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Comparing Lab Quality Essentials to ISO 15189:2012 Standards

This activity involves breaking into small groups to relate the Quality Essentials to specific ISO 15189:2012 standards. Discuss challenges in labs regarding essentials and potential ways to meet requirements. Key elements include organization, personnel, equipment, purchasing, control, assessment, and more.

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Comparing Lab Quality Essentials to ISO 15189:2012 Standards

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

  2. 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.

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

  4. 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

  5. Module 4 Activity Worksheet

  6. Module 4 Activity Worksheet

  7. Module 4 Activity Worksheet

  8. Module 4 Activity Worksheet

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