Certifications and Audits for the Medical Industry
Orion is a trusted partner the medical industry can rely on for its certification needs.
We are currently the only firm endorsed by three industry associations to audit their members
We reward this trust by only using auditors that have an overall customer satisfaction rating of 99% or better. Our auditors have over 15 years of auditing experience, making them seasoned and proven professionals.
Our vast experience means that we truly know and understand the medical industry, including its typical processes, software, and terminology. As a result, our auditing services are efficient and effective, and we will work with you to establish mutual goals up front to make sure your needs are fully met.
If you are looking to certify to multiple standards, we also provide integrated audits so that you can achieve certification to multiple standards in one audit (e.g. ISO 9001 / ISO 14001 / ISO 45001 / R2), ultimately saving you both time and money.
Why Is Certification Important to the Medical Industry ?
The medical industry has certain quality system expectations and regulatory requirements for organizations involved in one or more stages of a medical device’s lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
When it comes to the devices that can save lives and improve health, standards certifications are unquestionably critical. Orion can facilitate accreditation for required standards for manufacturers of medical devices, as suited to a variety of markets.
Medical Industry Standards
13485: Medical Devices Standard
This standard represents the requirements for a comprehensive management system within the design and manufacture of medical devices. This standard is somewhat unique in that some of its requirements separate it from the main ISO 9001 quality management standard, so many organizations that are ISO 13485 compliant are not able to also be ISO 9001 compliant. Some of these unique considerations include the need to ensure that all medical devices are sterile, the ability to track and inspect devices that are implanted in patients, and the management of risk during product development.