When a customer is vetting Complemar, how do they know that we are a viable and consistent option for their business needs? They usually start by looking at our certifications and do they align with Complemar competitors. The industry standard for these certifications is ISO 9001 for manufacturing/warehousing and ISO 13485 for the assembly of medical devices.
Complemar is currently certified in ISO 9001 at all of our Fulfillment and Print locations, Rochester, Buffalo (Print), Oklahoma City, Sparks, and Middletown and 13485 at our Healthcare facility in Rochester, NY. This means that we have a robust quality system, and this system is audited yearly by an independent ISO auditor.
Every year an independent auditor enters our facilities and looks at our quality system, procedures, and interviews not only the quality team but the operators on the manufacturing floor, the project management team, and company leadership. Then they can audit any of the corresponding work orders and the quality documentation that is associated with those work orders, to make sure that we are following our procedures, are following good documentation practices, and doing what we say we are doing in our quality system. The auditor also can look at the way we purchase material or train our staff, they have an open door to our company and how we do business.
First, what is ISO?
What is 9001?
What is 13485?
What is a medical device?
What does this mean to our customers?
These standards are the backbone of how we do business at Complemar. It gives our customers the peace of mind that their experience at Complemar has been audited to a consistent standard that has crossed the industry. This also provides the customer the security to not only know that we have a robust quality system but that we also follow that system, giving the “peace of mind, delivered”.