the permanent internal control of production exercised by the manufacturer. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic manner in the form of written policies and procedures. This production control system documentation shall ensure a common understanding of quality assurance and enable the achievement of the required product characteristics and the effective operation of the production control system to be checked., ohje - kvaliteedi juhtimise osa, mis käsitleb vaadeldava objekti kontrolli all hoidmist kehtestatud protseduuride, menetluste, meetodite jms abil