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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 053 Date of Entry 12/23/2019 
FR Recognition Number 7-293
Standard
CLSI  QMS01, 5th ed. June 2019 (Replaces QMS01-A4)
A Quality Management System Model for Laboratory Services.
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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
 Lorie Erikson
  FDA/OC/CDRH/OPEQ/OIDRH/DPOM/
  301-796-7511
  Lorie.Erikson@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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