In 1979, the British Standards Institution (BSI) established BS 5750, the first standard for quality management systems, which is considered the forerunner of the ISO 9000 series. Based on this, the ISO 9000 series of standards was introduced and internationally recognised in 1987.
With the EN ISO 9000 series of standards, standards have been created that document the principles for quality management measures. Together they form a coherent set of standards for quality management systems, which are intended to facilitate mutual understanding at national and international level. The successful management and operation of an organisation requires that it be managed and directed in a systematic and clear manner. One path to success can be the implementation and maintenance of a management system that is focused on continuous performance improvement by taking into account the needs of all interested parties. Leading and directing an organisation includes quality management among other management disciplines. The EN ISO 9000:2000 ff. standards are basically process-oriented.
ISO 9001 applies to contractual customer-supplier relationships. This is the reason why more and more industries increasingly regard ISO 9001 as the foundation of company policy. Companies that seriously and consistently align their quality management systems with ISO 9001 benefit from the systematics and contents of these standards. They demonstrably lead to continuous improvement, decreasing process and error costs, more motivated employees and more satisfied customers.
The standard is based on the Plan-Do-Check-Act (PDCA) cycle and defines the requirements for context analysis, management, planning, support, operation, evaluation and improvement of a QMS. It is applicable to organisations of all sizes and industries and can help improve the effectiveness and efficiency of business processes and increase the confidence of customers and other stakeholders.
The current EN ISO 9001 was last revised in 2015 (EN ISO 9001:2015-09). Dubbed an "amendment", these are not major changes, but mostly clarifications (such as the choice of words "legal and regulatory requirements", definition of "outsourced process", choice of words "competence" instead of "training", introduction of the term "risk" in the introduction).