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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. 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.

  6. List of ISO standards - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards

    Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Help; Learn to edit; Community portal; Recent changes; Upload file

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    Tax-free growth for education. A 529 plan gives you a tax-advantaged way to save for education. You can stash money on an after-tax basis and then grow it tax-free. When you withdraw the money for ...

  8. List of ISO standards 16000–17999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_16000...

    ISO 16016:2016 Technical product documentation – Protection notices for restricting the use of documents and products; ISO 16020:2005 Steel for the reinforcement and prestressing of concrete – Vocabulary; ISO/IEC 16022:2006 Information technology - Automatic identification and data capture techniques - Data Matrix bar code symbology ...

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