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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 sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
The sub-clause 7.3.10 of ISO 13485:2016 requires a manufacturer of a medical device to maintain (and control) a design and development file for a medical device to document the design history of a medical device. This file shall also contain records for changes in design and development (per device type or family).
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. 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 ...
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes ISO/IEC 13490 Information technology – Volume and file structure of read-only and write-once compact disk media for information interchange
ISO/IEC 23005-3:2016 Part 3: Sensory information; ISO/IEC 23005-4:2016 Part 4: Virtual world object characteristics; ISO/IEC 23005-5:2016 Part 5: Data formats for interaction devices; ISO/IEC 23005-6:2016 Part 6: Common types and tools; ISO/IEC 23005-7:2017 Part 7: Conformance and reference software; ISO/IEC 23006 Information technology ...
Diet can help with constipation, eating more fiber and fewer high-fat foods. These are the most effective foods at relieving constipation, a dietitian says.
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes ISO 16000-40 :2019, Indoor air - Part 40: Indoor Air Quality Management System ISO/TS 17582 :2014, Quality management systems - Particular requirements for the application of ISO 9001:2008 for electoral organizations at all levels of government
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