Quality management in the laboratory - the UCLA Department of ...

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Regulatory Requirement• CLIA Regulations (§493.1200 - §493.1299)– Subpart K – Quality System for Non-Waived Testing• CMS approves accrediting organizations– CAP - COLA– AABB - TJC
Choosing a QMS Framework• Quality System Essentials (QSE)• Similar elements described– AABB - CLIA– CAP - FDA– CLSI - ISO 15189
Page 1 and 2: Quality Managementin the Laboratory
Page 3 and 4: “Quality” Terminology• Qualit
Page 5 and 6: Progression of Quality• 1940s - 1
Page 7: Why have a QM Program?Enhances thes
Page 11 and 12: The Quality Manual• Defines and d
Page 13 and 14: Quality Management Plan• Required
Page 15 and 16: Where can you get ideas forimprovem
Page 17 and 18: Acting on Quality Indicator Data•
Page 19 and 20: Management Review• The QMS shall
Page 22 and 23: Evaluating Your QM Program1. Is the
Page 24 and 25: Lab Director’s Role in aQM Progra
Page 26 and 27: Key Points for theLaboratory Direct
Page 28 and 29: Resources• College of American Pa
Page 30: Thank you

Quality management in the laboratory - the UCLA Department of ...

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