ISO 13485:2016 internal audit checklist

meras

Registered
Hi All ,

Can anyone in this cove help me to provide ISO 13485:2016 internal audit checklist? I need to do the internal audit and need the checklist for reference.

tks
 

yodon

Leader
Super Moderator
If you mean a clause-by-clause checklist, it's not the appropriate way to do an internal audit. You want to take a process approach. For example, if you audit the purchasing process, it includes an assessment of the personnel (are they competent to perform the role assigned), document and record control (is the purchasing information captured and controlled), and so on.

Having a checklist that just asks, for example, "did the organization determine the competence for personnel performing work affecting product quality" you will likely miss out on specific cases.

Do you have a copy of the standard? That would help you derive questions to ask.
 

RAQA Support

Supporting your goals and objectives since 1989.
@yodon is correct. Using the standard is best. I would add that the checklist could be used as a starting point to a deeper audit. Just beware of using the checklist - when your company undergoes a government regulatory audit, a checklist internal audit may (most likely) not be seen as substantial enough.
 

meras

Registered
Tks. BTW I have to do process audit right? if that is the case is there any format to do the process audit. are u telling me that , I need to set a question base on the ISO 13485 :2016 standard ? Yes , I have the standard.
 

RAQA Support

Supporting your goals and objectives since 1989.
@meras Your processes should follow the 13485 standard, therefore any audit that follows the standard will be auditing your processes. It is typical that audits are structured in a similar manner to the 13485 standard simply to make sure all aspects are followed/audited. The question base you refer to would come directly from the 13485 standard in this instance.
 

ALEONARD

Registered
Tks. BTW I have to do process audit right? if that is the case is there any format to do the process audit. are u telling me that , I need to set a question base on the ISO 13485 :2016 standard ? Yes , I have the standard.
Make it simple on yourself, use Excel and list your core business processes in column A (e.g. Purchasing, Design, Quality Control, Equipment Maintenance and Calibration). Then in columns B --> list the ISO 13485 clauses that these processes will cover. Finally, make a list of your QMS docs that will be needed for each process.

When you scroll along your rows, column A will be a process, and columns B --> will refer to the covered clauses. That way, you can show your auditor that you have covered the standard entirely with your process audit schedule.

Add other regulations (e.g. QSR, MDSAP) as required using the same format.

Hope this helps
 

meras

Registered
Make it simple on yourself, use Excel and list your core business processes in column A (e.g. Purchasing, Design, Quality Control, Equipment Maintenance and Calibration). Then in columns B --> list the ISO 13485 clauses that these processes will cover. Finally, make a list of your QMS docs that will be needed for each process.

When you scroll along your rows, column A will be a process, and columns B --> will refer to the covered clauses. That way, you can show your auditor that you have covered the standard entirely with your process audit schedule.

Add other regulations (e.g. QSR, MDSAP) as required using the same format.

Hope this helps



Tks , I shall work on this. I'm very new on this field .
 
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