About Awareness Training on ISO/IEC 17025 & NABL 133 Document
This awareness training program provides participants with a foundational understanding of ISO/IEC 17025:2017 – "General requirements for the competence of testing and calibration laboratories" – and its practical application through the NABL 133 Document. In today's highly competitive and regulated environment, demonstrating technical competence and the reliability of test and calibration results is paramount for laboratories. This course will illuminate the critical role these standards play in achieving and maintaining accreditation, enhancing laboratory credibility, and ensuring consistent quality of services.
Participants will gain insights into the key principles, clauses, and requirements of ISO/IEC 17025, which forms the international benchmark for laboratory competence. The training will also specifically delve into NABL 133 (Specific Criteria for Accreditation of Medical Laboratories), explaining how this NABL (National Accreditation Board for Testing and Calibration Laboratories) document provides supplementary and interpretative guidance for medical laboratories seeking accreditation in India.
By the end of this program, attendees will be equipped with a clear understanding of the benefits of accreditation, the fundamental requirements for establishing and maintaining a robust quality management system in a laboratory setting, and the specific considerations outlined in NABL 133 for medical laboratories.
Training Shall Broadly Cover
- What is accreditation and why is it important for laboratories?
- Benefits of ISO/IEC 17025 accreditation.
- Overview of NABL and its role in India.
- Structure and key clauses of the standard.
- General requirements for competence, impartiality, and consistent operation of laboratories.
- Process requirements (e.g., review of requests, tenders and contracts; selection and verification of methods; sampling; handling of test or calibration items; ensuring validity of results; reporting results).
- Management system requirements (e.g., options for management system documentation, control of documents, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits, management reviews).
- Purpose and scope of NABL 133.
- Interpreting ISO/IEC 17025 requirements specifically for medical laboratories as per NABL 133.
- Key supplementary requirements and clarifications provided by NABL 133 (e.g., personnel, accommodation and environmental conditions, pre-examination processes, examination processes, post-examination processes, reporting of results, information management).
- Overview of essential elements of a quality management system in a laboratory.
- Importance of documentation, record-keeping, and internal audits.
- Introduction to Measurement Uncertainty (Conceptual): Brief overview of the concept of measurement uncertainty and its relevance in testing and calibration (without deep dive into calculations).
- Traceability of Measurements (Conceptual): Understanding the concept of metrological traceability.
- Discussion on the advantages of implementing ISO/IEC 17025 and NABL 133.
- Common challenges faced by laboratories in achieving and maintaining accreditation.
- Interactive Sessions: Dedicated ‘Question and Answer’ sessions to facilitate and provide participants with the opportunity to engage actively, seek clarification, and deepen their understanding through interactive dialogue.
Self-Evaluation
- Pre-Evaluation: A short pre-assessment may be conducted to gauge participants' existing familiarity with laboratory quality concepts.
- Post-Evaluation: A post-assessment will be administered to ensure participants have grasped the core concepts and achieved the learning objectives.
Prerequisites
There are no formal prerequisites for attending this awareness training. It is designed for individuals seeking an initial understanding of ISO/IEC 17025 and NABL 133.
Who Should Attend?
This awareness training is beneficial for:
- Laboratory Managers
- Quality Managers and Quality Assurance Personnel in testing and calibration laboratories (especially medical laboratories)
- Technical Managers and Supervisors
- Laboratory Staff involved in testing, calibration, and quality control
- Personnel involved in the implementation or maintenance of laboratory management systems
- Individuals new to laboratory accreditation concepts
- Anyone interested in understanding the requirements for laboratory competence as per international and national standards.
What’s Included?
- Learning Materials
- Certificate of Participation (Issued as a 'Soft Copy' from our Training Portal. This certificate can be verified anytime from our website tcb.qcin.org by entering its unique ID number or scanning the QR Code).
Enquire Now
Rohit Varshney, Project Manager, TCB/QCI, rohit.varshney@qcin.org, Ph. 9773500376