PD ISO IEC TS 17021-15 2023 提供管理体系审核和认证的机构的合格评定要求 第15部分 医疗保健组织质量管理体系审计和认证的能力建设要求(英文版).pdf

1.5,ISO,普定,管理体系,认证,国外及港澳台标准
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Conformityassessmentrequirementsfor bodiesproviding audit and certification

ofmanagementsystems

Part 15: Competence requirements for auditing and certification ofmanagement systems for quality inhealthcare organizations

bsi.

Nationalforeword

This Published Document is the UK implementation of ISO/1EC TS 17021-15:2023.

The UK participation in its preparation was entrusted to TechnicalCommittee CH/304 Healthcare Organization Management.

A list of organizations represented on this mittee can be obtained onrequest to its mittee manager.

Contractual andlegal considerations

This publication has been prepared in good faith however noimplied) is or will be made and no responsibility or liability is or will bereasonableness of this publication. All and any such responsibility andliability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is and is to be used at the recipient's own risk.

The recipient is advised to consider seeking professional guidance withrespect to its use of this publication.

This publication is not intended to constitute a contract. Users areresponsible for its correct application.

This publication is not to be regarded as a British Standard.

The British Standards Institution 2023 Published by BSI Standards Limited 2023

ISBN 978 0 539 25444 0

ICS 03.120.20

from legal obligations. Compliance with a Published Document cannot confer immunity

This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 December 2023.

Amendments/corrigenda issued since publication

Date

Text affected

TECHNICAL SPECIFICATION

Conformityassessmentrequirements certificationofmanagement forbodiesprovidingauditand systems-

Part 15: Competencerequirementsfor auditingandcertificationof managementsystemsforqualityin healthcareorganizations

Exigences relatives a l'evaluation de la conformite pour lesorganismes procedant a I'audit et α la certification des systemes de management-

Partie15:Exigencesdepetencepourluditetlacertificationdessystemes de management delaqualite danslesorganismes de sante

PD ISO/IEC TS 17021-15:2023 ISO/IEC TS 17021-15:2023(E)

COPYRIGHTPROTECTEDDOCUMENT

@ ISO/IEC 2023

All rights reserved. Unless otherwise specified or required in the context of its implementation no part of this publication maybe reproduced or utilized otherwise in any form or by any means electronic or mechanical including photocopying or posting on the intermet or an intranet without prior written permission. Permission can be requested from either ISO at the address belowor ISO's member body in the country of the requester.

ISO copyright officeCH-1214 Vernier Geneva CP 401 • Ch. de Blandonnet 8Email:copyright@ Phone: 41 22 749 01 11Website: iso.argPublished in Switzerland

Contents

Page

Foreword. ivIntroduction. V1 Scope.. 12 Normative references. 13 Terms and definitions. 14 Generic petence requirements. 15 Competence requirements for auditors and audit teams in management systems for quality in healthcare organizations. 25.2 5.1 General. Knowledge of healthcare delivery requirements outlined in ISO 7101. 25.3 Context of the organization. 2 25.4 Client outes services processes and organization. 3Competence requirements for other personnel. 6.1 General.6.2 Competence of personnel reviewing audit reports and making certification decisions.Annex A (informative) Knowledge for auditing and certification of management systemsfor quality in healthcare organizations.Bibliography.

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