ISO 9001 is the most popular and most commonly used standard for quality management systems in the world. It is the only standard within the ISO 9000 series to which organisations can certify.
The ISO standards are published by the International Organization for Standardization.
What is ISO 9001?
The ISO 9001 standard is an internationally-agreed set of documented rules and guidelines that provide clear criteria for implementing and maintaining a quality system in your business.
The latest version of the standard is ISO 9001:2015. Its criteria are based on seven quality management principles:
- customer focus - to understand and fulfil customer needs
- leadership - to increase employee motivation
- involvement of people - to recognise, empower and enhance the competence of people in the organisation and their role in delivering quality products or services
- process approach - to identify your essential business activities and consider each one as part of a process
- continuous improvement - to make improvement a permanent business objective
- evidence-based decision making - to use analysis of data to inform decisions
- relationship management - to recognise the interdependence of your business and its suppliers
The principles describe which requirements your products, services and organisation have to meet in order to comply with the standard.
Key requirements of ISO 9001
The ISO 9001:2015 standard is broadly divided into ten sections (called ISO clauses).
Clauses 1, 2 and 3 deal with the scope of the standard, normative references, terms and definitions contained in the standard. Clauses 4 to 10 specify the requirements for the different areas of the quality management system:
- Clause 4 - establishes the context of the organisation and requires you to determine external and internal issues, the needs and expectations of interested parties, the scope of the quality management system and its processes
- Clause 5 - requires top management to demonstrate leadership and customer commitment, establish and communicate a quality policy, and assign responsibilities
- Clause 6 - emphasises the importance of planning and requires you to address organisational risks and opportunities, changes and establish quality objectives
- Clause 7 - requires that you provide resources and support that are needed, including infrastructure and skilled staff, and document information to support the quality management system
- Clause 8 - requires planning for product or service provision, to ensure that you deliver what customers want, looking at areas such as sales processes, design and development, purchasing, production or service activities
- Clause 9 - requires that you carry out performance evaluation, and monitor, measure, analyse and evaluate your quality management system
- Clause 10 - requires continual improvement of your quality management system, including taking preventive and corrective actions, addressing non-conformities, etc
Find out more about the key requirements of ISO 9001:2015.
These requirements can apply to any business in any industry and can guide any organisation in the implementation of quality management.
ISO 9001:2015 documentation requirement
To comply with the ISO 9001:2015 standard, you must maintain the following documentation:
- your quality policy
- your quality objectives
- the scope of the quality management system
The ISO 9001:2015 no longer requires any documented procedures or a quality manual, but refers to 'documented information' instead, as the information that the organisation has to retain, control and maintain.
The standard requires you to maintain documented information 'to the extent necessary to support the operation of processes'. You have the flexibility to work out what you need and how you want to document it.
Bear in mind that documented information is used as evidence of conformance, can help provide consistency in processes, help with staff training and preservation of knowledge.
Transition to ISO 9001:2015
ISO 9001:2015 is the latest revision of the standard which replaced the previous 9001:2008 version in September 2015.
If your business was certified to ISO 9001:2008, you had until 14 September 2018 to upgrade your certification to the 2015 standard in order to maintain compliance. For more information, see the ISO 9001 transition guidance.
ISO 9004:2018 standard
If you have implemented ISO 9001 in your business, and you wish to go further, consider the ISO 9004: 2018 standard. It helps businesses achieve sustained success by using a quality management approach based on continuous improvement. The standard sets out voluntary guidelines and recommendations, and you cannot certify as achieving it.
Find out more about the advantages of quality management systems.