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ISO 13485

  • Date: March 30, 2011
  • Source: Admin
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REQUIREMENTS FOR ISO 13485

Systemic Requirements

Establish a Quality  System for Medical Devices

  • Develop a quality management system for medical devices
  • Implement a quality management system for medical devices
  • Maintain your medical device quality management system

Document Your Medical Device Quality System

  • Develop quality management system documents
  • Prepare quality management system manual
  • Control quality management system documents
  • Maintain quality management system records

 


Management Requirements

Support Quality

  • Promote the importance of quality
  • Develop a quality management system
  • Implement your quality management system
  • Maintain your quality management system

Focus on Customers

  • Identify customer requirements
  • Meet customers requirements

Establish a Quality Policy

  • Define your quality policy
  • Manage your quality policy

Perform Quality Planning

  • Formulate quality objectives
  • Plan quality management system

Control the Quality Management System

  • Define responsibilities and authorities
  • Appoint management representative
  • Support internal communications

Carry Out Management Reviews

  • Review quality management system
  • Examine management review inputs
  • Generate management review outputs

 

 

Resource Requirements

Provide Quality Resources

·         Identify quality management system resource requirements

·         Provide quality management system resources

Provide Quality Personnel

·         Use competent personnel

·         Support competence

Provide Quality Infrastructure

·         Identify infrastructure needs.

·         Provide needed infrastructure

·         Maintain your infrastructure

Provide Quality Environment

·         Identify needed work environment

·         Implement needed work environment

·         Manage needed work environment

 

Source

http://www.iso.org/iso/catalogue_detail?csnumber=36786

http://www.praxiom.com/iso-13485.htm

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