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GB/T 27021.3-2021Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

May 21, 2021

Implementation date

December 1, 2021

Scope

GB/T 27021.3-2021 (Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems) is available as an English-translated PDF.

GB/T 27021.3-2021 — This document specifies the additional competence requirements for personnel participating in the quality management system (QMS) audit and certification process, which is a reference to GB/T 27021.1 Supplement to existing requirements. Note. This document applies to QMS audit and certification in accordance with GB/T 19001, and can also be applied to other QMS.

Document preview — GB/T 27021.3-2021

National Standard of the People's Republic of China

Classification: A 00

Issued by: State Administration for Market Regulation, China National Standardization Administration

1 Scope1
2 Normative references1
3 Terms and definitions1
4 General competency requirements1
5 Competence requirements for QMS auditors and audit team1
5.1 General1
5.2 Basic concepts and quality management principles1
5.3 Organizational environment2
5.4 Customer's products, services, processes and organization2
6 Competence requirements for other personnel2
6.1 General2
6.2 Competence of personnel who review audit reports and make certification decisions2
Appendix A (informative) QMS audit and certification knowledge3
Reference4

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"

Drafting.

This document is Part 3 of GB/T 27021 "Requirements for Conformity Assessment Management System Audit and Certification Bodies". GB/T 27021 has

Publish the following 9 parts.

---Part 1.Requirements;

---Part 2.Environmental management system audit and certification capability requirements;

---Part 3.Requirements for quality management system audit and certification capabilities;

---Part 4.Sustainability management system audit and certification capability requirements for large-scale events;

---Part 5.Requirements for asset management system audit and certification capabilities;

---Part 6.Requirements for business continuity management system audit and certification capabilities;

---Part 7.Requirements for road traffic safety management system audit and certification capabilities;

---Part 9.Anti-bribery management system audit and certification capability requirements;

---Part 10.Occupational Health and Safety Management System Audit and Certification Ability Requirements.

This document replaces GB/T 27021.3-2016 "Requirements for Conformity Assessment Management System Audit and Certification Bodies Part 3.Quality Management

Compared with GB/T 27021.3-2016, the main changes of this document are as follows.

---Added additional capabilities required for auditing against the new requirements of GB/T 19001-2016;

---Expanded the basic concepts, quality management principles and their applications;

---Contains knowledge of the leadership role related to the quality management system in an organization;

---Contains the applied knowledge of risk-based thinking, including the identification of risks and opportunities;

---Contains the auditor's ability to understand the organization's environment.

The translation method used in this document is equivalent to the adoption of ISO /IEC 17021-3.2017 "Requirements for Conformity Assessment Management System Audit and Certification Bodies"

Part 3.Requirements for Quality Management System Audit and Certification Ability.

The Chinese documents that have consistent correspondence with the normatively cited international documents in this document are as follows.

---GB/T 19000-2016 Quality Management System Fundamentals and Terminology (ISO 9000.2015, IDT)

1 Scope

This document specifies the additional competence requirements for personnel participating in the quality management system (QMS) audit and certification process, which is a reference to GB/T 27021.1

Supplement to existing requirements.

Note. This document applies to QMS audit and certification in accordance with GB/T 19001, and can also be applied to other QMS.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations

Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to

This document.

GB/T 27021.1-2017 Conformity Assessment Management System Audit and Certification Bodies Requirements Part 1.Requirements (ISO /IEC

17021-1.2015, IDT)

ISO 19000 Quality Management System Fundamentals and Terminology (Qualitymanagementsystems-Fundamentalsandvo-

cabulary)

3 Terms and definitions

The terms and definitions defined by GB/T 27021.1 and ISO 19000 are applicable to this document.

4 General competency requirements

The certification body shall determine the competence requirements for each certification function described in Table A.1 of GB/T 27021.1-2017.In determining these capabilities

The certification body shall consider all the requirements specified in GB/T 27021.1 and the technical field of QMS (see

GB/T 27021.1-2017, 7.1.2) related to all requirements specified in Chapter 5 and Chapter 6 of this document.

Note. Appendix A provides a summary of the knowledge required for QMS audit and certification.

5 Competence requirements for QMS auditors and audit team

5.1 General

The audit team composed of auditors (and technical experts, if necessary) should have the overall ability to undertake audits. This capability should include

General capabilities described in GB/T 27021.1, and QMS knowledge described in 5.2~5.4.

Note. Each member of the audit team does not have to have the same ability, but the overall ability of the audit team needs to be sufficient to achieve the purpose of the audit.

5.2 Basic concepts and quality management principles

Every QMS auditor should have the following knowledge.

a) Basic concepts and quality management principles and their applications;

b) Terms and definitions related to quality management;

c) Process methods, including related monitoring and measurement;

d) Leadership in the organization and its impact on QMS;

e) Application of risk-based thinking, including the identification of risks and opportunities;

f) Application of PDCA (Planning, Implementation, Inspection, Disposal) cycle;

g) The structure and interrelationship of documented information specific to quality management;

h) Quality management related tools, methods, techniques and their applications.

5.3 Organizational environment

The audit team should have knowledge of the business area to determine whether the organization has appropriately determined.

a) Internal and external factors related to its purpose and strategic direction and affecting its ability to achieve the expected results of the QMS;

b) The needs and expectations of related parties related to the organization's QMS, including the requirements for the organization's products and services;

c) The boundaries and applicability of QMS to determine its scope.

Note. A business area can be understood as an economic activity covering a variety of related technical fields.

5.4 Customer's products, services, processes and organization

The audit team should have the following knowledge.

a) Terminology and technology in specific technical fields;

b) The legal and regulatory requirements applicable to products or services in a certain technical field;

Note. The requirements of laws and regulations can be referred to as statutory requirements.

c) The characteristics of products, services and processes in specific technical fields;

d) Infrastructure and process operating environment that affect the quality of products and services;

e) The supply of externally provided processes, products and services;

f) The type, size, governance, structure, functions and relationships of the organization, the establishment and implementation of QMS, its documented information and certification

The impact of activities.

6 Competence requirements for other personnel

6.1 General

The personnel involved in other certification functions should have the overall ability to undertake the corresponding functions. This capability should include GB/T 27021.1

The general capabilities described, and the QMS knowledge described in 6.2.

6.2 Competence of personnel who review audit reports and make certification decisions

The person who reviews the audit report and makes a certification decision should have the following knowledge.

a) Basic concepts and quality management principles;

b) Terms and definitions related to quality management;

c) process method;

d) The application of risk-based thinking, including the identification of risks and opportunities;

e) The scope and applicability of the organization's QMS.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 27021.1-2017 · ISO 19000

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