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Optronic has started the work to re-certify according to ISO 13845 – Medical Devices Quality Management System, commonly used within medical technology. The investment is a part of the company’s drive to grow in the medtech area.
“One of the benefits is that we simplify things for our customers. When we are certified according to ISO 13485 it will be easier for our medtech customers to address all requirements valid for them,” says Joacim Lindström, Vice President at Optronic.

One example is the latest customer side addition, Lumito, which was recently certified to the same standard.
“It’s an advantage for them to have suppliers working to the same standard. It is also good timing for us, since we have a recently certified partner that we can have an exchange with during the process.”

ISO 13485 specifies requirements for a quality management system for organizations and actors that operate in one or more parts of the life cycle of a medical device, including e.g., design, development and manufacturing. The standard ISO 13485 complements the technical requirements that apply in the medtech field and is applicable to all organizations that provide medical devices. It covers all key elements that a quality management system must contain in accordance with ISO 9001, at the same time as the requirements are specially adapted to the regulations for medical devices.

The certification work has begun and will take up to a year to complete.
What takes time is external reviews, for example, and the certification process itself, which is conducted in several stages.
“We have respect that this will mean a lot of work. Such a process involves extensive documentation about how we work to ensure that we constantly comply with the requirements of the respective standards. This applies not least to how we deal with non-compliance. We are in an uncertain position on the global market with a greater risk of supply problems. The certification creates an interaction between us and our customers when it comes to how we both deal with such issues.”

“We already have the hardware and equipment required since last time we were certified to this standard. We see this primarily as an investment in knowledge, in which we sharpen our structures and processes for precisely this type of production. We have a great deal in place through our long-term quality work as well as earlier certifications and this means that we can carry out the work relatively quickly.” Joacim concludes.

Author Optronic

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