Has anyone been directly involved with or implemented an ISO9001-2000 system in the healthcare field? If so please share some the steps that were critical in setting up and certifying such a system. My core background with ISO has been limited to mfg. My goal is to migrate into the healthcare environment and provide the benefits of ISO to this industry. My belief is there is great benefit in the effective implementation of a robust system and this area is virtually a new market. Any links to information on the web or personal experiences would be a great benefit. Thank you in advance.
David

Any links to information on the web or personal experiences would be a great benefit. Thank you in advance.
David http://elsmar.com/Forums/showthread.php?t=14174
Hope this helps. And yes, the healthcare sector could definitely use better management practices. Their perspective of "quality" is terribly flawed.

Has anyone been directly involved with or implemented an ISO9001-2000 system in the healthcare field?

Why not refer ISO 13485 also as Medical devices are a subset of Healthcare field ?

Has anyone been directly involved with or implemented an ISO9001-2000 system in the healthcare field? If so please share some the steps that were critical in setting up and certifying such a system. My core background with ISO has been limited to mfg. My goal is to migrate into the healthcare environment and provide the benefits of ISO to this industry. My belief is there is great benefit in the effective implementation of a robust system and this area is virtually a new market. Any links to information on the web or personal experiences would be a great benefit. Thank you in advance.
David
David

We have helped a couple of NHS organisations to retain 9K compliance under the Yr2000 revision. The first was a new registration for which we used a "process approach" well in advance of the new standard, and the second was an Accident and Emergency department which had a "lapsed" narrative system which we tranformed into a set of process descriptions. They refer to it as their Clinical Governance system rather than as a quality system, and they use it to define and improve their processes. In both cases certification tends to be less important than understanding and communicating how they operate - the benefit is in seeing the flow of processes, and identifying responsiblities and interfaces.

According to a recent article in Quality Progress (http://www.asq.org/quality-progress/2007/09/quality-assurance/keeping-current-sept-07.pdf), the Malaysian government is directing hospitals in that country to stop seeking certification to ISO 9001.
Malaysian Hospitals Told To Stop Chasing ISO 9000
Malaysian Health Minister Chua Soi Lek recently scolded his nation’s hospitals for focusing too much on attaining ISO 9000 registration and too little on patients.
“Lately, I’ve received numerous complaints from doctors who were so bogged down with paperwork related to the ISO (9000) certification that their main duties of caring for patients were being neglected,” he said.
To date, 46% of the 134 government hospitals had obtained ISO 9000 registration.
Chua said some hospitals might have ISO 9000 registration, but their quality of care is still sub par. He said registration to an ISO 9000 standard is more suitable for factories and establishments dealing with administrative and management work.
He told hospitals that if they want to set a benchmark for quality of service, they should opt for Joint Commision International (JCI). No Malaysian hospital has applied for JCI, although it is a norm in neighboring countries, such as Singapore and Thailand.
Chua said the hospitals could also get accreditation from the Malaysian Society of Quality and Health (MSQH). Fiftysix government hospitals (42%) are MSHQ accredited.
I find amazing that our quality profession keeps incurring in the same mistakes over and over again. Seems that PA/CA is a foreign concept for us. We repackage ineffective systems for emerging markets. When that experience fail, we chase the next prey. Obviously, the HealthCare sector is a prime candidate for performance improvements. Their quality performance is horrible, for the most part. Seeking ISO 9001 certification as a marketing ploy, rather than a performance improvement process leads to this type of negative reaction. I would be interested to know from our Malaysian covers if they have any additional comments about these news.

Has anyone been directly involved with or implemented an ISO9001-2000 system in the healthcare field? If so please share some the steps that were critical in setting up and certifying such a system. My core background with ISO has been limited to mfg. My goal is to migrate into the healthcare environment and provide the benefits of ISO to this industry. My belief is there is great benefit in the effective implementation of a robust system and this area is virtually a new market. Any links to information on the web or personal experiences would be a great benefit. Thank you in advance.
David

I have not applied this yet, but am in the final stages of developing a "modified" ISO 9001 program designed specifically for healthcare. Some brief thoughts:

ISO, straight out of the box is not ideal for healthcare. Nothing wrong with the standard. But, nobody at the hospital understands it, so they end up doing it wrong. The Malaysia example is a perfect example. They got bogged down in paperwork, when the whole point is trying to improve performance. The Malaysian Director's comment to seek JHACO instead shows just how much he misses the point. However, he was right on target that if the performance does not improve, it is pointless. If 34 out of 100+ hospitals are certified, there should be MASSIVE improvements...if they did it right.

