Iso 13485:2012 iso#

Iso 13485:2012 iso#

This also includes additional regulatory requirements with regards to complaint handling, regulatory notifications and post-market surveillance.ДЄs you can see now, the amount of knowledge and stringency required of an ISO 13485 consultant and certification body is of a different scale altogether and should not be compared against ISO 9001.

The companies need to show how risk management principles are incorporated into the entire product realisation and post-market feedback. Lastly, the ISO 13485 has got more requirements for the management of risk.

In terms of documentation, based on our experiences in setting up the Quality Manual, Procedures, Form templates and Work Instructions, the amount of ISO 13485 documentation is on average more than twice of those needed for ISO 9001, though the number of documents may differ between different companies and should not be a definitive gauge towards actual compliance. In addition, ISO 9001 now requires the product manufacturers to focus on continuous improvement, while ISO 13485 requires the company to demonstrate implementation and consistent maintenance of the quality management system. Looking deeper into their differences, the ISO 9001 requirements are set towards ensuring that your organisation put more focus on achieving customer satisfaction, while ISO 13485 puts a lot more emphasis on patient safety during the usage of the medical devices, and greater efficacy in the results of diagnosis for example. This greatly impacts the impression that the ISO 13485 standard is very similar in nature, which is far from the truth due to the differences in structure and framework of the standard. 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. To add to the challenge, the most commonly adopted ISO standard - the ISO 9001 standard is also known as a Quality Management System, though the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels & hospitality, just to name a few.