ISO 13485:2003 Medical Device Quality Manual

Medical Device Quality Manual - quality control manual for manufacturers of medical devices providing compliance with ISO 13485:2003 , ISO 9001:2000 , Canadian CMDCAS requirements, Medical Device Directive 93/42/EEC of the European Union and Quality System.

1. The Quality Management System will also be continually improved for effectiveness according to the ISO 13485:2003 Standard
2. Determined criteria and methods needed to ensure that both the operation and the control of these processes are effective
3. The Quality Management System is documented and includes a Quality Policy and Quality Objectives, a Quality Manual, documented procedures, internal documents and Quality Records.
4. Quality records are controlled according to SOP 4.0 , Quality Management System
5. Responsibility, authority and communication are addressed in SOP 5.0 , Management Responsibility.

It Provides information on:

1. Quality Management System (ISO 4.0).
2. Management Responsibility (ISO 5.0).
3. Resource Management (ISO 6.0).
4. Product Realization (ISO 7.0).
5. Measurement, Analysis and Improvement (ISO 8.0).