ISO/TC 176 - Quality management and quality assurance

This document specifies processes that can be used to govern, manage and implement organizational change management (OCM) for organizations, projects or smaller activities. It comprises generic process descriptions that describe the OCM processes. Supporting diagrams describing the processes are also provided. This document is applicable, but not limited, to change sponsors, change agents, change team members and project managers, particularly those responsible for governing, managing and implementing organizational change.

This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership. The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides. NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement

This document gives guidance on planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization. It is applicable to any organization engaged in, or planning to be engaged in, a B2C ECT, regardless of size, type and activity. The focus of this document is on organizations that directly offer and provide products and services to consumers. This document aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers’ confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers. The guidance given in this document can complement an organization’s quality management system.

This document gives guidelines for the selection of appropriate statistical techniques that can be useful to an organization, irrespective of size or complexity, in developing, implementing, maintaining and improving a quality management system in conformity with ISO 9001:2015. This document does not provide guidance on how to use the statistical techniques.

This document gives guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach uses the quality management principles and quality management system described in the ISO 9000 family of management system standards to: a) monitor and manage trends in key performance metrics; b) take improvement action based on the observed metrics. This document is directed specifically to the top management of an organization. This document is applicable to any organization, whether from the public, private or not-for-profit sector, regardless of its business model, revenue, number of employees, diversity of product and service offerings, organizational culture, complexity of processes, place or number of locations. This document complements ISO 9001:2015 and ISO 9004:2018 for performance improvements and provides examples of achievable benefits from the application of concepts in those standards. This document identifies associated practical management methods and tools to assist in realizing the benefits.

This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization. This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.

This document gives guidelines for engaging people in an organization's quality management system and on enhancing their involvement and competence within it. This document is applicable to any organization, regardless of its size, type or activity.

This document gives guidelines for an organization to establish, implement, maintain and improve systems for competence management and people development to positively affect outcomes related to the conformity of products and services and the needs and expectations of relevant interested parties. This document is applicable to all organizations regardless of their type or size. It does not add to, change or otherwise modify requirements for the ISO 9000 family or any other standards.

This International Standard 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. This document specifies requirements for a quality management system where an electoral organization: — needs to demonstrate its ability to manage elections by secret ballot, to provide reliable, transparent, free and fair results that comply with electoral requirements; — within the established legal framework, aims to enhance the trust and confidence of citizens, candidates, political organizations and other electoral interested parties through the effective implementation of the electoral quality management system, including processes for continual improvement. NOTE 3 Electoral bodies can be constituted to reflect local legal requirements. NOTE 4 In this document, the term "product" only applies to the electoral service provided by an electoral body. This document is applicable to the election period, including pre-election and post-election activities or processes. This document is applicable to all electoral bodies involved in any aspect of the electoral process, whether they are permanent organizations or temporary organizations established in support of a particular election period.

This International Standard 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. This document gives guidelines for local governments on understanding and implementing a quality management system that meets the requirements of ISO 9001:2015, in order to meet the needs and expectations of their customers/citizens and all other relevant interested parties by consistently providing them with products and services. It promotes implementing a quality management system in a responsible and accountable manner, through the application of ISO 9001 on a comprehensive basis. These guidelines do not add, change or modify the requirements of ISO 9001. It is applicable to all local government processes at all levels (i.e. strategical, tactical-managerial and operational) in order to constitute a comprehensive quality management system that focuses on the local government achieving its objectives. The comprehensive character of this system is essential to ensure that all the areas of the local government have a specified level of reliability (i.e. effectiveness of the processes). Annex A, as a starting point for users of this document, gives a diagnostic methodology for local governments to evaluate the scope and maturity of their processes and products and services. Annex B gives the processes necessary to provide reliable products and services to customers/citizens.

