Impartiality of Internal Auditor ISO 9001/13485

[Sidney Vianna]

It would really be wonderful if TC-176 would explain exactly why they removed "auditors shall not audit their own work" from the latest version of the standard.

I have no intention of rehashing the exhaustive debate we had at the thread I hyperlinked in my previous post. As to why the TC 176 SC2 people's rationale to remove the words you mention, the only plausible explanation, for me, is the obvious fact that they had to go with the HLS text for internal auditing and decided to get rid of that statement.

The sad reality about internal auditing for the overwhelming majority of ISO 9001 certified organizations is that they are, for the most part, useless. They are poorly planned and executed by people who were poorly selected and poorly trained. The end result, are audits that don't add any value to the organization and are perceived as a waste of time and energy. To add to this appalling picture the possibility of people auditing their own work would only make a bad situation, worse. But c'est la vie....as they say in the Champs-Élysées.

​

 

[Big Jim]

I have no intention of rehashing the exhaustive debate we had at the thread I hyperlinked in my previous post. As to why the TC 176 SC2 people's rationale to remove the words you mention, the only plausible explanation, for me, is the obvious fact that they had to go with the HLS text for internal auditing and decided to get rid of that statement.

The sad reality about internal auditing for the overwhelming majority of ISO 9001 certified organizations is that they are, for the most part, useless. They are poorly planned and executed by people who were poorly selected and poorly trained. The end result, are audits that don't add any value to the organization and are perceived as a waste of time and energy. To add to this appalling picture the possibility of people auditing their own work would only make a bad situation, worse. But c'est la vie....as they say in the Champs-Élysées.

View attachment 26304 ​

Interesting. How does that address "auditors shall not audit their own work"?

I think it is sad that you think so lowly of ISO 9001 certificate holders. Sure, some are that way but my experience shows there are many that do take it seriously. I would even go so far as to say most of the clients I call on do take it seriously.

 

[Ronen E]

I’m having trouble auditing my own work but I am having no problem reviewing it.

Sorry, that doesn't sound like a definition. Am I missing something?

 

[Ronen E]

They are poorly planned and executed by people who were poorly selected and poorly trained.

What is, in your opinion, the root cause for that?

 

[tony s]

Is it acceptable for another member of the quality team to conduct this audit or does the person need to be further removed?

Yes it is acceptable.

Can a one-person company conform with 9.2.2, concerning objectivity and impartiality? I believe so. The standard is applicable to any organization regardless of type and size. As long as the organization can demonstrate objectivity and impartiality, auditing your own function should not be a problem. Like internal audit, everyday, when we look at the mirror, we audit ourselves. You must have objectivity and impartiality to fix those things reflected in front of you.

 

[Ronen E]

As long as the organization can demonstrate objectivity and impartiality

And how does it do that?

Like internal audit, everyday, when we look at the mirror, we audit ourselves. You must have objectivity and impartiality to fix those things reflected in front of you.

Sometimes fixing oneself is too difficult or painful. In these situations there's always the enticement of looking away.

 

[John Broomfield]

Sorry, that doesn't sound like a definition. Am I missing something?

We all can use a dictionary so I thought I’d give some evidence instead.

 

[tony s]

And how does it do that?

To demonstrate objectivity and impartiality, the following comes to mind:

• findings are raised against well established requirements, not on opinions or interpretations;
• findings are well supported with objective evidence;
• the samples are taken randomly;
• findings are stated on a fact-finding and not a fault-finding style;
• subjective statements are avoided (e.g. "insufficient training", "unorganized storage");
• working within agreed rules;
• audit findings and conclusion are reproducible (i.e. other auditors will have judgment similar to your judgment);
• findings don't have to be popular...

 

[Ronen E]

We all can use a dictionary so I thought I’d give some evidence instead.

I wasn't disputing your argument, I was trying to better understand it.
Fact: Different dictionaries sometimes provide different definitions for the same term. When you broaden your scope and include other sources, it might get even more diverse.