Workshops

Training event: ISO 15189:2023 - The New Standard For The Competence Of Medical Laboratories

A two-day training workshop by the Pancyprian Union of Chemists and the Eurachem Education & Training Working Group

Overview

PUCThe Division of Quality Assurance of the Pancyprian Union of Chemists (PUC) and Eurachem are organising a two-day training course on the accreditation of medical laboratories, focusing on the publication of the revised standard ISO 15189:2023. The training course, one of a series of successful events organised by PUC and Eurachem, will present and discuss the new standard, providing the opportunity for interaction between laboratory personnel and other stakeholders. The topic of accreditation of medical laboratories is of interest especially in the light of recent developments with regard to other documents, i.e. legislation, standards and guides (including Eurachem guidance) which will also be discussed.

It is expected that by the completion of the training, the participants will have a good understanding of the critical issues addressed in ISO 15189:2023 and will acquire a clear picture of the work to be done in their laboratories or in their accreditation bodies as appropriate. The training will be delivered by tutors that have been actively involved for many years in Eurachem activities and its working groups and/or the Executive Committee.

A two-day training workshop by the Pancyprian Union of Chemists and the Eurachem Education & Training Working Group

Overview

PUCThe Division of Quality Assurance of the Pancyprian Union of Chemists (PUC) and Eurachem are organising a two-day training course on the accreditation of medical laboratories, focusing on the publication of the revised standard ISO 15189:2023. The training course, one of a series of successful events organised by PUC and Eurachem, will present and discuss the new standard, providing the opportunity for interaction between laboratory personnel and other stakeholders. The topic of accreditation of medical laboratories is of interest especially in the light of recent developments with regard to other documents, i.e. legislation, standards and guides (including Eurachem guidance) which will also be discussed.

It is expected that by the completion of the training, the participants will have a good understanding of the critical issues addressed in ISO 15189:2023 and will acquire a clear picture of the work to be done in their laboratories or in their accreditation bodies as appropriate. The training will be delivered by tutors that have been actively involved for many years in Eurachem activities and its working groups and/or the Executive Committee.

Scope and Information

Scope

The scope of the training is to:

  • present and discuss critical issues of interest to medical laboratories addressed in ISO 15189:2023 and other relevant documents
  • discuss the experience of laboratories in various sectors, problems and solutions
  • present recent publications (Eurachem guides and others)

Workshop information

Date: 16-17 March 2023
Venue: Cleopatra Hotel, Nicosia, Cyprus
Programme Programme (PDF, 760 kB)
Details and invitation Course details, speaker information and invitation (PDF, 210 kB)
Registration: Complete and email the registration form (PDF, 106 kB)



Programme

Programme

The event programme can be viewed in PDF format here. Brief information about scheduled speakers can be found in the workshop invitation information.

The programme is listed below. 

Day 1 - Thursday 16 March 2023

Welcome and introductions

  • Welcome addresses
    • Eurachem Education & Training WG
    • Association of Clinical Laboratory Directors, Biomedical and Clinical Laboratory Scientists
    • PUC (Division of Quality Assurance)
  • Presentation of the tutors and the participants

Technical programme

  • Introduction – Scope and expectations of the training
    • Kyriacos Tsimillis, Division of Quality Assurance, PUC
  • The new standard; what is changing
    Kyriacos Tsimillis and Despina Charalambous
    • Comparison with the 2012 version (in brief)
    • The structure of the standard - Terminology
    • The new provisions - An introduction – POCT requirements
    • Transition to the new standard
    • Laboratory activities - Scope of accreditation
  • Provisions of the new ISO 15189 Standard
    Kyriacos Tsimillis and Despina Charalambous
    • General requirements
    • Structural and governance requirements

Break

  • Provisions of the new ISO 15189 Standard (continued)
    Kyriacos Tsimillis and Despina Charalambous

    • Resource requirements – Personnel – Facilities – Equipment
    • Process requirements

Lunch break

  • Metrological traceability - ISO 17511*
    • Elvar Theodorsson [Remote]
  • Regulation in in vitro diagnostics
    • Elvar Theodorsson [Remote]

Break

  • Technical requirements: Steps to be followed by laboratories
    • Irini Leimoni
  • Exercise 1
  • Discussion on Exercise 1

Top ^^

Day 2 – Friday 17 March 2023

  • Discussion on Exercise 1 (cont.)
  • Control of data and information management
    • Kyriacos Tsimillis and Despina Charalambous
  • The management system - Options A and B
    • Kyriacos Tsimillis and Despina Charalambous
  • Risks and opportunities
    • Kyriacos Tsimillis and Despina Charalambous

Break

  • Measurement uncertainty*
    • Mike Ramsey [Remote]
  • Uncertainty arising from sampling
    • Mike Ramsey
  • Exercise 2

Lunch break

  • Discussion on Exercise 2 (cont.)

Break

  • Management requirements: Steps to be followed by laboratories
    • Irini Leimoni
  • Genetic Epidemiology of SARS-CoV-2 Infection in Cyprus
    • Leontios Kostrikis
  • Concluding remarks and close
    • Kyriacos Tsimillis, Division of Quality Assurance, PUC

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