Medical devices — Quality management

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electro technical Commission (IEC) on all matters of electrotechnical standardization.

This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.

It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical requirements for products.
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs,particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices. These groups are defined in Clause 3.

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