Formalised quality assurance originally came from the Defence Industry’s need for standards. For example, to supply the Ministry of Defence (MoD) a company had to write up its procedure for making its product, have the procedure inspected by the MoD and then ensure that its workers followed the published procedures.
The idea of quality assurance spread beyond the military and in 1966, the UK Government led the first national campaign for quality and reliability with the slogan “Quality is everyone’s business.” However, by this time, suppliers were being assessed by any number of their customers and it was widely recognised that such duplication of effort was a chronic waste of time and money. Progress was finally made in 1969, when a UK Government committee report on the subject recommended that suppliers’ methods should be assessed against a generic standard of quality assurance.
In 1971, the British Standards Institute (BSI) published the first UK standard for quality assurance (BS 9000), which was developed for the electronics industry. Then, in 1974, the BSI published BS 5179; Guidelines for Quality Assurance. This led to a shift in the burden of inspection from the customer to the supplier, as quality assurance could be guaranteed by the supplier to the customer through third-party inspection.
Through the 1970’s, the BSI organised meetings with industry to set a common standard, which culminated in the BS 5750 standard in 1979. Key industry bodies agreed to drop their own standards and use BS 5750 instead. The purpose of BS5750 was to provide a common contractual document, demonstrating that industrial production was controlled.
The ISO 9000 certification standard has evolved over several revisions. The initial 1987 version (ISO 9000:1987) had the same structure as the UK Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organisation. The language of this first version of the Standard was influenced by existing US and other Defence Military Standards, so it was more accessible to manufacturing and was well suited to the demands of a rigorous, stable, factory-floor manufacturing process. With its structure of twenty ‘elements’ or requirements, the emphasis tended to be overly placed on conformity with procedures rather than the overall process of management; which was the original intent.
The 1994 version (ISO 9000:1994) was an attempt to break from the practices which had somewhat clouded the use of the 1987 standard. It also emphasised quality assurance via preventive actions and continued to require evidence of compliance with documented procedures. Unfortunately, as with the first edition, companies tended to implement its requirements by creating shelf-loads of procedure manuals and become burdened with ISO bureaucracy. Adapting and improving processes could be particularly difficult in such an environment.
The 2000 version of the standard (ISO 9001:2000) sought to make a radical change in thinking. It placed the concept of process management at the heart of the standard, making it clear that the essential goals of the standard – which had always been about ‘a documented system’ not a ‘system of documents’ – were reinforced. The goal was always to have management system effectiveness via process performance measures. This third edition makes this more visible and so reduced the emphasis on having documented procedures if clear evidence could be presented to show that the process was working well. Expectations of continual process improvement and tracking customer satisfaction were also made explicit in this revision. A new set of eight core quality management principles, designed to act as a common foundation for all standards relating to quality management, were also introduced; namely:
- Improved consistency with traceability
- Enhanced customer focus
- Focused leadership
- The involvement of people
- A system approach to management
- Continual improvement
- A factual approach to decision making
- Mutually beneficial supplier relationships
The fourth edition of the standard (ISO 9001:2008) arrived on November 14th 2008. This revision contains minor amendments only. The aim of this revision is to clarify existing requirements and to improve consistency of approach with other management standards, like ISO 14001:2015.
During September 2015, a revised version – ISO 9001:2015 – was launched to bring the standard up to date, reflecting latest quality management good practice. Whilst some requirements have been tightened, the standard is now far less prescriptive and has even greater integration with other ISO management standard thanks to a common high-level structure.