3.7.14 Inspections in the "regulated area" Estimated reading: 1 minute 49 views Authors Goal and purpose The hospital is inspected by supervisory authorities to ensure that it fulfils the requirements of laws and regulations. The preparation through possible internal audits, briefing of employees and processing of deviations should be regulated. Application Description of the process Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 3.7 QM coordination - Previous 3.7.13 Conformity assessment by a Notified Body Next - 3.7 QM coordination 3.7.15 External quality assurance