Medical Devices Quality Manual, ISO 13485:1996

1. This QMS ensures that necessary procedures and instructions are in place as a documented part of the work process.
2. This quality manual defines the QMS , policy, objectives, organization, responsibilities and procedures used to ensure the effective planning, operation and control of processes that affect the quality, reliability and safety of products and services.
3. Information created during the operation of the QMS is retained in hardcopy format, microfiche or computer files.
4. The resources needed to implement and maintain the QMS , continuously improve its effectiveness and enhance Customer satisfaction are achieved by practicing Total Quality Management (TQM).

It Provides information on:

1. Quality Management System.
2. Management Responsibility.
3. Resource Management
4. Product Realization
5. Measurement, Analysis and Improvement
6. Medical Device Reporting (MDR), Medical Device Tracking, Corrections And Removals (CAR), and Registration and Listing.