Accreditation Audit/Certfication Audit for ISO 17025

Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence. For specific tests/measurements, based on third party assessment and following international standard. Accreditation plays an important role in social sectors such as medical, food, environmental and forensic science testing laboratories.

Two types of audits are conducted by accreditation bodies to minimise the risk of inappropriate accreditation of accreditation certificate and the invalid creation of accreditation certificates:

• Pre-assessment audits

• 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 the accreditation body like NABL / UKAS etc

• Final assessment Audits of certificate creation and ongoing compliance (verifications).
• Final Assessment at the laboratory site(s) for its compliance to ISO 17025 Criteria and for that purpose an assessment team is appointed.
• 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 accreditation body.

Pre-assessment audits are used to address specific eligibility issues such as record keeping systems, laboratory infrastructure and resources.

In final assessment, Assessor’s team reviews the laboratory’s documented quality system and verified its compliance with the requirements of ISO/IEC 17025 and specific criteria. The laboratory’s technical competence to perform specific test/calibrations is also judged.

In order for accreditation bodies to recognise each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

In the US there are multiple Accreditation Bodies (ABs). The non-profit, non- government multidisciplinary ABs are A2LA American Association for Laboratory Accreditation, AIHA American Industrial Hygiene Association, NVLAP (smaller but focused technical areas and some government involvement) and American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB)(crime labs). For-profit ABs are ANSI-ASQ National Accreditation Board/ACLASS, International Accreditation Service (IAS), Laboratory Accreditation Bureau (L-A-B),Perry Johnson Laboratories (PJLA), and Forensic Quality Services, Inc. (FQS).

In Canada, there are two Accreditation bodies; The Standards Council of Canada and The Canadian Association for Laboratory Accreditation. The accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada (SCC) Program for the Accreditation of Laboratories-Canada (PALCAN), and the National Research Council of Canada (NRC) Calibration Laboratory Assessment Service (CLAS). The CLAS program provides quality system and technical assessment services and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System.

In other countries there is often only one Accreditation Body. Typically these bodies encompass accreditation programs for Management Systems, Product Certification, Laboratory, Inspection, Personnel and others. The first laboratory accreditation bodies to be established were NATA in Australia (1947) and TELARC in New Zealand (1973) most other bodies are based on the NATA/TELARC model and include UKAS in the UK, FINAS in Finland and DANAK in Denmark to name a few. In India National Accreditation Board For Testing & Calibration Laboratories (NABL) under the Ministry of Department of Science & Technology, Government of India provides accreditation.