Recognized standard
QMS06-A3 (Formerly GP22-A3)
FDA recognition 7-223 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-223 |
|---|---|
| Designation | QMS06-A3 (Formerly GP22-A3) |
| Title | Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | This guideline considers continuous quality improvement (CQI) as five integrated quality system components, which include Quality Planning, Quality Teamwork, Quality Monitoring, Quality Improvement, and Quality Review. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: