ISO 15189:2022
PRESENTATION AND INTERPRETATION OF THE REQUIREMENTS OF THE STANDARD AND GUIDANCE ON ITS IMPLEMENTATION IN MEDICAL LABORATORIES –
PRESENTATION OF INTERNAL AUDITS.
The objectives of the training course are:
- To provide a clear and analytical presentation and interpretation of the requirements of the ISO 15189:2022
standard,
- To analyze and clarify concepts such as accreditation, metrological traceability, quality control, calibration,
verification, validation, measurement uncertainty, risk assessment and management.
- To provide guidance on the implementation of the requirements in medical laboratories,
- To present the internal audits methodology.
To whom it is addressed:
The training course is addressed to Quality Managers, Technical Managers, Internal Auditors of QMS according to ISO/IEC 15189, as well as to Scientific and Technical Staff of Medical Laboratories.
Trainer:
Miltiadis Volotopoulos, Chemical Engineer, MSc Quality Management,
Member of the Chartered Quality Institute of UK,
Management Systems Development Consultant of PROSPERITY Ltd. with experience since 1995 in more than 60 laboratory accreditations and delivery of more than 200 training courses.
COURSE PROGRAM
FIRST DAY
11.00 – 11.45 Introduction,
The concept and the standards of accreditation (ISO 15189, EA, ILAC),
The basic standard ISO 15189:2022 – Medical Laboratories - Requirements for quality and competence.
11.45 – 12.00 Break
12.00 – 12.45 The basic standard ISO 15189:2022,
Impartiality and confidentiality,
Requirements regarding patients,
Structural and governance requirements.
12.45 – 13.00 Break
13.00 – 13.45 Management System – Structure of the Management System,
Control of management system documents,
Control of records,
Structure and authority,
Actions to address risks and opportunities for improvement.
13.45 – 14.00 Break
14.00 – 14.45 Improvement,
Non-conformities and Corrective Actions,
Evaluations - Internal Audits,
Management Reviews.
14.45 – 15.00 Break
15.00 - 15.45 Resource requirements,
Personnel,
Facilities and environmental conditions.
15.45 – 16.00 Break
16.00 – 16.45 Laboratory equipment, reagents and consumables,
Equipment calibration and metrological traceability.
SECOND DAY
11.00 – 11.45 Service agreements,
Externally provided products and services,
Referral laboratories and consultants,
Pre-examination processes.
11.45 – 12.00 Break
12.00 – 12.45 Examination processes,
Ensuring the validity of examination results - Internal Quality Control (IQC).
12.45 – 13.00 Break
13.00 – 13.45 Examination processes
Ensuring the validity of examination results - External Quality Assessment (EQA),
Comparability of examination results,
Post-examination processes - Reporting of results.
13.45 – 14.00 Break
14.00 – 14.45 Post-analytical processes - Reporting of results.
Post-examination handling of samples,
Control of data and information management,
Information systems management,
Complaints,
Continuity and emergency preparedness planning.
14.45 – 15.00 Break
15.00 – 15.45 Internal audits,
Planning and conducting horizontal and vertical internal audits,
Use of checklists,
Recording audit results and non-conformities.
15.45 – 16.00 Break
16.00 - 16.45 Exercise Identifying the paragraphs of the ISO 15189 standard.