Considering a supplier with ISO 9001 or 13485? What’s the difference?

ISO 9001

You’ve heard of the international standard for quality management systems. The goal of the 9001 standard is continuous improvement, producing consistent parts that satisfy our OEM customers’ needs.

Profile’s robust QMS follows these guidelines to efficiently monitor and improve our processes. We first acquired ISO 9001 certification in 2007, and the latest version is 9001:2015.

What is ISO 13485 and do I need it?

The newer ISO 13485:2016 standard applies specifically to the medical device industry. Generally, it’s ISO 9001 plus additional requirements for medical device regulations. Those include greater documentation, traceability, and safety.

The difference is that the medical device standard focuses more on product development as a key process. Whether you need it for your plastic components hinges on the level of safety risk.

• Do the parts need to be sterile, manufactured in a clean room environment?
• Could patients potentially contact the parts?
• Are they considered consumables?

Thin gauge thermoformers that produce trays for medical consumables packaging pursue ISO 13485 certification. For example, these trays may be used for prepared vaccination kits, which get disposed after a single use.

Heavy gauge thermoformed parts, like the cover of an X-ray machine, are usually designed for a long service life, up to 20 years. Medical technicians may contact them while patients normally do not. The equipment is cleaned and disinfected after each use.

How we support you

Profile supplies best-in-class heavy gauge thermoformed components to OEMs, including cover panels and internal components for medical equipment. Our engineering assistance helps customers take full advantage of our processes.

We work with engineers to adapt their own parts designs for the thermoforming process. We don’t produce high-risk or sterile medical device parts, which necessitate ISO 13485 certification.