ISO 9001 Auditing in a Healthcare setting

John Broomfield said:

Completing a form is a task within a process.

It may or may not capture the data required and the auditor investigates this by interviewing the recipients of the form (and the rest of the process/system) as necessary to fulfill the audit objective.

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thank you yes - and it is the interviewing that is not happening - and the boss sees no need for that - so I am on a journey to convince him...bearing in mind the extra cost of training, time taken up of staff etc that it will give him added value

Karenlb1970 said:

I'm actually a qualified ISO 9001:2015 Lead Auditor...so I know what is expected. I was recruited to try and get ISO 9001 for my employers but I am having trouble convincing my boss that we need to change the way we audit and the argument being given is that the current audit is giving him what he needs.....but my argument is that they wouldn't comply. and I don't think assessor would pass us....but it appears from my reading and research that many healthcare settings focus on just data ...not process (effectiveness).

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Have you established the objectives of the internal audit program yet?

John Broomfield said:

Have you established the objectives of the internal audit program yet?

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Yes. the requirements from our regulator regarding an internal audit programme are:
Determine whether the quality management system (QMS) conforms to:
the planned arrangements
to the requirements of the Code of Practice
and that the QMS is effectively implemented and maintained.

so I know that we need proper (ISO9001 style) internal audit. I just keep doubting myself as there is no-one here that understands quality management and what would be acceptable to an assessor. Everyone I know who works in quality likes to debate how to do things...except there isn't anyone here for me to thrash things out with....so this forum is the place!

Karenlb1970 said:

the requirements from our regulator regarding an internal audit programme

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Obviously, the regulator is not responsible for running your company well.

That is the responsibility of top management.

How about drafting fresh business objectives for the internal audit programme for approval?

This then would provide you with a source of objectives for each audit and the authority to choose which auditing tools and methodologies to use.

Karenlb1970 said:

.....but my argument is that they wouldn't comply. and I don't think assessor would pass us....

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I still feel like I'm missing something....

If, as a qualified ISO 9001:2015 Lead Auditor auditor, you determine they don't comply, then don't argue, just write the nonconformance(s). You know how to properly write a nonconformace, just do it. Whether as part of an internal audit or just something you discover in the normal course of the day. Why not?

My gut sense is that we're blending audit "types" (for lack of a better word). There is a difference between the 'chart audit process' and the 'audit of the chart audit process.'

Your clinical staff are auditing the charts. Ideally, they are looking for conformance to certain forms being included (and properly completed) such as consent, med reconciliation, treatment/care plans, etc. Even more, they are hopefully reporting more than just the % compliance but trends that can be actioned. If there is, for example, a particular team/unit with consistently lower conformance rates. This chart audit process should be aligned to clinical requirements - accreditation, college, pick your source.

From an ISO 9001 perspective, you're likely looking to confirm that they are are following their process. You are not necessarily looking to see if they included properly completed consent forms (although, this could come up during a sample record check), but rather that they follow their chart audit process.