The ISO 13485 Documents You Need for Medical Device Quality Management Compliance

To align with ISO 13485:2016, contents of the QMS should address the specific, applicable requirements of the standard, as well as the specific, applicable regulatory requirements based on markets where you plan to manufacture and market medical devices.

When it comes to ISO 13485 Certification, one thing companies can count on is a mountain of documentation. It's especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products-and the effectiveness of their quality processes. 

ISO 13485 has a lot of requirements regarding documentation, so it is imperative that you optimize the volume of your QMS documentation by trying to develop ISO 13485 documents that meets all requirements. 

So, which ISO 13485 documents do you need to achieve ISO 13485 certification?

1. ISO 13485 Manual
2. Procedures
3. Exhibits
4. Blank Formats / Templates
5. Standard Operating Procedures
6. Process Flow Charts
7. ISO 13485 Audit Checklist

The whole process of figuring out what needs to be documented, how to document it, and how all of the ISO 13485 documents ties together can be a struggle, even for people with extensive experience. If you are overwhelmed by the prospect of producing all this documentation, Global Manager Group comes with ISO 13485 Documentation Toolkit. 

ISO 13485 Documentation Toolkit is set of customisable documents templates that will make Quality Management easier to implement and improve. By using this documentation kit, it enables you to:

• Easily implement quality management system for your medical device
• Be provided with the documentation for ISO 13485 certification
• Save months of work
• Rapidly deploy your project
• Enjoy a simplified route to implementing best practices of achieving ISO 13485 certification
• Modify the templates as per your activity and create own documents for your organization.