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:
t: +1 201 508 3000