- Date: March 29, 2011
- Source: Admin
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REQUIREMENTS FOR ISO 13485
Systemic Requirements
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Establish a Quality System for Medical Devices
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- Develop a quality management system for medical devices
- Implement a quality management system for medical devices
- Maintain your medical device quality management system
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Document Your Medical Device Quality System
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- Develop quality management system documents
- Prepare quality management system manual
- Control quality management system documents
- Maintain quality management system records
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Management Requirements
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Support Quality
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- Promote the importance of quality
- Develop a quality management system
- Implement your quality management system
- Maintain your quality management system
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Focus on Customers
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- Identify customer requirements
- Meet customers requirements
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Establish a Quality Policy
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- Define your quality policy
- Manage your quality policy
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Perform Quality Planning
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- Formulate quality objectives
- Plan quality management system
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Control the Quality Management System
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- Define responsibilities and authorities
- Appoint management representative
- Support internal communications
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Carry Out Management Reviews
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- Review quality management system
- Examine management review inputs
- Generate management review outputs
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Resource Requirements
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Provide Quality Resources
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· Identify quality management system resource requirements
· Provide quality management system resources
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Provide Quality Personnel
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· Use competent personnel
· Support competence
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Provide Quality Infrastructure
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· Identify infrastructure needs.
· Provide needed infrastructure
· Maintain your infrastructure
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Provide Quality Environment
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· Identify needed work environment
· Implement needed work environment
· Manage needed work environment
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Source
http://www.iso.org/iso/catalogue_detail?csnumber=36786
http://www.praxiom.com/iso-13485.htm
