ISO 13485 vs ISO 9001

Maria
May 13
2 min read

ISO 13485 vs ISO 9001: What Medical Device Companies Need to Know

When navigating international regulatory pathways for medical devices, companies often encounter two common quality standards: ISO 13485 and ISO 9001. While both relate to quality management systems (QMS), they serve different purposes and have distinct requirements—especially critical when operating in regulated industries like MedTech.

At AF Pharma, we support startups and established manufacturers in aligning their QMS with the appropriate standards for each market. Here's a clear breakdown of ISO 13485 vs ISO 9001, and how to choose the right path.

What is ISO 9001?

ISO 9001 is a general quality management standard applicable across all industries. Its core principle is continual improvement and customer satisfaction. It is widely used to demonstrate that a company has processes in place to consistently meet customer and regulatory requirements.

Key features:

Applicable to any industry
Emphasizes customer satisfaction and process improvement
Includes risk-based thinking, but not specific to regulatory compliance
Can support business growth and improve internal efficiency

What is ISO 13485?

ISO 13485 is a sector-specific QMS standard for medical devices. It builds on ISO 9001 but adds stringent requirements to ensure product safety, risk management, traceability, and compliance with global medical device regulations, including the EU MDR and FDA QSR.

Key features:

Specifically designed for medical device manufacturers and suppliers
Emphasizes regulatory compliance and risk management
Requires strict documentation, design control, and process validation
Mandatory (or expected) for CE marking and other global approvals

Key Differences at a Glance

Feature	ISO 9001	ISO 13485
Industry Scope	All industries	Medical devices only
Regulatory Focus	Low	High (EU MDR, FDA, etc.)
Risk Management	General	Extensive, device-specific
Design Controls	Not required	Required if applicable
Regulatory Reporting	Not addressed	Explicitly required
Continual Improvement	Mandatory	Encouraged but not required
Customer Satisfaction	Core focus	Secondary to safety and compliance

Which One Do You Need?

If you manufacture or distribute medical devices: ISO 13485 is essential. It is often a prerequisite for market access in the EU, UK, Canada, Australia, and beyond.
If you're a service provider or operate in a non-regulated industry: ISO 9001 may be sufficient.
For dual compliance: ISO 13485 is based on ISO 9001 principles but with added controls. You don’t need both—ISO 13485 supersedes ISO 9001 for medical device businesses.

Final Thoughts

ISO 13485 is not just about quality—it’s about ensuring patient safety and meeting global regulatory expectations. While ISO 9001 offers a good foundation, it does not meet the rigorous needs of the medical device sector on its own.

At AF Pharma, we guide companies through every step of implementing and maintaining an ISO 13485-compliant QMS. Whether you're preparing for CE marking, UKCA, or FDA registration, we’re here to ensure your quality system supports both compliance and growth.

Need help with ISO 13485 implementation or remediation?