ISO 9001: 2008
ISO 9001: 2008 (updated from the original ISO 9001: 2000) is the best known of the ISO 9000 family of International Standards for quality management. The standard 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).1 ISO 9001: 2008 does not give requirements for specific products or services; rather, 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 (leading to an ISO 9001: 2008 certificate), although this is not compulsory unless it is a market or regulatory requirement.
Assessments for certification are carried out against the ISO 9001: 2008 standard, which is the only certification standard in the ISO 9000 family. To comply with ISO 9001: 2008 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:
The organisation compiles a Quality Manual, outlining the implementation of quality management procedures and how the ISO 9001: 2008 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. However, an organisation can implement ISO 9001: 2008 without having its management system audited and certified. ISO does not itself certify organisations. Most countries have formed accreditation bodies that in turn approve individuals and organisations to audit and certify organisations applying for ISO 9001: 2008 compliance certification.
In the UK, such accreditation is conducted by the United Kingdom Accreditation Service (UKAS), the only UK accreditation body recognised by the Government. Organisations that seek certification to ISO 9001: 2008 are encouraged by the Government to use the services of those individual organisations that UKAS has authorised in order to receive the National Accreditation Mark. An ISO 9001: 2008 certificate is temporary and must be renewed at regular intervals recommended by the certification body – usually between one and three years.
ISO has also developed a family of environmental management standards called ISO 14000. ISO 14001:2004 is the certification standard similar to ISO 9001:2000 in concept and structure. They both require organisations that implement them to continually improve their performance. Both standards concern processes and not products directly. Both will share some similar benefits and limitations due to these similarities.
ISO 14001:2004 (the latest version) is primarily concerned with ‘environmental management’ or what the organisation does to minimise harmful effects on the environment caused by its activities. The ISO 14000 family consists of standards relating to Environmental Management Systems (EMS), which are tools to help the organisation develop its environmental policy, objectives and targets, and classify them by when they apply to:
ISO 14001:2004 ensures that organisations are aware of environmental aspects of their work in order to minimise negative impacts and improve environmental performance. ISO suggests that the standard can provide significant tangible benefits, including:
The standard can be implemented by a wide variety of organisations, whatever their current level of environmental maturity. However, a commitment to compliance with applicable environmental legislation and regulations is required, along with a commitment to continuous improvement.
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’. ‘Generic’ means that 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.
Senior individuals in an organisation will need to be fully committed.
Proficiencies or skills
Training in understanding the standards may be required. Actions taken to meet implementation to the requirements are left to the organisation itself. The organisation then needs to address the issues needed to comply with the standards.
Whilst this may vary depending on the size of the organisation and the change that has to be implemented, estimates from organisations the Charities Evaluation Services and the Scottish Executive indicate that it can take from between 6 and18 months to implement.
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.2 ISO publications include the handbook, ISO 9001 for small businesses.
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. It was created in 1947 and has a strategic partnership with the World Trade Organisation (WTO).3
The ISO does not itself audit or assess the management systems of organisations. The Scottish Executive estimates that a typical organisation of between 60 and 70 people would expect to pay £2,000–£3,000 for the initial assessment and £1,000–£1,600 each year for the audits, in addition to the cost of publications.
Examples from other sectors
There are thousands of companies throughout the world that have implemented ISO standards. Articles giving examples can be found on the ISO website.
Paton, R. (2003) ‘Do ‘Kitemarks’ Improve and Demonstrate Performance’. Managing and Measuring Social Enterprises, (London: Sage) pp.99-118.
Charities Evaluation Services (CES) can provide support and information specifically for third sector organisations on a range of quality systems, including ISO 9001. See the CES website for more details.
1 For ISO, ‘Management system’ refers to the organisation’s structure for managing its processes – or activities – that transform inputs of resources into a product or service which meet the organisation’s objectives, such as satisfying the customer’s quality requirements, complying to regulations, or meeting environmental objectives.
2 The British Standards Institution website also features training information in the UK: British Standards Institution, Tel: 020 8996 9001 www.bsi-global.com
3 When ISO began to develop a set of generic quality management standards for worldwide application, it drew upon existing national standards and military quality assurance specifications. The ISO 9000 ‘core series’ was first published in 1987 and revised, improved editions published in 1994 and 2000.