Obsah

Contents

Strana

Page

Předmluva.............................................................................................................................................................................................. 5

Úvod........................................................................................................................................................................................................ 6

1......... Předmět normy......................................................................................................................................................................... 7

2......... Citované dokumenty................................................................................................................................................................ 7

3......... Termíny a definice................................................................................................................................................................... 7

4......... Zásady........................................................................................................................................................................................ 7

5......... Obecné požadavky.................................................................................................................................................................. 7

5.1...... Právní a smluvní záležitosti.................................................................................................................................................... 7

5.2...... Management nestrannosti...................................................................................................................................................... 7

5.3...... Odpovědnost a financování................................................................................................................................................... 7

6......... Požadavky na strukturu........................................................................................................................................................... 8

6.1...... Organizační struktura a vrcholové vedení........................................................................................................................... 8

6.2...... Provozní řízení.......................................................................................................................................................................... 8

7......... Požadavky na zdroje............................................................................................................................................................... 8

7.1...... Kompetence pracovníků......................................................................................................................................................... 8

7.1.1... Obecné aspekty........................................................................................................................................................................ 8

7.1.2... Stanovení kompetenčních kritérií.......................................................................................................................................... 8

7.1.3... Procesy hodnocení.................................................................................................................................................................. 8

7.1.4... Další záležitosti......................................................................................................................................................................... 9

7.2...... Pracovníci zapojení do certifikačních činností.................................................................................................................... 9

7.3...... Využití jednotlivých externích auditorů
a externích technických poradců........................................................................................................................................... 9

7.4...... Osobní záznamy....................................................................................................................................................................... 9

7.5...... Outsourcing............................................................................................................................................................................... 9

8......... Požadavky na informace...................................................................................................................................................... 10

8.1...... Veřejné informace................................................................................................................................................................. 10

8.2...... Certifikační dokumenty......................................................................................................................................................... 10

8.3...... Odkaz na certifikaci a značky.............................................................................................................................................. 10

8.4...... Důvěrnost................................................................................................................................................................................ 10

8.5...... Výměna informací mezi certifikačním orgánem a jeho klientem................................................................................ 10

9......... Požadavky na proces............................................................................................................................................................ 10

9.1...... Činnosti před certifikací........................................................................................................................................................ 10

9.1.1... Žádost....................................................................................................................................................................................... 10

9.1.2... Přezkoumání žádosti............................................................................................................................................................. 10

9.1.3... Program auditů....................................................................................................................................................................... 10

9.1.4... Určování doby trvání auditu................................................................................................................................................. 10

9.1.5... Vzorkování na více místech (pracovištích)........................................................................................................................ 12

9.1.6... Více norem systémů managementu.................................................................................................................................. 13

9.2...... Plánování auditů.................................................................................................................................................................... 13

9.3...... Prvotní certifikace................................................................................................................................................................... 13

9.4...... Provádění auditů.................................................................................................................................................................... 14

9.5...... Rozhodnutí o certifikaci......................................................................................................................................................... 14

9.6...... Udržování platnosti certifikace............................................................................................................................................ 15

9.7...... Odvolání................................................................................................................................................................................... 15

9.8...... Stížnosti.................................................................................................................................................................................... 15

9.9...... Záznamy o klientech............................................................................................................................................................. 15

10....... Požadavky na systém managementu
certifikačního orgánu............................................................................................................................................................. 15

Příloha A (normativní) Kompetenční kritéria................................................................................................................................. 16

A.1...... Obecně..................................................................................................................................................................................... 16

A.2...... Porozumění jadernému průmyslu
a obeznámenost s kulturou jaderné bezpečnosti a znalost technologického sektoru klienta................................ 18

A.3...... Znalost ISO 19443................................................................................................................................................................. 19

A.4...... Obecné odborné kompetence............................................................................................................................................. 19

A.4.1.. Vzdělání................................................................................................................................................................................... 20

A.4.2.. Pracovní zkušenosti............................................................................................................................................................... 21

