Can a Lead Auditor be Audited?

[jzengj]

Hi all,

I'm the lead auditor as well as the document controller for my organization. I understand the clause in ISO 13485 states that "Auditors should not audit their own work". So I was wondering if I am allowed to be audited for the section on Documentation Requirements, while still serving my role as a lead auditor, which would include the compilation and presentation of audit findings to my organization at the end of the audit. Appreciate any advice on this matter, thank you!

 

[Jen Kirley]

You can and absolutely should be audited, that is for your ability to present the documentation describing and exhibiting effective function of both these processes. After all, it is a process audit, not a jzengj audit, true?

The clause you refer to means you will not be able to audit your own work within these processes. Do you have another auditor who can do the audit on them?

If you have an active audit group, you can audit their work and they can audit yours.

 

[jzengj]

Hi Jennifer, thanks for the reply!

May I paraphrase what you just said to ensure I fully understood you? Our documentation and records control are one part of the process in our quality system, and hence we need to audit it. If I am involved in the process, which I am (as a document controller), I should appoint someone independent to audit this process.

Let me know if I got your meaning right. If yes, do you suppose I am still able to carry out the audit as a lead auditor? This would involve compiling all the audit findings made by my internal auditors, including those findings pertaining to the process I am involved in. Will this be a NC against the statement "Auditors should not audit their own work."

Sorry if this seems like a very basic question.

 

[qusys]

Hi Jennifer, thanks for the reply!

May I paraphrase what you just said to ensure I fully understood you? Our documentation and records control are one part of the process in our quality system, and hence we need to audit it. If I am involved in the process, which I am (as a document controller), I should appoint someone independent to audit this process.

Let me know if I got your meaning right. If yes, do you suppose I am still able to carry out the audit as a lead auditor? This would involve compiling all the audit findings made by my internal auditors, including those findings pertaining to the process I am involved in. Will this be a NC against the statement "Auditors should not audit their own work."

Sorry if this seems like a very basic question.

The audit is related to the process not on the person..you can organize to assure the objectivity and the impartiality of this internal audit.
Otherwise you can rely on external auditpr ( consultant or auditor of another site of your company) to do it.

 

[Jen Kirley]

Hi Jennifer, thanks for the reply!

May I paraphrase what you just said to ensure I fully understood you? Our documentation and records control are one part of the process in our quality system, and hence we need to audit it. If I am involved in the process, which I am (as a document controller), I should appoint someone independent to audit this process.

This is correct.

Let me know if I got your meaning right. If yes, do you suppose I am still able to carry out the audit as a lead auditor? This would involve compiling all the audit findings made by my internal auditors, including those findings pertaining to the process I am involved in. Will this be a NC against the statement "Auditors should not audit their own work."

To ensure complete conformance to the standard I would not want to be involved in this audit in any way. Do have more than one lead auditor? If not, do you have a colleague at another organization who can perform this service for you? Maybe a trade can be worked out. Small organizations often face this challenge and must be creative in addressing it while staying away from assessing our own processes.

 

[Nite1922]

Just my 0.02 Jennifer. You are absolutely right.
If I can offer my help, jzengi.
In our company, we started with 2 auditors.
The minimum amount of internal auditors you can have is 2.
That is what I started out with and we walked back and forth on the audit and completed it except when we came to auditing the internal audit. Cannot be done.
So I went to the manager, who also has auditing training and told him "you are recruited".

 

[jzengj]

To ensure complete conformance to the standard I would not want to be involved in this audit in any way. Do have more than one lead auditor? If not, do you have a colleague at another organization who can perform this service for you? Maybe a trade can be worked out. Small organizations often face this challenge and must be creative in addressing it while staying away from assessing our own processes.

Thanks Jennifer for the clarification and suggestions! We do not have more than one lead auditor for now, but I guess we could always appoint another one of our internal auditors as one. In which case, it would free me up to be audited for the processes I am involved in, while at the same time, I could still serve as an internal auditor for the processes I am not involved in. And I guess having an external party come conduct the audit for us is another feasible alternative we can consider too if our internal auditors are all tied up. Thanks again for the valuable advice

 

[jzengj]

Just my 0.02 Jennifer. You are absolutely right.
If I can offer my help, jzengi.
In our company, we started with 2 auditors.
The minimum amount of internal auditors you can have is 2.
That is what I started out with and we walked back and forth on the audit and completed it except when we came to auditing the internal audit. Cannot be done.
So I went to the manager, who also has auditing training and told him "you are recruited".

Nite1922, thank you for sharing your experience as well! Am definitely much clearer on what I have to do to carry out my next internal audit