Where I can find an ISO 13485:2016 Audit Schedule example?

Mark Meer

Trusted Information Resource
Trusted
#2
The standard simply calls for "the audit program shall be planned". Many interpret this to mean a pre-planned schedule, but you could also argue that planning could just be having an ongoing process that outputs audit activities.

If you want to go the scheduling route, how you do it is up to you. Whatever works best in the context of your organization. You can maintain such a schedule in a table, a calendar, a whiteboard,...

For example, you might just maintain a simple table with the following headings:
- Planned date
- Assigned auditor(s)
- Audit criteria and Scope

...and add rows as needed (e.g. following management reviews, CAPA actions, previous audits, etc.). Just make sure that all processes are covered at justified intervals.
 

Marc

Retired Old Goat
Staff member
Administrator
#3
There are compliance (to a standard) audits, and "process" (and related) audits of internal systems and their processes.

I'm not clear as to which the OP is wanting, but I think the OP is looking for a compliance (to a standard) audit template. The OP may want to clarify.
 

AndyN

A problem shared...
Staff member
Super Moderator
#5
The standard simply calls for "the audit program shall be planned". Many interpret this to mean a pre-planned schedule, but you could also argue that planning could just be having an ongoing process that outputs audit activities.

If you want to go the scheduling route, how you do it is up to you. Whatever works best in the context of your organization. You can maintain such a schedule in a table, a calendar, a whiteboard,...

For example, you might just maintain a simple table with the following headings:
- Planned date
- Assigned auditor(s)
- Audit criteria and Scope

...and add rows as needed (e.g. following management reviews, CAPA actions, previous audits, etc.). Just make sure that all processes are covered at justified intervals.
I agree with Mark Meer. People frequently shoot themselves in the foot by creating a calendar of audits which then overwhelm them - and such a "plan" isn't required, nor is it very practical. Having "planning" audits isn't having a calendar of audits...
 
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