ISO 13485 and 21 CFR 820, What’s The Difference?

Regulations mandated by ISO (International Organization for Standardization) and CFR (Code of Federal Regulations) specify the requirements for manufacturers to implement quality management systems that ensure the safety and security of their products. A quality management system, or QMS, helps to demonstrate an organization’s ability to follow regulations and meet the needs of their customers. And when it comes to medical devices, both ISO 13485 and 21 CFR 820 may seem similar in their goals, but there are a few key differences. Let’s look at an overview of each of these regulations.

What is ISO 13485?

The 2016 version of ISO 13485 is a voluntary standard based upon the general quality management system outlined by ISO 9001:2008. This rule is frequently utilized by manufacturers to establish and maintain a system that can meet the demands of the medical device market. The latest version of ISO 13485 includes heightened regulatory emphasis on product safety, risk management requirements in products and processes, and improvements of reporting systems to regulatory bodies.

What is 21 CFR 820?

FDA 21 CFR 820 is the quality system approved by the Federal Drug Administration of the United States. Its requirements are aimed at ensuring the safety and efficacy of medical devices. While the rule defines a specific quality management system to follow, it is up to the manufacturers to determine which limits apply to their processes and products. In other words, the maker of the medical equipment is responsible for determining how they intend to comply with QMS set by the FDA.

Some Major Differences

While both standards involve the implementation of quality standards for organizations, there are a few key differences between the two.

  1. 21 CFR 820 is a mandatory quality system for the distribution and regulation of medical devices in the US, while ISO 13485 is neither a regulation nor law. Think of the ISO requirements as an internal endeavor by the company to ensure customer satisfaction while the FDA requirements are imposed externally by a government body.
  1. ISO 13485 is a standard that does not mandate a specific quality management system structure. But with 21 CFR 820, companies should line themselves up with the outlined documentation structure. Fulfilling the ISO requirements is known as conformance, while fulfilling the FDA requirements is known as compliance.
  1. ISO 13485 is a globally accepted standard that provides ways to comply with general regulatory requirements, while CFR 820 is a regulation mandatory for US manufacturers. Countries outside the US can still have their own laws and regulations.
  1. The standards created by ISO 13485 are based on input by the FDA and other members of ISO, but the CFR 820 is not based on input from the International Organization for Standardization.

A Change in Standards?

While both standards exist simultaneously and are used for different purposes, the FDA has revealed their plans to adopt ISO 13485 as the new standard for medical device companies in the US, essentially replacing 21 CFR 820. This intends to achieve more global harmonization and make it easier for US companies to comply internationally. It will also simplify the quality management systems of companies who are looking for FDA approval for medical devices. But until then, remember what sets these standards apart and how they affect your business.