Medical Devices Kit

Medical Devices Kit - manual and validation plan according to ISO 13485-1996 - this Kit will be obsolete in 2006

1. 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.
2. 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).
3. The procedures of this standard are not intended for use with destructive tests or when product screening is not feasible or desirable and/or when end-product testing does not reveal all variations that may occur in the product that may impact on safety and effectiveness.
4. The Company shall establish and implement an internal prevention-based quality system as a means of ensuring that all products conform to requirements specified by the contract and associated specifications and standards.

It Provides information on:

1. Medical Devices Quality Manual
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement, Analysis and Improvement
2. Validation Plan
• Quality System
• Elements of a Validation Program
• Process Validation Tools
• SPC Planning
• Gagging and measurement
• Attributes sampling inspection log