![iso 13485 quality management system iso 13485 quality management system](https://www.ascentworld.com/wp-content/uploads/2021/02/ISO-13485-Certification-Medical-Devices-Quality-Management-System.png)
![iso 13485 quality management system iso 13485 quality management system](http://isocertificationservices.co/wp-content/uploads/ISO13485-CERTIFIED.png)
There is a separate standard, called “ISO 10013:2001 Guidelines for quality management system documentation,” which offers some direction as to the number and size of the documents your organization will likely need.
![iso 13485 quality management system iso 13485 quality management system](https://i.pinimg.com/736x/ed/7f/38/ed7f38c069a7af66425bd1ff695c8fc7.jpg)
For example, small companies may choose to document a simple overview of their procedures in the Quality Manual. The standard allows an organization the flexibility to decide on the amount of documentation it needs, and the level of detail to include.
ISO 13485 QUALITY MANAGEMENT SYSTEM ISO
The ISO 13485 standard requires various types of information to be documented but, not every piece of information has to have its own separate document. So, when you set out to create your QMS documentation, your focus should be on efficiency, and on creating only those processes and documents that will benefit your organization.