In this post, we’ll take a closer look at the most important aspects of manufacturing medical refrigerators in accordance with the ISO 13485 standard and the quality process requirements this entails for the manufacturer
The Importance of the ISO 13485 Standard
In the case of medical-grade refrigerators—perhaps more so than with any other product—quality directly affects the effectiveness of the device and the safety of patients, users, and possibly others.
For this reason, 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 often face greater difficulties in gaining approval in major markets.
Expiration of the regulation
Companies that already hold a certificate under the EN ISO 13485 standard were required to transition their certification to the new standard by May 31, 2019. All certificates issued under the old standard will now remain valid for a period of three years until the European Commission publishes the expiration date of the superseded standard.
After this publication, the expiration date will become the validity date. Manufacturers with certificates that still have a longer validity period should prepare in advance and ensure that their certificate is converted to the new EN ISO 13485:2016 standard before the expiration date of the old standard.
What is the ISO 13485 standard?
The EN ISO 13485 standard, «Medical Devices: Quality Management Systems—Requirements for Regulatory Purposes,» addresses the Requirements that manufacturers and suppliers of medical devices must meet in the development, implementation, and maintenance of management systems for the medical device industry.
Originally developed in the 1990s, the standard sets forth requirements for quality management systems that meet customer requirements as well as regulatory requirements in the European Union (EU), Canada, and other major markets around the world.
The EN ISO 13485 standard has a scope and purpose similar to those of the ISO 9001 standard, but it contains additional requirements specific to medical devices—including medical refrigerators—and revises some of the requirements of the ISO 9001 standard.
Therefore, in most markets, certification under ISO 9001 is not an adequate substitute for certification under the requirements of EN ISO 13485.
Harmonized Versions of ISO 13485 (EN ISO 13485)
- the conformity assessment procedures under the Medical Devices Directive (93/42/EEC),
- the Directive on in vitro diagnostic medical devices (98/79/EC)
- the Directive on Active Implantable Medical Devices
- devices (90/385/EEC).
Why is auditing in accordance with the EN ISO 13485 standard important?
In the EU, the requirements of the EN ISO 13485 standard have been harmonized with the 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 to the EN ISO 13485 standard by an accredited certification body gives rise to a presumption of conformity. This means that a manufacturer certified to the EN ISO 13485 standard is presumed to comply with those aspects of the requirements of these directives that are covered by the standard.
Regulatory Approval in the U.S. and Canada
In the United States, audit reports in accordance with the EN ISO 13485 standard are currently accepted by the authority responsible for the approval of medical devices, the Food and Drug Administration (FDA), as evidence that a manufacturer complies with the FDA’s requirements regarding quality management systems (Quality System Regulations, QSR).
Health Canada also requires that manufacturers of medical devices who wish to market their products in Canada have their quality management systems certified in accordance with the EN ISO 13485 standard. In the future, quality management audits for Canada will be required through MDSAP audits.
Drafting of Regulations
The standard was developed by the ISO/TC 210 Technical Committee «Quality management and related general aspects for medical devices» (secretariat: ANSI, U.S.) 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 relevant national agencies also participate in the working committees on «Quality Management and General Issues Related to Medical Devices.».
Specifications
The DIN EN ISO 13485:2016-08 standard specifies the requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
These companies may be involved in one or more stages of a medical device’s life cycle, including the development, production, storage, and distribution of a medical device; the installation or maintenance of a medical device; and the development or provision of related activities.
In the case of Coreco, S.A., we have met all the requirements of the standard and we provide refrigeration equipment that meets very high quality standards.
Can the regulation be applied to suppliers?
The standard may also be applied by suppliers or external parties that provide products—including services related to the quality management system—to such organizations.
Compared to the DIN EN ISO 13485:2012-11 standard, a fundamental technical revision has been carried out. These include, in particular:
- Compliance with the ISO 9001:2008 standard,
- Review of the definitions,
- Review of documentation requirements,
- Integration of a risk-based approach,
- addition of requirements for the validation of software use,
- Review of infrastructure requirements, as well as the work environment;,
- Addition of requirements for the manufacture 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 medical devices, 93/42/EEC on medical devices, and 98/79/EC on in vitro diagnostic medical devices.