To enhance the performance aspect of ISO, I wrap Lean and Baldrige, etc. into the program. It is not about certification, it is about improving performance. To quote ANAB, "Output Matters."

According to a recent article in Quality Progress (http://www.asq.org/quality-progress/2007/09/quality-assurance/keeping-current-sept-07.pdf), the Malaysian government is directing hospitals in that country to stop seeking certification to ISO 9001.
I find amazing that our quality profession keeps incurring in the same mistakes over and over again. Seems that PA/CA is a foreign concept for us. We repackage ineffective systems for emerging markets. When that experience fail, we chase the next prey. Obviously, the HealthCare sector is a prime candidate for performance improvements. Their quality performance is horrible, for the most part. Seeking ISO 9001 certification as a marketing ploy, rather than a performance improvement process leads to this type of negative reaction. I would be interested to know from our Malaysian covers if they have any additional comments about these news.

Our Civil Service (government servants) is notoriously bureaucratic. When bureaucracy meets (paper work) systems, it is a recipe for disaster. While some are talking here about a 4 page manual, these people are capable of giving you 400 pages. They ended up having an unending stream of procedures, SOPs and what nots’ because no body wants to exercise common sense and they will only act when a procedure/sop/directive is available.

They are masters at beautiful posters, slogans and rhetoric’s. Luckily, we have a Health Minister who was not sleeping and not carried away by these posters, slogans and bulls.

Perhaps the only consolation we have is that these people are not really 'quality professionals' but their consultants (if any) and auditors are!

Completely agree with what has been said above. In fact, in most of the organisations, wether healthcare, or otherwise, people either fail to understand the standard or they just do not want to, resulting in poor effectiveness of the system loaded with lots of paperwork and in fact decreasing the performance of the organisation. In turn ---- ISO 9001 gets to be seen in poor light.

I have been involved with implementing ISO 9001 based system at a couple of hospitals (and were certified too). Benefits were seen in -

- Ability to manage and treat increased number of patients,
- Better in-patient care, Faster post-operative recovery,
- Increased effectiveness in follow-up treatment,
- Technological advancements,
- Better attendent care,
- Addition of specialities, and, effectively,
- OT availability for more number of cases per day,
- Educated/Trained staff ready to handle any emergency and guide the patients / attendents, or, better emergency preparedness,
- Faster retrieval of equipments, medicines etc, both, in planned and unplanned (emergency) cases,
- Smoothly addressing Consumer grievances whenever required (primarily because of maintaining appropriate records and good control),
- Faster and accurate response to queries / requirements of the district administration / Government.

These were a few coming to my mind offhand. The entire credit goes to the management, doctors, and the staff of the hospitals who were committed to
the cause of providing good healthcare service to the society. I was only a facilitator helping them to develop and implement an effective system -
effectively. The approach was usual as with any other organisation. The steps taken were the same, except in this case, discussions were more often, and it took more time to establish the system due to the varying and heavy schedules effecting the availability of the practicing Doctors, Management and staff.

The entire credit goes to the management, doctors, and the staff of the hospitals who were committed to the cause of providing good healthcare service to the society.

You are right. We do have some success examples but the problem is the unsuccessful ones are too numerous and neglecting their regular duties in the name of ISO implementation got into the nerves of the Minister.

