Branching out – ISO 13485 beyond medical sector

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What does certification tell you about a manufacturer? Many sectors in the field of technology have their own specific certificates that validate their expertise on the type of products they specialize manufacturing, such as automotive and aerospace. However, certification tells a lot more about the company other than their specialization in a certain product. 


ISO 13485 in the world of certification 


In short, the role of an ISO certificate is to validate that a company meets established international standards for quality, safety, and efficiency. It boosts credibility, indicating adherence to recognized norms and fostering trust among customers, partners, and stakeholders. 


The most relevant certificate for Innokas Medical and any other technology manufacturer that makes medical technology is ISO 13485, a standard for managing the quality of medical devices. It applies to organizations engaged in designing, producing, and servicing medical devices. Its main goal is to ensure devices consistently meet both customer and regulatory standards, prioritizing safety, and effectiveness. Innokas has been ISO 13845 certified for a long time and there was a recent renewal.


Key aspects of ISO 13485: 

  • Ensuring compliance with medical device regulations. 
  • Integrating risk management across the device's lifecycle. 
  • Prioritizing documentation, traceability, and quality control. 
  • Addressing processes spanning design, development, production, installation, and servicing. 


Applicability of ISO 13485 


So, what does this kind of certification say about the manufacturer, other than their specialization? “Simply put, it substantiates functionality of our protocols and quality output by third party inspection. It works as a tangible promise for our customers,” says Päivi Isomäki, Head of QMS at Innokas Medical.  She goes on explaining that as ISO 13485 is a standard for medical devices that will have a central role in saving and preservation of human life and health, it is obvious that the standards in general are quite strict and regulated.


“Thus ISO 13485 covers the standards of other certificates as well, such as ISO 9001, that is a more general quality management standard that is applicable to a wide range of industries and organizations,” Päivi states. ISO 9001 is a generalized certificate that is not characteristic to any one type of product manufacturing in particular. 


As mentioned, a manufacturer with ISO 13485 certification is committed to regulatory compliance, ongoing risk management across the device's lifecycle, and a focus on documentation, traceability, and quality control. All these elements are applicable to any high-quality electromechanical device.


“Although this certification might not appear on product packaging, I see that being able to state that your products are manufactured in a production house that adheres to ISO 13485 brings a tangible merit for any company,” Päivi reiterates. “There is no need for on-the-go troubleshooting; instead, well-established operational systems are already in place. This ensures the product enters market as efficiently as possible while being safe to use and working as intended,” she adds. 


Innokas Medical’s commitment to quality 


To recap, ISO 13485 is a recognized medical device certificate strongly linked to the medical technology field and signifies a manufacturer's credibility in medical devices. Additionally, it reflects a high standard of quality and commitment, applicable beyond medical devices.


The certification demonstrates a commitment to strict quality, production, and development protocols which can extend to other sectors and products, highlighting the company's dedication to maintaining excellence and product longevity across various domains, medical or not. If this is something you are looking for in a manufacturer, we encourage you to contact us and talk about your design. 


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