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Quality management systems: a reliable proof of conformity
1European Diagnostic Manufacturers Association, Brussels, Belgium.
Medical Device Technology
|June 6, 1997
Summary
A certified quality management system is appropriate for in vitro diagnostic screening tests for infectious diseases like HIV and hepatitis. This system offers enhanced requirements beyond standard quality systems, ensuring safety for blood donations.
Area of Science:
- Medical Device Regulation
- In Vitro Diagnostics
- Public Health
Background:
- Concerns exist regarding the suitability of standard quality management systems for in vitro diagnostic (IVD) products used in blood screening.
- Specific IVDs for detecting HIV, hepatitis B, and hepatitis C in blood donations are under scrutiny.
Purpose of the Study:
- To review arguments concerning the use of certified full quality management systems for blood screening IVDs.
- To determine the appropriateness of these systems for ensuring blood safety.
Main Methods:
- Comprehensive review of existing arguments and regulatory considerations.
- Analysis of quality management system requirements in the context of high-risk diagnostic applications.
Main Results:
- The review found that a certified full quality management system is indeed appropriate for blood screening IVDs.
- The proposed system incorporates requirements that exceed standard quality system expectations.
Conclusions:
- The enhanced requirements of a certified full quality management system provide a higher level of assurance for critical in vitro diagnostic tests.
- This approach is beneficial for safeguarding the blood supply against transfusion-transmissible infections.