This course provides an in-depth understanding of the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation process, its quality management system (QMS), and the practical aspects of implementing the NABL standards. The course includes an analysis of case studies to enhance the understanding of real-world applications of the NABL accreditation process. Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com

1. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Program Name: B.Sc. Medical Lab Technology
Syllabus of Program Elective course - III (Introduction to NABL)
Course Name: Program Elective course - III (Introduction to NABL) Course Type
Course Coordinator: Attuluri Vamsi Kumar – B.Sc. MLT, M.Sc. MLT, PhD (Perusing)
Designation: Assistant Professor
Department: Department of Medical Lab Technology (MLT)
Program
Elective
PRE-REQUISITE Program Elective -II Sem: 6 S. No: 44
About Vamsi: I am academician in Medical Laboratory Sciences with a strong desire to improve Outcome
based education (OBE) structured MLT education. I am constantly focusing on building an academic
atmosphere that is set high standards with strong multi blended teaching pedagogy models.
YouTube: https://www.youtube.com/@vamsiMLT
SlideShare: https://www.slideshare.net/VamsiIntellectual
Website: www.mltmaster.com / https://sites.google.com/view/vamsi-intellectual-protfolio/home
LinkedIn: https://www.linkedin.com/in/vamsi-kumar-attuluri-ab8987128/?originalSubdomain=in
Research Gate: https://www.researchgate.net/profile/Attuluri-Kumar
Orcid ID: https://orcid.org/0000-0001-9278-6714
Contact No: +91 7416660584
Mail ID: vamsifmlt@gmail.com
A. COURSE DESCRIPTION
This course provides an in-depth understanding of the National Accreditation Board for
Testing and Calibration Laboratories (NABL) accreditation process, its quality management
system (QMS), and the practical aspects of implementing the NABL standards. The course
includes an analysis of case studies to enhance the understanding of real-world applications of
the NABL accreditation process.
B. COURSE OBJECTIVES:
1. Students will be able to explain the history, role, and benefits of NABL accreditation, as well as
understand the core NABL accreditation standards.
2. Students will be able to outline the steps for achieving NABL accreditation and understand the
relevance of a Quality Management System (QMS) in laboratories.
3. Students will apply their knowledge to assess the process of implementing NABL standards in a
practical scenario, such as staff training and equipment calibration.
4. Students will be able to analyze case studies about the journey towards NABL accreditation and
the challenges faced during the process.
5. Students will be able to evaluate the audit and assessment process, non-conformities, corrective
actions, and continual improvements required for maintaining NABL accreditation.
C. COURSE OUTCOMES
CO
No
Statement Performance
Indicator
Level of
Learning
(Highest BT
Level)
Target
Attainment
CO1 Students will recall the historical context and role of
NABL, and the significance of its accreditation.
PI 1 Knowledge (K1) 70%
CO2 Students will understand the NABL accreditation
standards and interpret the relevance of a Quality
Management System (QMS) in medical
laboratories.
PI 2.1, PI 4 Comprehension
(K2)
70%

2. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
CO3 Students will apply their understanding to execute
the steps required for achieving NABL
accreditation.
PI 2.2, PI 2.3,
PI 2.4, PI 2.5,
PI 2.6, PI 2.7,
PI 2.8, PI 2.9,
PI 4, PI 6
Application
(K3)
70%
CO4 Students will analyze different case studies related
to the journey towards NABL accreditation,
highlighting the challenges and solutions in the
process.
PI 3 Analysis (K4) 70%
CO5 Students will develop a strategy for effective
implementation of NABL standards, focusing on
staff training, equipment calibration, and quality
control practices.
PI 2.5, PI 5, PI
7, PI 8
Synthesis (K5) 70%
CO6 Students will evaluate the audit and assessment
process of NABL, understanding the identification
and correction of non-conformities, and the
necessity of continual improvement.
PI 2.7, PI 2.8,
PI 2.9, PI 3, PI
4, PI 6, PI 7,
PI 8
Evaluation (K6) 70%
D. SYLLABUS
Unit-1 Understanding NABL Contact Hours:15
Chapter 1.1 Introduction to NABL- History of NABL, NABL's role in Laboratory Accreditation, Benefits
of NABL accreditation, International Recognition of NABL
Chapter 1.2 NABL Accreditation Standards- Overview of ISO/IEC 17025, Overview of ISO 15189,
Importance of these standards, The process of accreditation
Experiment 1 /
Case study
Case Study 1: The formation of NABL and its international impact
Experiment 2 /
Case study
Case Study 2: A comparison of laboratories before and after achieving NABL accreditation
Experiment 3 /
Case study
Case Study 3: The role of NABL in improving patient safety in India
Unit-2 Accreditation Process and Quality Management Contact Hours:15
Chapter 2.1 The Accreditation Process - 44
Chapter 2.2 Quality Management System (QMS) in Labs- The Introduction to QMS, QMS & its
importance in labs, Implementation of QMS in labs as per NABL standards, Monitoring and
continual improvement of QMSAccreSteps for achieving NABL accreditation,
Documentation, Assessments, Scopes of Testing/Calibrationditation Process
Experiment 4 /
Case study
Case Study 4: A step-by-step breakdown of a laboratory's journey to accreditation
Experiment 5 /
Case study
Case Study 5: A detailed analysis of assessment and corrective action in the accreditation
process
Experiment 6 /
Case study
Case Study 6: An overview of the challenges faced by a laboratory in defining scopes of testing
Experiment 7 /
Case study
Case Study 7: Insights from unsuccessful attempts at achieving accreditation
Unit-3 Implementation and Assessment Contact Hours:15
Chapter 3.1 Practical Implementation of NABL Standards- Staff Training, Equipment calibration and
management, Quality Control in Laboratory Practices, Documentation and Record Keeping
Chapter 3.2 Audit and Assessment- Preparing for NABL audits, NABL assessment - what to expect, Non-
conformities and corrective actions, Continual improvement and re-accreditation
Experiment 8 /
Case study
Case Study 8: A success story of effective staff training leading to NABL accreditation
Experiment 9 /
Case study
Case Study 9: A look at how a laboratory overcame challenges in equipment calibration

3. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Experiment 10 /
Case study
Case Study 10: An evaluation of effective quality control practices in accredited laboratories
Self-study topics for Advance learners: Advanced Quality Management Systems: This can
include lean and six sigma methodologies in medical laboratories, and other tools for advanced quality
management., International Comparisons: An analysis of other international laboratory accreditation
bodies like CAP, ISO, and comparison with NABL., Advanced Risk Management in Medical
Laboratories: This can involve a deeper exploration of potential risks and the implementation of
mitigation strategies in the context of medical laboratories., In-depth Study of Non-conformities: Case
studies and analyses of major non-conformities reported in medical labs, how they were addressed,
and what measures were taken to prevent them from recurring., Advanced Calibration Techniques:
Calibration is a critical aspect of medical lab technology, and a deeper understanding of advanced
calibration techniques could be useful for advanced learners.
E. TEXT BOOKS/REFERENCE BOOKS
TEXT BOOKS
T1 Quality Management in the Medical Laboratory by Elsie Ho, Kristine Krafts
T2 Laboratory Quality Management: A Single Model by Lucia Berte
T3 Quality Assurance in Medical Education: A Practical Guide by K. Singh, M. Saini
REFERENCE BOOKS
R1 Laboratory Quality Control and Patient Safety by Jay B. Jones
R2 ISO 15189:2012, Medical laboratories - Requirements for quality and competence by -
R3 Quality Control in the Clinical Laboratory by A. Sarkar, M. Ray

4. B.Sc. MLT Syllabus
Attuluri Vamsi Kumar I Assistant professor I Dept of MLT I Ph No: 7416660584 I Website: mltmaster.com
Website: www.mltmaster.com I YouTube: https://www.youtube.com/@vamsiMLT
Code Performance Indicators
PI 1 Demonstrate professional interpersonal, oral, and written communications skills sufficient to
serve the needs of patients and the public including an awareness of how diversity may affect
the communication process.
PI 2 Perform pre-analytical, analytical, and post-analytical processes:
PI 2.1 Demonstrate ability to understand investigation/test requisition.
PI 2.2 Collecting the relevant clinical samples along with complete and accurate documentation with
proper safety measures in relation to sample accountability.
PI 2.3 To transport the samples with precautionary measures to the relevant lab section.
PI 2.4 Demonstrate the ability to prepare clinical sample for processing
PI 2.5 To demonstrate the knowledge of accurate sample processing for the required lab
investigation. Perform routine clinical laboratory tests in clinical chemistry,
haematology/haemostasis, immunology, immunohematology, microbiology, Histopathology,
Cytopathology, body fluid analysis, and laboratory operations.
PI 2.6 Perform mathematical calculations related to all areas of the clinical laboratory
PI 2.7 Ability to record the test results/data.
PI 2.8 To demonstrate the ability to interpret the test reports and its documentation in lab records.
PI 2.9 Demonstrate ability to release the report to the right person in minimum turn-around time
(TAT).
PI 3 Perform problem solving and troubleshooting techniques for laboratory methodologies
Correlate laboratory test results with patient diagnosis and treatment.
PI 4 To follow basic quality assessment protocol of clinical laboratory.
PI 5 Demonstrate routine laboratory techniques sufficient to orient new employees within the
clinical laboratory.
PI 6 Apply basic scientific principles in learning new techniques/procedures; demonstrate
application of principles and methodologies.
PI 7 Utilize computer technology applications to interact with computerized instruments and
laboratory information systems.
PI 8 Demonstrate adequate knowledge of computer software as it applies to document production,
spreadsheets, and presentations.
PI 9 Demonstrate professional behaviour with co-team mates.
PI 10 Demonstrate sensitivity and compassion towards patients.