Understanding NABL Norms for Diagnostic Laboratory

What makes a diagnostic lab a NABL lab

Contributed by- Dr. Manjula Sardana, Quality Head, Healthians

These days we hear most of the laboratories citing their NABL Accreditation and this definitely leaves many of us wondering, how exactly will it affect our reports?

To simply put in better words, NABL accredited labs mean diagnostic labs continuously striving for providing better and quality services. Customers can trust NABL compliant labs for their reliable services. Healthians provides accurate, cost-effective and quality services to its customers through an efficient chain of NABL compliant labs.

To know all about NABL accreditation and to know why you should ask for NABL compliance next time you book a health test, read on.

NABL stands for National Accreditation Board for Testing and Calibration Laboratories and has agreements with ILAC (International Laboratory Accreditation Conference) and APLAC (Asia Pacific Laboratory Accreditation Cooperation). These accreditations are expressly valuable for International recognition and mutual acceptance of the test results. To be precise accreditation has a worldwide acceptance.

NABL is a Constituent Board of (QCI) Quality Council of India. NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers. NABL accredits those medical laboratories that have aligned their Quality Management System with Internationally accepted Standards and Guidelines, i.e. ISO 15189:2012.

 

Importance of Accreditations

Accreditation helps in providing a formal recognition to the competent laboratories. This delivers an inclusive means for users to find about the reliable testing services in order to meet their requirements.

Accreditation also boosts the user’s confidence in accepting the tests reports issued by such laboratories. The certificate of Analysis issued by these accredited laboratories is globally acceptable, as NABL has established its Accreditation System in accordance with the internationally adopted Standard.

 

NABL Accreditation Procedure

It is important to know how this NABL Accreditation procedure goes, it starts by:

  • The applicant laboratory needs to submit 5 copies of the application ad 5 copies of the quality manual
  • After which the quality manual will be forwarded by NABL to a lead assessor, who will judge the adequacy of the quality manual
  • After this the lead assessor will conduct a pre-assessment of the laboratory for one day. Based on the reports of this pre-assessment the laboratory will have to make certain corrective measurement, to be prepared for the final assessments
  • Once the laboratory is ready, the Lead Assessor and a team of technical assessors will conduct the final assessment. The number of technical assessors will depend on the number of disciplines applied for
  • The accreditation process involves and follows a thorough assessment of all the elements of the laboratory that contribute to the production of accurate and reliable test data. These elements include:
  1. Staffing
  2. Training
  3. Supervision
  4. Quality control
  5. Equipments used
  6. Recording and reporting of test results and the environment in which the laboratory operates

Once the final assessment is done, the laboratory may have to take certain corrective actions. One the satisfactory corrective actions are taken by the laboratory (within a period of 3 months), the Accreditation Committee will examine the report and if they are satisfied with the report, they would recommend an accreditation

 Note:

Time required for the accreditation process will depend upon the readiness of the laboratory and its response to the non – conformances rose during the pre-assessment and final assessment. Total duration mostly ranges between 6 and 8 months

Accreditation to a laboratory is valid for a period of two years.

 

NABL Norms

To get the NABL Accreditation, certain norms have been laid down and the laboratory applying for the accreditation has to fulfil these norms:

  • Inter-lab comparison and proficiency testing
  • Define authority and responsibility of the each personnel in the organisation who are involved in the testing activities
  • Report generation software and format of the final test report shall be changed in accordance with NABL standard ISO 15189:2012 requirements
  • A well-defined laboratory area in the organisation showing all the major equipments, testing area along with safety precautions
  • All the instruments should be calibrated
  • Uncertainty calculation of all the instruments being used shall be within the acceptable limits specified by the NABL
  • Maintaining environmental conditions of the laboratory test
  • Test method and methods validations should be defined

NABL is a very professional and ethical body. A NABL Accredited laboratory is endlessly striving for quality and they will further progress their cause of providing the quality service.

NABL Accredited laboratory provides the customer the satisfaction they are looking for.

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