According to p.7.11.4 from the new standard ISO/IEC 17025:2017 when the laboratory information management system (LIMS) is maintained through an external provider the laboratory shall ensure the provider – how this should be documented? Only with a contract or some extra documents are needed?
According to cl.7.11.4 the external provider shall comply with all applicable requirements of cl. 7.11
- The lab shall ensure through its procedure (cl 6.6.2) and the criteria set how the evaluation and monitoring of the performance of the external provider shall be done so, to conform to the relevant requirements in particular of cl. 7.11 (as per 6.6.2c). A contract could be acceptable if before accepting the contract the criteria of selection of the provider are adequately set and if the lab has proper competence and is able to evaluate that the provider conforms with them
- On site monitoring could be another option if the lab is able to visit on site and ensure the provider’s compliance, with cl. 7.11.2 and 7.11.3
- In any case the software of LIMS shall always be documented and validated for its functionality before implementation by the lab