Laboratory NABL accrediation guidelines

                The laboratory should carry out the following important tasks towards getting ready for accreditation:

1.Contact NABL Secretariat with a request for procuring relevant NABL documents (NABLContact address and the list of NABL documents).

2. Get fully acquainted with all relevant documents and understand the assessment Procedure and methodology of making an application.

3.Train a person on Quality Management System and Internal Audit (4-day residential training courses conducted by NABL. Contact NABLSecretariat for details).

4.Prepare QUALITY MANUAL as per ISO 15189 standards.

5.Prepare Standard Operating Procedure for each investigation carried out in the laboratory.

6. Ensure effective environmental conditions (temperature, humidity, storage placement, etc.).

7.Ensure calibration of instruments / equipment.Only NABL ACCREDITED CALIBRATION LABORATORIES are aut horized to provide calibration. NABL website gives the names of NABL accredited calibration laboratories in the various fields of Accreditation.

8. Impart training on the key elements of documentation, such as document format,authorization of document, issue and withdrawal procedures, document review and change, etc. Each document should have ID No., name of controlling authority, period of retention, etc.

9. Ascertain the status of the existing quality system and technical competence with regard to NABL standards and address the question“Is the system documented and effective OR does it need modification?”.

10. Remember Quality Manual is a policy document,which has to be supplemented by a set of other next level documents. Therefore ensure that these documents are well prepared.

11. Ensure proper implementation of all aspects that have been documented in the Quality Manual and other documents.

12.Incorporate Internal Quality Control (IQC) practicewhile patients’ samples are analysed.

13. Document IQC data as well as uncertainty of measurements. Maintain Levy Jennings charts.

14. Participate in External Quality Assessment Schemes (EQAS). If this is not available for certain analytes, participate in inter-laboratory comparison through exchange of samples with NABL accredited laboratories.

15. Document corrective actions on IQC / EQA outliers.

16. Conduct Internal Audit and Management Review.

17. Apply to NABL along with appropriate fee.