ISO 9001

ISO 9001:2015 Quality management systems - Requirements, is the 5th edition of this standard.

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.

 

If you are using ISO 9001:2015

Firstly, we offer you our congratulations.

Where do you go next to improve your organization's quality management system ?

We recommend you take a look at ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach.

This standard is intended for an organization's management and its purpose is to provide information and guidance on the use of improvement methodologies. This will help your organization in making its journey towards the ultimate goal of 'sustained success' - achieving and maintaining its long-term objectives. Please also take a look at our Next Steps guidance.

 

Making the transition from using ISO 9001:2008 to using ISO 9001:2015

A "transition period" of 3 years has been agreed for accredited certification to ISO 9001:2008 to migrate to using ISO 9001:2015. This period will end on 15 September 2018.

The following have been prepared by ISO/TC 176/SC2 to inform and assist your organization in making the transition:

ISO 9001:2008

ISO 9001:2008 Quality management systems - Requirements is the 4th edition of ISO 9001. It has now been superseded by the 5th edition, ISO 9001:2015.

Guidance on ISO 9001:2008

ISO/TC 176/SC2 has developed the following supporting guidance documents to assist users of the 4th edition of the standard.  These guidance documents have been collected into an 'Introduction and Support Package' and are further supplemented by a set of 'frequently asked questions'. Additionally, 'Implementation Guidance' was developed to support the publication of ISO 9001:2008.

ISO 9001:2008 Introduction and Support Package

[TRANSLATIONS - Links to French, German, Italian, Japanese, Russian and Spanish translations of these documents ]

 

ISO 9000:2015

ISO 9000:2015, Quality management systems - Fundamentals and vocabulary was developed by ISO/TC 176/SC1.

It describes the fundamental concepts and principles of quality management, as well as giving the terms (and their associated definitions) that are applicable to all the quality management and quality management system standards developed by ISO/TC 176.

It is essential that users of ISO 9001 have an understanding of the fundamental concepts and principles given in ISO 9000 before seeking to apply the standard.

In addition, you need to be aware that there are many words and terms used in ISO 9001 which may seem familiar in your day-to-day language, but which have a very specific technical meaning in the standard; these have been formally defined in Clause 3 of ISO 9000.

Further, there are several words and terms used in ISO 9001 for which a formal definition has not been created, but for which a specific dictionary definition has been applied. A Glossary of these terms has been created to assist users.

 The fundamental concepts and principles of quality management 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.

 

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Mr Charles Corrie (UK)
Secretary ISO/TC 176/SC 2

Ms Tian Wu (China)
Co-Secretary ISO/TC 176/SC 2