Benefits were seen in -

- Ability to manage and treat increased number of patients,
- Better in-patient care, Faster post-operative recovery,
- Increased effectiveness in follow-up treatment,
- Technological advancements,
- Better attendent care,
- Addition of specialities, and, effectively,
- OT availability for more number of cases per day,
- Educated/Trained staff ready to handle any emergency and guide the patients / attendents, or, better emergency preparedness,
- Faster retrieval of equipments, medicines etc, both, in planned and unplanned (emergency) cases,
- Smoothly addressing Consumer grievances whenever required (primarily because of maintaining appropriate records and good control),
- Faster and accurate response to queries / requirements of the district administration / Government.You should consider developing a paper/article and submitting it to the ISO Management Systems Magazine to contrast your experience and results with some of the Malaysian hospitals and the decision taken by their government. It would make for interesting reading, imo.

David,

'Healthcare' could apply to an enormous spectrum of businesses, as you'll have seen by some of the responses. Assuming you are referring to one that is service-based, then yes, there is a fair bit of difference in ISO 9001 applied to this kind of field in contrast to a manufacturing one.

But, that said, the principles still remain the same. The key is in interpreting the Standard intelligently, and applying it appropriately. (Easily said, not quite so easily done :) But with this version of ISO 9001 (unlike the old version), it's very able to be done, by really focussing on the principles that underpin it, and thinking through the meaning of the various clauses & requirements.

For example, currently I"m assisting a firm which provides contract nurses to hospitals to cover shortfalls/extra demand - that's their core business. But they still need to establish their customer requirements (what kind of nurse is required for this shift?), find & select their 'product' (the experienced & qualified nurses), marry the two, and of course make sure the customers are happy with what they get.

Some bits are easily dropped off (eg, calibration of equipment isn't required here), whereas others assume even greater importance, such as personnel competence.

The manufacturing experience should be helpful, as it's experience. But I do tend to agree with Peter, that:
the benefit is in seeing the flow of processes, and identifying responsiblities and interfaces.

To which I'd also add having a systematic approach to managing problems/weaknesses, as well as defining metrics and reviewing progress against them.

You are right. We do have some success examples but the problem is the unsuccessful ones are too numerous and neglecting their regular duties in the name of ISO implementation got into the nerves of the Minister.


The two key phrases in your comment jump out at me:

"unsuccessful ones" are too numerous and

"neglecting their regular duties."

Obviously that is the fault of the organization or the individual - not an indictment of the ISO program. It is never appropriate to neglect one's duties - it contradicts the principles of ISO in the first place.

In the beginning post, where it said 24 of 100+ hospitals were already certified, it was already clear they had not implemented an effective "system."

I hope they don't ruin it for the rest of the world industry. It needs a good ISO badly.

......................In the beginning post, where it said 24 of 100+ hospitals were already certified, it was already clear they had not implemented an effective "system."

I hope they don't ruin it for the rest of the world industry. It needs a good ISO badly.

Reports from just a paragraph of a 'selected' report can produce distorted pictures. The minister was aiming at some bureaucrats or hospital administrators who introduced so much paperwork that it affects the routine work of some doctors.

With regards to the numbers quoted, it does not in any way indicate that 'they had not implemented an effective system'. Government hospitals were at one time encouraged to go for certification in the hope of further improving their services. Some are already certified, some are on the way and there are others who had yet to start. The article merely state that to date, 48% of the hundred odd hospitals were certified. Not 48% managed to be certified!

Effectiveness depends very much on each individual hospital and its administrators, much like factories where top management affects it to a large extend. It's no secret that some hospitals had dinosaur systems that create more paperwork than necessary much like any dysfunctional systems in some factories. These were the ones that I termed 'unsuccessful' but they could have attain certification.

Another factor that many overlook is that Doctors, like most other so called professionals are reluctant to accept something not from their profession - 'ISO' being deemed to be for manufacturing only. As a result, other certification systems which claimed to be more aligned to the medical/health care industry came into being.

I hope they don't ruin it for the rest of the world industry. It needs a good ISO badly

At 48% certification for public hospitals and almost 100% for private hospitals, I think it's very high. (Any body knows what are the figures for their country?) I am not boasting nor trying to run down our government owned hospitals but as a citizen concerned with 'real' quality, I am wary of those with dysfunctional systems and the part played by bureaucrats. I think that was what the minister meant when he made that comment.