What is the difference between ISO 9001 and ISO 13485?

ISO 9001 FAQ
ISO 9001 / ISO 9001 FAQ

What is the difference between ISO 9001 and ISO 13485?

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ISO 9001 and ISO 13485 are two different quality management systems standards. ISO 9001 is a general quality management system standard that can be applied to any organization, while ISO 13485 is a specific standard that can be applied to organizations that design and manufacture medical devices. Both standards share some common features, such as a focus on quality control and continuous improvement, but they have different requirements. ISO 9001 is less prescriptive than ISO 13485 and does not require a documented quality management system. ISO 9001 is also less focused on product safety and quality than ISO 13485.

There are several major differences between ISO 9001 and ISO 13485. Firstly, whereas ISO 9001 is applicable to any type of organization, regardless of its size or sector, ISO 13485 is specifically tailored for organizations that design and manufacture medical devices. As such, it includes additional requirements related to risk management, product traceability, and post-market surveillance. Secondly, while certification to ISO 9001 is voluntary, certification to ISO 13485 is often mandatory in order to do business in the medical device sector. Finally, while organizations certified to ISO 9001 can use the standard’s logo on their products and marketing materials, only those certified to both ISO 9001 and ISO 13485 can use the combined logo.

In summary, the main differences between ISO 9001 and ISO 13485 are that the latter is specifically designed for the medical device sector, it includes additional requirements related to product safety and traceability, and certification is often mandatory in order to do business in this sector. By contrast, ISO 9001 can be applied to any type of organization and is voluntary.

However, both standards share a commitment to quality and continuous improvement.

And while certification to ISO 9001 is not a requirement for certification to ISO 13485, many organizations choose to pursue both certifications in order to demonstrate their commitment to the highest quality standards.

The table below provides a more detailed comparison of the two standards:

ISO 9001 ISO 13485
Scope Can be applied to any type of organization  specifically tailored for organizations that design and manufacture medical devices
Risk management No specific requirements includes additional requirements related to risk management, product traceability, and post-market surveillance
Product safety No specific requirements includes additional requirements related to product safety and traceability
Certification Voluntary often mandatory in order to do business in the medical device sector
Logo usage Organizations certified to ISO 9001 can use the standard’s logo on their marketing materials  only those certified to both ISO 9001 and ISO 13485 can use the combined logo

 

As you can see, there are several key differences between ISO 9001 and ISO 13485. By understanding these differences, you can make an informed decision about which standard is right for your organization.


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