Setup & Equipments for
laboratoriesas per ISO/IEC 17025 (NABL)

Setting up a laboratory inaccordance with ISO/IEC 17025, which is the international standard for testing and calibration laboratories, requires careful planning and adherence to specific requirements outlined in the standard. The National Accreditation Board for Testing and Calibration Laboratories (NABL) in India is the accrediting body that assesses laboratories against the ISO/IEC 17025 standard. Here’s a guide to setting up a laboratory and selecting equipment in compliance with ISO/IEC 17025:

• Infrastructure and Facilities:

Design and layout the laboratory space to accommodate various testing and calibration activities, ensuring adequate separation between different work areas to prevent cross-contamination or interference.

Provide sufficient space for equipment, storage of samples, reference materials, and documentation.

Ensure proper ventilation, lighting, and environmental conditions to meet the requirements of the tests and calibrations being performed.

• Management System:

Establish and document quality management procedures and processes in accordance with ISO/IEC 17025 requirements.

Implement a quality manual, standard operating procedures (SOPs), and documentation control procedures to ensure consistency and traceability of laboratory activities.

• Competence of Personnel:

Employ qualified and competent staff with appropriate education, training, and experience to perform testing and calibration activities.

Provide ongoing training and competency assessment to ensure staff proficiency and compliance with ISO/IEC 17025 requirements.

• Equipment and Measurement Traceability:

Select and calibrate equipment and measurement standards traceable to national or international standards.

Maintain records of equipment calibration and verification, including calibration certificates, calibration schedules, and measurement uncertainty calculations.

• Method Validation and Verification:

Validate and verify test and calibration methods to ensure they are fit for purpose, accurate, and reliable.

Document validation and verification procedures, including acceptance criteria, test results, and uncertainty estimates.

• Quality Control and Assurance:

Implement quality control measures to monitor the performance of tests and calibrations, including the use of reference materials, internal quality control samples, and proficiency testing programs.

Establish procedures for handling non-conforming work, corrective actions, and continuous improvement.

• Accreditation and Compliance:

Seek accreditation from NABL or other recognized accreditation bodies to demonstrate compliance with ISO/IEC 17025.

Prepare for accreditation assessments by conducting internal audits, addressing non-conformities, and maintaining documentation of compliance.

When selecting equipment for the laboratory, consider factors such as accuracy, precision, reliability, and suitability for the intended tests or calibrations. Calibration standards, reference materials, and measurement devices should be traceable to national or international standards to ensure metrological traceability. Additionally, ensure that equipment meets any specific requirements outlined in ISO/IEC 17025 and relevant testing methods. Regular maintenance, calibration, and verification of equipment are essential to maintain measurement traceability and ensure the quality and reliability of laboratory results.