Guidelines for testing labs
http://www.nabl-india.org/nabl/asp/users/documentMgmt.asp?docType=both
What is the process for accreditation at NABL…?
Stage I
Prepare your laboratory's application for NABL accreditation, giving all desired information and enlisting the test(s) / calibration(s) along with range and accuracy for which the laboratory has the competence to perform. Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL 151 & NABL 152 are to be used by Testing Laboratories and Calibration Laboratories respectively for applying to NABL for accreditation.
Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply. In case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons.
Laboratories are required to submit five sets of duly filled in application forms for each field of testing / calibration along with five sets of Quality Manual and Application Fees.
NABL Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for further processing of application.
NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.
Stage II
NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the laboratory sites.
The pre-assessment helps the laboratory to be better prepared for the Final Assessment. It also helps the Lead Assessor to assess the preparedness of the laboratory to undergo Final Assessment apart from Technical Assessor(s) and Total Assessment Man-days required vis-à-vis the scope of accreditation as per application submitted by the laboratory.
A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
The laboratory shall submit Corrective Action Report to NABL Secretariat.
After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL.
Stage III
NABL Secretariat shall organise the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoint an assessment team.
The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed.
Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment.
The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL Secretariat.
Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a report to NABL within a maximum period of 3 months.
Stage IV
After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommend additional corrective action, if any, by the laboratory.
Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL requirements as well as commensurate with the claims made by the laboratory in its application.
Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat.
Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL.
Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL Observer. Sometimes, NABL may at its own cost depute a newly trained Technical Assessor as "Observer" subject to convenience of the laboratory to be accessed.
Stage V
Accreditation to a laboratory shall be valid for a period of 3 years and NABL shall conduct periodical Surveillance of the laboratory at intervals of one year.
Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.
16. Who at NABL should a laboratory contact before initiating the process of accreditation...?
Enquiries for accreditation may be addressed to Director NABL or mail at info@nabl-india.org
17. What are the preparations required by a laboratory before applying for accreditation...?
Laboratory management should first decide about getting accreditation for its laboratory from NABL.
It is important for a laboratory to make a definite plan of action for obtaining accreditation and nominate a responsible person to coordinate all activities related to seeking accreditation. The person nominated should be familiar with laboratory's existing Quality System. S/he should be formally designated as the Quality Manager.
Procure all relevant NABL documents from NABL Secretariat and get fully acquainted with each of these.
Laboratory needs to ascertain the status of its existing Quality System and Technical Competence with regards to requirements for NABL Accreditation. Is the system documented and effective or does it need modification. Does it need to build the Quality System of the laboratory from scratch?
It must be remembered that Quality Manual is a policy document, which has to be supplemented by a set of other documents like Procedural Manuals, Work Instructions etc. to align the Quality System in accordance with NABL Criteria. The laboratory must ensure that the procedures described in the Quality Manual and other documents are being implemented. For preparing Quality Manual or verifying its contents, the laboratory may take help of " Guide for Preparing Quality Manual" (NABL 160). The laboratory may also get its personnel trained in NABL's training programme on Laboratory Quality System, Management and Internal Audit.
Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. This will enable them to understand their weaknesses and strengths.
Quality Manager must conduct an Internal Audit and take corrective actions before applying for accreditation.
18. Is there a publication that can guide me through the accreditation process...?
General Information Brochure NABL 100 is published by NABL to guide you about NABL accreditation and its procedure.
1. What are the aims and objectives of NABL...?
2. Where is NABL office located...?
3. What are the office timings of NABL...?
4. What is laboratory accreditation...?
5. Why is laboratory accreditation required...?
6. What are benefits of accreditation...?
7. How is NABL accreditation different from ISO 9000 certification...?
8. What types of laboratories can seek accreditation...?
9. Which fields of testing and calibration are covered by NABL...?
10. Which are the other organizations in India providing accreditation services...?
11. Why use an accredited laboratory...?
12. How would NABL accreditation help a laboratory reach out to the global customers...?
13. Is accreditation a one-time phenomenon...?
14. Is it mandatory for laboratories to participate in Proficiency Testing programs...?
15. What is the process for accreditation at NABL…?
16. Who at NABL should a laboratory contact for initiating the process of accreditation...?
17. What are the preparations required by a laboratory before applying for accreditation...?
18. Is there a publication that can guide me through the accreditation process...?
19. What is Mutual Recognition Arrangements (MRA) with international bodies and what are the benefits of such arrangements for the laboratories accredited by NABL...?
20. Does NABL publish periodic newsletters?
21. How can we know of the Proficiency Testing programmes organised by NABL or APLAC ?
22. What training courses are offered by NABL...?
23. How to use NABL logo...?
24. How does using an accredited laboratory benefit Government and Regulators…?
25. How do I know a laboratory is accredited by NABL…?
26. Why is a laboratory’s technical competence so critical to you as a manufacturer, supplier, exporter or customer…?
27. How does NABL determine the number of assessors that will be assigned to conduct laboratory’s assessment…?
28. What is peer evaluation…?
29. How long does it take for a laboratory to obtain NABL accreditation…?
30. What is the “Scope of Accreditation”…?
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