How to Follow ISO 13485: 2016

ISO 13485: 2016 sets the expectations of how quality management must be handled by medical device companies. If you are not following ISO 13485, then your business will be in trouble. Here is what you need to know about complying with ISO 13485:2016 and how an ERP (Enterprise Resource Planning) system can help.

What is ISO 13485?

From the International Organization for Standardization (ISO), ISO 13485:2016 outlines the requirements for the quality management systems of medical device manufacturers. A quality management system ensures the consistency of quality in medical devices to protect consumers.

What are the requirements of ISO 13485?

There are many pieces of ISO 13485, but here is a boiled down version of what it asks for:


You must have procedures in place that will allow you to ensure quality consistently and follow the requirements your organization is legally bound to adhere to.

Procedures must be intertwined with software if you want your team to be able to execute them easily. If you want to weave your business processes into your ERP to ensure that they are executed correctly every time, talk to the ERP consultants at Datix. With our business-first approach, we tailor your software to what you need.

Tracking and traceability

Every piece of your quality system must be traceable and include tracking. Tracking allows you to spot problems immediately and traceability allows you to identify the source of the problem. This transparency is particularly helpful for major issues that require Corrective and Preventive Actions (CAPA).

With the right ERP, you can utilize history, revision and recall tracking to oversee operations. These features are crucial for audit tracking and understanding your strengths and weaknesses. To track with an ERP system to the fullest, Datix can help. We make it simple to see the key data you need to assess quality control. We will support you every step of the way in maintaining quality standards.


Everything must be documented. It sounds simple, but your system needs to make it easy to record all the information you track and present it for internal reviews or audits by regulatory bodies like the FDA. On a fundamental level, documentation allows you to prove that you are following quality standards. You can show how to manage quality at your organization by keeping an up-to-date Quality Manual.

Risk analysis and prevention

Establishing potential risk to consumers is one of the most important tasks a medical manufacturer can do. Equally important is determining when and how to minimize risk for a product in development.

Determine Ways to Inspect Quality and Respond to Issues

Medical manufacturers are responsible for the entire process of creating a medical device. That means that even work that is outsourced must meet quality standards. For your organization, vendors, and any other company involved in creating your products, you must inspect the work completed to confirm that quality standards are consistently being met. And, if there are issues, you have to have a plan in place to respond.

Wrap Up

ISO 13485 creates numerous expectations for medical manufacturers, but it is possible to smoothly address each of its expectations without getting bogged down in complicated business processes. The right technology and the right partner make it simple to maintain a quality management system.

Simplify Your Systems

Read How to Effectively Manage Your Multi-Level Supply Chain

About Datix

For medical manufacturers, Datix is the ERP consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.

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