Course Title: Certification in ISO 15189: Medical Laboratory Accreditation Training

Designed by: Skillversity
Duration: 1 Month (4 Weeks)
Mode: Online / Hybrid
Level: Beginner to Intermediate

Weekly Modules Breakdown

Week 1: Introduction to ISO 15189 & Accreditation Essentials

• Overview of ISO 15189: Scope & Importance in Medical Laboratories

• Key Differences Between ISO 15189 & Other Standards (ISO 17025, CLIA)

• Accreditation Bodies: NABL, CAP, WHO, ILAC & Regional Authorities

• Fundamental Requirements: Quality Management System (QMS) & Competency

• Case Study: Benefits of ISO 15189 Accreditation in a Clinical Lab

Week 2: Implementing ISO 15189 Requirements in Laboratories

• Management & Technical Requirements for Accreditation

• Quality Control & Quality Assurance (QC/QA) Under ISO 15189

• Equipment Validation, Calibration & Maintenance Best Practices

• Staff Competency & Training Programs for ISO 15189 Compliance

• Case Study: Overcoming Challenges in ISO 15189 Implementation

Week 3: Audit, Risk Management & Continuous Improvement

• Conducting Internal & External Audits in ISO 15189 Labs

• Document Control, Data Integrity & Record Management

• Risk Management Strategies & Root Cause Analysis for Non-Conformities

• Continuous Improvement & Corrective Action Plans (CAPA)

• Case Study: ISO 15189 Accreditation Process & Common Pitfalls

Week 4: Regulatory Compliance, Future Trends & Certification

• Integration of ISO 15189 with NABH, WHO & National Guidelines

• Role of Digitalization, AI & Automation in ISO 15189 Labs

• Ethical & Legal Considerations in Accredited Laboratories

• Preparing for ISO 15189 Accreditation Audit & Recertification

• Final Project: Developing a Roadmap for ISO 15189 Accreditation

Assessment & Certification

• Weekly Quizzes & Assignments

• Practical Demonstrations (if applicable)

• Final Online Examination

• Certificate of Completion by Skillversity