We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and with the ability to charge fees, etc. My question is would that be possible without establishing the lab as its own company (LLC, division, etc.)? If we charge fees, would we be considered a third party lab in relation to our parent company with our own, HR, admins, IT, etc separate from the parent company?
The ISO/IEC 17025 accreditation (not certification) process allows for captive laboratory under a parent organization to accredited. ISO/IEC 17025:2005 Clause 4.1.4 states:
“If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.
NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory’s compliance with the requirements of this International Standard.
NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.”
There is no requirement that the “laboratory should have its own name and have ability to charge fees”. It is up to the laboratory to organize in a manner that it sees fit as long potential conflicts with the parent organization are identified. Notes 1 and 2 provide more guidance for this Clause. Nor is there a requirement that it have its own IT, HR and other departments as long as those arrangements are identified and any potential conflict of interest resolved to the Accrediting Body’s interest.
Dilip A. Shah
ASQ Fellow, ASQ-CQE, CQA, CCT,
President, E = mc3 Solutions,
Technical Director, Sapphire Proficiency Testing Services
Chair, ASQ Measurement Quality Division (2016, 2012-2013, 2007, 2004-2005)
Past Member of the A2LA Board of Directors (2006-2014)