About Centre for Laboratory Accreditation (CLA)

QAI’s CLA has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of accreditation/certification of laboratories including medical, testing and calibration laboratories. The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ . Accreditation for ISO 15189 ‘Medical laboratories -- Requirements for Quality and Competence’, QAI Certification for Basic Composite Medical Laboratories as per Clinical Establishment Act and Accreditation for ISO 20387:2018 'Biotechnology-Bio banking- General requirements for biobanking'. The Scope of accreditation is listed in the application form as well under scope in this document. We offer accreditation services in a non-discriminatory manner. These services are accessible to all testing including medical and calibration laboratories in India and other countries regardless of the size of the applicant laboratory or its membership of any association or group. QAI-CLA will establish its accreditation system in accordance with ISO/ IEC 17011 ‘Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies’. Our accreditation system also takes note of the requirements of Mutual Recognition Arrangements (MRAs). We have made avaliable the relevant documents for laboratories, assessors and stakeholders on the website.

The organization structure of CLA has been designed to meet the requirements of an effective and efficient accreditation system. The Centre is governed by a Board. The Board frames and approve policies and guidelines, and provide direction to QAI’s CLA. CEO, QAI is the Member Secretary of the Board.

CLA operates its accreditation process through a structured framework of competent staff and pool of empanelled Lead Assessors and Assessors covering specified expertise.

Special Features of Laboratory Accreditation Programme

Quality Policy

‘Centre for Laboratory Accreditation’ of Quality and Accreditation Institute (QAI) will provide accreditation service to the satisfaction of its customers in accordance with the national and international norms. It is committed to provide equal opportunity to all the applicants with regard to impartiality, transparency, integrity, and confidentiality.

The Centre will strive for the international recognition of its accreditation programmes through regional and international forums like APAC, ILAC etc. and through bilateral and multilateral mutual recognition arrangements. We aim to operate globally.

We strive to comply with the requirements of ISO/IEC 17011:2017 “Conformity assessment —requirements for accreditation bodies accrediting conformity assessment bodies” and other relevant national/international standards and applicable APAC/ILAC documents.

Impartiality Policy

Impartiality is the backbone of QAI CLA activities and is of paramount significance in maintaining the confidence amongst the stakeholders about its accreditation system. QAI CLA is committed to safeguard the impartiality while dealing with accreditation at all levels. QAI CLA adheres to the requirement of ISO/IEC 17011: 2017 ‘Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies’ that accreditation shall be undertaken impartially.

QAI-CLA is a part of QAI and is designed in such a way as to ensure that impartiality is not compromised by any undue commercial, financial or other pressures.

QAI-CLA does not engage in any activities which could compromise its impartiality; it does not provide consultancy to CABs, nor does it undertake any conformity assessment activities itself and it does not promote the services of any specific body.

QAI CLA does provide training to external parties although these courses are confined to the provision of the requirements of ISO/IEC 17011.

QAI CLA applies its policies and procedures in a non-discriminatory manner and its services are available to all bodies whose accreditation applications fall within its defined scope of activities. It is applicable to all regardless of number of personnel, number of bodies already accredited or membership of any association or group.

QAI CLA board as the apex body, responsible for making all kind of policy decisions regarding providing resources and financial support including feasibility studies of the new accreditation programs, review of performance of personnel involved in accreditation and safeguarding the impartiality arising out of its activities, is having fair representation from the stakeholders ensuring that no one interest predominates.

The impartiality and objectivity of the accreditation services that QAI CLA provides is tightly controlled. All personnel involved in management, assessments and any other QAI CLA accreditation activities are required to declare any potential conflicts of interest. Accreditation decisions are made by competent persons independent of the assessment of the CAB under review.

In the event that customers or other stakeholders have concerns regarding the impartiality or objectivity of QAI CLA, QAI CLA has non-discriminatory procedures in place for handling complaints and appeals.