How to do competenary assessment in a lab as per NABL/ISO/IEC 17025:2017

Procedure for Integrated Assessment of Testing Laboratories to obtain Recognition / Approval from Regulatory Body

This document describes specific requirements of assessment that a testing laboratory, seeking recognition /approval from Export Inspection council (EIC), APEDA, FSSAI and other commodity boards, has to meet, in parallel to the accreditation in accordance with of ISO/IEC 17025 by NABL

The application for integrated Accreditation/Recognition/ Approval scheme for the specific scope shall be taken into consideration only on the scrutiny by NABL and evaluation of competence and compliance through integrated assessment approach by NABL /EIC / APEDA /FSSAI, grant of accreditation by NABL and parallel recognition from concerned regulatory Body based on the decision of NABL. Relevant information may be downloaded from NABL website

Application fee and Assessment charges will be paid to NABL only. All other charges including the Annual Accreditation fee/ Membership fee/ Approval fee as applicable shall be payable to the respective regulatory body.

Laboratory seeking approval from regulatory Body with NABL accreditation through integrated assessment approach, shall apply to NABL Office in the prescribed application form (NABL 154) for all the parameters under applied commodity/ product group as specified by the respective Regulatory Body (ies), along with a copy of its Quality manual/ Management System document, enclosures, and application fee, as prescribed from time to time or through Online National Laboratory Portal. Application with partial scope for product/ matrix shall not be accepted and Approval/ Recognition shall not be granted for the partial scope to the laboratories.

On receipt of the application, laboratory quality manual/ Management System document along with the fee details and other requisite enclosures, NABL shall scrutinize the same for its completeness as well as adequacy of facilities with regard to list of equipments and details of personnel to meet the basic requirements, with the applied scope of interest to NABL, EIC, FSSAI and APEDA for accreditation/ approval.

The application shall be signed by the proprietor, partner or the Chief Executive Officer (CEO) of the Laboratory or any person duly authorized for this purpose. The authorization shall be supported with the Board resolution or a letter, as applicable under Companies Act /Rules. The name and designation of the person signing the application must be recorded legibly in a space apart for the purpose in the application form.

NABL shall process the application for Pre-assessment (which is optional) only after adjudging the suitability of management system by adequacy audit. Lead assessor shall be deputed to ascertain compliance to the documented Management System, equipment facilities/infrastructure, concerned Regulatory Body’s requirements and importing countries requirements as per international norms.

The assessment team shall be nominated by NABL for on-site witness audit of the laboratory pertaining to verification for the methods of sampling and analysis. The team so nominated shall conduct assessment; follow up assessments, if needed as well as surveillance of the laboratory.

The duration of assessment shall be normally of 5 days depending upon the scope applied. The assessment team will cover compliance to ISO/IEC 17025, importing countries’ requirements, sampling and relevant additional requirement of concerned Regulatory Body.

The integrated assessment conducted shall cover areas of the relevance to the scope of Accreditation /Recognition/ Approval of the laboratory.

Assessment shall include verification of test facilities, accommodation and environment, examination of documents and records, in house internationally accepted method validation documents in place, that shall be matrix specific for the scope applied for Accreditation /Recognition/ Approval, competence of laboratory personnel in conducting laboratory analysis/ testing, performance in witness tests, documentary evidence of participation in International Proficiency testing programs for relevant analytes and matrices and compliance to its Annual Plan for participation in such programs.

 The assessment team shall recommend for Accreditation /Recognition/ Approval of the laboratory for the specific scope in case there is no major or minor NC. The Lead assessor and the corresponding technical assessor shall duly sign on the recommended scope with appropriate recommendation.

 In case of any NC, the assessment team may recommend for Accreditation /Recognition/ Approval of the laboratory subject to closure of those said NCs. No NC shall be closed at the time of assessment.

The accredited/ approved/ recognized laboratory shall be subject to on-site surveillance once in a year by NABL to verify the continued compliance, competency and the implementation of quality system established by the laboratory. 

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