What is ISO 13485 and what’s recently changed?

19 March, 2024


Understanding the ISO 13485 certification is vital for medical device businesses and their fulfilment partner. 

As an online retailer of medical devices, you’ll know competition is fierce and customer trust is key. So, making sure your orders reach their destination safely and with the quality of your medical devices intact is crucial.

It’s therefore important, that you look at achieving various standards set by the British Standards Institution (BSI), to show you can be trusted as a supplier to put you one step ahead of your competitors.

This is where ISO 13485 comes in, a globally recognized standard for quality management systems (QMS) specific to medical devices.

While traditionally associated with brick-and-mortar manufacturers and suppliers, ISO 13485 is becoming increasingly relevant for online retailers who sell medical devices.

This is especially true with the recent revision of the standard, which partners with another standard to introduce key changes that online retailers need to be aware of.

What is ISO 13485?

ISO 13485 outlines a framework for establishing and maintaining a robust QMS for medical devices. This framework encompasses various aspects such as:

  • Risk management: Identifying and reducing potential risks associated with medical devices.
  • Quality control: Implementing stringent measures for product quality and consistency.
  • Regulatory compliance: Adhering to relevant medical device regulations in the areas you operate in.
  • Documentation and record-keeping: Maintaining comprehensive documentation of all processes and procedures.

Why is ISO 13485 important for online retailers?

Several factors highlight the importance of ISO 13458 for online retailers selling medical devices:

  • Greater trust from customers: Customers increasingly demand assurance of the safety and quality of medical devices they purchase online. Demonstrating compliance with ISO 13485 builds trust and credibility, potentially boosting sales and brand loyalty.
  • Minimised legal risks: Regulatory compliance is crucial for online retailers selling medical devices. Adherence to ISO 13485 can help avoid legal risks linked to non-compliance of regulations.
  • Improved efficiency: A structured QMS as outlined in ISO 13485, allows online retailers to streamline their operations, improve product tracking and traceability, and even reduce costs.

What are the key changes in the latest revision of ISO 13485?

The original ISO 13486 (2016) was withdrawn in 2021. But the latest revision also incorporates A11:2021 with several key updates, including:

  • Greater emphasis on risk management: The revised standard places a stronger focus on being proactive to identify risks and remove them throughout the product lifecycle.
  • Enhanced regulatory alignment: The standard has been updated to better align with evolving medical device regulations globally.
  • Focus on post-market monitoring: The revised standard emphasizes the importance of monitoring and addressing product performance and safety concerns after devices are placed on the market.

What should online retailers do?

While formal ISO 13485 certification is not mandatory for all online retailers, understanding and incorporating the principles outlined in the standard can offer significant benefits.

Here are some steps, and their benefits, that online retailers can take:

  • Evaluate your current processes and procedures to identify areas where you might need to adapt so you can comply with the revised ISO 13485 standard.
  • Focus on key areas like risk management, quality control, documentation, and supplier management, aligning them with the principles of ISO 13485.
  • Partner with consultants or experts specializing in medical device regulations and QMS, such as who will handle your orders once they leave your hands, so your practices align with the revised standard.

Of course, this is just a starting point, but once you’ve looked at implementing these steps, you could customise it even further:

  • Highlight specific aspects of the standard relevant to your target audience.
  • Add examples of how other online retailers have benefitted from implementing ISO 13485.
  • Provide resources for online retailers to learn more about the standard and why it’s important.

To find out more about ISO 13485, head to the BSI website, and to find out how Asendia could partner with you to help make sure your shipping, handling and packaging comply with this important standard, get in touch.

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