QUALITY

MANAGEMENT
SYSTEM
PREPARED BY: CHARMAINE V. ROSALES, RMT
 12
QUALITY
SYSTEM
ESSENTIALS
ORGANIZATION
ELEMENTS:
• Organizational structure
• Planning process (Mission, Vision, Value)
• Leadership
• Implementation
• Monitoring
PERSONNEL

ELEMENTS:
• human resources • competency assessment
• job qualifications • professional
• job descriptions development
• orientation • continuing education
• training
EQUIPMENT
ELEMENTS:
• acquisition • calibration
• installation • troubleshooting
• validation • service and repair
• maintenance • records
PURCHASING AND INVENTORY
ELEMENTS:
• supplies and reagents
• vendor qualifications
• contract review
• inventory management
PROCESS CONTROL
ELEMENTS:
• quality control
• sample management
• method validation
• method verification
INFORMATION MANAGEMENT
ELEMENTS:
• confidentiality
• requisitions
• logs and records
• reports
• computerized laboratory
• information systems (LIS)
DOCUMENTS AND RECORDS
Documents Records
creation collection
revisions and review review
control and storage and
distribution retention
OCCURRENCE MANAGEMENT
ELEMENTS:
• complaints • immediate actions
• mistakes and • corrective actions
problems • preventive actions
• documentation
• root cause analysis
ASSESSMENT

INTERNAL EXTERNAL
Proficiency testing
Quality indicators
(EQA)
Audit program Inspections
Audit review Accreditations
PROCESS IMPROVEMENT
ELEMENTS:
• opportunities for improvement (OFIs)
• stakeholder feedback
• problem resolution
• risk assessment
• preventive actions
• corrective actions
CUSTOMER SERVICE
ELEMENTS:
• customer group identification
• customer needs
• customer feedback
FACILITIES AND SAFETY
ELEMENTS:
• safe working environment • waste management
• transport management • ergonomics
• laboratory security
• laboratory safety
• containment
Hope you
benefited from
that presentation!