ISO15189:2022 Medical laboratories — Requirements for quality and competence

Training highlights

To equip participants with the knowledge, skills, and tools required to effectively lead and manage medical laboratory quality management system audits in accordance with ISO 15189:2022 standards.

Key Features

  • In-Depth Understanding

Delve into the core concepts and requirements of ISO 15189 and gain insight into effective medical laboratory QMS implementation.

  • Auditing Techniques

Master the art of auditing – from planning and conducting audits to reporting and follow-up.

  • Expert Guidance

Learn from seasoned auditors who provide invaluable insights into best practices and challenges.

  • Practical Learning

Interactive Workshop with opportunity to understand the implementation process and clarify your doubts for better understanding.

Comprehensive Course Curriculum

  1. Introduction to ISO 15189:
    • Principles of QMS
    • Benefits of ISO 15189
  2. ISO 15189 Requirements:
    • Deep dive into clauses with an audit perspective
    • Practical implementation insights
  3. Internal Auditing Fundamentals:
    • Audit types and planning
    • Effective preparation
  4. Auditing Techniques:
    • Interview skills
    • Evidence documentation
  5. Audit Reporting and Follow-Up:
    • Report creation
    • Action monitoring
    • Understanding NABL Accreditation
    • Application
    • Preparation
    • Assessment