If you’re in the medical device industry, you probably have a Quality Management System that’s a combination of paper-based processes and general tools in command of document control. Although this works— and probably has been working for you– this method is full of risks.

So what to do when you’re using a highly risky, non-scalable Quality Management System?

Switch to ISO 13485.

What Is ISO 13485?

ISO 13485 is a Quality Management System QMS used in the medical field. It’s a highly customizable, configurable, and scalable system that helps medical device companies, especially manufacturers, set up technical support. It also assists production, storage, distribution, installation, servicing, final decommissioning and disposal of medical devices.

What Is The Purpose of ISO 13485?

ISO 13485 is based on a process approach to quality management. An activity that requires input and produces output is known as a process— so, the ISO 13485 manages several multifaceted processes all at once. It standardizes medical device regulatory requirements for QMS and is based on its previous model, ISO 9001.

Like any QMS, ISO 13485 must be regularly maintained and updated. This is so that it’s up to date with the latest changes in regulations, processes, and products with intents to improve the QMS constantly.

A man on a yellow forklift carrying packages

Why Do I Need ISO 13485?

ISO 13485 is a requirement that’s intended for organizations that deal with any aspect of the life-cycle of medical devices, such as packaging and even servicing. ISO 13485 registration allows a medical device company to focus on its resources and understand its roles, rights and authorities. ISO 13485 also assists management in organizing in a consistent manner that’s recognized on a global scale.

ISO 13485 is also internationally-recognized, so it’s an added bonus for companies looking to sell their products and devices outside of the United States.

If you’re on the search for ISO 13485 certification consultants for medical device manufacturing, you’ve come to the right place. At Barile Consulting, we’re the leading certified ISO 13485 consultant in Cleveland. With over 15 years of experience, our professional consultants are dedicated to ensuring you the smoothest transition to your new QMS.

Contact us at (440) 628-8271 or email us at dabarile@barileconsulting.com for more info.