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GB/T 19015-2021Quality management - Guidelines for quality plans (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

August 20, 2021

Implementation date

December 1, 2021

Scope

GB/T 19015-2021 (Quality management - Guidelines for quality plans) is available as an English-translated PDF.

GB/T 19015-2021 — This document provides guidelines for the formulation, review, acceptance, application and modification of the quality plan. This document applies to any expected output (whether it is a process, product, service, project, or contract) and any type or size of organization Quality plan. This document is applicable to organizations that have established a quality management system that meets the requirements of GB/T 19001 or not. This document provides guidance and does not specify requirements. This document mainly focuses on the provision of output and is not a planning guide for the development of a quality management system. Note. In order to avoid "processes, products, services, projects or contracts" too repetitive, the term "specific matters" is used in this document.

Document preview — GB/T 19015-2021

National Standard of the People's Republic of China

Classification
A 00

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

Contents

  • 1 Scope1
  • 2 Normative references1
  • 3 Terms and definitions1
  • 4 Application Quality Plan2
  • 4.1 Overview2
  • 4.2 Require external suppliers to provide quality plan2
  • 4.3 Managing the quality plan of external suppliers3
  • 5 Formulation of quality plan3
  • 5.1 The environment of the quality plan3
  • 5.2 Input to Quality Plan3
  • 5.3 Determine the scope of the quality plan4
  • 5.4 Preparation of quality plan4
  • 5.4.1 Initial preparation4
  • 5.4.2 Determine the quality plan4
  • 5.4.3 Consistency and compatibility4
  • 5.4.4 Form and structure4
  • 6 Contents of the quality plan5
  • 6.1 General5
  • 6.2 Scope of the quality plan5
  • 6.3 Input to Quality Plan5
  • 6.4 Quality objectives5
  • 6.5 Responsibilities of the quality plan6
  • 6.6 Control of documented information6
  • 6.7 Resources6
  • 6.7.1 Provision of resources6
  • 6.7.2 Materials, products and services6
  • 6.7.3 Personnel6
  • 6.7.4 Infrastructure and environment for process operation7
  • 6.7.5 Monitoring and measuring resources7
  • 6.8 Communication with customers and other related parties7
  • 6.9 Design and development7
  • 6.9.1 Design and development process7
  • 6.9.2 Control of design and development changes7
  • 6.10 Externally provided processes, products and services8
  • 6.11 Production and service provision8
  • 6.12 Identification and traceability8
  • 6.13 Property of customers or external providers9
  • 6.14 Protection of output9
  • 6.15 Control of unqualified output9
  • 6.16 Monitoring and measurement9
  • 6.17 Audit10
  • 7 Implementation and control of the quality plan10
  • 7.1 Review and acceptance of the quality plan10
  • 7.2 Implementation and monitoring of the quality plan10
  • 7.3 Revision of the quality plan11
  • 7.4 Feedback and improvement11
  • Appendix A (Informative) Sample Quality Plan Format12
  • Appendix B (Informative) Schematic diagram of process methods applicable to quality planning18
  • Appendix C (informative) Comparison table between this document and GB/T 19001-2016 clause19
  • Appendix D (informative) Comparison table between the terms of this document and GB/T 19000-2016 quality management principles21
  • Reference23

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 one of the GB/T 19000 family of standards.

This document replaces GB/T 19015-2008 "Guidelines for Quality Management System Quality Planning". Compared with GB/T 19015-2008, except

In addition to editorial changes, the main technical changes are as follows.

---Introduce "risk-based thinking" (see 4.2, 6.11);

--- Added "Application Quality Plan" (see Chapter 4);

---The order and title of the chapters have been revised, the "Environment of the Quality Plan" (see 5.1) has been added, and the "Implementation of the Quality Plan" has been expanded to "Quality

Implementation and monitoring of the plan" (see 7.2, 6.2 of the.2008 edition).

The translation method used in this document is equivalent to ISO 10005.2018 "Guidelines for Quality Management Quality Planning".

This document has made the following editorial changes.

---Respectively in Appendix B, Appendix C, Appendix D to supplement the reference to Figure B.1, Table C.1 and Table D.1.

Introduction

0.1 General

The purpose of this document is to provide guidance for organizations that have quality plan needs.

Separate management activities. In either case, the quality plan provides a way to combine the specific requirements of a process, product, service, project, or contract with

Ways to associate working methods with practice. The quality plan is most effective when it is compatible with other related plans. When combining quality planning with other management

When planning or quality management systems are integrated, the guidelines in this document can also be used.

The benefits of developing a quality plan include. increasing confidence in meeting requirements, ensuring that the process is more controlled, stimulating the initiative of relevant personnel, and

Provide insight into innovation and opportunities for improvement.

