The ISO 9001 family of standards gives the requirements for a quality management system and is one of more than 15,000 voluntary international standards published by the International Organisation for Standardisation (ISO). It provides a set of generic requirements relating to the processes of development and production, and how they will be managed, reviewed and improved in order achieve customer satisfaction.
The requirements call for the processes to be comprehensively documented as procedures to which staff are expected to consistently conform. This is with the aim of meeting the needs and expectations of the customer and helping organisations to comply with applicable regulations. Implementation involves making production procedures explicit (say what you do), documenting them, ensuring they are followed and checking they are effective. A quality management system can be audited by an independent certification body as conforming to the standard, although this is not compulsory unless it is a market or regulatory requirement.
To comply with the standard an organisation needs to review its processes in accordance with the standard’s requirements in order to meet the needs and expectations of the ‘customer base’. The ISO requirements cover a wide range of topics:
- Management commitment to quality.
- ‘Customer’ focus.
- Adequacy of an organisation’s resources.
- Employee competence.
- Process management (for production, service delivery and relevant administrative and support processes).
- Quality planning.
- Design, purchasing, monitoring and measurement of its processes and products.
- Processes to resolve customer complaints.
- Corrective/preventive actions.
- A requirement to drive continual improvement of the organisation.
- A requirement to monitor ‘customer’ perceptions about the quality of the goods and services it provides.
The organisation compiles a Quality Manual, outlining the implementation of quality management procedures and how the requirements are being met.
When the quality system and requirements are in place and established, organisations like the British Standards Institution recommend a pre-assessment by a third party to identify areas where an organisation may not be operating according the standard’s requirements and to help make effective change towards that goal.
Organisations then seek an independent auditing by a certification body to check conformity with the requirements of the standard and to ensure that they are working in practice. In the UK, such accreditation is conducted by the United Kingdom Accreditation Service (UKAS), the only UK accreditation body recognised by the Government. An ISO 9001 certificate is temporary and must be renewed at regular intervals recommended by the certification body – usually between one and three years.
A note on the ISO 14000 Series
ISO has also developed a family of environmental management standards called ISO 14000. The ISO 14000 family consists of standards relating to Environmental Management Systems (EMS), tools to help the organisation develop its environmental policy, objectives and targets, and classify them by when they apply to:
- The organisational level (implementing EMS, conducting environmental auditing and related investigations, and evaluating environmental performance).
- Products and services (using environmental declarations and claims, conducting life cycle assessment), addressing environmental aspects in product standards, and understanding terms and definitions).
The vast majority of ISO standards are highly specific to a particular product, material, or process. However, ISO 9001 (quality) and ISO 14001 (environment) are ‘generic management system standards’. The same standard can be applied to any organisation, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. ISO 9001 contains a generic set of requirements for implementing a quality management system and ISO 14001 for an environmental management system.
Courses, support, and information
The ISO website contains information on all aspects of the ISO 9000 family as well as hardcopies, a Magical Demystifying Tour of ISO 9000 and ISO 14000 and the ISO magazine, ISO Management Systems, and other publications. ISO publications include the handbook, ISO 9001 for small businesses.
Development, ownership and support
The ISO is responsible for developing, maintaining and publishing the ISO 9000 family. The ISO is a non-governmental organisation (NGO) network of the national standards institutes of 150 countries with one member per country, with a Central Secretariat in Geneva, Switzerland, that co-ordinates the system.