History of ISO 13485: 2003

ISO 13485: 2003 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: 2003 is a single standard which is largely based on ISO 9001. All Blue/ italic printed text in the ISO 13485 is additional to the requirements of ISO 9001. All other text is a copy of the ISO 9001 text.

Although ISO9001 forms the basis for ISO 13485, this does not mean that it compliance with the requirements of ISO 13485 means that you also meet the requirements of ISO 900 (ISO 13485: 2003 section 1.1)

If you want to be certified for both ISO 13485 and ISO 9001 you must ensure that the requirements from 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).