Self-paced, short online course, consisting of 4 sequential modules. Starts: February 2023.

TOPICS

• What was the process for revision?
• Contentious topics
• Implementation of the 4th edition
• Preventive action vs Risk management: ISO 15189:2022:  throughout the document
•  Relationship to ISO 22367, Medical laboratories — Application of risk management to medical laboratories - Risk-based thinking”
• Why is the ISO 15189:2022 patient focused? 
• Which are the new requirements regarding patients and other considerations related to patients that are included in the ISO 15189:2022?
• How does ISO 15189 now cover POCT? What this means for labs. What this means for POCT operators.
• Internal evaluations. Different mechanisms to evaluate the management sytem
• Management review. Purpose and usefulness. Differences between the 3rd and 4th edition
• Supporting documentation

INSTRUCTORS

Sheila Woodcock MBA, FCSMLS(D) - President and Principal Consultant QSE CONSULTING INC

Sheila is the Convenor of ISO/TC212 WG1 Quality and competence in the medical laboratory, and project leader for the recent revision of ISO15189. Sheila volunteers with Canadian Standards Association (CSA) and Standards Council of Canada (SCC) for ISO /TC212 Clinical laboratory testing and in vitro diagnostic test systems and ISO/TC304 Healthcare organization management.

Dr. Hayato Miyachi, MD, PhD - Chair of the Committee for Standardization of Molecular-genetic Testing - Japanese Committee for Clinical Laboratory and Standards (JCCLS)

Chair of Japanese National Mirror Committee for ISO Technical Committee 212 (Clinical laboratory testing and in vitro diagnostic test systems) and serves in the Working Group 1, as a project team member of the newly established international standard for medical laboratories (ISO 15189: 2022 – Medical Laboratories – Requirements for quality and competence), in the Working Group 4, as a project leader for development of the international standards for in vitro diagnostic medical devices (ISO 21474-1: 2020 – Multiplex molecular testing for nucleic acids – Terminology and general requirements for nucleic acid quality evaluation, ISO 21474-2: 2022 – Validation and verification, and ISO/CD 21474-3 – Interpretation and reports), as well as in the Joint Working Group 6, as a co-project leader for development of the newly established international standard for in vitro diagnostic test systems for SARS-CoV-2 (ISO/TS 5798: 2022  In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods.

Dr. David Rickets, DBMS - Head of Laboratory Process Improvement. Head of Laboratory Process Improvement Health Services Laboratories

David chairs the UK's TC212 mirror committee, and is head of the UK delegation on the TC- 212 committee. David has extensive  experience writing standards, and was the project lead on ISO 22870, on the writing team of  ISO 15189:2022,  as well as supporting many other standards including ISO 22367. David has written many expert commentaries for British Standards. The commentaries are designed to explain the changes in new version of ISO standards and explain how to use them in the laboratory setting, ISO 22367 and ISO 15190 (safety) are two recent commentaries.

Dr. William Castellani, MD - Member of the ISO 15189 work group TC 212

Dr. William Castellani is a retired professor of pathology at Pennsylvania State -Hershey College of Medicine in Pennsylvania, and is the former medical director of clinical chemistry at Hershey Medical Center.  He has been an active member of ISO working group TC 212 for over twenty years, and has participated in writing all four editions of the standard.

Anne Marie Martel, MT - Member, CSA Group for Medical Laboratory Quality Systems

In the last 15 years, Mrs. Martel has specialized in standard development for medical laboratories and pre-examination activities. She was a member and chair of many committees and expert panels at the Clinical and Laboratory Standards Institute (CLSI), in the United States. She was also a member and past chair of the medical laboratory technical committee of the Canadian Standards Association, CSA, for many years, as well as a member of the mirror committee, representing Standards Council of Canada at the International level. This has allowed her to participate as a member of Technical committee 212 Clinical laboratory testing and in vitro diagnostic tests systems, the committee responsible for the revision of ISO 15189. As part of the working group 1, she was able to comment on version 2012 and 2022 of ISO 15189, Medical laboratories, Requirements for quality and competence. Mrs. Martel now works as a project manager at CSA Group.

Analía S. Purita - Member of ISO/TC 212 and ISO/TC212/WG1, ISO 15189 Quality and competence in the medical laboratory 

Analia currently works for the National Standardization Organization called “IRAM - Instituto Argentino de Normalización y Certificación” (“Standardization and Certification Argentinian Institute”), and she has been supporting  ISO 15189-Medical laboratories. Requirements for quality and competence” since the first edition developed in 2003. 

 Analia is the Lead convener of the ISO/TC212/STTF (Spanish translation task force), which is responsible for the official translations of the ISO standards into Spanish. She is currently the Senior Convener of the national technical committees: Biobanks; Biological risk Management; Biotechnology; Biosecurity; Extraction and transfusion equipment; Quality and competence in medical laboratories; Patient centered care; Promotion of gender equity; Reference systems and others.

Doris Mueni Mengo, MSc - Manager, Medical Laboratory Accreditation Department, Kenya Accreditation Service (KENAS).

Doris Mueni Mengo is the Manager in charge of the Medical Laboratory Accreditation Department which is responsible for point of care testing, diagnostic imaging, and proficiency testing  at the Kenya Accreditation Service (KENAS) based in Nairobi, Kenya.

Doris has over 16 years of work experience in the public sector supporting healthcare. Her interests span from; the development of health-related standards; to promoting accreditation and the use of accredited medical laboratories for improved health outcomes in Kenya, East Africa, and Africa.

Janette Wassung  - Managing Director, Quality First PTY Ltd

In addition to her laboratory experience, Mrs Wassung is a certified ISO 15189 auditor, on both technical and management systems, through the South African National Accreditation System (SANAS).

During her professional career in QMS implementation, she was a member of many drafting committees and expert panels at the Clinical and Laboratory Standards Institute (CLSI), in the United States. In 2012 Janette started the mirror committee to ISO TC 212 in South Africa, SABS TC 212, representing South Africa at the international committee TC 212. TC 212 is responsible for drafting and reviewing ISO standards and other documents for the medical laboratory industry. As part of work group 1, Mrs Wassung participated as team lead on the drafting committee for the revision of ISO 15189:2012, which has been published as Ed 4 in December 2022.

REQUIREMENTS FOR COMPLETION:

Learners must complete all requirements of each module in order to advance to the next module, but you may do so at your own pace. Successful completion of each module and the final course survey will result in a certificate of completion.

Learners who successfully complete the course are eligible for continuing education (CE) credits with CSMLS, ASCP and can apply to their respective institutions.