ISO 9001 Auditing in a Healthcare setting

#1
Process auditing in a healthcare setting - discuss.
This is my first time in a healthcare setting and typically I am finding the audits that have been done to date are based around data not process...were the consent to treatment forms completed, was paperwork completed in the lab, were these blood tests done, were the screening tests done. They are all desktop reviews - pick your sample, look up the data, fill in a spreadsheet.

Would these be sufficient for an ISO 9001 audit? My gut feeling is no....because it doesn't identify who did what....e.g. consents were done....but only because nurses ran around like headless chickens chasing forms that the doctors should have done. Would adding an extra column for "consents uploaded by" be sufficient.

I am looking for
1) some persuasive arguments I can take to my boss explaining why process audits would add value over and above what he gets already
and/or
2) feedback from people who have implemented in ISO 9001 in healthcare settings more generally and how successful it works
 
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John Broomfield

Staff member
Super Moderator
#2
First ask for an objective for your internal audit. This may come from the objectives set by top management for the internal audit program.

Then you will be able to show how auditing the work of the employees and their interactions (aka processes) will fulfill the audit objectives.

You may wish to start with auditing the effectiveness of the internal audit program and its processes for obtaining value from auditing, selecting and training auditors, planning audits, conducting audits and reporting the results.

Then feed the results into audits of the management review process.
 

Randy

Super Moderator
#3
I've done 3rd party audits for healthcare in the US & Canada, and I'm continuing to do healthcare in the next few weeks, here's the secret...It's not any different than anything else... "What's required? Is it being done?". The subject matter or industry is different of course, but the audit process is that same.
 
#4
I've done 3rd party audits for healthcare in the US & Canada, and I'm continuing to do healthcare in the next few weeks, here's the secret...It's not any different than anything else... "What's required? Is it being done?". The subject matter or industry is different of course, but the audit process is that same.
I guess that comes down to the crux of the matter though...
What's required: a consent form
Was it done: yes

so to all intents and purposes their current audits show that.....and my boss is happy. In his eyes everything is working.

but if ISO 9001 is about process surely the missing bit is "by whom". We are currently unable to evidence total conformity nor effectiveness - in my view. Do people understand the process? Is the entire process being followed? We jump from input to output with none of the steps in between being evaluated.

If a third party auditor was to come in would we pass or fail? I don't think I would pass us - but I need to convince my boss of that.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Do people understand the process? Is the entire process being followed? We jump from input to output with none of the steps in between being evaluated.
You might benefit from
DNV GL Internal Audits for Healthcare Training Course
Taking Your Management System to the Next Level ISO 2.0 Training Course
DNV GL Healthcare Management System Implementation Training Course

DNV is one of very few Hospital Accreditation entities in the USA and has developed ISO 9001:2015 Requirements Basics of NIAHO® Requirements Alignment of ISO and NIAHO® Planning phase of Implementation Implementing ISO 9001 in the healthcare setting.

Funny that some people think that auditing suppliers of medical devices and equipment is the same as auditing Healthcare organizations.

One of our long time Covers, @RoxaneB works in the Healthcare sector and she has tremendous experience in quality systems and internal audits and she might be able to offer you some insight and perspective.

Good luck.
 

Randy

Super Moderator
#6
Sidney's right, healthcare has multiple variables, I've been involved with home nursing care more than hospitals and have nothing to do with medical suppliers or manufacturers (on the quality side).
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
I guess that comes down to the crux of the matter though...
What's required: a consent form
Was it done: yes

so to all intents and purposes their current audits show that.....and my boss is happy. In his eyes everything is working.

but if ISO 9001 is about process surely the missing bit is "by whom". We are currently unable to evidence total conformity nor effectiveness - in my view. Do people understand the process? Is the entire process being followed? We jump from input to output with none of the steps in between being evaluated.

If a third party auditor was to come in would we pass or fail? I don't think I would pass us - but I need to convince my boss of that.
Maybe I'm missing something. Seems to me the process definition is where the focus should be, not the audit. Document what you want to happen, then see if it is happening.

Instead of "What's required? a consent form" maybe it should be "What's required? a consent form completed by the doctor when the patient agrees to the procedure". Then, audit to see if that is happening.
 

John Broomfield

Staff member
Super Moderator
#8
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.
 
#9
I have a feeling that the original poster doesn't understand what is in ISO 9001:2015. Start there. Buy a copy of the Standard and read it then find a way to understand what all is in it. There is more to it than simply processes.
 
#10
I have a feeling that the original poster doesn't understand what is in ISO 9001:2015. Start there. Buy a copy of the Standard and read it then find a way to understand what all is in it. There is more to it than simply processes.
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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