Certificazione DM ISO 13485:2016

ISO 13485

CERTIFICATION

UNI CEI EN ISO 13485:2021
The Quality Management System for Medical Devices

CERTIFYING BODY

Since 2001, Bericah S.p.A. has been certified under ISO 13485 by the accredited certifying body IMQ.

ISO 13485

Perhaps more than any other type of product, the quality of medical devices has a direct impact on their effectiveness, as well as on the safety of patients, users and, where applicable, other individuals. For this reason, most national regulatory frameworks require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently assessed and verified. Medical devices manufactured or supplied by organizations without a verified quality management system are regularly prohibited from legally entering major markets, usually resulting in delays in market access and loss of revenue opportunities.

Originally developed in the 1990s, the standard details the requirements for a quality management system that meets customer requirements and regulatory provisions in the European Union (EU), Canada, and other major jurisdictions around the world. UNI CEI EN ISO 13485 has a scope and purpose similar to ISO 9001, but it includes additional requirements specific to medical devices, while excluding certain provisions of ISO 9001. Therefore, in most jurisdictions, ISO 9001 certification is not considered an acceptable substitute for certification compliant with the requirements of UNI CEI EN ISO 13485:2021. In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU Medical Devices Directive (93/42/EEC), the In Vitro Diagnostic Medical Devices Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). Certification, issued by an accredited Certification Body, provides a presumption of conformity with the essential requirements of these important directives, which have now been replaced by Regulations (EU) 2017/745 and 2017/746.

Benefits of UNI CEI EN ISO 13485:2021 certification

UNI CEI EN ISO 13485:2021 is the internationally recognized standard for quality management systems in the medical devices sector; it is intended for use by any organization involved in the design, development, production, installation, and technical support of medical devices or related services.

for Medical Device manufacturers, UNI CEI EN ISO 13485:2021 certification provides a presumption of quality system conformity when assessing the requirements for CE Marking carried out by a Notified Body;
for Class I Medical Device manufacturers (self-certification), UNI CEI EN ISO 13485 certification allows for a direct and independent verification of the activities implemented to meet the requirements of Regulation (EU) 2017/745 and is preparatory to any market surveillance activities carried out by the Ministry of Health;
for companies that distribute or market medical products and for companies that provide services related to devices, UNI CEI EN ISO 13485:2021 certification allows participation in public tenders issued by the Public Administration.

Cosa prevede la norma
UNI CEI EN ISO 13485:2021?

It focuses on activities associated with the effective use of feedback information to ensure compliance with the safety and performance requirements of medical devices throughout their entire life cycle;
It emphasizes the need to evaluate the “Usability” of medical devices;
It gives particular consideration to the role and responsibilities of the various parties that play a decisive role in the device life cycle: suppliers, logistics service providers, distributors, importers, etc.;
It recognizes service providers, processes, and semi-finished products as important elements in the realization cycle of medical devices;
It introduces the design transfer requirement;
It provides for the monitoring of products after commercialization through the introduction of new requirements;
It requires the validation of software used for the quality management system and of software involved in production and service delivery processes;
It places strong emphasis on the risk-based approach in process management.

These sections are based on a PDCA cycle (Plan-Do-Check-Act)

The Quality Management System (QMS) is in fact based on process management (each operation is considered as a process with inputs, controls, and desired outputs) and primarily aims at full customer satisfaction, as well as improving the efficiency and effectiveness of results in order to increase companies’ chances of success in the market.

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