ISO/IEC TS 17021-15:2023

Conformity assessment requirements for bodies providing audit and certification of management systems — Part 15: Competence requirements for auditing and certification of management systems for quality in healthcare organizations

This document specifies competence requirements for personnel involved in the audit and certification process for management systems for quality in healthcare organizations. It complements the existing requirements of ISO/IEC 17021-1.

Exigences relatives à l'évaluation de la conformité pour les organismes procédant à l'audit et à la certification des systèmes de management — Partie 15: Exigences de compétence pour l'audit et la certification des systèmes de management de la qualité dans les organismes de santé

General Information

• Status: Published
• Publication Date: 06-Dec-2023
• ICS: 03.120.20 - Product and company certification. Conformity assessment
• Technical Committee: ISO/TC 304 - Healthcare organization management
• Drafting Committee: ISO/TC 304 - Healthcare organization management
• Current Stage: 6060 - International Standard published
• Start Date: 07-Dec-2023
• Due Date: 03-Jan-2025
• Completion Date: 07-Dec-2023

Standards Content (Sample)

TECHNICAL ISO/IEC TS
SPECIFICATION 17021-15
First edition
2023-12
Conformity assessment requirements
for bodies providing audit and
certification of management
systems —
Part 15:
Competence requirements for
auditing and certification of
management systems for quality in
healthcare organizations
Exigences relatives à l'évaluation de la conformité pour les
organismes procédant à l'audit et à la certification des systèmes de
management —
Partie 15: Exigences de compétence pour l'audit et la certification des
systèmes de management de la qualité dans les organismes de santé
Reference number
ISO/IEC TS 17021-15:2023(E)
© ISO/IEC 2023

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ISO/IEC TS 17021-15:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO/IEC 2023 – All rights reserved

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ISO/IEC TS 17021-15:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Generic competence requirements . 1
5 Competence requirements for auditors and audit teams in management systems
for quality in healthcare organizations . 2
5.1 General . 2
5.2 Knowledge of healthcare delivery requirements outlined in ISO 7101 . 2
5.3 Context of the organization . . 2
5.4 Client outcomes, services, processes and organization . 3
6 Competence requirements for other personnel . 3
6.1 General . 3
6.2 Competence of personnel reviewing audit reports and making certification
decisions . 3
Annex A (informative) Knowledge for auditing and certification of management systems
for quality in healthcare organizations . 4
Bibliography . 5
iii
© ISO/IEC 2023 – All rights reserved
...

FINAL
TECHNICAL ISO/IEC DTS
DRAFT
SPECIFICATION 17021-15
ISO/CASCO
Conformity assessment requirements
Secretariat: ISO
for bodies providing audit and
Voting begins on:
2023-08-07 certification of management
systems —
Voting terminates on:
2023-10-02
Part 15:
Competence requirements for
auditing and certification of
management systems for quality in
healthcare organizations
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEC DTS 17021-15:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO/IEC 2023

---------------------- Page: 1 ----------------------
ISO/IEC DTS 17021-15:2023(E)
FINAL
TECHNICAL ISO/IEC DTS
DRAFT
SPECIFICATION 17021-15
ISO/CASCO
Conformity assessment requirements
Secretariat: ISO
for bodies providing audit and
Voting begins on:
certification of management
systems —
Voting terminates on:
Part 15:
Competence requirements for
auditing and certification of
management systems for quality in
healthcare organizations
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/IEC DTS 17021-15:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO/IEC 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO/IEC 2023

---------------------- Page: 2 ----------------------
ISO/IEC DTS 17021-15:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Generic competence requirements . 1
5 Competence requirements for auditors and audit teams in management systems
for quality in healthcare organizations . 2
5.1 General . 2
5.2 Knowledge of healthcare delivery requirements outlined in ISO 7101 . 2
5.3 Context of the organization . . 2
5.4 Client outcomes, services, processes and organization . 3
6 Competence requirem
...

ISO/IEC TS 17021-15:2023(E)
TC 304 / CASCO
Secretariat: ISO
2023-06-2007-21
Conformity assessment — Requirements for bodies providing audit and certification of
management systems — Part 15 : Competence requirements for auditing and certification of
healthcare quality management systems for quality in healthcare organizations

DTS stage

Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.



© ISO #### – All rights reserved

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© ISO 20XX

---------------------- Page: 2 ----------------------
ISO/IEC TS DTS 17021-15:2023(E)
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation,
no part of this publication may be reproduced or utilized otherwise in any form or by any means,
electronic or mechanical, including photocopying, or posting on the internet or an intranet,
without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO #### – All rights reserved
ii © ISO/IEC 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/IEC TS DTS 17021-15:2023(E)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Generic competence requirements . 1
5 Competence requirements for Healthcare quality management systems auditors and
audit teams . 1
5.1 General . 1
5.2 Knowledge of healthcare delivery requirements outlined in ISO 7101 . 2
5.3 Context of the organization . 2
5.4 Client outcomes, services, processes and organization . 2
6 Competence requirements for other personnel . 3
6.1 General . 3
6.2 Competence of personnel reviewing audit reports and making certification
decisions . 3
Annex A (informative) Knowledge for healthcare quality management systems auditing
and certification . 4
Bibliography . 5

Foreword . v
Introduction . vi
1 Scope .
...