An inspection body which is part of a larger entity, carries out inspections of clean rooms and related controlled environments (biosafety cabinets, LAF cabinets, etc.) for third party clients.
That entity also provides sterilization and testing services other than inspection activities. The entity owns and uses clean rooms and controlled environments (cabinets) in order to provide sterilization and test services.
ISO/IEC 17020:2012 Annex A-A1-(c)-NOTE 2 reads as “This does not preclude the purchase, ownership, maintenance or use of inspected items that are necessary for the operations of another part of the same legal entity, or for personal purposes by the personnel.”
IEC 17020:2012 Annex A-A1-(b) reads as “The inspection body and its personnel shall not engage in any activities that may conflict with their independence of judgment and integrity in relation to their inspection activities. In particular, they shall not be engaged in the design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected.”
Is it correct to say that this inspection body would be considered in line with ISO/IEC 17020:2012 as type-A inspection body considering exceptions described in Annex-A-A1-(c)-NOTE 2?
March 2024
ISO/IEC 17020:2012 standard, in the Annex A, clause A.1.b) states that “The inspection body and its personnel shall not engage in any activities that may conflict with their independence of judgment and integrity in relation to their inspection activities. In particular, they shall not be engaged in the design, manufacture, supply, installation, purchase, ownership, use, or maintenance of the items inspected”.There is also the NOTE 2: “This does not preclude the purchase, ownership or use, of the inspected items that are necessary for the operations of the inspection body, or the purchase, ownership or use, of the items for personal purposes by personnel”.
In the case of the FAQ, the inspection body cannot provide inspection of clean rooms as type A inspection body because it belongs to a larger entity which provides sterilization services and testing services for clean rooms/cabinets because there is a clear conflict of interest. The Note 2 cannot be applied here: these cabinets are not necessary for the operations of the inspection body nor for personal purposes by the personnel.