A.4.3.. Možný dodatečný kredit........................................................................................................................................................ 21

Příloha B (informativní) Souhrn výsledků auditu......................................................................................................................... 22

Příloha C (normativní) Kritéria způsobilosti
pro vzorkování na více místech........................................................................................................................................... 23

Bibliografie........................................................................................................................................................................................... 24

Foreword................................................................................................................................................................................................... 5

Introduction............................................................................................................................................................................................... 6

1......... Scope............................................................................................................................................................................................ 7

2......... Normative references................................................................................................................................................................ 7

3......... Terms and definitions................................................................................................................................................................ 7

4......... Principles...................................................................................................................................................................................... 7

5......... General requirements................................................................................................................................................................ 7

5.1...... Legal and contractual matters.................................................................................................................................................. 7

5.2...... Management of impartiality...................................................................................................................................................... 7

5.3...... Liability and financing................................................................................................................................................................ 7

6......... Structural requirements............................................................................................................................................................. 8

6.1...... Organizational Structure and top management.................................................................................................................... 8

6.2...... Operational control..................................................................................................................................................................... 8

7......... Resource requirements............................................................................................................................................................. 8

7.1...... Competence of personnel........................................................................................................................................................ 8

7.1.1... General considerations.............................................................................................................................................................. 8

7.1.2... Determination of competence criteria.................................................................................................................................... 8

7.1.3... Evaluation processes................................................................................................................................................................. 8

7.1.4... Other considerations.................................................................................................................................................................. 9

7.2...... Personnel involved in the certification activities................................................................................................................... 9

7.3...... Use of individual external auditors and external technical advisors................................................................................. 9

7.4...... Personnel records....................................................................................................................................................................... 9

7.5...... Outsourcing.................................................................................................................................................................................. 9

8......... Information requirements....................................................................................................................................................... 10

8.1...... Public information.................................................................................................................................................................... 10

8.2...... Certification documents.......................................................................................................................................................... 10

8.3...... Reference to certification and marks.................................................................................................................................... 10

8.4...... Confidentiality........................................................................................................................................................................... 10

8.5...... Information exchange between a certification
body and its client..................................................................................................................................................................... 10

9......... Process requirements.............................................................................................................................................................. 10

9.1...... Pre-certification activities........................................................................................................................................................ 10

9.1.1... Application................................................................................................................................................................................. 10

9.1.2... Application review.................................................................................................................................................................... 10

9.1.3... Audit programme...................................................................................................................................................................... 10

9.1.4... Determining audit time............................................................................................................................................................ 10

9.1.5... Multisite sampling..................................................................................................................................................................... 12

9.1.6... Multiple management systems standards........................................................................................................................... 13

9.2...... Planning audits......................................................................................................................................................................... 13

9.3...... Initial certification...................................................................................................................................................................... 13

9.4...... Conducting audits..................................................................................................................................................................... 14

9.5...... Certification decision............................................................................................................................................................... 14

9.6...... Maintaining certification.......................................................................................................................................................... 15

9.7...... Appeals....................................................................................................................................................................................... 15

9.8...... Complaints................................................................................................................................................................................. 15

9.9...... Client records............................................................................................................................................................................ 15

10....... Management system requirements
for certification bodies............................................................................................................................................................. 15

Annex A (normative) Competence criteria....................................................................................................................................... 16

A.1...... General....................................................................................................................................................................................... 16

A.2...... Understanding of the nuclear industry
and familiar with nuclear safety culture
and knowledge of client’s technological sector.................................................................................................................. 18

A.3...... Knowledge of ISO 19443........................................................................................................................................................ 19

A.4...... General professional competences...................................................................................................................................... 19

A.4.1.. Education................................................................................................................................................................................... 20

A.4.2.. Work experience....................................................................................................................................................................... 21

A.4.3.. Possible supplemental credit................................................................................................................................................. 21

Annex B (informative) Summary of audit results........................................................................................................................... 22

Annex C (normative) Eligibility criteria for multi-site sampling.................................................................................................... 23

