Greetings, our internal audits have revealed several minor findings lately. As per our procedure, all internal audit findings should undergo corrective action. Nevertheless, if a finding can be addressed with a correction action, I am curious to know if ISO 13485:2016 requires the initiation of the full corrective action process.
Step 1: Define the Problem. ...
Step 2: Establish the Scope of the Problem. ...
Step 3: Take Containment Actions. ...
Step 4: Find the Root Cause of the Problem. ...
Step 5: Plan Corrective Actions to Fix the Root Cause. ...
Step 6: Implement the Corrective Action Plan.
Is it possible for you to Stop at step 3?
Step 1: Define the Problem. ...
Step 2: Establish the Scope of the Problem. ...
Step 3: Take Containment Actions. ...
Step 4: Find the Root Cause of the Problem. ...
Step 5: Plan Corrective Actions to Fix the Root Cause. ...
Step 6: Implement the Corrective Action Plan.
Is it possible for you to Stop at step 3?