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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:
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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 Information Management Process Control Quality Control & Specimen Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety
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