ISO 10005:2018
Quality management — Guidelines for quality plans
This document gives guidelines for establishing, reviewing, accepting, applying and revising quality plans.
This document is applicable to quality plans for any intended output, whether a process, product, service, project or contract, and any type or size of organization.
It is applicable whether or not the organization has a management system in conformity with ISO 9001.
This document provides guidance and does not specify requirements.
It is focused primarily on the provision of outputs and is not a guide to the planning of quality management system development.
NOTE To avoid undue repetition of "process, product, service, project or contract", this document uses the term "specific case".
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Using a quality plan
4.1 Introduction
4.2 Requesting external provider quality plans
4.3 Managing external provider quality plans
5 Development of a quality plan
5.1 Context of the quality plan
5.2 Inputs to the quality plan
5.3 Defining the scope of the quality plan
5.4 Preparation of the quality plan
5.4.1 Initiation
5.4.2 Defining the quality plan
5.4.3 Consistency and compatibility
5.4.4 Presentation and structure
6 Content of the quality plan
6.1 General
6.2 Scope of the quality plan
6.3 Quality plan inputs
6.4 Quality objectives
6.5 Quality plan responsibilities
6.6 Control of documented information
6.7 Resources
6.7.1 Provision of resources
6.7.2 Materials, products and services
6.7.3 People
6.7.4 Infrastructure and environment for the operation of processes
6.7.5 Monitoring and measuring resources
6.8 Customers and other interested parties communication
6.9 Design and development
6.9.1 Design and development process
6.9.2 Control of design and development changes
6.10 Externally provided processes, products and services
6.11 Production and service provision
6.12 Identification and traceability
6.13 Property belonging to customers or external providers
6.14 Preservation of outputs
6.15 Control of nonconforming outputs
6.16 Monitoring and measurement
6.17 Audits
7 Operation and control of the quality plan
7.1 Review and acceptance of the quality plan
7.2 Implementation and monitoring of the quality plan
7.3 Revision of the quality plan
7.4 Feedback and improvement
Annex A (informative) Examples of formats for quality plans
Annex B (informative) Schematic representation of a process approach applied to quality plans
Annex C (informative) Correlation matrix between the clauses in this document and those in ISO 9001:2015
Annex D (informative) Correlation matrix between the clauses of this document and the quality management principles from ISO 9000:2015
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Using a quality plan
4.1 Introduction
4.2 Requesting external provider quality plans
4.3 Managing external provider quality plans
5 Development of a quality plan
5.1 Context of the quality plan
5.2 Inputs to the quality plan
5.3 Defining the scope of the quality plan
5.4 Preparation of the quality plan
5.4.1 Initiation
5.4.2 Defining the quality plan
5.4.3 Consistency and compatibility
5.4.4 Presentation and structure
6 Content of the quality plan
6.1 General
6.2 Scope of the quality plan
6.3 Quality plan inputs
6.4 Quality objectives
6.5 Quality plan responsibilities
6.6 Control of documented information
6.7 Resources
6.7.1 Provision of resources
6.7.2 Materials, products and services
6.7.3 People
6.7.4 Infrastructure and environment for the operation of processes
6.7.5 Monitoring and measuring resources
6.8 Customers and other interested parties communication
6.9 Design and development
6.9.1 Design and development process
6.9.2 Control of design and development changes
6.10 Externally provided processes, products and services
6.11 Production and service provision
6.12 Identification and traceability
6.13 Property belonging to customers or external providers
6.14 Preservation of outputs
6.15 Control of nonconforming outputs
6.16 Monitoring and measurement
6.17 Audits
7 Operation and control of the quality plan
7.1 Review and acceptance of the quality plan
7.2 Implementation and monitoring of the quality plan
7.3 Revision of the quality plan
7.4 Feedback and improvement
Annex A (informative) Examples of formats for quality plans
Annex B (informative) Schematic representation of a process approach applied to quality plans
Annex C (informative) Correlation matrix between the clauses in this document and those in ISO 9001:2015
Annex D (informative) Correlation matrix between the clauses of this document and the quality management principles from ISO 9000:2015
Bibliography