information about its audit process and certification process, and about the certification status (i.e. the granting, extending, maintaining, renewing, suspending, reducing the scope of, or withdrawing of certification) of any organization, in order to gain confidence in the integrity and credibility of certification. Openness is a principle of access to, or disclosure of, appropriate information. 4.5.2 To gain or maintain confidence in certification, a certification body should provide appropriate access to, or disclosure of, non-confidential information about the conclusions of specific audits (e.g. audits
...
SLOVENSKI SIST EN ISO/IEC 17021
STANDARD
april 2011
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja (ISO/IEC 17021:2011)
Conformity assessment – Requirements for bodies providing audit and
certification of management systems (ISO/IEC 17021:2011)
Évaluation de la conformité – Exigences pour les organismes procédant à l'audit
et à la certification des systèmes de management (ISO/IEC 17021:2011)
Konformitätsbewertung – Anforderungen an Stellen, die Managementsysteme
auditieren und zertifizieren (ISO/IEC 17021:2011)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17021 (sl, en)
Nadaljevanje na strani II in od 1 do 75
© 2014-10: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17021 : 2011
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17021 (sl,en), Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in
certificirajo sisteme vodenja (ISO/IEC 17021:2011), 2011, ima status slovenskega standarda in je
istoveten evropskemu standardu EN ISO/IEC 17021, Conformity assessment – Requirements for
bodies providing audit and certification of management systems (ISO/IEC 17021:2011), 2011.
NACIONALNI PREDGOVOR
Besedilo standarda EN ISO/IEC 17021:2011 je pripravil tehnični odbor ISO/CASCO "Odbor za
ugotavljanje skladnosti" v sodelovanju s tehničnim odborom CEN/CLC/TC 1 "Merila za organe za
ugotavljanje skladnosti", katerega sekretariat vodi BSI. Slovenski standard SIST EN ISO/IEC
17021:2011 je prevod angleškega besedila evropskega standarda EN ISO/IEC 17021:2011. V primeru
spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v
angleškem jeziku. Slovensko-angleško izdajo standarda je pripravil SIST/TC UGA Ugotavljanje
skladnosti.
Odločitev za izdajo tega standarda je 3. marca 2011 sprejel SIST/TC UGA Ugotavljanje skladnosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standardov, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 9000:2005 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)
SIST EN ISO/IEC 17000:2005 Ugotavljanje skladnosti – Slovar in splošna načela (enakovreden z
ISO/IEC 17000:2004)
OSNOVA ZA IZDAJO STANDARDA
– Privzem standarda EN ISO/IEC 17021:2011.
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17021:2006.
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v SIST EN ISO/IEC
17021:2011 to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO/IEC 17021:2011 in je objavljen z dovoljenjem
CEN
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17021:2011 and is published with the
permission of
CEN
Avenue Marnix 17
1050 Bruxelles
Belgium
II
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EVROPSKI STANDARD EN ISO/IEC 17021
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE februar 2011
ICS: 03.120.20 Nadomešča EN ISO/IEC 17021:2006
Slovenska izdaja
Ugotavljanje skladnosti – Zahteve za organe, ki presojajo in certificirajo
sisteme vodenja (ISO/IEC 17021:2011)
Conformity assessment – Évaluation de la conformité – Konformitätsbewertung –
Requirements for bodies providing Exigences pour les organismes Anforderungen an Stellen, die
audit and certification of procédant à l'audit et à la Managementsysteme auditieren und
management systems certification des systèmes de zertifizieren (ISO/IEC 17021:2011)
(ISO/IEC 17021:2011) management
(ISO/IEC 17021:2011)
Ta evropski standard je CEN sprejel 17. januarja 2011.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard.
Najnovejši seznami teh nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko
dobijo pri Upravnem centru CEN-CENELEC ali katerem koli članu CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih različicah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Hrvaške,
Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije, Nizozemske,
Norveške, Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice in
Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Upravni center CEN: Centralni sekretariat CENELEC:
Avenue Marnix 17, B-1000 Bruselj Avenue Marnix 17, B-1000 Bruselj
© 2011. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17021:2011 E
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SIST EN ISO/IEC 17021 : 2011
Predgovor Foreword
Ta dokument (EN ISO/IEC 17021:2011) je This document (EN ISO/IEC 17021:2011) has
pripravil Odbor za ugotavljanje skladnosti v been prepared by the Committee on conformity
sodelovanju s tehničnim odborom assessment in collaboration with Technical
CEN/CENELEC/TC 1 "Merila za organe za Committee CEN/CENELEC/TC 1 “Criteria for
ugotavljanje skladnosti", katerega sekretariat conformity assessment bodies” the secretariat of
vodi BSI. which is held by BSI.
