Our instrument qualification services can help your laboratory with the commissioning of new equipment and with maintaining the qualified status of your existing instruments in accordance with accreditation requirements.
This includes the following key activities
Establishing appropriate user requirement specifications (URS), and converting these into functional requirement specifications (FRS) and operational specifications.
Assessing the quality, compliance and business consequences of and potential failure of any functionality of your equipment and identifying appropriate mitigation activities.
Assuring the equipment was delivered to your laboratory as ordered
Assuring your laboratory meets the requirements for the instrument.
Documenting correct instalment .
Identifying key quality parameters that affect the test results, and establishing checks and calibrations to control key quality parameters
Establishing the laboratory systems required to maintain the instruments in their qualified state.
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Clause 6.4.1 requires:
A laboratory have access to equipment required for the correct performance of the tests or calibrations and that can influence the results.
Clauses 6.4.4 requires:
A laboratorytoverifythatequipmentconformstospecifiedrequirementsbeforebeing placed or returned into service
Clause 6.4.5 requires:
All equipment used for measurement to be capable of achieving the accuracy and/or uncertainty required to provide validresults.
Clause 6.4.7 requires:
A laboratory to establish a calibration programmewhichshallbereviewedandadjustedas necessary in order to maintain confidence in the status of calibration.
Clause 6.4.9 requires:
Any equipment that been mishandled, or is otherwise not operating within specification, shall not be used and steps shall be taken to prevent use until it can be repaired.