ISO 13485:2016 is an industry standard that specifies the requirements for a quality management system (QMS) for medical devices. According to ISO.org, this standard is intended to give companies the tools that are needed to demonstrate its ability to provide medical device development and related services that consistently meet customer regulatory requirements.
Welch’s goal has always been to maintain a high level of quality for its customers. This strong commitment to quality goes back to the company’s 1985 roots and its founder, Evan Welch.
Evan believed that quality is a discipline and it is key to producing a good product. He engrained this philosophy within the company and its culture. Welch’s quality management system was born years before its first ISO certification, ISO 9001:2008, that was pursued in 2010. This certification formalized Welch’s commitment to the requirements of an effective quality management system. The company carried the ISO 9001 certification until 2018, when the decision was made to transition to the medical device standard, ISO 13485:2016.
Welch Fluorocarbon Inc. received ISO 13485:2016 certification in order to better serve its customer base. Welch’s ISO 13485:2016 certified quality management system allows for greater alignment with its customers’ quality management systems. As a supplier of custom components for medical device customers, it is crucial that Welch supplies a consistent quality product on time, every time. Welch’s ISO 13485:2016 certification ensures success in achieving this goal, which in turn helps Welch to maintain a strong, long-term strategic partnership with its customers.
ISO13485:2016 ensures that Welch has robust processes in place from initial design validation through qualification and release to manufacturing.