12 quality system essentials (QSE's)

• Organization

  • Structure
  • Quality planning
  • Communication
• Customer Service

  • Our communication with customers
  • Customer feedback
  • Opportunities for improvement
• Facilities and Safety

  • OH&S
  • Facility Maintenance/ security
  • Emergency preparedness
  • Chemical Hygiene
• Personnel

  • Training
  • Qualifications
  • SOPs
  • Confidentiality
• HIPA


  Health information protection act
• Purchasing and Inventory

  • Contracts
  • Supplies and reagents
  • Inventory management
• Equipment

  • Installation
  • Maintenance
  • Calibration
  • Service and repair
• The laboratory block

  1. Organization
  2. Customer service
  3. Facilities and safety
  4. Personnel
  5. Purchasing and inventory
  6. Equipment
• Process control

  • Quality control
  • Sample management
  • Method verification
• Documentation and Record Keeping

  • Everything in the lab is documented for legal reasons
• Information Management

  • Lab information systems (LIS)
  • Confidentiality
  • Logs and records
  • Reports
• The work block


  7. Process control

  8. Documents & Records

  9. Information management
• Occurrence management

  • An error that should not have happened+
  • RRID- Recognizing, Reporting, Initiating, Documenting
• Assessments

  • ISO
  • Accreditation Inspection
  • Proficiency Testing
  • Internal Assessments
• Process Improvement

  • PDSA- Plan, Do, Study, Act
  • Problem resolution
  • Risk assessment
  • Opportunities for improvement (OFIs)
• The performance block


  10. Occurrence Management

  11. Assessments

  12. Process Improvement