“Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.” – International Organization for Standardization

What is ISO-13485 for?

ISO 13485 is a quality management system, with a specific focus on the medical industry. It represents the requirements for a quality management system (QMS) for the design and manufacture of medical devices. It was created to help ensure the safe design, manufacture, and distribution of medical devices. It also helps to create a globally adopted model of QMS requirements. Although it was first published in 1996, it has been continually improved upon over the last 24 years. The newest standard is ISO 13485-2016.

All ISO standards are reviewed every five years to establish whether revisions need to be made. This helps to keep the standard relevant and up to date with the latest quality standards and QMS practices. In the 2016 updated standard, there is a greater emphasis on risk-based decision making and risk management. Examples of some of the most recent changes with regards to risk management are as follows:

• Training of employees
• Software
• Monitoring, testing, and traceability
• Management of both corrective and preventative action (CAPA)
• Outsourcing and supplier control

What can be classified as a Medical Device?

Medical Devices are instruments that are intended to diagnose, treat, or prevent diseases or any other medical condition. Products that would be classified as Medical Devices would be those such as an instrument, machine, in vitro reagent, or implant. However, in the case of BTI, it would be any medical machine or instrument.

Why BTI is Getting ISO 13485 Certified

At Butler Technologies, we believe that quality is the single-most-important standard to implement within our company culture. Although ISO 13485 is not a required certification, it goes hand-in-hand with our current ISO 9001-2015 certification with design. ISO 9001 sets the criteria for a quality management system. When certified, you must continually show that you are adopting better quality standards within your organization. As stated by ISO, ISO 9001 “helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits”.

Because our company is constantly striving to adopt better quality standards, we felt it was only right to continue to do so in every aspect. As we shift further into the medical device industry, we want to ensure we are following the best quality standards, as well.

Our Adoption of ISO 13485’s Benefit to You

Although there are distinct benefits of getting ISO 13485 certified for our organization, there are also distinct benefits for our customers. Some of the benefits are as follows:

1.     Better Quality Products

Better quality products will be a key benefit for you and your team. As better-quality standards are implemented, better quality products are bound to follow.

2.     Safer Products

Because better quality standards will be put into place, you will also get safer products. There will be a set of best practices for creating each component for your medical device.

3.     Consistent Product Design & Production

With a QMS system in place, consistency will also be a key benefit. Your product will be created with the same process each time, meaning a more consistent design, and production for your product.

4.     Faster Cycle Times & Better Service

Faster cycle times will be a key benefit of adopting ISO 13485, as your production, processes, and system are under constant review. Quality can lead to faster cycle times, and ultimately better service for our customers.

ISO 13485 is an essential certification when it comes to quality management within an organization. Stay tuned, as Butler Technologies is in the process of getting ISO 13485 certified. We’re excited to see where this certification will take our team as we dive deeper into the production of medical devices.