ISO 15189: 2022 Medical laboratories - Requirements for quality and competence




8.00 Hours.




Medical Laboratory System and Internal Audit as per ISO 15189: 2022

Description of the course:

  • The Standard ISO 15189:2022 specifies requirements for quality and competence in medical laboratories.
  • This course gives a structured and comprehensive approach on interpretation of the requirements of ISO 15189:2022 for implementation in a Medical Laboratory.
  • This course includes aspects on planning, managing, conducting and leading the internal audits of in a Medical Laboratory.
  • The revised Standard notably includes perspectives of Risk Management and Point-of-Care Testing (POCT), placing emphasis on effective, timely and efficient Patient Care.

Target Learners:

This training course is aimed at the personnel of a Laboratory, including that of the laboratory management and Assessors associated with Accreditation Body, specifically-

  • Directors/Laboratory Managers, Scientists, Engineers, Auditors, Assessors and Consultants
  • Personnel of ISO 15189 accredited and applicant laboratories.
  • Personnel responsible for technical or quality management of medical laboratories

Structure of the course:

This course is designed to provide the participant a deep understanding of the Standard, covering all its clauses, and addressing areas for effective implementation of 15189:2022 within a medical laboratory.

**Module-Based Learning**: Our course consists of 14 modules, each meticulously designed to cover not only the standards clauses but also areas crucial for the effective implementation of 15189:2022.

The online training is equipped with PowerPoint presentations, exercises and case studies for a better understanding of the requirements of ISO 15189:2022.  

Module No.


Module – 1

Introduction, Scope, Normative Reference

Module – 2

Terms and Definitions

Module – 3

General Requirements

4.1 – Impartiality

4.2 – Confidentiality

4.3 – Requirements Regarding Patients

Module – 4

Structural and Governance Requirements

5.1 – Legal Identity

5.2 – Laboratory Director

5.3 – Laboratory Activities

5.4 – Structure and Authority

5.5 – Objectives and Policies

5.6 – Risk Management

Module – 5

Resource Requirements

6.1 – General

6.2 – Personnel

6.3 – Facilities and Environmental Conditions

Module – 6

Resource Requirements

6.4 – Equipment

6.5 – Equipment Calibration and Metrological Traceability

6.6 – Reagents and Consumables

Module – 7

Resource Requirements

6.7 – Service Agreements

6.8 – Externally Provided Products and Services

Module – 8

Process Requirements

7.1 – General

7.2 – Pre-Examination Processes

Module – 9

Process Requirements

7.3 - Examination Processes

Module – 10

Process Requirements

7.4 – Post-Examination Processes

Module – 11

Process Requirements

7.5 – Nonconforming Work

7.6 – Control of Data and Information Management

7.7 – Complaints

7.8 – Continuity and Emergency Preparedness Planning

Module – 12

Management System Requirements

8.1 – General Requirements

8.2 – Management System Documentation

8.3 – Control of Management System Documents

8.4 – Control of Records

Module – 13

Management System Requirements

8.5 – Actions to Address Risks and Opportunities for Improvement

8.6 – Improvement

8.7 – Nonconformities and Corrective Actions

Module – 14

Management System Requirements

8.8 – Evaluations

8.9 – Management Reviews

 Learning Outcomes:

Completing this program will assist you in:

  • Grasping the fundamental concepts of accreditation.
  • Acquiring knowledge and expertise in documenting and implementing management systems in medical testing laboratories, aligning with the ISO 15189:2022 standard.
  • Understanding and interpreting the requirements of ISO 15189:2022
  • Understanding the requirements for accrediting medical testing laboratories.
  • Implementing ISO 15189 requirements, including NABL 112 Specific Criteria for Accreditation of Medical Laboratories, within your laboratory.
  • Recognizing the purpose and synergy of a quality management system, encompassing both managerial and technical aspects.
  • Implementing these requirements to enhance service quality and instil greater confidence in your laboratory’s results.
  • Developing and implementing a system as per ISO 15189:2022 for a Medical Laboratory
  • Planning, managing, conducting and leading the internal audit of Medical Laboratory as per ISO 15189:2022
  • Improving the laboratory’s operations and management system
  • Preparing the Medical Laboratory for the NABL accreditation in a structured way

 What’s included:

  • Learning materials.
  • Type of examination: It will be a computer-based examination which will include multiple choice questions (MCQ). The said questions will be from the topics covered in the course.
  • Certificate of Competency shall be issued as a ‘Soft Copy’ from our Training Portal. This certificate can be verified anytime from our website  by entering its unique ID number. 

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