This is a comparison between your current ISO 13485:2003 or ISO 13485:2012 in terms of documentation and the requirements of ISO 13485:2016. Essentially it is snapshot of the “gap” between where you are now, and where you would like to be in order to become certified to the updated standard.
You are requested to provide top level information regarding the operating scope of your company e.g. processes, products, business lines, plus any available quality or operational documents such as quality manual, quality procedures, work instructions, standard operating procedures. Lower level documentation is typically not required, but a records list should be provided if available.
What You Will Receive
An executive overview of your current status with regard to ISO certification, plus a list of points to be addressed within each of the ISO elements and main clauses. You will also receive advice on how to treat the different aspects of your business within an ISO system. This is a substantial document and will provide you with the information which you need in order to generate your own project plan, based on your individual needs, resources and timing for certification. This project plan will be used throughout the project, so the initial input is critical and ensures you are going in the right direction.
In addition, we can provide some support templates such as procedures, process maps, metric and key objective tables, and internal audit schedules.
Benefits of a Gap Analysis Review
The Gap Analysis Review provides you with the following:
- Tangible evidence that you have reviewed your systems and processes and have made a commitment to upgrade your quality management system to the new standard.
- A clause by clause analysis of the extent to which your current QMS meets the new standard
- A starting point for your own project plan, as you will be informed as to the key areas which need to be addressed