Optional Identification Exercise

We have talked about Guidance Documents and who issues them.

We have also covered Regulations and the authorities having jurisdiction over them.

How could this help you with an Audit Program? If you complete this optional exercise, you will have identified your company, and its physical locations, the device manufactured, and what markets it will be in. This allows you to determine the Authorities Having Jurisdiction and which regulations you will need to comply with. Based on your device type, you can also identify your device’s relevant standards and guidance documents.

Combine all of that together and you are really close to defining the extent of your Audit Program, its Scope, and Criteria.

Take you time to answer the questions provided and you will have all of this information gathered in a single easy to reference spot. The questions are simple and straightforward but you will have to do your homeworking to search and find the answers to them.

Below is the download link to a Microsoft Word file to fill out.