Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

To whom it may concern, 

I'm not sure if the attached will help in anyway but please find attached "some" relevant information I got from LinkedIn posts & for this reason I think they are copyright free to post on this forum.
From my own experience for internal auditing remember that it's only required to know where every single file is stored / located and not a memory game on knowing e.g. SOP's off from memory. Ensure all employees are able to present, easily find and talk through in detail as for each department standard.

Just in case there is an oversight -  always remember to ensure all equipment is calibrated and has up to date calibration certificates to go with them. 

Please correct me if I'm wrong anyone??

Yes, I attached other information I think is good noting the ISO 13485 is primarily risk based approach.

------------------------------
John Barry
Project Engineer
Mullingar
Ireland
------------------------------

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

Hello Anon,

Most Internal Audit Plan (or some call them Agendas) are usually specific to the company and for others they are proprietary.  You might need to reach out to some individuals directly who could probably provide a "vanilla" version of a plan.  If scouring the Internet, might also find where someone posted a version of an internal audit plan specific to medical devices.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Feb-2023 11:53
From: John Barry
Subject: ISO 13485 Internal Audit

To whom it may concern, 

I'm not sure if the attached will help in anyway but please find attached "some" relevant information I got from LinkedIn posts & for this reason I think they are copyright free to post on this forum.
From my own experience for internal auditing remember that it's only required to know where every single file is stored / located and not a memory game on knowing e.g. SOP's off from memory. Ensure all employees are able to present, easily find and talk through in detail as for each department standard.

Just in case there is an oversight -  always remember to ensure all equipment is calibrated and has up to date calibration certificates to go with them. 

Please correct me if I'm wrong anyone??

Yes, I attached other information I think is good noting the ISO 13485 is primarily risk based approach.

------------------------------
John Barry
Project Engineer
Mullingar
Ireland

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

Good Morning,

Greenlight Guru has a pretty good checklist.  You will need to fill in your name/email in order to download it.

https://www.greenlight.guru/downloads/internal-quality-audit-checklist?hsCtaTracking=dec6513d-084e-401d-abe4-4831d89c7047%7C6e073f16-0a1e-45c0-adee-05d9a9796f56  

Regards,

Dawn

------------------------------
Dawn Snow
Marshfield MA
United States
------------------------------

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

A good way is to start with P0002.007  MDSAP Audit Approach Revision Date: 2022-04-15. It all the things you need to check for ISO 13485:2016 and more. In you case the "and more" can cause a bit of a problem because you will need to ignore that stuff.

It is organized by Process and Task. Just use the wording in the tasks that have a reference to ISO 13485:2016. Ignore the regulatory region stuff such as Australia and Brazil.

There is a lot of material here, so expect it take about one week to get through it. As an internal audit, you could split it over time, to fit schedules.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

I would highly recommend obtaining and studying ISO 19011 as it is the standard that provides guidelines for auditing management systems. Doing so should provide a framework for you to build off of in order to get started creating your internal audit plan..

The internal auditor having a certificate or proof of experience auditing under the guidelines under 19011 is a way to demonstrate the credibility/competence of your internal auditor during an ISO 13485 audit by your Registrar/NotifiedBody.

Lastly, since I do not know your current context (experience, available resources, etc..), I would be remiss if I did not state this: Do not forget that the internal auditor cannot audit their own work.

------------------------------
Charley Ford
College Station TX
United States
------------------------------

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.

You've gotten some good advice already but I might also add that showing competency and obtaining practical methods to audit to ISO 13485:2016 could be built by taking an Internal or Lead Auditor class in the standard.  There are many resources for such classes and, depending on the timeframe needed to do the internal audit, I'm sure you and another person (if not already available) could get such training fairly quickly.  This second person would be useful for making sure that you don't audit your own work (as already mentioned by Charley).

Last, I'd recommend not making this a "check the box" activity by scheduling audits of various areas using a risk-based approach and allowing enough time for each to do a decent job.  This is your opportunity to catch nonconformities before the certification authority does and improve your quality as soon as possible.

Happy internal auditing.

------------------------------
Rem Siekmann BSE, RAC, MBA, ASQ CMDA
Senior Principal Engineer
Bellaire MI
United States
------------------------------

Original Message:
Sent: 14-Feb-2023 11:17
From: Anonymous Member
Subject: ISO 13485 Internal Audit

This message was posted by a user wishing to remain anonymous

Hi everyone, 

I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. Does any one have internal audit plan that can kindly share with me. This is my first time taking part in an internal audit so would be very grateful if you could help. 

thanks.