ISO 17025 Quality Manual ISO 17025 Quality Manual Template

Thursday, May 04, 2006

 

4.5 Subcontracting of Tests and Calibrations

4.5.2 Customer Approval
Customers must be advised in writing when any portion of their work is subcontracted to another laboratory.

Note:
It is not a requirement that the lab identify to whom they had subcontracted a test or the name of the subcontractor. Under the requirement of this section, the lab must however inform their clients of their intent to subcontract prior to having the work subcontracted. Records of client consent must be retained.

An ISO 17025 accreditation for a specific scope of capabilities and for a specific site. The requirements for subcontracting actually apply in principle only to the subcontracting of an accredited test/calibration. The subcontracting of accredited tests/calibrations should not be confused with subcontracting of other tests and work. Organizations routinely subcontract work for a variety of reasons and when this work is not an accredited test/calibration, the conditions of ISO 17025 section 4.5.1 do not actually apply as far as accreditation requirements are concerned.

Examples of activities and work that are not considered subcontracting:
- calibration of measurement or test equipment when the lab is not accredited for calibrations
- outsourcing part of a test/calibration for which the lab is not accredited

These examples would essentially be considered purchasing and in the case of the second point the accrediting body would not be reviewing the activity. The first item would be reviewed under the requirements of 4.6 Purchasing and 5.6 Traceability.

ISO 17025 views subcontracting much more formally than what most organizations normally practice. When an organization has different subcontracting practices than those required by ISO 17025, then different procedures are required with a clear distinction within the procedures as to when the ISO 17025 procedures apply.

When a lab is subcontracting an accredited test/calibration (for whatever reason) to another lab that is part of the same legal entity and is accredited for the specific test being subcontracted, the accrediting body does not consider the movement of this test/calibration item between such facilities as subcontracting. The test/calibration report produced will however need to be identified to the facility that conducted the test/calibration. The requirements of ISO 17025 section 5.8 Handling of Test and Calibration Items applies.


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