ISO/IEC 17021-3:2017 適合性評価 — 管理システムの監査と認証を提供する機関の要件 — Part 3: 品質管理システムの監査と認証の能力要件 | ページ 2

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, ISO and IEC develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO).

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 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, 2 (see www.iso.org/directives ).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO and IEC 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 ).

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

For an explanation on 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 the following URL: www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 176, Quality management systems, Subcommittee SC 3, Supporting technologies, and 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 first edition of ISO/IEC 17021-3 cancels and replaces ISO/IEC/TS 17021-3:2013, which has been technically revised.

The following major changes have been made compared with ISO/IEC/TS 17021-3:2013:

• addition of new requirements of ISO 9001:2015, which require additional competence to audit;
• expansion of fundamental concepts and quality management principles and their application;
• inclusion of the knowledge of the role of leadership of an organization in relation to its quality management system;
• inclusion of knowledge of application of risk based thinking, including the determination of risks and opportunities;
• inclusion of competence criteria for the auditor to understand the context of the organization.

A list of all parts in the ISO/IEC 17021 series can be found on the ISO website.

Introduction

This document complements 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 interested parties, 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 allowed to conduct quality management system (QMS) audits.

It is intended that all personnel involved in certification functions possess the generic competence described in ISO/IEC 17021-1, as well as the specific QMS knowledge described in this document.

Certification bodies will need to identify the specific audit team competence needed for the scope of each QMS audit. The selection of a QMS audit team will depend upon various factors, including the client’s technical area and specific 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 can be found in the ISO/IEC Directives, 2.

1 Scope

This document specifies additional competence requirements for personnel involved in the audit and certification process for quality management systems (QMS) and complements the existing requirements of ISO/IEC 17021-1.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC 17021-1 and ISO 9000 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography