Quality Control, Biosafety, Laboratory Accreditation (NABL/ISO 15189), Waste Management, Case-Based Practical Exercises, OSPE, Viva Voce, and Laboratory Record Writing
Updated: Sep 6
https://doi.org/10.66715/cerebral-link/2026.v4.c15.169194 | Cerebral Link | Publish by Cerebral Publication Private Limited | 2026 | Volume 4 | Page 169-194 |ISBN: 978-81-689463-6-1 | Book Title: - Text-book of Practical Microbiology | Chapter 15: Quality Control, Biosafety, Laboratory Accreditation (NABL/ISO 15189), Waste Management, Case-Based Practical Exercises, OSPE, Viva Voce, and Laboratory Record Writing
Author:- Dr Onkar Nath Tiwari, Assistant Professor, Department of Biochemistry, Shri Gorakhnath Medical College Hospital and Research Centre, UP, India
Abstract
Quality management, biosafety, laboratory accreditation, and competency-based practical assessment are essential components of modern microbiology laboratory practice. This chapter provides an integrated overview of quality control and quality assurance procedures, emphasizing standard operating procedures, equipment calibration, reagent validation, internal quality control, external quality assessment, documentation, and corrective and preventive actions. Principles of laboratory biosafety are discussed with reference to risk assessment, personal protective equipment, containment practices, exposure prevention, spill management, and safe handling of potentially infectious materials. The chapter introduces the requirements and significance of NABL accreditation and ISO 15189, highlighting laboratory competence, quality management systems, traceability, documentation, and continual improvement in medical laboratories. Biomedical waste management is addressed through segregation, collection, labeling, storage, treatment, and appropriate disposal practices to minimize occupational and environmental risks.
The chapter also incorporates case-based practical exercises designed to strengthen clinical reasoning, problem-solving, interpretation of microbiological findings, and laboratory decision-making. Objective Structured Practical Examination (OSPE) and viva voce components provide structured approaches for assessing practical skills, procedural knowledge, interpretation, biosafety awareness, and professional competency. Guidance on laboratory record writing emphasizes accurate documentation of objectives, principles, materials, procedures, observations, results, interpretation, and conclusions. Collectively, these elements promote safe, reliable, standardized, and competency-oriented microbiology laboratory practice while preparing students for academic assessment and professional diagnostic laboratory responsibilities.
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