An overview of quality management system, quality system essentials , document structure , responsibilities of a quality team member

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QUALITY ASSURANCE OFFICE
Omphemetse Stella Sesinyi

2. National Health Laboratory intends to
improve the quality of services by
ensuring the implementation of Quality
Management System.
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3. The quality management system fulfils the
requirements of the;
 ISO 15189:2022 standard
 National regulations
 International guidelines
 Accreditation requirements
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4. Quality
Management
System
A quality
management
system can be
described as a set of
building blocks
needed to control,
assure and manage
the quality of the
laboratory's
processes
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5. Layers of Quality Management
System
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6. 6
Quality Assurance Office
Document structure hierarchy

7. The strengths of NHL (Diagnostics
and quality assurance) QMS
 Personnel
 Noticeable zeal for work
 Improved participation of employees
 Additional personnel resources from the
University of Botswana and Forensic
Laboratory
 An established system of students and staff
orientation
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8. The strengths of NHL (Diagnostics
and quality assurance) QMS
 Documents and records
 A system of controlling documents
 Availability of quality management
documents
 Quality manual and Quality Policy statement
 Safety manual
 Sample collection manual
 System SOPs
 Technical sops
 Test requisitions forms
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9. The strengths of NHL (Diagnostics
and quality assurance) QMS
 Process control
Enrolment and Participation in External
quality assessment
 Assessments
Routine internal audit system
 Facility and safety
Proactive safety and wellness committee
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10. The strengths of NHL (Diagnostics
and quality assurance) QMS
 Equipment
 Availability of equipment
 Customer service
 Improved turnaround times
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11. GAPS IDENTIFIED
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Quality Assurance Office
QMS
EQUIPMENT
• Calibration
• Consistent routine
maintenance
• Service
• Verification
• Management of obsolete
equipment
• Down time logs
FACILITY AND
SAFETY
• Immunization
• Access control
• First aid
• Facility & safety
assessments
• Safe disposal of waste
• MSDS
• Spill kits
DOCUMENTS AND
RECORDS
• Document quality
objectives
• Review and alignment of
QMS Documents
• Creation of pending SOPS
• Documents control
• Maintenance and retention
of records
PERSONNEL
• Orientation
• Training
• Organizational code of
conduct
• Deputation
• Competency assessments
• Creation and maintenance
of personnel files
• Job descriptions for
pathologists
ASSESSMENTS
• Monitoring of quality
indicators
• Baseline QMS assessment
• Internal audit
• External audit
• Accreditation
Occurrence
management
• Risk assessment and
mitigation
• Management of NC’S
PROCESS
CONTROL
• Method verification
• Review of EQA results
• Review of tests results
• Lot to lot verification
• Consistent monitoring of
environmental conditions

13. Quality Management Team
responsibilities
 Implementation, maintenance and improvement of the
management system.
 Identification of deviations from ISO 15189 International
Standard, Laboratory requirements and relevant national
guidelines.
 Initiate actions to prevent or minimize such deviations.
 Reporting to laboratory management on the performance of
the management system and any need for improvement
 Ensuring the effectiveness of the laboratory activities.
 Identification, management and mitigation of risks in the
pre-examination, examination and post-examination
processes.
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14. Indicators of a correctly
implemented QMS
 Top management's direct
involvement
 Strong customer orientation
 Problems solved by systematic
methods
 Everyone participates
 Continuous improvement is the
theme
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15. THANK YOU ………
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Quality Assurance Office