Ta evropski standard mora z objavo istovetnega This European Standard shall be given the
besedila ali z razglasitvijo dobiti status status of a national standard, either by
nacionalnega standarda najpozneje do avgusta publication of an identical text or by
2011, nacionalne standarde, ki so v nasprotju s endorsement, at the latest by August 2011, and
tem standardom, pa je treba umakniti najpozneje conflicting national standards shall be withdrawn
do avgusta 2011. at the latest by August 2011.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. CEN [in/ali CENELEC] ne prevzema subject of patent rights. CEN [and/or CENELEC]
odgovornosti za identifikacijo katerih koli ali vseh shall not be held responsible for identifying any
takih patentnih pravic. or all such patent rights.
Ta dokument nadomešča EN ISO/IEC This document supersedes EN ISO/IEC
17021:2006. 17021:2006.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Czech Republic, Denmark, Estonia, Finland,
Italije, Latvije, Litve, Luksemburga, Madžarske, France, Germany, Greece, Hungary, Iceland,
Malte, Nemčije, Nizozemske, Norveške, Poljske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Portugalske, Romunije, Slovaške, Slovenije, Malta, Netherlands, Norway, Poland, Portugal,
Španije, Švedske, Švice in Združenega Romania, Slovakia, Slovenia, Spain, Sweden,
kraljestva. Switzerland and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO/IEC 17021:2011 je CEN odobril The text of ISO/IEC 17021:2011 has been
brez sprememb kot EN ISO/IEC 17021:2011. approved by CEN as a EN ISO/IEC 17021:2011
without any modification.
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SIST EN ISO/IEC 17021 : 2011
VSEBINA Stran CONTENTS Page
Predgovor.5 Foreword . 5
Uvod.6 Introduction. 6
1 Področje uporabe . 8 1 Scope . 8
2 Zveza s standardi . 8 2 Normative references. 8
3 Izrazi in definicije . 8 3 Terms and definitions. 8
4 Načela. 10 4 Principles.10
4.1 Splošno. 10 4.1 General. 10
4.2 Nepristranskost. 11 4.2 Impartiality. 11
4.3 Kompetentnost . 12 4.3 Competence. 12
4.4 Odgovornost. 12 4.4 Responsibility . 12
4.5 Odprtost. 12 4.5 Openness.12
4.6 Zaupnost. 13 4.6 Confidentiality.13
4.7 Odzivnost na pritožbe. 13 4.7 Responsiveness to complaints. 13
5 Splošne zahteve . 13 5 General requirements . 13
5.1 Pravne in pogodbene zadeve. 13 5.1 Legal and contractual matters. 13
5.2 Obvladovanje nepristranskosti . 14 5.2 Management of impartiality. 14
5.3 Obveznosti in financiranje.16 5.3 Liability and financing. 16
6 Strukturne zahteve . 16 6 Structural requirements. 16
6.1 Organizacijska struktura in najvišje 6.1 Organizational structure and top
vodstvo 16 management . 16
6.2 Odbor za varovanje nepristranskosti. 17 6.2 Committee for safeguarding impartiality 17
7 Zahteve glede virov . 18 7 Resource requirements . 18
7.1 Kompetentnost vodstva 7.1 Competence of management and
in osebja. 18 personnel. 18
7.2 Osebje, vključeno v aktivnosti 7.2 Personnel involved in the certification
certificiranja. 20 activities . 20
7.3 Uporaba posameznih zunanjih 7.3 Use of individual external
presojevalcev in zunanjih tehničnih auditors and external technical
strokovnjakov. 22 experts. 22
7.4 Zapisi o osebju . 22 7.4 Personnel records . 22
7.5 Oddajanje del zunanjim izvajalcem.23 7.5 Outsourcing . 23
8 Zahteve glede informacij . 24 8 Information requirements . 24
8.1 Javno dostopne informacije. 24 8.1 Publicly accessible information . 24
8.2 Certifikacijski dokumenti. 24 8.2 Certification documents . 24
8.3 Register certificiranih strank . 25 8.3 Directory of certified clients. 25
8.4 Sklicevanje na certifikacijo in uporaba 8.4 Reference to certification and use
znakov. 25 of marks. 25
8.5 Zaupnost. 26 8.5 Confidentiality.26
8.6 Izmenjava informacij med certifikacijskim 8.6 Information exchange between a
organom in njegovimi strankami . 27 certification body and its clients. 27
9 Zahteve glede procesov . 29 9 Process requirements . 29
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SIST EN ISO/IEC 17021 : 2011
9.1 Splošne zahteve. 29 9.1 General requirements .29
9.2 Začetna presoja in certifikacija . 41 9.2 Initial audit and certification. 41
9.3 Nadzorne aktivnosti . 45 9.3 Surveillance activities . 45
