Importance of ISO 13485
In the case of medical range refrigerators, the quality directly affects the effectiveness of the device and the safety of patients, users and others.
Therefore, many national regulations require manufacturers and suppliers of medical refrigerators to demonstrate that they have a quality management system that has been independently audited and certified.
Medical devices manufactured or offered by companies that do not have a certified quality management system are often more difficult to approve in markets.
Expiry of the rule
Companies that had a certificate according to EN ISO 13485 needed to change it from May 31st, 2019. All certificates under the old rule will be valid for a period of three years until the European Commission publishes the expiry date of the new rule.
After this publication, the expiry date shall become the validity date. Manufacturers with certificates that still have a longer period of validity should prepare in advance and ensure that their certificate is converted to the new standard.
What is ISO 13485?
EN ISO 13485 «Medical devices: Quality management systems – Requirements for regulatory purposes» addresses the requirements to be met by manufacturers and suppliers of medical devices in the development, the implementation and maintenance of management systems for the medical device industry.
Originally developed in the 1990s, the standard contains requirements for quality management systems that meet customer requirements, as well as regulatory requirements for the European Union (EU), Canada and other major markets around the world.
EN ISO 13485 has a scope and purpose similar to those of ISO 9001. The difference is that it contains additional requirements to medical devices, including medical refrigerators, and reformulates some of the requirements of ISO 9001.
Therefore, in most markets, ISO 9001 certification is not a suitable substitute for certification according to the requirements of EN ISO 13485.
Harmonization of ISO 13485 (EN ISO 13485)
• The conformity assessment procedures of the Medical Devices Directive (93/42/EEC),
• Directive on in vitro diagnostic medical devices (98/79/EC)
• Active Implantable Medical Devices Directive
• Devices (90/385/EEC).
Why is auditing according to EN ISO 13485 important?
In the EU, the requirements of EN ISO 13485 have been harmonised with the requirements of the EU Medical Devices Directive (93/42/EEC), the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and the Directive on active implantable medical devices (90/385/EEC).
Certification according to EN ISO 13485 by an accredited certification body gives rise to a presumption of conformity. This means that a manufacturer certified according to EN ISO 13485 is presumed to meet the aspects of the requirements of these directives covered by the standard.
Approval in USA and Canada
In the United States, EN ISO 13485 audit reports are currently accepted by the Food and Drug Administration (FDA), the authority responsible for approving medical devices, as proof that a manufacturer meets the FDA’s requirements for quality management systems (QSR).
Health Canada also requires medical device manufacturers who wish to market their products in Canada to have their quality management systems certified according to EN ISO 13485. In the future, quality management audits for Canada will be required through MDSAP audits.
Preparation of the legislation
The standard has been developed by the ISO/TC 210 Technical Committee «Quality Management and Related General Aspects for Medical Devices» (Secretariat: ANSI, USA) in collaboration with the CEN/CLC/TC 3 Technical Committee «Quality management and related general aspects for medical devices» (secretariat: NEN, Netherlands) with the participation of experts from all European countries.
All responsible national bodies are also involved within the working committees on «Quality management and general aspects related to medical devices».
DIN EN ISO 13485:2016-08 specifies requirements for a quality management system when a company is required to demonstrate its ability to provide medical devices.
Such undertakings may participate in one or more stages of the life cycle of a medical device, including the development, production, storage and distribution, installation or maintenance of a medical device, and the development or provision of related activities.
In the case of Coreco. S.A., we have complied with all the requirements and we provide refrigeration equipment with very high quality standards.
Can the standard be applied to suppliers?
The standard may also be applied by suppliers, including services associated with the quality management system.
In comparison with DIN EN ISO 13485:2012-11, a fundamental technical review has been carried out. These include, in particular:
• Alignment with ISO 9001:2008,
• Revision of definitions,
• Review of documentation requirements,
• Integration of a risk-based approach,
• addition of requirements for the validation of the use of software,
• Review of infrastructure and work environment requirements;
• Addition of requirements for the realisation of products,
• Review of measurement, analysis and improvement requirements.
The relationship between ISO 13485:2016 and ISO 9001:2015 is presented in an informative annex.
The standard supports the essential requirements of EU Directives 90/385/EEC on active implantable devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic medical devices.