Processes, required properly manage the traceability of products and the management of product withdrawal in post incidents. Focus on risk management in the development and manufacturing of medical devices. Implement improvements in the quality management systems of manufacturing companies in the sector. Sector acceptance of this regulation the latest version of the iso 13485:2016 standard includes a comparison with the iso 9001 standard, which makes it a prestigious benchmark in quality management. From the point of view of society the increase in
demand for medical supplies in the face of the covid-19 pandemic, as well as quality control in the pharmaceutical industry in the context of e commerce photo editing the pandemic, has triggered the demand for manufacturers who have wanted to be certified under this regulation in order to have this seal of quality. Prestigious in the sector. Although in the quality sector the most demanded and prestigious standard is iso 9001 , it is nonetheless a general standard. Regarding the iso 13485 standard, which is based on a similar approach to iso 9001 but which also focuses on very specific particularities of the health sector, as well as specific processes and products where new materials arise in industrial design. All this makes the iso 13485 standard highly recognized in the sector and
having its implementation in manufacturing companies is an almost mandatory prestigious seal in the sector to be able to offer suppliers the catalog of manufactured products. In the sector, it is complemented by other regulations such as the reach legislation focused on chemical products in the sector. From the point of view of the health sector this iso 13485 standard applies to the entire manufacturing sector of medical and pharmaceutical products, and focuses on justifying that the applicable regulatory requirements are met at each manufacturing point of the