9.4 Obnovitev certifikacije.46 9.4 Recertification. 46
9.5 Posebne presoje. 47 9.5 Special audits . 47
9.6 Začasni odvzem, preklic ali krčenje 9.6 Suspending, withdrawing or reducing
obsega certifikata. 48 the scope of certification . 48
9.7 Prizivi . 49 9.7 Appeals . 49
9.8 Pritožbe . 50 9.8 Complaints .50
9.9 Zapisi o vložnikih in strankah . 51 9.9 Records of applicants and clients . 51
10 Zahteve za sistem vodenja 10 Management system requirements for
certifikacijskih organov. 52 certification bodies. 52
10.1 Možnosti . 52 10.1 Options.52
10.2 Možnost št. 1: Zahteve za sistem 10.2 Option 1: Management system
vodenja v skladu requirements in accordance with
z ISO 9001 . 52 ISO 9001. 52
10.3 Možnost št. 2: Splošne zahteve za 10.3 Option 2: General management
sistem vodenja . 53 system requirements. 53
Dodatek A (normativni): Potrebna znanja in Annex A (normative): Required knowledge
veščine . 58 and skills .59
Dodatek B (informativni): Možne metode Annex B (informative): Possible evaluation
vrednotenja. 60 methods .61
Dodatek C (informativni): Primeri poteka Annex C (informative): Example of a process
procesa za ugotavljanje in vzdrževanje flow for determining and maintaining
kompetentnosti . 64 competence. 65
Dodatek D (informativni): Zaželeno osebno Annex D (informative): Desired personal
vedenje. 66 behaviours. 67
Dodatek E (informativni): Proces presoje in Annex E (informative): Third-party audit
certificiranja, ki ga izvaja tretja stranka . 68 and certification process . 69
Dodatek F (informativni): Kaj je treba Annex F (informative): Considerations
upoštevati pri programu, obsegu ali planu for the audit programme, scope
presoje. 72 or plan . 73
Literatura.74 Bibliography. 75
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SIST EN ISO/IEC 17021 : 2011
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
in IEC (Mednarodna elektrotehniška komisija) Standardization) and IEC (the International
tvorita specializiran sistem za svetovno Electrotechnical Commission) form the
standardizacijo. Nacionalni organi, ki so člani specialized system for worldwide standardization.
ISO ali IEC, sodelujejo pri pripravi mednarodnih National bodies that are members of ISO or IEC
standardov prek tehničnih odborov, ki jih za participate in the development of International
obravnavanje določenih strokovnih področij Standards through technical committees
ustanovi ustrezna organizacija. Tehnični odbori established by the respective organization to
ISO in IEC sodelujejo na področjih skupnega deal with particular fields of technical activity.
interesa. Pri delu sodelujejo tudi druge ISO and IEC technical committees collaborate in
mednarodne, vladne in nevladne organizacije v fields of mutual interest. Other international
povezavi z ISO in IEC. Odbor ISO za organizations, governmental and non-
ugotavljanje skladnosti (CASCO) je odgovoren governmental, in liaison with ISO and IEC, also
za pripravo mednarodnih standardov in vodil na take part in the work. In the field of conformity
področju ugotavljanja skladnosti. assessment, the ISO Committee on conformity
assessment (CASCO) is responsible for the
development of International Standards and
Guides.
Mednarodni standardi so pripravljeni skladno s International Standards are drafted in
pravili, podanimi v Direktivah ISO/IEC, 2. del. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Osnutki mednarodnih standardov se pošljejo Draft International Standards are circulated to
nacionalnim organom v glasovanje. Za objavo the member bodies for voting. Publication as an
mednarodnega standarda je treba pridobiti International Standard requires approval by at
soglasje vsaj 75 odstotkov nacionalnih organov, least 75 % of the member bodies casting a vote.
ki glasujejo.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. ISO ne prevzema odgovornosti za subject of patent rights. ISO shall not be held
prepoznavanje katerih koli ali vseh takih responsible for identifying any or all such patent
patentnih pravic. rights.
ISO/IEC 17021 je pripravil Odbor ISO za ugo- ISO/IEC 17021 was prepared by the ISO
tavljanje skladnosti (CASCO). Committee on conformity assessment (CASCO).
