Guide: The Differences Between ISO 13485 and ISO 9001
A Comprehensive Guide to Choosing the Right Quality Management Standard
What is ISO 9001?
ISO 9001:2015 is a quality management standard developed by the International Organization for Standardization (ISO). This standard helps organizations create a quality management system to ensure their products and services meet customer and regulatory requirements. ISO 9001 is designed to be applicable to any organization, regardless of size, and can be applied to any industry.
What is ISO 13485?
ISO 13485:2016 is a standard developed by the International Organization for Standardization (ISO) to provide guidance on medical device quality management systems. This standard is designed to help businesses that design, produce, install, and service medical devices that meet customer and regulatory requirements. ISO 13485 is applicable to any business involved in the manufacturing and servicing of medical devices.
How Do I Determine Which Standard Is Right for Me?
Choosing the right quality management standard can be daunting. It's important to consider your specific business needs and industry in order to select the right standard for your organization. To help you make the best decision, we've created a comprehensive guide that compares ISO 13485 and ISO 9001. With this guide, you can make an informed decision and ensure that your organization is compliant with the correct quality management standard.
Key Differences Between ISO 13485 and ISO 9001
One of the main differences between ISO 13485 and ISO 9001 is the scope of the standards. ISO 13485 is specifically designed for medical devices, whereas ISO 9001 is applicable to all industries. Additionally, while ISO 9001 focuses on customer satisfaction, ISO 13485 has a stronger focus on regulatory requirements.
Another key difference is that ISO 13485 has stricter requirements for documentation and record-keeping than ISO 9001. In addition, ISO 13485 has more emphasis on corrective and preventive actions, as well as risk management, than ISO 9001 does.
Learn more by downloading our Differences Between ISO 13485 and ISO 9001 Guide below: