EN ISO 13485 concerns organizations involved in one or more stages of the life cycle of a medical device, such as:
- design
- manufacture
- installation
- maintenance
- marketing
- storage
- technical support
- scientific support
- repackaging
- education
Key points of the standard are the risk approach for the design and implementation of the product, the validation of the procedures, the compliance with legal and regulatory requirements, the ongoing training of company staff and the existence of traceability and recall procedures with reference to the relevant principles.
It is an internationally recognized standard of quality and safety for the manufacture of medical devices while the certification according to ISO 13485 helps companies, through better control of their processes, to continuously improve and strengthen their position in international and local markets.
EN ISO 13485: 2016 is the pre-eminent standard for a manufacturer of medical devices to comply with the instructions of Medical Devices Directive 93/42 / EEC. The standard is expected to be updated to correlate with the MDR745 guidelines.
System Evaluation
The evaluation of a quality system is carried out in two phases. In the first includes the evaluation of the system documentation and its determination based on the objectives, the assessment of the internal inspection and review, as well as whether the management system has been sufficiently developed and implemented. The second phase evaluates the implementation and effectiveness of the system in relation to the applicable legal and regulatory requirements, objectives and quality policy of the organization.
The validity of the issued certificates is three years.
Throughout the validity of the certification, surveillance inspections are carried out on an annual basis in order to confirm the continuous application of the approved quality system.
The renewal of the certification requires a re-evaluation of the system in relation to the applicable requirements. The process must be completed prior to the expiration date of the valid certificate.
The procedure and conditions for issuing, maintaining and renewing certificates are described in detail in the Quality Systems and Products Certification Regulation.
