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  2. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/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.

  3. Device Master Record - Wikipedia

    en.wikipedia.org/wiki/Device_Master_Record

    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.

  4. List of ISO standards 12000–13999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_12000...

    ISO/TS 13399-307:2016 Part 307: Creation and exchange of 3D models - End mills for indexable inserts; ISO/TS 13399-308:2016 Part 308: Creation and exchange of 3D models - Milling cutters with arbor hole for indexable inserts; ISO/TS 13399-309:2016 Part 309: Creation and exchange of 3D models - Tool holders for indexable inserts

  5. ISO 9000 family - Wikipedia

    en.wikipedia.org/wiki/ISO_9000_family

    ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.

  6. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

  7. Download, install, or uninstall AOL Desktop Gold - AOL Help

    help.aol.com/articles/aol-desktop-downloading...

    Learn how to download and install or uninstall the Desktop Gold software and if your computer meets the system requirements.

  8. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.

  9. List of ISO standards 10000–11999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_10000...

    ISO 11418-1:2016 Part 1: Drop-dispensing glass bottles; ISO 11418-2:2016 Part 2: Screw-neck glass bottles for syrups; ISO 11418-3:2016 Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms; ISO 11418-5:2015 Part 5: Dropper assemblies; ISO 11418-7:2016 Part 7: Screw-neck vials made of glass tubing for liquid dosage forms

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