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:

• Risk Mitigation:Both standards emphasize the need to incorporate a risk-based approach in design and production and focus on the importance of making evidence-based decisions.
• Process approach:Both ISO 9001 and ISO 13485 use the Plan-Do-Check-Act process approach, despite having different structures.
• Role of organization:Both standards require a clear definition of employee roles in the organizational structure.
• QMS requirements:Organizations require effective tools and processes for employee training, document control, corrective action and audits to comply with either standard.
• Customer focus:Both standards are designed to ensure customer expectations are met and exceeded.

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.

• QMS goals:While the ISO 9001 puts more emphasis on defining the ‘policies, processes and procedures” of the QMS, the ISO 13485 focuses on “maintaining the effectiveness of the QMS,” along with the efficacy of medical devices.
• Resource management:While both standards adopt an in-depth focus on resource management, additional requirements are specified for device manufacturers that focus on clinical evaluation, contamination control and environmental standards.
• Product realization:The ISO 9001 standard sets forth operating standards to support quality product realization and ISO 13485 builds on these requirements with in-depth specifics to improve safety, customer satisfaction and standards for products and supply chain.
• Risk management:Organizations that adopt the medical device standard will also need to incorporate risk management principles into post-market feedback and product realization.

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

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.