Recognized standard
QMS01, 5th ed. June 2019 (Replaces QMS01-A4)
FDA recognition 7-293 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-293 |
|---|---|
| Designation | QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
| Title | A Quality Management System Model for Laboratory Services. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | This guideline provides a structure for a comprehensive, systematic approach to build quality into the laboratory?s processes, assess the laboratory?s performance, and implement quality improvements. |
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: