Last Updated on July 8, 2021 by The Health Master
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released NABL 126: Specific criteria for calibration of medical device.
The purpose of this document is to specify requirements with which a laboratory has to operate and demonstrate its competency to carry out calibration of medical devices in accordance with ISO/IEC 17025: 2017, ISO 13485, IEC 60601, IEC 62353, Global Harmonization Task Force (GHTF).
This is also aimed at achieving uniformity between the laboratories, assessors and assessment process in terms of maximum permissible error, CMC, measurement uncertainty etc in line with national/international standards.
This will also help achieve uniformity in selection of equipment, calibration methods, maintaining required environmental conditions, and personnel with relevant qualification and experience.
This specific criterion lays down the requirements for management system and technical requirements for calibration of medical devices which needs to demonstrate its ability to consistently provide medical devices that meet customer and applicable statutory and regulatory requirements.
It is envisaged to enhance customer satisfaction through the effective application of the system and technical requirements, including processes for continual improvement of the system and the assurance of conformity to customers.
All requirements of this document are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirements of this document cannot be applied due to the nature of an organization and its products, this can be considered for exclusion.
If any requirement of this document is not applicable due to the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system and appropriate justification shall be recorded, provided such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
Technical personnel management needs to understand the scope, significance, and complexity of the program.
As per the standards, a calibration personnel should possess a degree in electrical/electronics/biomedical engineering/instrumentation or equivalent or post graduate in the relevant field, with at least one year experience in the relevant field of calibration or, graduate, diploma in science with physics /electronics/instrumentation with experience of 3 years in the relevant field of calibration.
The personnel shall have relevant knowledge of basic principles of testing, evaluation of calibration results, equipment capabilities and uncertainty of test results and applicable regulations and general requirements expressed in relevant and associated standards.