Standard je bil poslan v glasovanje nacionalnim It was circulated for voting to the national bodies
organom ISO in IEC; obe organizaciji sta ga of both ISO and IEC, and was approved by both
odobrili. organizations.
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO/IEC 17021:2006), ki je revidirana first edition (ISO/IEC 17021:2006), which has
zaradi širitve področja uporabe. Prva izdaja se been revised to expand the scope. The first
začasno ohrani za obdobje enega leta do edition is provisionally retained for a period of
sistematičnega pregleda te druge izdaje. one year until the systematic review of this
second edition.
Objavljena je tudi neuradna izdaja tega This International Standard has also been
mednarodnega standarda z označenimi published in an unofficial, marked version
spremembami glede na prejšnjo izdajo. indicating changes from the previous edition.
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SIST EN ISO/IEC 17021 : 2011
Uvod Introduction
Certificiranje sistema vodenja organizacije, Certification of a management system, such as a
kakršen je npr. sistem vodenja kakovosti ali quality or environmental management system of
sistem ravnanja z okoljem, je eden od načinov an organization, is one means of providing
zagotavljanja, da ima organizacija uveden assurance that the organization has implemented
sistem za vodenje pomembnih vidikov svojih a system for the management of the relevant
aktivnosti v skladu s svojo politiko. aspects of its activities, in line with its policy.
Ta mednarodni standard opredeljuje zahteve za This International Standard specifies requirements
certifikacijske organe. Z upoštevanjem teh for certification bodies. Observance of these
zahtev se zagotavlja, da certifikacijski organi requirements is intended to ensure that certification
kompetentno, dosledno in nepristransko izvajajo bodies operate management system certification in
certificiranje sistemov vodenja, s čimer a competent, consistent and impartial manner,
omogočajo priznavanje takih organov in thereby facilitating the recognition of such bodies
sprejemanje njihovih certifikacij na nacionalni in and the acceptance of their certifications on a
mednarodni ravni. Ta mednarodni standard je national and international basis. This International
temelj za omogočanje priznavanja certifikacije Standard serves as a foundation for facilitating the
sistemov vodenja v interesu mednarodne recognition of management system certification in
trgovine. the interests of international trade.
Certifikacija sistema vodenja je neodvisen Certification of a management system provides
dokaz, da je sistem vodenja organizacije: independent demonstration that the management
system of the organization
a) skladen s specificiranimi zahtevami, a) conforms to specified requirements,
b) sposoben dosledno dosegati politiko in b) is capable of consistently achieving its
cilje, ki jih navede organizacija, ter stated policy and objectives, and
c) učinkovito izvajan. c) is effectively implemented.
Ugotavljanje skladnosti, kamor sodi certificiranje Conformity assessment such as certification of
sistemov vodenja, s tem zagotavlja vrednost za a management system thereby provides value
organizacijo, njene odjemalce in zainteresirane to the organization, its customers and
strani. interested parties.
V točki 4 tega mednarodnega standarda so In this International Standard, Clause 4
opisana načela, na katerih temelji verodostojna describes the principles on which credible
certifikacija. Ta načela bralcu pomagajo certification is based. These principles help the
razumeti bistvo certifikacije in so nujen uvod v reader to understand the essential nature of
točke od 5 do 10. Ta načela podpirajo vse certification and they are a necessary prelude
zahteve v tem mednarodnem standardu, to Clauses 5 to 10. These principles underpin
vendar pa taka načela sama po sebi niso all the requirements in this International
zahteve, ki bi jih bilo mogoče presojati. V točki Standard, but such principles are not auditable
10 sta opisana dva alternativna načina requirements in their own right. Clause 10
podpiranja in dokazovanja stalnega doseganja describes two alternative ways of supporting
zahtev iz tega mednarodnega standarda s tem, and demonstrating the consistent achievement
ko certifikacijski organ vzpostavi sistem of the requirements in this International
vodenja. Standard through the establishment of a
management system by the certification body.
Ta mednarodni standard je namenjen za uporabo This International Standard is intended for use by
organom, ki izvajajo presojo in certificiranje bodies that carry out audit and certification of
sistemov vodenja. Podaja splošne zahteve za management systems. It gives generic require-
certifikacijske organe, ki izvajajo presojo in ments for such certification bodies performing
certificiranje sistemov vodenja kakovosti, ravnanja audit and certification in the field of quality,
z okoljem ter drugih oblik sistemov vodenja. Taki environmental and other forms of management
organi se imenujejo certifikacijski organi. To systems. Such bodies are referred to as
poimenovanje pa naj ne bo ovira za drugače certification bodies. This wording should not be an
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SIST EN ISO/IEC 17021 : 2011
imenovane organe, ki izvajajo aktivnosti s obstacle to the use of this International Standard
področja uporabe tega dokumenta, da bi by bodies with other designations that undertake
uporabljali ta mednarodni standard. activities covered by the scope of this document.
