The Benefits of Integrating ISO 9001 and ISO 13485

ISO 9001 and ISO 13485 are internationally recognized standards that help organizations to improve their quality. ISO 13485 is the international standard that sets out the requirements for a quality management system specific to the medical devices industry. As a medical device manufacturer and contract medical device manufacturer you would need to comply with ISO 13485 and/or ISO 9001 to demonstrate your quality management system fulfils industry standards. To expand your market or to become a supplier to medical device manufactures, you might need to comply with ISO 9001 and/or ISO 13485 standards.

During the webinar, we will review the benefits of a joint registration and explore the similarities and the differences between the two standards since ISO 9001 and ISO 13485 have diverged with the introduction of the high-level structure adopted by ISO 9001:2015.

For further information, please contact:

Victoria Leo
Marketing Specialist
t: +1 201 508 3000