| Popis: |
Internal audit is quality system requirement, and QS is requirement from EU Directive 2004/23. EU Directives are transposed in legal system of MS by competent authorities. Audits are an essential element of the quality assurance system and legal requirement. Audits in IVF laboratory should be performed at regular intervals to check whether the rules of good manufacturing practice are being applied. Audits should be focused on personnel, premises, equipment, documentation, process, quality control, and distribution. Audits should be pre- arranged and laid down in the form of an inspection program. In preparation, the rough process should be defined in advance. This means that specific key aspects are detailed. Checklists should be compiled (questionnaires). Carried out by competent auditor. During audit nonconformities are detected, analysed and CAPA are implemented. Audits are not primarily used to find faults, but to promote an awareness of quality and improve quality system. |
