Looking for ISO 15189:2022 (Medical laboratories) Lead Auditor Training?

ISO 15189:2022 (Medical laboratories) Lead Auditor Training

What is ISO 15189:2022 Lead Auditor Training?

ISO 15189 Lead Auditor Training is a specialized course designed for individuals who wish to develop the expertise to audit Medical Laboratories’ Quality Management Systems (QMS) against the ISO 15189 standards. This training is crucial for professionals involved in the auditing, maintaining, or supervising of the management systems of medical laboratories. ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. It is widely recognized and accepted globally, making the role of a lead auditor in this field highly significant.

Objectives of ISO 15189:2022 Lead Auditor Training

The primary objectives of ISO 15189 Lead Auditor Training include:

  • Understanding ISO 15189 Requirements: Trainees learn the detailed requirements of the ISO 15189 standard, focusing on quality management systems and competence in medical laboratories.
  • Auditing Skills Development: The course equips participants with the skills and knowledge necessary to conduct and lead a management system audit against ISO 15189. This includes understanding the audit cycle, from planning and conducting audits to reporting and follow-up.
  • Management System Familiarity: Participants gain a deep understanding of how medical laboratories operate within a QMS, ensuring that they can effectively assess compliance with ISO 15189.
  • Professional Development: Completing the training enhances the professional standing of auditors, providing them with a certification that is recognized internationally.

Key Components of the Training

ISO 15189 Lead Auditor Training typically covers several key components, including:

  • ISO 15189 Standards Overview: Detailed review of the standard’s requirements, including quality management principles specific to medical laboratories.
  • Audit Principles and Practices: Comprehensive coverage of auditing techniques, principles, and practices specific to ISO 15189.
  • Nonconformity Management: How to identify, document, and manage nonconformities during audits.
  • Audit Planning and Execution: Skills for planning, conducting, reporting, and following up on audits to ensure effective compliance and continual improvement.
  • Communication Skills: Enhancing interpersonal and communication skills to effectively lead an audit team and interact with the auditee.

Who Should Attend

This training is ideal for:

  • Quality managers and professionals in the medical laboratory industry.
  • Individuals responsible for maintaining conformity to ISO 15189 in medical laboratories.
  • Auditors wanting to perform and lead Medical Laboratory Management System (MLMS) audits.
  • Consultants who wish to provide in-depth guidance on ISO 15189 compliance.

Benefits of ISO 15189 Lead Auditor Training

  • Enhanced Expertise: Gain comprehensive knowledge and skills to audit medical laboratories effectively.
  • Career Advancement: Opens up opportunities for professional growth in quality management and auditing within the healthcare sector.
  • Improved Laboratory Quality: Contribute to the improvement of medical laboratory quality and reliability, ultimately impacting patient care positively.


ISO 15189 Lead Auditor Training is an essential step for professionals aiming to specialize in the auditing of medical laboratories’ management systems. It not only enhances individual career prospects but also plays a crucial role in advancing the quality and competence of medical laboratories worldwide. Pacific Certifications offers ISO 15189 Lead Auditor Training accredited by ABIS which can significantly contribute to the overall improvement of quality management systems in the medical laboratory sector.

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