Clause 6.2.6 in ISO/IEC 17020 states that “where appropriate measurement equipment having a significant influence on the results of the inspection shall be calibrated before being put into service”. What about cases where no calibration services are available in the market? Would verification from a manufacturer be enough in such cases? In this context; what is the meaning of “appropriate”?
STANDARD: ISO/IEC 17020 · CLAUSE: 6.2.6 · TOPIC: Calibration of measurement equipment
In ISO/IEC 17020 clauses 6.2.6 and 6.2.7 there occur the phrases “where appropriate”, “having a significant influence on the results”, “wherever applicable”, “where available” and “where traceability to national standards is not applicable”. In all of these cases the need to calibrate or not depends on the assessment of the appropriateness and the applicability or the availability of traceable calibration. It is not possible for ILAC to provide specific guidance on specific fields of measurement in specific economies. Reference should be made to the ILAC P15 application note 6.2.6 a: “The justification for not calibrating any equipment that has a significant influence on the on the outcome of inspection should be recorded.” Accreditation bodies should encourage inspection bodies to record the rationale for their decisions on the appropriateness or applicability or availability of calibration for a particular measurement. By doing this the inspection body will reveal their level of understanding of measurement systems and the criticality of a particular measurement for a particular inspection result. It will then be for a technical expert member of the assessment team to assess the technical appropriateness of the decisions made by the inspection body. This may also be used as one factor in determining their level of competence in the inspections they undertake. In general, decisions should always be taken primarily on technical grounds. If the main reason for deciding that traceable calibration is not appropriate, or applicable is on the basis of cost then this implies inherent differences in the quality and reliability of the same inspections from different economies. This goes against the intent of Mutual Recognition Arrangements (MRAs). It may be that some inspections cannot be performed appropriately, and therefore not under accreditation, in some economies until the infrastructure is improved sufficiently to support the activity. On the other side it would be inappropriate for accreditation bodies to insist on traceable calibration for measurements that are not critical to particular inspections. The reasons for decisions on these issues are always critical. Under these circumstances the accreditation body should review each set of circumstances on a case by case basis and have a discussion with the inspection body concerned.