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PDF Technical Requirements and CLSI Guidelines for Laboratory

21 CFR 820 30 CLIA2 REQUIREMENTS NYS3* QMS FS; S1-S7 Director: DR FS; S1-S5 Human Resources: HR FS; S1-S10 ISO4-8 ISO 9001:2015 Clauses: 8 2 1 8 2 2 8 2 3 8 3 1 through 8 3 6 CLSI GUIDELINES** General: EP12 QSRLDT Process Management: EP19 QMS13 Documents: QSRLDT QMS02

PDF C24 Statistical Quality Control for Quantitative Measurement

C24 highlights the technical issues that need a careful scientific approach to designing implementing and assessing QC strategies in order for laboratories to achieve the quality requirements needed by the physicians and patients they serve

  • What is the CLSI consensus process?

    CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods, and protocols afecting the laboratory or health care. CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants in the reviewing and commenting process.

  • What is the 4th edition of CLSI C24?

    The 4th Edition of CLSI C24, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions J Appl Lab Med. 2017 Mar 1;1 (5):581-584. doi: 10.1373/jalm.2016.022269. 1 Bio-Rad Laboratories, Plano, TX. What's New in Laboratory Statistical Quality Control Guidance?

  • What does C24 do?

    C24’s approach provides medical laboratory scientists with practical guidance on how to satisfy recommendations by authorities and/or accreditation organizations.1

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