What is the difference between ISO and EN ISO 13485?

In the world of quality management systems (QMS), ISO and EN ISO 13485 are two commonly used standards that ensure the safety and effectiveness of medical devices. While both standards have similar objectives, there are significant differences between them in terms of scope, application, and certification requirements.

The Scope of ISO and EN ISO 13485

ISO, or the International Organization for Standardization, develops and publishes international standards that apply to various industries. ISO 13485 specifically addresses the unique requirements for companies involved in the design, production, installation, and servicing of medical devices.

EN ISO 13485, on the other hand, is a European Norm (EN) that adopts the ISO 13485 standard and adds additional requirements specific to European regulations. It is harmonized with the European Union (EU) Medical Device Directives, making it mandatory for organizations seeking CE marking, which allows for the free movement of medical devices within the EU market.

Application and Certification Requirements

ISO 13485 can be applied by any organization, regardless of its geographical location. Compliance with this standard demonstrates a commitment to quality management and continuous improvement in the medical device industry.

In contrast, EN ISO 13485 applies specifically to organizations operating within the European Economic Area (EEA) and seeking compliance with EU regulations. Compliance with this standard is necessary for the CE marking, indicating conformity to the essential requirements and undergoing scrutiny by EU authorities.

For certification, ISO 13485 requires organizations to undergo audits by accredited certification bodies to assess compliance with the standard. Certification is not mandatory but offers many benefits, such as enhanced customer confidence and access to new markets.

EN ISO 13485, however, requires organizations to undergo a third-party audit by a Notified Body accredited by the EU. This is mandatory for obtaining the CE marking and accessing the EU market.

In Conclusion

In summary, ISO 13485 is an international standard applicable to all organizations involved in the medical device industry, while EN ISO 13485 is a European Norm specific to companies operating within the EU. Compliance with EN ISO 13485 is crucial for obtaining the CE marking and accessing the EU market. Understanding these differences is essential for organizations seeking to navigate the regulatory landscape and ensure the safety and efficacy of their medical devices.