NABL Handbook for Medical Laboratories

ISO 15189:2022 Simplified

De: Tanmay Mehta

Narrado por: Virtual Voice

Dr. Tanmay Mehta’s NABL Handbook for Medical Laboratories: ISO 15189:2022 Simplified serves as a comprehensive guide for laboratory professionals navigating the intricacies of the ISO 15189:2022 standard. This book has been meticulously crafted to simplify complex concepts, making it accessible to both experienced lab professionals and those new to accreditation processes.

Key Features:
1. Clause-by-Clause Explanation
Each clause of ISO 15189:2022 is thoroughly explained in straightforward language. Practical examples and real-world scenarios make understanding these requirements easier. Dr. Mehta connects theoretical concepts with their practical applications in laboratory settings.

2. Focused on NABL Accreditation
The book emphasizes compliance with NABL (National Accreditation Board for Testing and Calibration Laboratories) guidelines, aligning with India's specific accreditation needs while adhering to global ISO standards.

3. Simplified Approach to Complex Processes
Dr. Mehta simplifies challenging topics, such as:
o Risk management and quality improvement (Clause 8.5)
o Nonconformities and corrective actions (Clause 8.7)
o Sample transportation, receipt, and storage (Clauses 7.2.5–7.2.7)
o Evaluation of measurement uncertainty (Clause 7.3.4)

4. Practical Insights and Examples
The handbook includes tools, templates, and checklists for implementation. This helps labs establish effective systems to ensure compliance and streamline audit processes.

5. FAQs and Assessor Perspectives
A dedicated section addresses frequently asked questions (FAQs) based on NABL assessor experiences. The inclusion of assessor tips provides insight into what evaluators look for during assessments and audits.

6. Evidence-Based Compliance
For each clause, Dr. Mehta outlines the evidence and documentation required to demonstrate compliance. This section proves invaluable for labs preparing for NABL assessments.

Relevance:
The book is particularly valuable for laboratory managers, quality managers, and technical staff seeking to achieve or maintain NABL accreditation. It also serves as a quick reference guide during audits, internal assessments, and management reviews.