What is the purpose of ISO 13485?

ISO 13485 is the medical device industry's most generally used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

What are the requirements of ISO 13485?

ISO 13485:2016 specifies necessities for a Quality Management System to produce ISO medical devices and related services that consistently meet customer and applicable regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services supplied by the organization.

What is the difference between ISO 13485 and EN ISO 13485?

ISO 13485 is an internationally recognized standard set of requirements issued by the International Organization for Standardization (ISO) to create a Quality Management System for those in the medical device industry. The ISO standard includes all of the requirements that are needed to create a QMS to demonstrate your capability to provide medical devices that consistently meet the requirements of customers and regulators.

EN ISO 13485 is a parallel standard that is issued in the European Union for the purpose of creating a QMS in the medical device industry for use in the European Union. The requirements of these two standards are identical, and the entirety of the ISO 13485:2016 standard is included in the EN ISO 13485:2016 document. However, the European version of the standard (EN ISO 13485) also includes several invaluable tables that align the ISO 13485:2016 requirements to the three EU directives for medical devices (EU directive 90/385/EEC, EU directive 93/42/EEC, and EU directive 98/79/EC). This makes it easy to see how implementing the ISO 13485:2016 standard will help you to meet these particular EU directives.