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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.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions.
ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
The Extensible Configuration Checklist Description Format (XCCDF) is an XML format specifying security checklists, benchmarks and configuration documentation. XCCDF development is being pursued by NIST , the NSA , The MITRE Corporation , and the US Department of Homeland Security .
ISO 14000 Environmental management systems (This is a set of standards, rather than a single standard); ISO 14001:2015 Environmental management systems – Requirements with guidance for use
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