How to Use the Checklist:
The first column of the checklist lists all the ISO 13485:2016 requirements by section number. The second column of the checklist named “Observations” is used to document what the auditor has observed during the assessment. The auditor should interview all the processes owners associated with the element. The auditor should document results of the interviews including any records examined and the results of the examination.
The next two columns are used to indicate the level of compliance with the ISO requirements. The auditor utilizes the results of the observations to determine the level of compliance with the requirement. The auditor checks the (NC) nonconformance box if the auditor observed that the process owners were unaware of the requirement, were not following the requirement, or records examined were not consistent with the standards’ record requirements. If the auditor observed some level of compliant practices, the percent compliant is entered into the (COM) compliant box.
The final column is used to document the auditors recommendations for converting the nonconformances observed during the assessment into compliant practices. This is a crucial step in the assessment and the recommendations should include best practices along with recommendations obtained from the process owners interviewed. The auditor should explore current untapped resources including software and informal practices that can be utilized if formalized to comply with the requirements.