This document gives guidelines for planning, designing, developing, implementing, maintaining and improving customer satisfaction codes of conduct. This document is applicable to product- and service-related codes containing promises made to customers by an organization concerning its behaviour. Such promises and related provisions are aimed at enhanced customer satisfaction. Annex A provides simplified examples of components of codes for different organizations. NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer. This document is intended for use by any organization regardless of its type or size, or the products and services it provides, including organizations that design customer satisfaction codes of conduct for use by other organizations. Annex C gives guidance specifically for small businesses. This document is aimed at customer satisfaction codes of conduct concerning individual customers purchasing or using goods, property or services for personal or household purposes, although it is applicable to all customer satisfaction codes of conduct. This document does not prescribe the substantive content of customer satisfaction codes of conduct, nor does it address other types of codes of conduct, such as those that relate to the interaction between an organization and its personnel, or between an organization and its suppliers.

This document gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer. This document is intended for use by any organization regardless of its type or size, or the products and services it provides. It is also intended for use by organizations in all sectors. Annex B provides guidance specifically for small businesses. This document addresses the following aspects of complaints handling: a) enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its products and services, including customer service; b) top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training; c) recognizing and addressing the needs and expectations of complainants; d) providing complainants with an open, effective and easy-to-use complaints process; e) analysing and evaluating complaints in order to improve the quality of products and services, including customer service; f) auditing of the complaints-handling process; g) reviewing the effectiveness and efficiency of the complaints-handling process. This document does not apply to disputes referred for resolution outside the organization or for employment-related disputes.

This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction. This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of this document is on customers external to the organization. NOTE Throughout this document, the terms "product" and "service" refer to the outputs of an organization that are intended for, or required by, a customer.

This document gives guidelines for an organization to plan, design, develop, operate, maintain and improve an effective and efficient dispute-resolution process for complaints that have not been resolved by the organization. This document is applicable to: — complaints relating to the organization's products and services, the complaints-handling process or dispute-resolution process; — resolution of disputes arising from domestic or cross-border business activities, including those arising from electronic commerce. This document is intended for use by any organization regardless of its type or size, or the products and services it provides, and deals with: — guidance on determining when and how organizations can participate in dispute resolution; — guidance on the selection of providers and use of their services; — top management involvement in, and commitment to, dispute resolution and deployment of adequate resources within the organization; — the essentials for fair, suitable, transparent and accessible dispute resolution; — guidance on management of an organization's participation in dispute resolution; — monitoring, evaluating and improving the dispute-resolution process. This document is particularly aimed at dispute resolution between an organization and — individuals purchasing or using products and services for personal or household purposes, or — small businesses. This document does not apply to the resolution of other types of disputes, such as employment disputes. It does not apply to complaints handling within an organization.

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 9000:2015 describes the fundamental concepts and principles of quality management which are universally applicable to the following: organizations seeking sustained success through the implementation of a quality management system; customers seeking confidence in an organization's ability to consistently provide products and services conforming to their requirements; organizations seeking confidence in their supply chain that their product and service requirements will be met; organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; organizations performing conformity assessments against the requirements of ISO 9001; providers of training, assessment or advice in quality management; developers of related standards. ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.

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.

This document gives guidelines for the selection of appropriate statistical techniques that can be useful
to an organization, irrespective of size or complexity, in developing, implementing, maintaining and
improving a quality management system in conformity with ISO 9001:2015.
This document does not provide guidance on how to use the statistical techniques.

ISO 10019:2005 provides guidance for the selection of quality management system consultants and the use of their services. It is intended to assist organizations when selecting a quality management system consultant. It gives guidance on the process for evaluating the competence of a quality management system consultant and provides confidence that the organization's needs and expectations for the consultant's services will be met.

ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met. ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons. ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.

ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. ISO 10002:2014 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes. It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses. ISO 10002:2014 addresses the following aspects of complaints handling: enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service; top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training; recognizing and addressing the needs and expectations of complainants; providing complainants with an open, effective, and easy-to-use complaints process; analysing and evaluating complaints in order to improve the product and customer service quality; auditing of the complaints-handling process; reviewing the effectiveness and efficiency of the complaints-handling process.

