ISO/TC 176/SC 2 - Quality systems

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".

ISO 9004:2018 gives guidelines for enhancing an organization's ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015. ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. ISO 9004:2018 is applicable to any organization, regardless of its size, type and activity.

ISO 10006:2017 gives guidelines for the application of quality management in projects. It is applicable to organizations working on projects of varying complexity, small or large, of short or long duration, being an individual project to being part of a programme or portfolio of projects, in different environments, and irrespective of the kind of product/service or process involved, with the intention of satisfying project interested parties by introducing quality management in projects. This can necessitate some tailoring of the guidance to suit a particular project. ISO 10006:2017 is not a guide to project management itself. Guidance on quality in project management processes is presented in this document. Guidance on project management and related processes is covered in ISO 21500. ISO 10006:2017 addresses the concepts of both "quality management in projects" and "quality management systems in projects". These are distinguished by being addressed separately by the following topics and clauses: - quality management in projects includes: quality management systems in projects (Clause 4); management responsibility in projects (Clause 5); resource management in projects (Clause 6); product/service realization in projects (Clause 7); and measurement, analysis and improvement in projects (Clause 8); - quality management systems in projects includes: project characteristics (4.1); quality management principles in projects (4.2); project quality management processes (4.3); and a quality plan for the project (4.4).

ISO 10007:2017 provides guidance on the use of configuration management within an organization. It is applicable to the support of products and services from concept to disposal.

ISO/TS 9002:2016 provides guidance on the intent of the requirements in ISO 9001:2015, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. ISO/TS 9002:2016 does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO 9004:2009 provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity. ISO 9004:2009 is not intended for certification, regulatory or contractual use.

ISO 9001:2008 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

ISO 10005:2005 provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001. ISO 10005:2005 is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning. ISO 10005:2005 is a guidance document and is not intended to be used for certification or registration purposes.

ISO 10007:2003 gives guidance on the use of configuration management within an organization. It is applicable to the support of products from concept to disposal. It first outlines the responsibilities and authorities before describing the configuration management process that includes configuration management planning, configuration identification, change control, configuration status accounting and configuration audit. Since ISO 10007:2003 is a guidance document, it is not intended to be used for certification/registration purposes.

ISO 10006:2003 gives guidance on the application of quality management in projects. It is applicable to projects of varying complexity, small or large, of short or long duration, in different environments, and irrespective of the kind of product or process involved. This can necessitate some tailoring of the guidance to suit a particular project. ISO 10006:2003 is not a guide to "project management" itself. Guidance on quality in project management processes is discussed in this International Standard. Guidance on quality in a project's product-related processes, and on the "process approach", is covered in ISO 9004. Since ISO 10006:2003 is a guidance document, it is not intended to be used for certification/registration purposes.

ISO 9001:2000 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization. This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties. This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

Provides guidelines to assist suppliers in the preparation, review, acceptance and revision of quality plans. These guidelines are not intended to be used as a checklist for compliance with requirements. Applicable where a quality plan is to be used for a particular product, project or contract.

Gives guidance on the use of configuration management in industry and its interface with other management systems and procedures. First provides management overview, then describes the process, organization and detailed procedures. Applicable to the support of projects from concept through to design, development, procurement, production, installation, operation and maintenance and to the disposal of products.

Adds text immediately after the sub-heading of clause A.8.4 (Example).

Gives management guidelines for implementing continuous quality improvement within an organization. The ways of adopting and implementing these guidelines depend upon factors such as the culture, size, nature of the organization, the types of products or services offered, and the markets and customer needs served. Therefore, an organization should develop an improvement process suited to its own needs and resources.

Covers the essential features of a comprehensive dependability programme for the planning, organization, direction and control of resources to produce products which will be reliable and maintainable. Is concerned with what has to be done, and why, and when and how it has to be done, but is not specific about who should do it and where. Applies to hardware and/or software products, where dependability characteristics are significant during the operation and maintenance phase. The requirements are aimed primarily at controlling influences on dependability at all product life-cycle phases from product planning to operation.