Collation of assurance evidence enables certification bodies, device end users and/or the acceptance authority to readily identify what activities have been undertaken and what evidence is available from these activities to demonstrate the manufactured device is fit for its intended application, and that it can meet the application and end user requirements.
Certification verifies that the device conforms to a minimum specification and is a requirement for some applications. Certification involves a review of the assurance evidence for the device by an accredited independent 3rd party; This may include an audit of company processes, for example quality control.
The RAPAT “Assurance & Certification” worksheet can be used to provide the necessary assurance trail, connecting the requirements and potential risks to achieving these, with the activities undertaken and the evidence produced from these activities to confirm that the manufactured device will fulfil these requirements. The worksheet is intended to cross reference the other RAPAT worksheets and relevant testing/analysis reports.
It is important to identify any functional, performance, or application limitations of the device, associated with, for example, operational environmental conditions or operability limits, and ensure that these are recorded in the assurance evidence worksheet. This may be important in relation to labelling, user instructions and training and also in relation to potential future applications of the device.
The documented evidence that each requirement/risk has been fully addressed will need to be approved to confirm that it is sufficient to demonstrate that the requirement has been met. This may be initiated before the testing and analysis plan is finalised to give opportunity for independent 3rd party review of the test plan. For some applications this will also require an accredited independent 3rd party who may also need to witness testing.
At the top of the RAPAT “Assurance & Certification” worksheet, the “Product Assurance Sheet Completion Status” will initially be set to “Not started”. Use the dropdown list to change this to “In progress”, “Completed” or “Updated” as appropriate.
Populate the “Evidence of Requirements” table, adding further rows using the “Add Row” button in the right-click context menu as required. The dashboard at the top of the worksheet automatically tracks progress against the requirements included in the table.
For each row in the "Evidence of Requirements” table, it should be indicated whether the requirements needs internal or external approval, using the dropdown menu. If 'no' is selected, there is no need to populate the 'External Approval' section of the table. If 'yes' is selected, both the 'Internal Approval' and 'External Approval' sections should be filled in. These sections can only be edited if the 'Completion Status' of the row is marked as 'Ready for Approval'. If the name of the approver and the date are provided for the relevant sections, they can then be assigned the 'Approved' status from the dropdown. When the necessary sections for the row have been marked as 'Approved', the row's completion status will be automatically updated to 'Approved and Completed', which will be reflected in the dashboard at the top of the sheet.
It is recommended that population of the RAPAT “Assurance & Certification” worksheet is started once the testing and analysis plan has been identified. Evidence can then be collated and assessed as it becomes available. This will facilitate progress tracking and engagement with end users and certification bodies, during the testing process, if test witnessing is required and on completion of the testing once the test results and their interpretation are available as evidence.
