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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. Annex SL - Wikipedia

   en.wikipedia.org/wiki/Annex_SL

   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.

5. 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

6. NFL Winners and Losers: Bengals can be fixed, but ... - AOL

   www.aol.com/nfl-winners-losers-bengals-fixed...

   The 2024 Cincinnati Bengals are an oddity in many ways. Joe Burrow might be the best quarterback in the NFL this season and has absolutely no chance of winning NFL MVP.

7. 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.