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ISO 9000 family. The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) which help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. [1]
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1] It is expressed as the organizational goals and aspirations, policies, processes, documented ...
The International Organization for Standardization (ISO / ˈaɪsoʊ / [3]) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. [4] Membership requirements are given in Article 3 of the ISO Statutes.
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published a number of separate standards which specify Quality Management System requirements for ...
ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method. In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant ...
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