Competence of technical staff and supervision emphasized.
Policies and procedures to identify training needs are required.
Personnel should be permanent or contract.
Minimum job description contents given.
Specific personnel assigned specific tests (i.e., authorized personnel).
6.3 Facilities and Environmental Conditions
Facility and environmental conditions must be adequate to ensure correct performance of tests / calibrations.
Tests / calibrations to be stopped if conditions compromise results.
Incompatible activities to be separated.
Access to facilities to be controlled.
Good housekeeping measures to be in place.
Equipment must be available, capable of achieving required accuracy, under an established calibration program, operated by authorized personnel and uniquely identified.
Records maintained and include location, model number, maintenance schedule, etc and check that it meets specifications.
Calibration status indicated.
Out of service equipment identified clearly.
If equipment goes outside the lab, it needs to be validated before use.
Safeguard against inadvertent adjustment (e.g., use passwords for computer control).
6.5 Metrological Traceability
Ensure an adequate program for equipment calibration.
Ensure calibration is traceable to SI units, Certified Reference Materials (CRM) or inter-lab validated agreed methods or consensus standards.
6.6 Externally Provided Products and Services
Subcontracting of tests and calibrations requires the lab to advise and seek approval from the customer, preferably in writing (specific or partial).
Lab is responsible for subcontractor's work unless specified by the customer of regulatory authority.
Maintain a register of all subcontractors (includes records).
Procedures are needed for the selection of service/supplies.
Use services/supplies of adequate quality and verified before use.
Formal approval OR procedures to ensure that services and materials comply with specifications.
Maintain records on the history and any QA approvals of suppliers.
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