Quality System Regulation
QUALITY MANAGEMENT SYSTEM
FDA's Title 21 Quality System Regulation requires domestic and foreign manufacturers of medical devices to maintain a quality system governing the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for U.S. commercial distribution.
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Benefits of a Quality Management System:
- Standardizes practices to ensure a consistent product
- Requires Quality Control activities to meet your standards
- Controls purchasing practices
- Ensures cleanliness of facility
- Increase life and effectiveness of equipment
- Assists in documenting worker competencies
- Enforces review of suppliers and subcontractors’ performance
- Requires root cause analysis of remakes and reworks
- Everyone Holds accountable to Quality Standards
- Improve customer satisfaction
- Complies with FDA’s Quality System Regulation - FDA Title 21 Part 820 aligned with ISO13485:2016
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