ISO 15189



What is Clinical Test Laboratory 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 and specifies additional requirements that relate to Point of Care Testing (POCT)..

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.  The latest edition of the standard was published in December 2022 on which our courses are now based.


All courses can be run in-house or on-line and modified to suit as required.

Introduction to ISO 15189: 2022 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
  • Differences between 2012 and 2022 editions
  • 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: 2022 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.

Root Cause Analysis and Corrective Action for Laboratories

Overview

Root Cause Analysis is a systematic problem-solving technique which mainly focuses on finding the ‘root causes’ of a problem or event from which effective and permanent corrective actions can be implemented to prevent recurrence.  This course specialises in issues relating to laboratory non-conformances identified by laboratories who are working in accordance with ISO/IEC 17025: 2017 or ISO 15189:2022.

It is designed to enable participants  to conduct Root Cause Analysis following the identification of issues such as complaints, quality control failures or internal audits,  along with a range of tools and methodologies to find and solve laboratory problems.

An interactive class which can be presented at your company location or virtually is  designed for those who need to manage, undertake or understand how to conduct effective Root Cause investigation and determine subsequent corrective actions.

Key Topics

  • Recap of ISO/IEC 17025 and ISO 15189 requirements relating to nonconformities and corrective action
  • Containment, Corrective action, prevention and risk assessment
  • Benefits and goals of Root Cause analysis and Corrective Action
  • Workshop – what constitutes a nonconformity?
  • Problem solving methodologies – overview
  • ‘8D’, Root Cause analysis (as per ISO 9001/15189 and ISOIEC 17020/25)
  • Problem solving tools
    • Cause and effect diagrams’ (including workshop)
    • ‘5 Whys’
    • Scatter diagrams/correlation charts
    • Control Charts
  • Problem solving case study (example follows the identification of an Interlaboratory Comparison issue and how it was analysed and solved)
  • Testing effectiveness of actions – hypothesis testing
  • Corrective actions arising from internal and external audits
  • Workshop – Examples of ‘good’ and ‘bad’ responses to audit nonconformities
  • Tips, summary and questions

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.

Resources

ISO 15189 Infographic (2022 Version)