Both ISO 9001 and ISO 13485 are international standard requirements that address different aspects of quality management systems (QMS).

While the goal of these standards is the same: to specify QMS requirements which an organization can use to ensure consistent customer and regulatory compliance for products and services, there are some differences between the two standards.

ISO 9001 specifies requirements for a QMS, which can be adopted by any organization, regardless of the company size, the industry it operates in and the products or services it offers.

One the other hand, ISO 13485 standardizes requirements for QMS in the medical device industry. Upon implementing ISO 13485, manufacturers can certify for medical device regulations, such as the EU Medical Device Regulation (MDR), the EU Medical Device Directive (MDD) and the US FDA 21 CFR 820.

In this blog post, we’ll discuss the similarities and key differences between the two standards, in addition to the stringent documentation requirements and product-specific demands that come with the ISO 13485 standard.

Similarities Between ISO 9001 And ISO 13485

As we mentioned earlier, both ISO 9001 and ISO 13485 are essentially about helping organizations create consistently high-quality and safe products. They also share some other similarities, such as:

Differences Between ISO 9001 And ISO 13485

Under the ISO 13485 standard, medical device manufacturers face additional requirements for QMS, including additional regulatory and documentation requirements, product realization, continual improvement and more.

Let’s look at the differences between the two standards other than not sharing the same structure.

Understanding the differences between the two standards allows device manufacturers to raise the bar on quality and streamline time to certification.

Business man checking organizational documents to ensure compliance

Get in touch with our ISO 9001 certification consultants and ISO 13485 consultants services for medical device manufacturing today to jumpstart your company’s certification and registration process. We also offer AS9001D certification consulting services.

Contact Barile Consulting for more information.