ISO 13485 ?

ISO 13485 certification is a standard for a specific industry. It outlines the requirements for a quality management system (QMS), which can be used by an organization that is involved with a medical device.

The standard applies to both the companies that make the parts and the companies that make the finished devices.

Steps to Get ISO 13485 Certification

First, you need to plan how your organization will monitor, measure, and analyze processes to make sure that products and the QMS are compliant and that the QMS is working well.

You will have to set up ways to get customer feedback and keep track of it, as well as ways to look into complaints, assess risk, take action and report results, including to regulatory authorities when necessary.

During the manufacturing process, you have to keep an eye on and measure the product to find any that don’t meet the standards. If you find a non-conforming product, you have to take the right steps to isolate it and stop it from being delivered or used.

Lastly, it’s important to look at data about your organization’s QMS to figure out how well it works and where it can be improved. When necessary, you should take corrective and preventive action to keep the QMS suitable, adequate, and effective so that medical devices are safe and work well.


ISO 13485

This is the standard that manufacturers of medical devices need to meet in order to be approved by the FDA.The standards include requirements like providing information on who had a part in developing the device and how it’s manufactured, as well as criteria for their validation and verification procedures.

The benefits of ISO 13485 are:

  • Helps minimize manufacturing defects safety as a key focus.
  • Helps growth efficiency, cut costs and monitor performance.
  • Determines that your company has the ability to produce safe medical devices.
  • Facilitates global trade.
  • Improves quality and safety.

Companies that want to get ISO 13485 certification have to list the regulatory requirements that apply to them.

Does the company have the responsibility and power to recall products? What documentation needs to be kept and for how long? Lastly, a company that implements ISO 13485 is expected to include the applicable regulatory requirements in the QMS. This means that there should be procedures for reporting to regulatory authorities and their customers, and then they should implement procedures for traceability.

The phrase “as appropriate” is used all over ISO 13485 if your company thinks that a part of the standard doesn’t apply. For example, you don’t offer service or installation for your product.

You must make a note of that and explain why it doesn’t apply. This is usually written in the scope and quality manual.

Interested in ISO 13485 Certification?

Feel free to send us a message today.