History of ISO 13485
ISO 13485 is an international standard in the field of medical devices. Forerunners were the EN46001 standard which had to be combined with ISO 9001: 1994. ISO 13485:1996 was based on ISO 9001:1994. The current ISO 13485: 2016 is a single standard which is largely based on ISO 9001:2008.
Although ISO 9001 forms the basis for ISO 13485, this does not mean that compliance with the requirements of ISO 13485 means that you also meet the requirements of ISO 9001.
If you want to be certified for both ISO 13485 and ISO 9001 you must ensure that the requirements of both standards are met.
The main differences between ISO 13485 and ISO 9001 are:
- Customer satisfaction (ISO9001) is not a regulatory requirement. The goal is to provide safe and effective medical devices (ISO13485).
- Continuous improvement (ISO9001) is not a regulatory requirement. Instead, ISO 13485 requires maintaining the effectiveness (ISO 13485).