The importance of auditing should not be overlooked. As longtime Quality columnist Jim Smith writes, “It’s rare that managers, or even most quality auditors, discuss how closely tied the findings of manufacturing audits are to the long-term ability of their companies to compete in this highly competitive market.”

Surely, it’s a bad thing when a business receives customer complaints. If the customer isn’t happy, then there must have been a poor interaction and we need to do everything we can to make the customer happy as quickly as possible, right? 

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

A good day on the shop floor has everything running smoothly. No issues with machines, staff, or suppliers, and products are shipped on time and without defects.

Whether you’re training employees, tracking defects, or conducting audits, a good quality management system should make life easier.

ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS).