ISO 15189-2022 Lead Implementer’s

Introduction

ISO 15189:2022 is a regulatory standard for medical laboratories that was developed by the International Organization for Standardization’s Technical Committee 212 (ISO/TC 212). ISO 15189 requirements for quality and competence is an international standard that lay down the quality management system requirements specific to medical laboratories. Its standards aid laboratories develop quality management systems and evaluate their individual competency. The standard is equally used by customers, accreditation bodies and regulators to certify or recognize a laboratory’s competence. Therefore, laboratory conforming to ISO 15189:2022 is a mark of assurance awarded to it that proves that they are dedicated to delivering a skillful and quality service across all phases of their operation.

Aqutest institute is here to guide you through the implementation process by explaining the ISO 15189:2022 requirements and how they can get applied by use of best international practices. Through the course, you will be trained on how to develop an implementation plan, create the required documentation, monitor the quality management system for laboratory, and attain continual quality and system development.

Duration; 3 Days

Learning Objectives

• Understand ISO 15189:2022 requirements for medical laboratories
• Learn the required documentation for medical laboratories accredited to the standard
• Understand how the standard is used in assessing the competence of medical laboratories
• Understand how to create documents and records used by ISO 15189:2022 QMS

Who should attend?

This program is designed as an educational and training tool for MLS, MT, and MLT personnel, medical laboratory science students and interns, pathology residents, and practicing pathologists.

Methodology

The instructor guided trainings get delivered using a blended learning technique and includes of presentations, led sessions of practical exercise and web-based tutorials. Our facilitators are experienced medical laboratory experts with years of experience, working as professional and trainers in these fields.

• Organization and management
•  Quality Management System
•  Management requirements
•  Technical requirements
•  Laboratory Information System

1. The participant must be conversant with English.
2. Upon completion of training the participant will be issued with an Authorized Training Certificate
3. Course duration is flexible and the contents can be revised to fit any number of days.
4. The course fee comprises facilitation training materials, 2 tea breaks, buffet lunch and a Certificate upon successful completion of Training for onsite trainings.
5. One-year post-training support Consultation and Coaching provided after the course.
6. Payment should be done at least a week before commence of the training, to AQUTEST INSTITUTE account, as indicated in the invoice so as to enable us prepare better for you.