ISO 13485 Quality Management System Certification: a certification system that ensures quality, builds trust and guarantees regulatory compliance in the medical devices sector

ISO 13485 "Medical devices - Quality Management Systems" is the internationally recognised standard for quality management systems in the medical devices industry

ISO 13485 is aimed at organisations involved 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, sterilisation, etc., and can be used by organisations that produce raw materials, components and sub-assemblies.

The main objective of ISO 13485, in an industry that is highly regulated worldwide, is to promote global harmonisation of the requirements of regulations governing medical devices. Choosing to certify your system in accordance with this standard demonstrates your commitment to achieving continuous improvement and giving customers confidence in your ability to bring safe products to the market.

For medical device manufacturers subject to conformity assessment procedures by a Notified Body in accordance with the annexes II, V and VI, certification to ISO 13485 provides the necessary evidence of quality system conformity. For manufacturers of class I medical devices, who are not subject to assessment by a Notified Body, certification enables direct, independent verification of activities relating to the devices, in preparation for any surveillance activity that may be carried out by the Ministry of Health.

ISO 13485

The standard specifies the requirements for quality management systems that enable an organisation to demonstrate its ability to supply medical devices and related services that meet customer needs and conform with the applicable regulatory requirements.

Since it is recognised as a harmonised standard under the directives governing the market release of medical devices, ISO 13485 can be used by manufacturers as a reference for the implementation of quality systems within the framework of regulatory procedures governing the design, production and market release of medical devices. 

The benefits of ISO 13485 certification

ISO 13485 certification, which organisations can apply for regardless of their size, helps improve overall performance, eliminate uncertainty, manage risk (identified in relation to the safety and performance of the medical device for end-users) and extend market opportunities. Companies in possession of this certification demonstrate their commitment to quality to all stakeholders, whether end-users, customers or regulatory authorities.

Implementing and certifying a quality management system is a highly effective means of optimising resources and preventing and managing clinical risks and emergency situations. Certification enhances company image and consequently increases the confidence of users, by reassuring them that the medical device complies with the applicable safety and performance requirements. To sum up, an ISO 13485 certified management system helps organisations involved in any phase of the medical device life-cycle to:

  • Demonstrate their compliance with mandatory requirements
  • Implement good practices that consistently result in the supply of safe medical devices
  • Manage risk effectively
  • Improve processes
  • Gain competitive advantage.


Why opt for CSQ ISO 13485 certification from IMQ?

  • IMQ has been operating in the certification of management systems for about 30 years. IMQ/CSQ maintains continuous relations with institutions, scientific societies and trade associations.
  • IMQ is a body notified by the Ministry of Health for the issuance of CE marking for medical devices. This means that manufacturers can apply for CE marking and system certification from the same body, thus optimising the time and resources spent on obtaining both awards.
  • IMQ is accredited by ACCREDIA. 
Certification for CSQ schemes is awarded to organisations that operate in accordance with the applicable standards. Certificates are valid for three years. The audits are planned on the basis of the customer’s requirements and in accordance with international standards. After the award of the certificate, the organisation undergoes periodic audits and an overall system review every three years. The auditors make on-site visits to organisations to analyse their ability to plan and manage their business processes. Management system certification is the endorsement enjoyed by organisations that have chosen to equip themselves with efficient management systems and suitable skills and structures, aimed at continuous improvement. And the higher the prestige of the awarding body, the higher the value of the guarantee. Equipped with state-of-the-art technology, our laboratories have full capability to put products through all the checks required by the major European directives and international standards. The certifications issued by IMQ are synonymous with trust. They guarantee safety, performance, efficiency and quality standards. More than 10,000 companies have turned to IMQ to certify their products and stand out on the market. Notified body for the main EU directives, IMQ offers tests and CE certifications to assess the conformity of the products to the requirements required to be marketed on the European market. Inspections and audits validate the conformity of electrical installations, equipment, supplies and services with the applicable technical and legislative specifications.