module 4 activity: compare quality essentials to iso 15189:2012 checklist sections
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 2 - 3 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
Organization Personnel Equipment
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 WorksheetQuality Essential ISO 15189:2012 Standards
SectionNotes 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 WorksheetQuality Essential WHO Checklist Section Notes and Comments
Documents and Records
Assessment / Specimen Management
Organization Personnel
Customer Service
Module 4 Activity WorksheetQuality Essential WHO Checklist Section Notes and Comments
Equipment
Assessment
Purchasing and Inventory
Process Control Quality Control & Specimen Management
Module 4 Activity WorksheetQuality Essential WHO Checklist Section Notes and Comments
Information Management
Process Control Quality Control & Specimen Management
Occurrence Management /Process Improvement
Facilities and Safety