The Quality Management System is a system of control, which is a set of activities designed to check that the results of a given process comply with established expectations. The organization of a System of Quality Management is based on the documentation that defines the activities implemented by the company for quality assurance.
The ISO 13485 is a standard recognized as a harmonized technical standard for quality systems designed specifically for companies that deal with the production, storage and distribution of medical devices. The ISO 13485 standard integrates the ISO 9001 standard and has many things in common with the latter. However, there are additional requirements for the control of processes, design, archiving reports, distribution of responsibilities, traceability and so on.
The ISO 13485 is the path most commonly chosen by companies that deal with medical devices to meet the requirements of a quality system required in Europe, Canada, Japan, Australia and other countries. The application of this standard is voluntary for manufacturers who wish to sell their medical devices in Europe, but almost all companies choose to apply it because, generally, it meets the requirements of the directives
and is considered suitable when applying the harmonized technical standards.
Di Renzo Regulatory Affairs provides the following services:
- Consultancy for the preparation and maintenance of the quality system according to ISO 13485
- Draw up the Quality Manual – that establishes the quality policy to be pursued and describes the system of quality management
- Draft SOPs – defining in detail, for each activity, actions, responsibilities, methods and means of operating, controls and registrations to be carried out
- Prepare data recording systems – that are intended to give objective evidence of activities performed, the checks carried out and the results obtained
- Taking on the role of Quality Assurance for the ISO 13485 systems
- Audit of the quality management system of the manufacturer and / or distributor
- Audits pre and post inspections by Notified Bodies and Competent Authorities at manufacturers of medical devices
- Audits at suppliers manufacturers / producers of medical devices to assess the level of compliance with ISO 13485
- Non-conformance management and CAPA (Corrective and preventive action)
- Participation in review meetings of the executive management
- Training of internal auditors
- Management of complaints and monitoring procedures on the market
- Control and update of the documentation of the quality system.