Partially. To add to the challenge, the most commonly adopted ISO standard — the ISO 9001 standard is also known as a Quality Management System. However, the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels & hospitality, to name a few.
Being the number 1 most popular standard being certified to, anyone in this industry would be familiar with the ISO 9001 standard or have worked with an organisation with the ISO 9001 certification. This dramatically impacts the impression that the ISO 13485 standard is very similar, which is far from the truth due to the standard’s differences in structure and framework.
Looking deeper into their differences, the ISO 9001 requirements ensure that your organisation focuses on achieving customer satisfaction. At the same time, ISO 13485 puts a lot more emphasis on patient safety during the usage of medical devices and greater efficacy in the diagnosis results. In addition, ISO 9001 now requires product manufacturers to focus on continuous improvement. In contrast, ISO 13485 requires the company to demonstrate implementation and consistent maintenance of the quality management system.
Therefore, ISO 13485 does not replace ISO 9001. ISO 13485, however, can fulfil partial requirements of ISO 9001 and vice versa.