7.1
Review of requests and contracts: capability, method, decision rule, contractual deviations
Request reviewTender review formDeviation managementDecision rule
7.2
Selection, verification and validation of methods: scope, performance, deviations
Method selectionValidation / verificationValidation fileMethod deviations
7.3 to 7.4
Sampling and handling of test items: representativeness, transport, storage, identification, receipt deviations, chain of custody
Sampling procedureSampling planHandling & storageItem identificationReceipt deviations
7.5 to 7.6
Technical records & measurement uncertainty evaluation (GUM, NIST TN 1297)
Technical recordsBench sheetsUncertainty evaluationGUM uncertainty budgetDecision rule
7.7
Ensuring the validity of results: internal QC, control charts, proficiency testing, interlaboratory comparisons
Internal QCControl charts (Levey-Jennings, Westgard)Proficiency Testing (PT)Interlab comparisonsOut-of-tolerance results
7.8 to 7.10
Reporting of results, opinions and interpretations, complaints, nonconforming work: content, processing, investigation
Report issuingAccredited test report templateCalibration certificateOpinions & interpretationsComplaint handlingComplaints registerNonconforming work
7.11
Control of data and information systems: validation, backup, LIMS data integrity (FDA 21 CFR Part 11 for regulated labs)
Data controlBackup & archivingIT systems validationIT security