{"id":1923,"date":"2019-05-22T07:56:47","date_gmt":"2019-05-22T07:56:47","guid":{"rendered":"http:\/\/icrpolska.e-ksperci.pl\/?page_id=1923"},"modified":"2022-09-07T22:58:41","modified_gmt":"2022-09-07T20:58:41","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/icrturkey.com\/en\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"

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What is ISO 13485?<\/h4>\n

The international ISO 13485 standard \"Medical devices - Quality management systems - Requirements for regulatory purposes\" refers to quality management systems in the manufacture of medical devices. It defines the requirements for a quality management system that should be met by the organization throughout the production cycle. The requirements of the ISO 13485 standard apply to the organization regardless of its size and type.<\/p>\n

The scope of application of the standard:<\/h4>\n

The ISO 13485 standard contains QMS requirements when the organization needs to demonstrate its ability to deliver medical devices and related services, constantly meeting customer requirements and applicable regulations. Such organizations may be involved in at least one stage of the product life cycle, including design and development, production, storage and distribution, installation or service of a medical device, and design and development or provision of related services (e.g. technical support).<\/p>\n

This standard may also be used by suppliers or external parties that provide the product to such an organization, including QMS related services.<\/p>\n

General requirements:<\/h4>\n

Each organization should:<\/p>\n