ISO 13485:2016 Certified
Microtech Welding Corp. has recently achieved its certification for showing compliance with the ISO standard 13485:2016. This is a major step up in our quality system as much of the medical device manufacturing sector is moving towards this higher standard of quality. This quality system is in place to assure that all of our services meet customer and regulatory requirements.
Some key differences between the ISO 9001:2015 and the ISO 13485:2016 standards are that ISO 9001:2015 encompasses a broader number of industries, services, and company sizes as well as it is tailored more towards specification in a quality management system. The ISO 13485:2016 standard has a much more direct focus on regulatory compliance and does not give as much flexibility to the organizational process that is in place.
The main objective of a quality management system is to ensure all processes being performed within a company follow and use the same control parameters every time. This ensures consistency and a higher level of overall quality for services and products being produced.
At Microtech our number one concern is satisfaction for our customers and we strongly believe that by achieving compliance to this standard we can better satisfy our customers.