The guidelines for quality planning in this document are based on the quality management principles set forth in GB/T 19000 and the establishment of quality management principles in GB/T 19001.

The concept used in the quantity management system. Chapter 6 describes the typical content of the quality plan, including guidelines for applying the relevant requirements of GB/T 19001.

South. The guidelines in this document are limited to quality plans and do not replace the guidelines on quality management concepts in GB/T 19000 or GB/T 19002

Guidelines on the application of GB/T 19001 requirements within the organization.

This document does not replace the guidelines given in the documented information for specific industries. When a quality plan is required in the application of the project, this document aims to

To supplement the guidelines provided by GB/T 19016.Some terms used in this document have been changed compared with the previous version in order to improve

Consistency with GB/T 19001-2016 and other management system standards. Whether it is stipulating quality plan requirements or formulating quality plan,

No organization is required to replace the terms used with the terms in this document.

The following auxiliary verbs are used in this document.

---"Shall" means recommendation;

---"May" means allow;

---"Enable" means possible or capable.

"Note" information is a guide for understanding or explaining related content.

Note. For a guide on the subject of this introduction, see https.//committee.iso.org/home/tc176sc2.

0.2 Use of this document

Chapters 1 to 3 provide basic information (scope, normative references, terms and definitions).

Chapter 4 summarizes how to apply the quality plan.

Chapter 5 describes the process of developing a quality plan.

Chapter 6 describes the typical content of a quality plan.

Chapter 7 describes the implementation and control of the quality plan.

Appendix A provides a simple example of a quality plan.

Appendix B provides a schematic diagram of the process method used for quality planning.

Appendix C provides a comparison table between this document and the provisions of GB/T 19001-2016.

Appendix D provides a comparison table between the terms of this document and GB/T 19000-2016 quality management principles.

References provide a list of standards and other related information.

0.3 Process method

Process approach refers to the systematic management of processes and their interactions to achieve expected results. Use process methods for quality planning to help

Organize and manage the inputs, activities and outputs of the interconnected processes in a coordinated system.

The processes involved in the quality plan can.

---Interactions (interactions between quality planning processes);

---Interact with other processes running in the organization's management system;

---Interaction with processes running in other organizations (for example, customers and external suppliers).

When considering how to manage the organization's processes and their interactions, the organization can respond through a quality plan, and whether the organization has established a quality plan.

The quantity management system is irrelevant.

Appendix B provides a schematic diagram of the process method used for quality planning.

0.4 Risk-based thinking

Risk-based thinking refers to the use of a systematic method to consider risks (the impact of uncertainty) in order to be able to recognize risks and deal with them appropriately.

The use of risk-based thinking in the formulation and application of quality plans enables the organization to determine the importance of specific issues and take appropriate measures.

Measures to deal with risks and opportunities.

Customers who require the supplier to develop a quality plan can use risk-based thinking to determine the best

Low requirements.

When formulating a quality plan, the organization can use risk-based thinking to determine the processes, resources, and control methods to be used. Especially the organization

When standard patterns or templates are used in different quality plans, risk-based thinking can help relevant personnel to develop suitable

Quality Plan.

Quality Planning Guide for Quality Management

1 Scope

This document provides guidelines for the formulation, review, acceptance, application and modification of the quality plan.

This document applies to any expected output (whether it is a process, product, service, project, or contract) and any type or size of organization

Quality plan.

This document is applicable to organizations that have established a quality management system that meets the requirements of GB/T 19001 or not.

This document provides guidance and does not specify requirements.

This document mainly focuses on the provision of output and is not a planning guide for the development of a quality management system.

Note. In order to avoid "processes, products, services, projects or contracts" too repetitive, the term "specific matters" is used in this document.

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

3 Terms and definitions

The following terms and definitions defined in GB/T 19000-2016 apply to this document.

The website of ISO and IEC 's standardized terminology database is.

3.1

Documentedinformation

The information and its carriers that the organization needs to control and maintain.

Note 1.Documented information can exist in any format and carrier, and can come from any source.

Note 2.Documented information may involve.

---Management system, including related quality plans and processes;

--- Information (a set of documents) generated for the organization's operation;

---Evidence that the results are achieved.

[Source. GB/T 19000-2016, 3.8.6, there are amendments, the first column of Note 2 is amended, and Note 3 is deleted]

3.2

Qualityplan

For specific objects, stipulate the norms of actions, responsibilities and related resources.

[Source. GB/T 19000-2016, 3.8.9, with amendments, use "actions, responsibilities and related resources" instead of "who and when

And related resources" and deleted the note]

......
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 19000-2016 · ISO 9000.2015

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