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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-223
Standard
CLSI  QMS06-A3 (Formerly GP22-A3)
Quality Management System: Continual Improvement; Approved Guideline - Third Edition
Scope/Abstract
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 820
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Leslie Landree
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  301-796-6147
  leslie.landree@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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