Předmluva

Foreword

ISO (Mezinárodní organizace pro normalizaci) je celo-
světová federace národních normalizačních orgánů (členů ISO). Mezinárodní normy obvykle vypracovávají technické komise ISO. Každý člen ISO, který se zajímá o předmět, pro který byla vytvořena technická komise, má právo být v této technické komisi zastoupen. Práce se zúčastňují také vládní i nevládní mezinárodní orga-
nizace, s nimiž ISO navázala pracovní styk. ISO úzce spolupracuje s Mezinárodní elektrotechnickou komisí (IEC) ve všech záležitostech normalizace v elektro-
technice.

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inter-
national Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

Postupy použité při tvorbě tohoto dokumentu a po-
stupy určené pro jeho další udržování jsou popsány ve směrnicích ISO/IEC, část 1. Zejména se má věnovat pozornost rozdílným schvalovacím kritériím potřebným pro různé druhy dokumentů ISO. Tento dokument byl vypracován v souladu s redakčními pravidly uvede-
nými ve směrnicích ISO/IEC, část 2 (viz
www.iso.org/directives).

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see           
www.iso.org/directives).

Upozorňuje se na možnost, že některé prvky tohoto dokumentu mohou být předmětem patentových práv. ISO nelze činit odpovědnou za identifikaci jakéhokoliv nebo všech patentových práv. Podrobnosti o jakýchkoliv patentových právech identifikovaných během přípravy tohoto dokumentu budou uvedeny v úvodu a/nebo v seznamu patentových prohlášení obdržených ISO (viz www.iso.org/patents).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Jakýkoliv obchodní název použitý v tomto dokumentu se uvádí jako informace pro usnadnění práce uživatelů a neznamená schválení.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

Vysvětlení nezávazného charakteru technických norem, významu specifických termínů a výrazů ISO, které se vztahují k posuzování shody, jakož i informace o tom, jak ISO dodržuje principy Světové obchodní orga-
nizace (WTO) týkající se technických překážek obchodu (TBT), jsou uvedeny na adrese          
www.iso.org/iso/foreword.html.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see

www.iso.org/iso/foreword.html.

Tento dokument vypracovala technická komise ISO/TC 85 Jaderná energie, jaderné technologie a radiologická ochrana.

This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies and radiological protection.

Jakákoli zpětná vazba nebo otázky týkající se tohoto dokumentu mají být adresovány národnímu normali-
začnímu orgánu uživatele. Úplný seznam těchto orgánů lze nalézt na adrese www.iso.org/members.html.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at           
www.iso.org/members.html.

Úvod

Introduction

Certifikace systému managementu kvality (QMS) orga-
nizace dodávající produkty a poskytující služby důležité z hlediska jaderné bezpečnosti je jedním ze způsobů, jak prokázat, že organizace zavedla systém pro řízení managementu v souladu se svojí politikou.

Certification of the Quality Management System (QMS) of an organization supplying products and services Important To Nuclear Safety (ITNS) is one means of providing assurance that the organization has implemented a system for the management of quality in line with its policy.

Tento dokument, který doplňuje požadavky ISO/IEC 17021-1, byl vypracován pro jaderný sektor jako pomůcka pro posuzování shody a certifikaci podle ISO 19443.

Supplementing ISO/IEC 17021-1 requirements, this document has been developed for the nuclear sector to assist in the conformity assessment and certification according to ISO 19443.

1 Předmět normy

1 Scope

Tento dokument doplňuje existující požadavky ISO/IEC 17021-1 pro orgány provádějící audit a certifikaci systémů managementu kvality podle ISO 19443.

This document complements the existing requirements of ISO/IEC 17021-1 for bodies providing audit and certification of quality management systems against ISO 19443.

POZNÁMKA Doporučuje se tento dokument používat jako dokument obsahující kritéria pro akreditaci, vzájemné posou-
zení nebo pro jiné procesy auditu.

NOTE This document is recommended for use as a criteria document for accreditation, peer assessment or other audit processes.