Why is ISO-Certification Good for a Design Firm?

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

Keith is a co-founder of Key Tech. He has extensive experience in the design, testing, and manufacturing oversight of heavy machinery, steel structures, hydraulic & electrical systems, and instrumentation & control systems. One of his passions is brewing craft beer with creative ingredients and specialty malts (as seen in the picture), and he was instrumental in the creation of the Key Tech Brew Crew, which has created numerous award winning beers through BJCP sanctioned events.

As Key Tech’s QA Manager, he has successfully developed and maintained Key Tech’s ISO 9001 and 13485 certification. He received an AA in Architectural Technology from the Anne Arundel Community College before completing his BS in Mechanical Engineering Technology from the University of Maryland.
Keith Lipford

Latest posts by Keith Lipford (see all)

Every challenge is different – Tell us about yours.