CERTIFICATE COURSE IN QUALITY MANAGEMENT SYSTEM AND INTERNAL AUDIT IN MEDICAL LABS AS PER ISO 15189:2022 || CIIMS

Course Details

Medical Laboratory Science(MLT/MLS)
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CERTIFICATE COURSE IN QUALITY MANAGEMENT SYSTEM AND INTERNAL AUDIT IN MEDICAL LABS AS PER ISO 15189:2022

By Prof.(Dr.)Savinder Singh
27/Nov/2025
0 Students

Course Description

**QMS & Internal Auditor Training on ISO 15189:2022 for Medical Laboratories**

- **Overview of ISO 15189:2022**: Structure, clauses, process approach, risk-based thinking.

- **Understanding Requirements**: Management and technical requirements, competence, impartiality, confidentiality.

- **QMS in Medical Laboratories**: Quality policy, objectives, quality manual, SOPs, records, document hierarchy.

- **Documentation in QMS**: Document control, record control, retention, revision management, forms and templates.

- **QC Protocols & Documentation**: Internal QC, EQA/PT, Levey-Jennings charts, Westgard rules, corrective actions.

- **Quality Indicators & Continual Improvement**: KPIs, TAT, sample rejection rates, customer complaints, improvement plans.

- **Risk Management**: Identification, assessment, mitigation, risk-based thinking.

- **Risk Assessment Tools**: FMEA, risk matrix, scoring.

- **Verification Procedures**: Method and calibration verification, precision, accuracy, reportable range.

- **Reagent & Instrument Verification**: Lot-to-lot comparison, IQ/OQ/PQ concepts, maintenance records.

- **Six Sigma in Quality**: Sigma metrics, DPMO, quality goals, process improvement.

- **Internal Audit Requirements**: Audit checklist preparation, conducting audits, evidence collection.

- **Nonconformity & Root Cause Analysis**: CAPA, RCA tools, corrective action tracking, mock audits.

- **Management Review**: Inputs/outputs, revisions, guidance for assessment.