What is ISO 9001 and 13485?

Tuesday, 13 October 2020

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?

  • ISO (International Organization for Standardization) is an independent, non-governmental international organization with a membership of 162* national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.


What is 9001?

  • A quality system needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
  • 9001 aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.


What is 13485?

  • This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.


What is a medical device?

  • A medical device is a product, such as an instrument, machine, implant, or in vitro reagent, that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.


What does this mean to our customers?

  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies as necessary
  • Gain a competitive advantage


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”.

Complemar Locations

Rochester, NY (Headquarters)
Harrisburg, PA
Oklahoma City, OK
Reno, NV
Buffalo, NY (Complemar Print)

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