ISO/TS 17582:2014 specifies requirements for a quality management system where an electoral organization needs to demonstrate its ability to manage elections by secret ballot, which provide reliable, transparent, free and fair results that comply with electoral requirements; within the established legal framework, aims to enhance the trust and confidence of citizens, candidates, political organizations, and other electoral interested parties through the effective implementation of the electoral quality management system, including processes for continual improvement. ISO/TS 17582:2014 applies to the election period, including pre-election and post-election activities or processes. ISO/TS 17582:2014 applies to all electoral bodies involved in any aspect of the electoral process, whether they are permanent organizations or temporary organizations established in support of a particular election period. ISO/TS 17582:2014 is applicable to elections at all levels of government, whether local, regional or national.

The objective of ISO 18091:2014 is to provide local governments with guidelines for achieving reliable results through the application of ISO 9001:2008 on an integral basis. These guidelines do not, however, add, change or modify the requirements of ISO 9001:2008. All the guidelines indicated in ISO 18091:2014 are generic and applicable to all local governments, regardless of their type, size and product/service provided. The user can apply the guidance contained in ISO 18091:2014 as a whole or, in part, as necessary, to their maximum benefit.

ISO 10008:2013 provides guidance for planning, designing, developing, implementing, maintaining and improving an effective and efficient business-to-consumer electronic commerce transaction (B2C ECT) system within an organization. It is applicable to any organization engaged in, or planning to be engaged in, a business-to-consumer electronic commerce transaction, regardless of size, type and activity. ISO 10008:2013 is not intended to form part of a consumer contract or to change any rights or obligations provided by applicable statutory and regulatory requirements. ISO 10008:2013 aims to enable organizations to set up a fair, effective, efficient, transparent and secure B2C ECT system, in order to enhance consumers' confidence in B2C ECTs and increase the satisfaction of consumers. It is aimed at B2C ECTs concerning consumers as a sub-set of customers. The guidance given in ISO 10008:2013 can complement an organization's quality management system.

ISO 10004:2012 provides guidance in defining and implementing processes to monitor and measure customer satisfaction. ISO 10004:2012 is intended for use by organizations regardless of type, size or product provided. The focus of ISO 10004:2012 is on customers external to the organization.

ISO 10018:2012 provides guidance on engaging people in an organization's quality management system, and on enhancing their involvement and competence within it. ISO 10018:2012 is applicable to any organization, regardless of size, type, or activity.

ISO 19011:2011 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit programme, auditors and audit teams. ISO 19011:2011 is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit programme. The application of ISO 19011:2011 to other types of audits is possible, provided that special consideration is given to the specific competence needed.

ISO/TS 10004:2010 provides guidance in defining and implementing processes to monitor and measure customer satisfaction. ISO/TS 10004:2010 is intended for use by organizations regardless of type, size or product provided. The focus of ISO/TS 10004:2010 is on customers external to the organization. ISO/TS 10004:2010 is not intended for certification or contractual purposes, nor is it intended to change any rights or obligations under applicable statutory or regulatory requirements.

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/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. ISO/TS 16949:2009 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949:2009. ISO/TS 16949:2009 can be applied throughout the automotive supply chain.

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 10001:2007 provides guidance for planning, designing, developing, implementing, maintaining and improving customer satisfaction codes of conduct. ISO 10001:2007 is applicable to product-related codes containing promises made to customers by an organization concerning its behaviour. Such promises and related provisions are aimed at enhanced customer satisfaction. Annex A provides simplified examples of components of codes for different organizations. ISO 10001:2007 is intended for use by organizations regardless of type, size and product provided, including organizations that design customer satisfaction codes of conduct for use by other organizations. Annex C gives guidance specifically for small businesses. ISO 10001:2007 does not prescribe the substantive content of customer satisfaction codes of conduct, nor does it address other types of codes of conduct, such as those that relate to the interaction between an organization and its personnel, or between an organization and its suppliers. ISO 10001:2007 is not intended for certification or for contractual purposes, and it is not intended to change any rights or obligations provided by applicable statutory and regulatory requirements.

