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Quality Management System according to ISO 13485

The Quality Management System (QMS) is a system of control, i.e. a set of activities designed to check that the results of a given process comply with established expectations. The organisation of a QMS is based on the documentation defining the activities implemented by the company for the quality assurance.

The UNI CEI EN ISO 13485 is a technical standard for quality systems specifically designed for companies dealing with the design, production, storage and distribution of medical devices/in vitro diagnostics.

The ISO 13485 standard integrates the ISO 9001 standard and has many requirements in common with it, however it also provides for additional requirements on typical MD and IVD processes.

Compliance with the ISO 13485 is the path most commonly followed by companies dealing with MDs and/or IVDs to meet the requirements of a QMS in Europe, Canada, Japan, Australia and other countries.

The application of this standard is mandatory for all subjects intervening in the life cycle of a MD or IVD sold in the EU, however its certification is voluntary; differently, for manufacturers who wish to sell their medical devices outside the EU, it is almost mandatory as most countries request it to grant access to their markets.

Moreover, it should be considered that Regulation (EU) 2017/745 expresses the need to clearly define the general obligations of the various economic operators, now all explicitly defined, including importers and distributors, each with their own obligations and responsibilities, with the scope of improving the compliance with the legal provisions by all concerned operators.

This inevitably involves, also for importers and distributors, the need to operate in the frame of an appropriate quality management system, ensuring that products and activities are appropriately managed and in compliance with the MDR requirements. 

Di Renzo Regulatory Affairs has highly qualified staff dedicated to the quality management services, and is able to assist companies in the following activities: 

  • advice for the setting up and maintenance of the Quality Management System according to the ISO 13485:2016
  • drafting of the Quality Manual 
  • drafting of Standard Operating Procedures (SOPs)
  • setting up of the data recording system
  • assumption of the role of Quality Assurance for ISO 13485 systems
  • audits on the Quality Management System of manufacturers and/or distributors
  • audits before and after inspections by Notified Bodies and Competent authorities at manufacturers and manufacturing sites of medical devices
  • audits at suppliers of manufacturers of medical devices to assess the level of conformity to the ISO 13485
  • assistance in the management of non conformities and corrective and preventive actions (CAPAs)
  • attendance of review meetings of the executive management and/or support in the drafting of the relevant minutes (management review)
  • in-house training on the QMS and on the general principles of specific ISO standards
  • management of the complaints and post-marketing surveillance procedures
  • control and update of the QMS documentation.

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