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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.

Provider: Quality-Control-Plan
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price:
$127.00
Product Details
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.
- The Quality Management System will also be continually improved for effectiveness according to the ISO 13485:2003 Standard
- Determined criteria and methods needed to ensure that both the operation and the control of these processes are effective
- The Quality Management System is documented and includes a Quality Policy and Quality Objectives, a Quality Manual, documented procedures, internal documents and Quality Records.
- Quality records are controlled according to SOP 4.0 , Quality Management System
- Responsibility, authority and communication are addressed in SOP 5.0 , Management Responsibility.
It Provides information on:
- Quality Management System (ISO 4.0).
- Management Responsibility (ISO 5.0).
- Resource Management (ISO 6.0).
- Product Realization (ISO 7.0).
- Measurement, Analysis and Improvement (ISO 8.0).
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