Purpose of Document
Regular audits are required to ensure compliance with legislation and the scope of the QMS certification to ISO 13485, 21 CFR 820 and the MDR/IVR. As a manufacturer of medical devices, it is also essential that Company conduct audits on its suppliers to ensure that contract manufacturers or subcontracted functions continue to carry out activities in accordance with applicable regulations, certifications, SOPs and quality agreements.
The Company internal quality audit and compliance auditing system is designed to fulfil the following objectives:
- Ensure compliance with existing requirements, or for the implementation of existing, new, or modified regulations
- Identification of areas of improvement, and to evaluate the effectiveness of CA/PAs and implemented changes
- Identification of potential risks
- Determine competence level of staff and effectiveness of the training system, and
- Training from audit and audit situations and sharing of quality knowledge.
This procedure defines the process for self-internal audit/quality audit to ensure regular appraisal of the effectiveness of the QMS and compliance with customer, quality, and regulatory requirements.
