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Can you mention all the necessary quality documents required for effective quality management system?

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Question ajoutée par chinedu onubogu , QA/QC Cordinator , Seplat Petroleum Development Company Limited
Date de publication: 2016/02/21
Saqib Mirza
par Saqib Mirza , Project Manger (Civil) , SABCON ASSOCIATES PVT. LTD

FOLLOWING ARE THE MAIN GENERAL REQUIREMENTS FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS

  1. Establishing and implementing a documented quality management system
  2. Implementing a documented quality management system
  3. Maintaining a documented quality management system
  4. Continually improving the effectiveness of the QMS
  5. Determining processes
  6. Determining process sequence and interaction
  7. Determining criteria and methods for operation and control of processes
  8. Availability of resources necessary to support the operation and control of processes
  9. Availability of information necessary to support the operation and control of processes
  10. Monitoring, measurement and analysis of processes
  11. Restoring the status quo
  12. Continual process improvement
  13. Process management
  14. Outsourcing processes
  15. Responsibility for outsourced processes

Ahmad Alsayed
par Ahmad Alsayed , Night Shift Supervisor , citystars

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related service. It is the most accepted standard internationally for medical devices producers

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