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Full Description

The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes ISO 13485:2003 and ISO/TR 14969:2004.
 

Document History

  1. ISO 13485:2016 Plus Redline


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  2. ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Most Recent
  3. ISO/TR 14969:2004


    Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

    • Historical Version
  4. ISO 13485 AND 14969 PACKAGE

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    ISO 13485:2003 and ISO/TR 14969:2004 Quality Managment Systems Medical Devices Package

    • Historical Version
  5. ISO 13485:2003


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  6. ISO 13485:1996


    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    • Historical Version