If you find yourself reviewing the certifications and qualifications of various packaging or medical device manufacturers, chances are you will see a mix of one or more ISO registrations, cGMP certifications, even FDA registrations. So how do you make sense of this “alphabet soup” and effectively compare one company to another? In other words, are all certifications created equal? Obviously, all companies need to meet a minimum level of requirements to achieve them. But is there more?
At TEQ, we think the answer is YES. We believe the difference lies in the story behind the certifications.
Take for example TEQ’s ISO 13485:2003 Registration.
This voluntary quality management system standard for companies that design, manufacture and distribute medical devices includes internationally recognized requirements for process validation, risk management and documentation.
In order to achieve ISO 13485 certification, companies must develop written policies for a variety of functions from process and design controls to accountability and traceability. Companies must also have a fully operative quality management system and be subject to a full cycle of audits.
While this may seem like a lot of work, at TEQ we were able to quickly build an ISO 13485:2003 Registered facility several years ago when we took over production of ear thermometer covers for a global leader of healthcare devices when the company decided to move manufacturing operations from Ireland to North America.
The reason we could do this so quickly, and become one of the first thermoform manufacturers in North America to achieve this registration, is because we already had many of the necessary processes in place to help our customers discover greater operational efficiencies, improve their risk management and increase their compliance with quality and safety regulations – not to mention achieve cost savings gained through improved efficiency and productivity.Today, we not only still hold this preferred certification, but we have also developed the expertise to build an ISO 13485:2003 Registered facility in virtually any location to support the unique needs of our clients - such as those that are on-shoring manufacturing operations to the United States, or those simply looking to create more efficient supply chains.
What about you? What are some of the stories behind your certifications?