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Medical Devices Quality Manual, ISO 13485:1996
Medical devices quality manual complies with ISO 13485:1996

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:
$97.00
Product Details
- This QMS ensures that necessary procedures and instructions are in place as a documented part of the work process.
- 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.
- Information created during the operation of the QMS is retained in hardcopy format, microfiche or computer files.
- 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:
- Quality Management System.
- Management Responsibility.
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
- Medical Device Reporting (MDR), Medical Device Tracking, Corrections And Removals (CAR), and Registration and Listing.
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