arcoro Glossar

Quality records

Quality records are concrete documentations that contribute to the effective application and review of the quality management system. Quality records contain information on medical corrective and preventive actions, evaluations on suppliers, reports on internal audits, evidence of document and data control but also minutes of management meetings, quality assurance meetings and internal decisions. All quality records are sorted in a quality record list by document number, archived and kept by a responsible person. The ISO 9001 standard is the main criterion according to which the quality records must be kept.