Kõik tootja kehtestatud kvaliteedisüsteemi meetmed, nõuded ja otsused peavad olema süstemaatiliselt ja korrapäraselt dokumenteeritud kvaliteediprogrammis, -plaanis, -käsiraamatus ja -aruandes viisil, mis võimaldab ühest tõlgendamist.
This quality system documentation must permit uniform interpretation of the quality programmes, quality plans, quality manuals and quality records.
It must include in particular an adequate description of: ... the quality records, such as reports concerning inspections, tests, calibration and the qualifications of the staff concerned, etc.
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