ISO 15189



What is ISO/IEC 15189 Clinical Test Lab Accreditation?

ISO 15189 Medical Laboratories — Particular requirements for quality and competencies a ‘variant’ standard derived from ISO/IEC 17025 with specific focus on clinical laboratories. The standard covers an ‘end-to-end’ approach to the application of quality assurance methodologies in a clinical environment. This ranges from definition of services offered through to collection of patient samples, sample transport, storage, transportation and test and includes the reporting, interpretation and delivery of test results. The standard also focuses on management responsibilities as well as supporting processes such as facilities, calibration, method validation, training etc

The first version was published in 2003, revised in 2007 and the third edition of the standard was published in 2012. In the UK, the role of clinical laboratory accreditation was previously undertaken by CPA (Clinical Laboratory Accreditation). In 2009 CPA became part of UKAS (the United Kingdom Accreditation Service) and since the latter part of 2013 laboratories have been assessed against the criteria of ISO 15189 instead of the former CPA requirements.


All courses can be run on an ‘in-house’ basis and modified to suit as required.

Introduction to ISO 15189: 2012 Training Course 

Overview

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.

Key Topics

  • Quality Management and improvement overview
  • Relationship between ISO 9001 & ISO 15189 and ISO/IEC 17025
  • Risks and opportunities
  • The difference between accreditation and certification
  • The requirements of ISO 15189
  • Structure of Laboratory Management System Documentation
  • Implementation Steps
  • Obtaining accreditation

Structure

This 1-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.


Internal Auditing to ISO 15189: 2012 Training Course

Overview

This 2-day interactive and practical course is designed to provide delegates with practical auditing techniques against the requirements of ISO 15189 within clinical laboratories.

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 principles in relation to ISO 15189 in order to improve evaluation and communication, develop more professional reporting and implement corrective action programmes.

Key Topics

  • Introduction and overview of ISO 15189 requirements (summary only)
  • Coordination of a quality management system audit against ISO 15189.
  • How to construct an audit programme
  • Audit planning, horizontal, vertical audits and checklists
  • The concept of ‘risk-based’ audit
  • Effective auditing techniques
  • Witness audits
  • Evaluating the significance of audit findings
  • Methods for improving communication skills during the audit
  • How to report the findings and conclusions
  • Developing and implementing corrective action
  • Sources of information and further development

Structure

This 2-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each will receive a set of course notes and, on successful completion, a certificate.