ISO 10003:2007 provides guidance for an organization to plan, design, develop, operate, maintain and improve an effective and efficient dispute-resolution process for complaints that have not been resolved by the organization. ISO 10003:2007 is applicable to: complaints relating to the organization's products intended for, or required by, customers, the complaints-handling process or dispute-resolution process; resolution of disputes arising from domestic or cross-border business activities, including those arising from electronic commerce. ISO 10003:2007 is intended for use by organizations regardless of type, size and product provided, and deals with guidance on determining when and how organizations can participate in dispute resolution, guidance on the selection of providers and use of their services, top management involvement in, and commitment to, dispute resolution and deployment of adequate resources within the organization, the essentials for fair, suitable, transparent and accessible dispute resolution, guidance on management of an organization's participation in dispute resolution, and monitoring, evaluating and improving the dispute-resolution process. ISO 10003:2007 is not intended for certification or for contractual purposes. It does not apply to the resolution of other types of disputes, such as employment disputes. It is not intended to change any rights or obligations provided by applicable statutory and regulatory requirements. ISO 10003:2007 does not apply to complaints handling within an organization.

ISO 10014:2006 provides guidelines for realizing financial and economic benefits from the application of the ISO 9000 quality management principles. ISO 10014:2006 is directed to top management of an organization and complements ISO 9004 for performance improvements. It provides examples of achievable benefits and identifies management methods and tools that are available to assist with the achievement of those benefits. ISO 10014:2006 consists of guidelines and recommendations, and is not intended for certification, regulatory or contractual use.

ISO 9000:2005 describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms. It is applicable to the following: a) organizations seeking advantage through the implementation of a quality management system; b) organizations seeking confidence from their suppliers that their product requirements will be satisfied; c) users of the products; d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators); e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies); f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization; g) developers of related standards.

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 10002:2004 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes. It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses. ISO 10002:2004 addresses the following aspects of complaints handling: -- enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service; -- top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training; -- recognizing and addressing the needs and expectations of complainants; -- providing complainants with an open, effective and easy-to-use complaints process; -- analysing and evaluating complaints in order to improve the product and customer service quality; -- auditing of the complaints-handling process; -- reviewing the effectiveness and efficiency of the complaints-handling process. ISO 10002:2004 is not intended to change any rights or obligations provided by applicable statutory or regulatory requirements.

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/TR 10017:2003 provides guidance on the selection of appropriate statistical techniques that may be useful to an organization in developing, implementing, maintaining and improving a quality management system in compliance with ISO 9001. This is done by examining those requirements of ISO 9001 that involve the use of quantitative data, and then identifying and describing the statistical techniques that can be useful when applied to such data. The list of statistical techniques cited in ISO/TR 10017:2003 is neither complete nor exhaustive, and does not preclude the use of any other techniques (statistical or otherwise) that are deemed to be beneficial to the organization. Furthermore, ISO/TR 10017:2003 does not attempt to prescribe which statistical technique(s) are to be used; nor does it attempt to advise on how the technique(s) are to be implemented. ISO/TR 10017:2003 is not intended for contractual, regulatory or certification/registration purposes. It is not intended to be used as a mandatory checklist for compliance with ISO 9001:2000 requirements. The justification for using statistical techniques is that their application would help to improve the effectiveness of the quality management system.

ISO 19011:2002 provides guidance on the principles of auditing, managing audit programmes, conducting quality management system audits and environmental management system audits, as well as guidance on the competence of quality and environmental management system auditors. It is applicable to all organizations needing to conduct internal or external audits of quality and/or environmental management systems or to manage an audit programme. The application of ISO 19011 to other types of audits is possible in principle provided that special consideration is paid to identifying the competence needed by the audit team members in such cases.

This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification. This Technical Specification can be applied throughout the automotive supply chain.