ISO 13485:2016
Gap Analysis Checklist

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Planning is an essential first step in the ISO 13485 quality management system implementation, and completing a gap analysis, using our ISO 13485 free download of the Gap Analysis Checklist will help ensure you, that you don’t miss any of the requirements of the medical device QMS. If you’re on a fast-track timeline, you don’t want to miss any of these ISO 13485 quality management system requirements or discover mid-way through the project that you did not plan enough resources, all of which could lead to significant delays in obtaining your ISO Certification.

It’s all about starting off with a good Plan before you Do, Check, Act, and that is exactly what our Gap Analysis Checklist provides is the foundation for your Plan.
 

Our ISO 13485 experts have helped many medical device industry companies conduct this gap analysis, and our experience will provide you with a robust implementation plan and provide you with a high degree of confidence, that you will meet your goals for your QMS Implementation and ISO Certification.

The Gap Analysis Checklist consists of 40+ questions to highlight gaps between your current QMS status and the requirements of the 5 elements of the ISO 13485:2016 standard. These questions also cover the majority of the requirements of FDA quality system regulations. There are also some general questions regarding the status of your medical device product development, as well as your complete manufacturing process readiness. These can be major factors in establishing your overall QMS implementation and certification timeline, as well as resources available to implement your QMS.

It can only take one missed gap to potentially prevent, or delay, your company from successfully obtaining Certification on plan. So don’t take that risk and make sure you understand the full requirements of ISO 13485:2016, complete the gap analysis, and finalize your implementation plan. Below is an example from the Gap Analysis Checklist that covers element 4 of ISO 13485

Quality Management System	Yes	No	Add Document Number and Reference Information
Do you currently have a documented Quality Management System?
Do you currently have a Quality Manual?
Do you currently have QMS documented procedures?
Do you currently have resources to support your QMS?
Have you a process for controlling QMS documents?

Our Gap Analysis is included as part of out Fast-Track Planning Kit along with:

If you need any help with completing this gap analysis, or with conducting the assessment of the results once you complete, we can assist you with this and can use the 30-minute call included with the Planning Kit or schedule more time if required.

Quality Management System	Yes	No	Add Document Number and Reference Information
Do you currently have a documented Quality Management System?
Do you currently have a Quality Manual?
Do you currently have QMS documented procedures?
Do you currently have resources to support your QMS?
Have you a process for controlling QMS documents?