ISO/IEC TS 17021-15:2023

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 2023
© ISO/IEC 2023
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Published in Switzerland
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© ISO/IEC 2023 – All rights reserved

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

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.
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 document 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 or
www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
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. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO), in collaboration
with ISO Technical Committee ISO/TC 304, Healthcare organization management.
A list of all parts in the ISO/IEC 17021 series can be found on the ISO and IEC websites.
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 and
www.iec.ch/national-committees.
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© ISO/IEC 2023 – All rights reserved

Introduction
ISO 7101 sets out requirements for management systems for quality in healthcare organizations of all
sizes and structures. Healthcare systems and organizations are complex, and the delivery of healthcare
is equally complex. The healthcare sector involves multiple stakeholders, its own terminology and
indicators, high levels of risk and safety considerations, diverse governance structures (public, private,
public-private partnerships) and a highly unique human element from the perspectives of both the
service user and the workforce.
This document is intended to be used in conjunction with ISO/IEC 17021-1. In particular, it clarifies
the requirements for the competence of personnel involved in the certification process set out in
ISO/IEC 17021-1:2015, Clause 7 and Annex A.
Certification bodies have a responsibility to stakeholders, including their clients and the customers of
the organizations whose management systems are certified, to ensure that only those auditors who
demonstrate the relevant competence are permitted to conduct management system audits. Personnel
certifying the management systems for quality in healthcare organizations must possess the generic
competencies described in ISO/IEC 17021-1, as well as the specific competencies described in this
document.
Certification bodies must identify the specific audit team competence needed for the scope of each audit
based on the complexity of the healthcare organization. The selection of an audit team will depend
upon various factors, including the client’s technical area and specific healthcare processes.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details
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