Module 4 Activity: Compare Quality Essentials to ISO 15189:2012 Checklist Sections.

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Presentation transcript:

Module 4 Activity: Compare Quality Essentials to ISO 15189:2012 Checklist Sections

Activity Directions: Break into small groups (or by individual labs) and have each group take of the 12 essential elements: Relate the Quality Essentials your group was given to the specific ISO 15189:2012 standards. Make a list of how each Quality Essential is essentially the same as the specific ISO 15189:2012 standards Discuss challenges within your own labs relative to essentials and elements, and possible ways to implement best lab practices to meet the specific requirements.

Lab Quality System: The 12 Quality Essentials OrganizationPersonnelEquipment Purchasing & Inventory Documents & Records Process Improvement Customer Service Occurrence Management Facilities & Safety Assessment Information Management Process Control Quality Control & Specimen Management

ISO 15189: 2012 Standards Documents and Records Management Reviews Organization and Personnel Client Management & Customer Service Equipment Internal Audit Purchasing & Inventory Process Control and Internal and External Quality Assessment Information Management Corrective Action Occurrence/Incident Management & Process Improvement Facilities and Safety

Module 4 Activity Worksheet Quality EssentialISO 15189:2012 Standards Section Notes and Comments Documents and Records Assessment / Specimen Management Organization Personnel Customer Service Equipment Assessment Purchasing and Inventory Process Control Quality Control & Specimen Management Information Management Process Control Quality Control & Specimen Management Occurrence Management / Process Improvement Facilities and Safety

Module 4 Activity Worksheet Quality EssentialWHO Checklist SectionNotes and Comments Documents and Records Assessment / Specimen Management Organization Personnel Customer Service

Module 4 Activity Worksheet Quality EssentialWHO Checklist SectionNotes and Comments Equipment Assessment Purchasing and Inventory Process Control Quality Control & Specimen Management

Module 4 Activity Worksheet Quality EssentialWHO Checklist SectionNotes and Comments Information Management Process Control Quality Control & Specimen Management Occurrence Management / Process Improvement Facilities and Safety