Why is ISO-Certification Good for a Design Firm?

We have long understood that to be one of the most successful companies for developing challenging, technology-based products (especially in the medical industry), we had to create and implement well-defined design processes and efficient design strategies.  Without robust design processes, it is all too easy to lose track of critical design issues – the consequence of which is usually schedule delays, added costs, and/or undesirable design compromises.

Therefore, following extensive research and planning, we decided to utilize ISO standards, which are recognized worldwide, as the basis for defining our design processes. With a sturdy foundation, we were able to then tailor the system to our needs as a design firm, adding the necessary design strategies that would enable us to confidently provide our clients with the highest quality and most cost effective solution to their product development needs.

We received our ISO 13485 certification in 2008.  Prior to that Key Tech was certified to ISO 9001. Our quality assurance program, combined with our design and development procedures, enable us to quickly and cost-effectively develop everything from simple mechanical parts to complex, automated, medical devices that require extensive regulatory compliance.  In addition, at the end of a project, we will have confidence that:

  • we haven’t overlooked a critical design issue
  • the product will be safe and effective for the intended use, and
  • all the documentation necessary to verify and validate the effectiveness of the product design will be available to satisfy regulatory requirements or to transfer to our client for their documentation needs.
Keith Lipford
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