Commitment to quality is integral at Celestica. Our global Quality Management System ensures that around the world our employees use standardized procedures and processes to drive predictability and consistency. We know that when we are building our customers’
medical devices, we’re holding their brand & reputation in our hands. Especially in the healthcare industry, quality cannot be compromised.
We bring a total quality mindset to work every day - to the protocols we write, the tests we conduct, the processes we follow. The products we enable impact the lives and well being of patients. We’re committed to embedding standardization into every
aspect of our business.
The result? Our manufacturing sites are healthcare audit-ready and we’re doing the right things at all times. Read more about our commitment to continuous
improvement.
Design for Quality
Incorporating quality considerations into the design process results in far fewer defects, lower costs, and speeds the regulatory review process. Celestica recommends conducting a Process Failure Mode and Effects Analysis (PFMEA) to scrutinize a product
design and identify any potential failures that may occur during the manufacturing process resulting from human error or equipment malfunctions.
A Design for Quality approach also streamlines the process of creating and submitting device history records (DHR) to regulatory agencies. These convey a product’s entire history to regulatory agencies – including who built it and when, who performed
testing and when, and details on the calibration and maintenance of testing equipment.
Patient safety in medical device manufacturing is paramount and governed strictly by ISO13485 and FDA regulations. Our teams work on some of the most highly regulated advanced surgical tools and instruments in the world. We understand how vitally important
they are, not only to our partners and our customers, but to the people who are using them. Find out more about our FDA registered and ISO 13485 sites.
With so much at stake, we take great pride in our reputation for best-in-class quality standards that enable the best possible patient outcomes.