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.
Where do you go next to improve your organization's quality management system after achieving ISO 9001:2015?
We recommend you take a look at ISO 9004:2018, Quality management - Quality of an organization - Guidance to achieve sustained success.
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.
The following have been prepared by ISO/TC 176/SC2 to inform and assist your organization in implementing ISO 9001:2015:
- A paper on ISO 9001 and Risk
- A presentation on ISO 9001 and Risk Based Thinking
- Guidance on the requirements for Documented Information of ISO 9001:2015
- How Change is addressed within ISO 9001:2015
- A paper on the Process Approach in ISO 9001:2015
- A presentation on the Process Approach in ISO 9001:2015
- Frequently Asked Questions (FAQs)
[TRANSLATIONS - Links to French, German, Italian, Japanese, Russian and Spanish translations of these documents ]
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.
Quality management systems - Requirements
Quality management systems - Fundamentals and vocabulary