Aktivnosti certificiranja vključujejo presojo Certification activities involve the audit of an
sistema vodenja organizacije. Oblika potrditve organization's management system. The form
skladnosti sistema vodenja organizacije s of attestation of conformity of an organization's
specifičnim standardom za sisteme vodenja ali management system to a specific management
z drugimi normativnimi zahtevami je praviloma system standard or other normative
certifikacijski dokument oziroma certifikat. requirements is normally a certification
document or a certificate.
V tej izdaji mednarodnega standarda je The publication of this International Standard
vključeno besedilo standarda ISO/IEC includes the text of ISO/IEC 17021:2006,
17021:2006, vključno z dopolnitvami za brisanje including amendments to delete relevant
ustreznih sklicev na ISO 19011, ter z novim references to ISO 19011, with new text adding
besedilom z dodanimi posebnimi zahtevami za specific requirements for third-party certification
certifikacijsko presojanje, ki ga izvajajo tretje auditing and the management of competence of
stranke, in vodenje kompetentnosti osebja, personnel involved in certification.
vključenega v certificiranje.
Prepoznane so posebne potrebe trga kot Specific market needs have already been
posledica pomanjkanja specifičnih in priznanih identified, resulting from a lack of specific and
zahtev za presojevalce iz vrst tretjih strank, ki recognized requirements for third-party auditors of
presojajo sisteme vodenja, kot so sistemi management systems, such as quality manage-
vodenja kakovosti, sistemi ravnanja z okoljem ment systems, environmental management
ali sistemi vodenja varnosti živil. Pomanjkanje systems or food safety management systems.
zahtev za kompetentnost presojevalcev in The lack of requirements for auditor competence
način, kako so ti presojevalci vodeni in and the way in which these auditors are managed
razporejeni, so kot pomanjkljivost označile and deployed has been identified by key
ključne zainteresirane strani, vključno z interested parties, including industry interested
zainteresiranimi iz industrije. parties, as being a drawback.
V tem mednarodnem standardu je podan This International Standard provides a set of
skupek zahtev za splošno presojanje sistemov requirements for management systems auditing
vodenja, namenjeno zagotavljanju zanesljivega at a generic level, aimed at providing a reliable
ugotavljanja skladnosti z veljavnimi zahtevami determination of conformity to the applicable
za certificiranje, ki ga izvaja kompetentna requirements for certification, conducted by a
presojevalska skupina z ustreznimi viri in po competent audit team, with adequate resources
usklajenem procesu ter z usklajenim and following a consistent process, with the
poročanjem o rezultatih. results reported in a consistent manner.
Ta mednarodni standard se lahko uporablja za This International Standard is applicable to the
presojo in certificiranje vseh vrst sistemov auditing and certification of any type of
vodenja. Nekatere od zahtev, zlasti tiste, ki se management system. It is recognized that some
nanašajo na kompetentnost presojevalcev, se of the requirements, and in particular those
lahko dopolnijo z dodatnimi kriteriji, da bi se related to auditor competence, can be
tako izpolnila pričakovanja zainteresiranih supplemented with additional criteria in order to
strani. achieve the expectations of the interested
parties.
V tem mednarodnem standardu besedica In this International Standard, the word “shall”
"mora" ("shall") označuje zahtevo in besedica indicates a requirement and the word “should” a
"naj" ("should") priporočilo. recommendation.
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SIST EN ISO/IEC 17021 : 2011
Ugotavljanje skladnosti – Conformity assessment –
Zahteve za organe, ki presojajo in Requirements for bodies providing
certificirajo sisteme vodenja audit and certification of management
systems
1 Področje uporabe 1 Scope
Ta mednarodni standard vsebuje načela in This International Standard contains principles and
zahteve za kompetentnost, doslednost in requirements for the competence, consistency and
nepristranskost presojanja in certificiranja vseh impartiality of the audit and certification of
vrst sistemov vodenja (npr. sistemov vodenja management systems of all types (e.g. quality
kakovosti ali sistemov ravnanja z okoljem) ter management systems or environmental
za organe, ki te aktivnosti izvajajo. management systems) and for bodies providing
Certifikacijski organi, ki delujejo po tem these activities. Certification bodies opera
...
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