This two day practical ISO 158189 Internal Auditor training course is designed to provide delegates with the skills necessary to conduct internal audits against the requirements of ISO 15189.

ISO 15189 is the internationally recognised standard relating to the competence of medical laboratories. It specifies criteria for the development and assessment of management systems and laboratory technical controls that provide confidence in the results obtained. The standard covers the medical laboratory services including examination requests, patient preparation, sample collection, transport and storage, processing, examination of clinical samples, interpretation and advice in addition to consideration of safety and ethics relating to clinical work.

Our course will equip delegates with effective auditing techniques and increase their understanding of audit methodologies to assess against ISO 15189 in order to ensure continued compliance, determine improvements, professionally report findings and implement corrective action programmes.

  • The role of accreditation
  • Introduction and review of ISO 15189 requirements
  • Quality and quality management principles
  • Individuals wishing to perform internal audits
  • Coordination of a management system audit using ISO 15189 (including the roles of the Quality Manager and Internal Auditors)
  • Audit planning, horizontal, vertical and witness
  • Checklist preparation
  • The concept of ‘risk-based’ auditing
  • Effective auditing techniques and communication skills
  • Witness/Technical audits
  • Reporting and grading of audit findings
  • Preparation of summary reports
  • Developing and verification of effectiveness of corrective action

  • Quality Managers
  • Companies seeking ISO 15189 accreditation
  • Certification / Registrar / Accreditation body auditors
  • Existing internal auditors who are looking to expand their skills in the area of laboratory practices
  • Supplier Quality Auditors who need to evaluate clinical laboratory services

This ISO 15189 Internal Auditor course is designed to build upon delegates’ prior knowledge of ISO 15189 and teach them the skills to undertake internal audits based on ISO 15189.

For those with little or no prior knowledge of ISO 15189 we recommend attending our Introduction to ISO 15189 training course (delivered the day before the Internal Auditor course) to gain an understanding of the requirements (clauses) of ISO 15189. We offer a £100 discount when booking these courses together.

Using a combination of interactive tutorials, discussions, practical workshops and case studies, our course will enable the delegates to:

  • Interpret the requirements of ISO 15189 as it relates to clinical laboratory operations
  • Apply auditing principles and objectively assess the compliance of a laboratory and identify areas to improve competency and management systems
  • Develop continuous improvement that provides on-going future benefits to the organisation

Interactive activities and workshops which encourage team discussions and act as a platform for later discussions how to perform an internal audit in line with ISO 15189 requirements within your organisation. Dedicated training is often more cost effective and convenient for those wishing to train several employees. The course can be held at your offices, a venue of your choice or online on a date which is convenient for your team.

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