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FAQ

41.2 Question on Facilities and equipment outside the labs permanent control

ISO/IEC 17025 permits the laboratories to use facilities and equipment outside its permanent control. So, ISO/IEC 17025 requires in section 6.3.5 “When the laboratory performs laboratory activities at sites or facilities outside its permanent control, it shall ensure that the requirements related to facilities and environmental conditions of this document are met” and in section 6.4.2 “When the laboratory uses equipment outside its permanent control, it shall ensure that the requirements for equipment of this document are met.”

Does these section permits this use of facilities or equipment just in special cases like, breakdown of own equipment, very special equipment, which is for example just at the producers facilities, or does these section permits the laboratories to be free in choosing if the tests will be done with its own equipment or for example with the equipment of some other, if the requirement for the facility (e.g. like environmental conditions) or the equipment (e.g. like calibration) meets the requirements given by ISO/IEC 17025 and the special test requirements?

ISO/IEC 17025 does not prevent the use of facilities or equipment that are outside the laboratory permanent control; therefore, as long as all ISO/IEC 17025 relevant requirements are fullfilled, laboratories can choose which equipment and/or facilities can be used.

However, the accredited laboratory will be still fully responsible for ensuring that the environment and equipment are suitable for the intended use, and that a risk based approach has been applied to the specific issue, covering also impartiality.