Pre ISO 9000 During World War II, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The solution adopted to address these quality problems required factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. The international standard was named ISO 9000.
ISO 9000: 1987 Version ISO 9000:1987 had the same structure as the British Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organisation: • ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organisations whose activities included the creation of new products •ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. •ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (MIL SPECS), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.
ISO 9000 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal. ISO 9000 is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence. ISO 9000 is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality. Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.
The story of ISO 9000 Standards is a story of standards, methods and regulation. The brief history that follows is in no way comprehensive but is intended to illustrate four things: 1. that ISO 9000 standards are an ancient concept that survived several millennia; that a means of verifying compliance often follows the setting of standards; 2. that the formalizing of working practices is centuries old and seen as a means to consistently meet standards; 3. that market regulation (relative to the standard of goods and services) has been around for centuries for the protection of both craftsmen and traders. 4. ISO 9000 is a symptom of practices that were around centuries before anyone coined the term quality management. It is in some respects a natural progression that will continue to evolve. The story is told from a British viewpoint.
ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997. The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments. During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally. In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.
Transition from ISO 9001:2000 to ISO 9001:2008 This reference guide was developed to help you understand the nature of the changes to the ISO 9001 standard. Clause Change/Emphasis Not Auditable 0.1 General Added language emphasizing statutory and regulatory requirements are a concern as it relates to products for this international standard. 0.4 Compatibility with Other Management Systems Standards - Emphasis was added on the consideration given to ISO 14001:2004 to ensure that the standards are compatible. 1.1 General 1.2 Application Statutory was added in certain paragraphs to ensure the user is aware that these requirements must be taken into consideration. Additional notes were added to explain that where the word product appears, it refers to every stage of its existence, from raw material received to the final product being shipped to the customer. 2. Normative Reference Reference to ISO 9000 (vocabulary and concepts) was updated to refer to the current revision (i.e. ISO 9000:2005). 3. Terms and Definitions The supplier/organization/customer model was removed. These relationships, in reality, are not always linears. The Auditable Requirements Clause Change/Emphasis 4.1 In 4.1 a, identify was replaced with determine to emphasize that an organization must give careful consideration to what processes are needed in order to fulfill requirements. A link is drawn to 7.4 in the additional note. This was done to show that the supplier approval, evaluation, and re-evaluation process is where evidence of controlled outsourced processes should be demonstrated. 4.2.1 References to records and documents were consolidated. Also, the organization can require records not specified in this international standard that are created and maintained. 4.2.3 Clarification is given to the requirement for outsourced documents. Only those needed for the planning and operation of the QMS need to be controlled. This could exclude documents related to occupational health and safety since ISO 9001 contains requirements only concerned with product (see 0.1). 4.2.4 Rephrased, but no additional clarifications or emphasis added. Editorial change only. 5.5.2 The management representative must be from the organizations management. This would exclude consultants and other individuals external to the organization (e.g. a management representative from the corporate entity). The purpose of this is to ensure that this individual, entrusted with the responsibilities of championing the quality management system, is not out of touch with the organization. 6.2.1 The boundaries of competence only extend to individuals who impact product conformity. However, this does not just include those who are directly involved in production. The decisions made by management affect product conformity; therefore, they must be competent as well. 6.2.2 If said personnel have not yet attained the competence needed to perform the assigned job, then the organization must provide training or some other remedy to ensure that competence is achieved. The organization must also have a mechanism to ensure that personnel have been evaluated based on how well they demonstrate their knowledge and skill (i.e. competence). It is not enough to merely provide training or consider an individuals experience.
