ISO 13485 Quality Management System Certification: the assurance that ensures quality, builds trust and guarantees compliance with medical device industry regulations.

ISO 13485 'Medical devices - Quality management systems' is the internationally recognized standard for quality management systems in the medical device sector

The ISO 13485 standard is aimed at organizations interested in the entire life cycle of medical devices, from design to production and subsequent activities, including decommissioning and disposal; it also covers areas such as logistics, distribution, service, testing, calibration, sterilization ... and can be used by organizations that produce raw materials, components and sub-assemblies

The main objective of ISO 13485, in a highly regulated context around the world, is to promote the global harmonization of the requirements of medical device regulations; the choice to certify its system in accordance with this standard demonstrates the will to pursue continuous improvement, and to provide customers with the confidence in their ability to place safe products on the market

For manufacturers of Medical Devices subject to conformity assessment procedures with intervention by the Notified Body according to Annexes II, V, and VI, certification in accordance with ISO 13485 provides the presumption of conformity of the quality system adopted. For manufacturers of Class I Medical Devices, not subject to the intervention of the Notified Body, the certification allows direct and independent verification of the activities of the devices, preparatory to any supervisory activities carried out by the Ministry of Health.

The ISO 13485 standard

The standard specifies the requirements for quality management systems that allow an organization to demonstrate its ability to provide medical devices and related services that comply with customer requirements and regulatory requirements applicable to such medical devices.

Being recognized as a harmonized standard pursuant to the Directives that regulate the placing on the market of Medical Devices, the ISO 13485 standard can be used by a Manufacturer as a reference for the implementation of Quality Systems within the regulatory procedures governing the design , the production and marketing of Medical Devices.

The advantages of ISO 13485 certification

ISO 13485 certification, which can be requested by organizations regardless of their size, helps improve overall performance, eliminate uncertainty, manage risk (identified in relation to safety and performance of the medical device for the end user) and expand opportunities market. Companies with this certification show a commitment to quality to their stakeholders, be they end users, customers or regulators.

The quality management system and related certification are a powerful tool for resource optimization, prevention and management of clinical risks and emergency situations. The certification improves the image of the company with the consequent increase in user confidence, increasing the confidence that the medical device can guarantee compliance with the required safety and performance requirements. In summary, an ISO 13485 certified management system helps an organization involved in any phase of the life cycle of a medical device to:

Demonstrate compliance with mandatory requirements
Ensure the implementation of good practices that consistently allow the supply of safe medical devices
Manage risk effectively
Improve processes
Gain competitive advantage.
Why get CSQ ISO 13485 certified with Cm Group

CM Group operates in the management systems certification sector. Cm Group maintains a continuous dialogue with institutions, scientific societies and trade associations.
CM Group is a body notified by the Ministry of Health for the issue of the CE marking for medical devices; it is therefore possible for manufacturers to request marking and system certification from the same body, optimizing time and resources for obtaining both awards.
CM Group is accredited by ACCREDIA.