Quality Plan Guidance

The third edition of ISO 10005, Quality management – Guidelines for quality plans, has been published.

This document gives guidelines for establishing, reviewing, accepting, applying, and revising quality plans. It is applicable to quality plans for any intended output, whether a process, product, service, project, or contract, and any type or size of organization.

ISO 10005:2018 is applicable whether the organization has a management system in conformity with ISO 9001:2015 or not. It 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. The prior edition, ISO 10005:2005, has been withdrawn.

ISO 10005:2018 is 27 pages and can be ordered at this ANSI web page for $162 (member price $129.60). Or, it can be ordered at this ISO web page for about $138.

Key Changes

The main changes in ISO 10005:2018 compared to ISO 10005:2005 are:

1. It applies terminology from ISO 9000:2015, which includes changes to definitions, such as:

  • Definition of “quality plan”, which has been modified to replace the phrase “procedures and associated resources to be applied when and by whom” by “actions, responsibilities and associated resources”;
  • Definition of “specific case”, which has been modified to refer to “service”, as ISO 9001:2015 now refers to “products and services” and no longer just to “products”;
  • Replacement of the terms “documentation” and “record” by the term “documented information”, which is generally used in ISO management system standards to include both “procedures” and “records” which are not necessarily distinct from each other in a digital environment.

Documented information to support process operation is “maintained”, which means that it is established and updated as required. Documented information that provides evidence of conformity with requirements is “retained”, which means that it is protected from unintended alterations.

2. It is aligned to ISO 9001:2015, leading to:

  • a significant revision in the clause and sub-clause sequence, titles, and the addition of new material, e.g., the inclusion of “5.2 Context of a quality plan”, and the extension of 7.2 to also reference the monitoring of a quality plan;
  • the incorporation of “risk-based thinking”.

3. A new clause 4 has been added on using a quality plan, including guidance on requesting and managing external provider quality plans.

Table of Contents

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: Examples of formats for quality plans
Annex B: Schematic representation of a process approach applied to quality plans
Annex C: Correlation matrix between the clauses in this document and those in ISO 9001:2015
Annex D: Correlation matrix between the clauses of this document and the quality management principles from ISO 9000:2015

Bibliography