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Mastering ISO 15189 Compliance for Laboratory Management

Mastering ISO 15189 Compliance for Laboratory Management

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Mastering ISO 15189 Compliance for Laboratory Management

Gain a comprehensive understanding of the ISO 15189 standard and its application in laboratory management. This course is designed to provide laboratory professionals with the knowledge and skills necessary to implement and maintain a quality management system that meets the requirements of ISO 15189.



Course Overview

This comprehensive course is divided into 12 modules, covering a wide range of topics related to ISO 15189 compliance. Participants will learn through a combination of lectures, discussions, case studies, and hands-on exercises.



Course Outline

Module 1: Introduction to ISO 15189

  • Overview of the ISO 15189 standard
  • History and evolution of the standard
  • Benefits of implementing ISO 15189
  • Key concepts and terminology

Module 2: Quality Management System (QMS) Fundamentals

  • Understanding the QMS framework
  • QMS principles and policies
  • Establishing a QMS in a laboratory setting
  • Documentation and record-keeping requirements

Module 3: Laboratory Management and Organization

  • Laboratory organizational structure and roles
  • Responsibilities and authorities
  • Communication and teamwork
  • Conflict resolution and complaint handling

Module 4: Personnel and Training

  • Personnel management and training requirements
  • Competence and awareness
  • Training programs and evaluation
  • Continuing education and professional development

Module 5: Equipment and Calibration

  • Equipment management and maintenance
  • Calibration and verification procedures
  • Measurement uncertainty and traceability
  • Equipment validation and qualification

Module 6: Sampling and Testing

  • Sampling procedures and techniques
  • Test methods and validation
  • Test result reporting and interpretation
  • Quality control and quality assurance

Module 7: Quality Control and Quality Assurance

  • Internal quality control procedures
  • External quality assessment and proficiency testing
  • Quality assurance activities and audits
  • Continuous improvement and corrective actions

Module 8: Document Control and Record-Keeping

  • Document control procedures and policies
  • Record-keeping requirements and best practices
  • Document and record retention and disposal
  • Audit trails and version control

Module 9: Audits and Accreditation

  • Audit principles and procedures
  • Types of audits and their purposes
  • Accreditation process and requirements
  • Preparing for accreditation audits

Module 10: Continuous Improvement and Risk Management

  • Continuous improvement principles and practices
  • Risk management and mitigation strategies
  • Identifying and addressing opportunities for improvement
  • Implementing corrective actions and monitoring effectiveness

Module 11: Laboratory Information Management Systems (LIMS)

  • LIMS overview and benefits
  • LIMS implementation and validation
  • LIMS functionality and features
  • LIMS and ISO 15189 compliance

Module 12: Maintaining ISO 15189 Compliance

  • Ongoing compliance requirements
  • Surveillance audits and reaccreditation
  • Continuous monitoring and improvement
  • Staying up-to-date with regulatory changes and updates


Course Benefits

Upon completion of this course, participants will:

  • Gain a comprehensive understanding of the ISO 15189 standard and its application in laboratory management
  • Develop the skills and knowledge necessary to implement and maintain a QMS that meets the requirements of ISO 15189
  • Understand the importance of continuous improvement and risk management in laboratory settings
  • Learn how to prepare for and maintain accreditation
  • Receive a Certificate of Completion issued by The Art of Service


Course Features

This course is designed to be:

  • Interactive: Engaging lectures, discussions, case studies, and hands-on exercises
  • Comprehensive: Covering a wide range of topics related to ISO 15189 compliance
  • Personalized: Opportunities for feedback and questions
  • Up-to-date: Reflecting the latest developments and updates in the field
  • Practical: Focusing on real-world applications and scenarios
  • User-friendly: Easy to navigate and access course materials
  • Mobile-accessible: Accessible on a variety of devices
  • Community-driven: Opportunities for discussion and networking
Certificate of Completion: Issued by The Art of Service upon completion of the course.

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