Overview

This two day practical foundation 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.

Delegates should have a reasonable working knowledge of ISO 15189 or equivalent (e.g. Clinical Pathology Accreditation requirements) prior to attending this course. Bywater also offers an Introduction ISO 15189 course which covers the standard in detail.

Key Topics

  • 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

Who Should Attend

  • 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

Outcomes

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

Dedicated Training

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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For Scheduled Training courses, please select from the Course Dates and Venues table below.