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.
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Module No.
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Bifurcation
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Module – 1
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Introduction, Scope, Normative Reference
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Module – 2
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Terms and Definitions
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Module – 3
General Requirements
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4.1 – Impartiality
4.2 – Confidentiality
4.3 – Requirements Regarding Patients
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Module – 4
Structural and Governance Requirements
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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
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Module – 5
Resource Requirements
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6.1 – General
6.2 – Personnel
6.3 – Facilities and Environmental Conditions
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Module – 6
Resource Requirements
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6.4 – Equipment
6.5 – Equipment Calibration and Metrological Traceability
6.6 – Reagents and Consumables
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Module – 7
Resource Requirements
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6.7 – Service Agreements
6.8 – Externally Provided Products and Services
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Module – 8
Process Requirements
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7.1 – General
7.2 – Pre-Examination Processes
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Module – 9
Process Requirements
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7.3 - Examination Processes
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Module – 10
Process Requirements
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7.4 – Post-Examination Processes
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Module – 11
Process Requirements
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7.5 – Nonconforming Work
7.6 – Control of Data and Information Management
7.7 – Complaints
7.8 – Continuity and Emergency Preparedness Planning
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Module – 12
Management System Requirements
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8.1 – General Requirements
8.2 – Management System Documentation
8.3 – Control of Management System Documents
8.4 – Control of Records
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Module – 13
Management System Requirements
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8.5 – Actions to Address Risks and Opportunities for Improvement
8.6 – Improvement
8.7 – Nonconformities and Corrective Actions
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Module – 14
Management System Requirements
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8.8 – Evaluations
8.9 – Management Reviews
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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 https://equest.co.in by entering its unique ID number.
For any query, please write to:
