ISO 9000: A system-oriented approach to quality management
Proponents say it can enhance impact of current tools
It sounds almost too good to be true: a system-oriented approach to health care quality that not only can be used in conjunction with other initiatives, such as Six Sigma and Malcolm Baldrige National Quality Award criteria, but actually can enhance their effectiveness. But that’s what proponents of ISO 9000 assert. "ISO" (pronounced "eye-so") is the International Organization for Standardization, a worldwide federation of national standards bodies. What is generically referred to as "ISO 9000" is in reality a family of standards primarily concerned with quality management. In the health care setting, it emphasizes:
- customer focus;
- leadership;
- involvement of people;
- a process approach;
- a systems approach to management;
- continual improvement;
- a factual approach to decision making;
- mutually beneficial supplier relationships.
"Health care facilities are looking at ISO 9000 because it is an international standard and there are quality management standards within it," notes Sandra L. Abnett, RHIT, CPHQ, director of quality management at WellSpan Health System in York, PA.
"I really believe in systems and processes, and I believe there’s much that we in health care need to do in this area," adds Judy Homa-Lowry, RN, MS, CPHQ, president of Homa-Lowry Healthcare Consulting in Canton, MI. She is planning to become an ISO 9000 certified auditor.
But what is it?
"I think the No. 1 distinction that needs be understood is that Six Sigma and TQM [total quality management] were specific process improvement initiatives — not systems," asserts Kirill Liberman, director of business development for West Bloomfield, MI-based TUV Management Service, one of the world’s leading ISO 9000 registrars. "What ISO 9000 does is lay the foundational and structural framework for a business management system or model. What it requires is that organizations take a look at what they do from a systems perspective and how those systems are in fact linked and integrated," he says.
"Once you’ve adopted this business-model approach, you can begin to apply things like Six Sigma, which are process improvement tools, to focus tactically on specific processes," Liberman explains. (For more information on Six Sigma, see QI/TQM, July 2001.)
"If you look at the health care industry historically, what you see is silo’ management,’" adds Michael Crago, PhD, TUV’s director of health and human services. "That’s what regulatory compliance and accreditation do. That is not a systems approach, which is absolutely essential to process improvement. Yet no one is filling in the white spaces between the silos."
"Process and cultural silos [administration, doctors, nurses] exist with little interaction between them," Liberman explains. "What is required to overcome the silo approach are lateral processes — creating synergy and interdependence within the silos. This approach has been adopted in industry since World War II. Unfortunately, health care lags behind literally every other industry," he says. ISO 9000 is advantageous in the health care setting precisely because of the silo-driven approach, says Liberman.
Homa-Lowry also sees a good fit with health care. "If you look across the board in health care, there is a lot of variation in the way we do things," she says. "ISO is a good attempt to have an actual system and process in place to cut down on variation." She adds that there are so many processes that health care organizations find it hard to prioritize. "But there is a way to combine and look at things in a uniform way, and combine the processes," Homa-Lowry asserts.
Liberman notes that ISO 9000 can address "the three primary issues health care must deal with — the questions that are giving health care executives, boards, and health plans nightmares." Those issues are:
• Patient safety. When you employ root-cause analysis, he says, you deal with people who care and who try to do their best, but you have a process disconnect. "How can you connect processes if you haven’t even articulated what your management system quality should be?" Liberman asks. "We provide a comprehensive framework and synchronize the efficacy of care processes with an overall management systems process."
• Economic effectiveness. "Approximately 48% of the industry operates in the red, and of the 52% in the so-called black,’ their profit margin is 1% to 3%," Liberman says. "This picture won’t improve if you don’t take a management systems quality approach."
• Provider and consumer morale. If you don’t have management system quality that lets you clearly understand your processes, he says, you have managers taking a wild swing to fix what’s broken. "They institute administrative controls, which impinge on physicians," he says. "Lack of clinical autonomy affects the morale of doctors, and the fallout affects others, starting with the nurses. It also adds to patients’ frustration. They become stressed, frustrated, scared, and tired of being jerked around."
One of the things ISO 9000 requires is process ownership, Liberman notes. "In order to capture what an organization does and ensure that it consistently does what it intends to do effectively, you must include the process owners’ in the development phase," he explains. This includes nurses, physicians, and middle and upper management. "This is where you transcend the silos," he asserts. "You must get the owners of the process and its customers to be able to rationalize and understand what the needs and abilities of each of them are. ISO provides the discipline to do this, and you are required to document what you’ve done."
Homa-Lowry agrees. "Sometimes there isn’t a good translation from upper management to the person at bedside," she observes. "They may often ask, What does this policy mean to me?’ ISO 900 can address this." In other words, you may have a great strategic plan, but the people who deliver the care may not be able to internalize how what they do affects that plan, she explains. "Leadership may say we should decrease length of stay, but the people who work the floor see many other things that can have an effect on costs," Homa-Lowry notes. "You can actually design these processes, but it takes a lot of time and investment."
It is the emphasis on accountability that also sets ISO 9000 apart, Crago says. "The difference is that ISO 9000 carries with it independent, objective validation and international certification." "It has nothing to do with the regulatory requirements within health care. We perform the audits based on the organization’s stated objectives," Crago adds.
Here, in simplified form, are some of the questions the audit asks:
- Did you state what you do as an organization and how you do it?
- Can you show that you document how you do this?
- Can you demonstrate that what you do is, in fact, effective in meeting the objectives and needs of your business?
- Can you document and show with tangible evidence that you continually are improving the system itself?
Homa-Lowry says such accountability is crucial in health care. "We have many policies and procedures put in writing that are in reaction to an error or to regulatory requirements. I’m not sure after we have written them, how often we go back and audit ourselves to see how many are being followed as we designed them. Even when we measure them, we often look at pathways and such," she continues. "I’m not always sure how vigilant all organizations are about aggregating the variance data and addressing the variances in a timely manner, or using those variances to improve things. Many are still at the data-collection phase, but are not analyzing the data with an eye toward improvement."
Clearing the confusion
With so many options available, how are quality managers to make sense of the different alternatives? Abnett offers her take on what’s out there: "Baldrige could be an accreditation process [such as ISO 9000 or the Joint Commission on Accreditation of Healthcare Organizations], but I think of it as another award health care facilities could use from a marketing standpoint," she observes.
"They do have a scoring mechanism, but for me, Baldrige basically offers guidelines," she explains. (For more on the Malcolm Baldrige self-assessment tool, see QI/TQM, August 2001, "Baldrige criteria spur ongoing change.") From those guidelines, however, hospitals can learn a lot; our surgical services lines have begun to look at Baldrige as an internal assessment tool," Abnett says. (Do hospitals need both ISO 9000 and Joint Commission accreditation? See "Do you need more than one accreditation?" in this issue.)
Six Sigma, on the other hand, offers a number of valuable tools. "Jack Welch used Six Sigma to turn GE around," she asserts. "You look at your internal processes and see what’s wrong with those and reward whoever has the best practices. There’s a lot to learn from the Six Sigma way: failure analysis, regression analysis."
To get to Six Sigma, you must aim at a specific low percentage of errors, "but ISO 9000 or even Baldrige don’t have a specific number," Abnett continues. "Six Sigma is where we all may envision ourselves to be. ISO 9000 or even Baldrige could be ways to get us to the Six Sigma. But I’m looking at all three at the same time to see pieces I can use in my job or to educate others."
Crago offers a different perspective. "If you look at Baldrige and quality award winners, and you ask the facilities what they did to get that state quality award, they’ll likely say, After we got accredited, we looked at what state quality required, and we did it,’" he says. "In other words, what silos did they look at? It takes a great energy focus and time to do this. How come the hospitals that get this award don’t get it every year? Because they can’t sustain it."
The acceptance of ISO 9000 by the health care industry is in the very early stages, Liberman notes. "At this point in time, there are eight certified hospitals and 42 certified health care organizations in the U.S." On the other hand, he adds, about 60,000 companies in the nation hold an ISO 9000 certification, and worldwide the number exceeds half a million.
"Health care is on the rear end of the train," Crago adds. "If management takes the same actions it has always taken, it should not be surprised to get the same results. In contrast with industry, they are applying the same old solutions to exacerbating problems." Part of the problem, he says, is that most health care executives would be hard put to explain the differences among Six Sigma, Baldrige, the Joint Commission, and ISO 9000. "What we’re trying to show is the difference between ISO and accreditation," Crago says. "Accreditation is very prescriptive. We don’t tell you what to do; you tell us. You say what you want to do, how well you want to do it, and then you show us that you did it through a process management system."
"We give the clients an objective vision of whether they have systematically achieved what they have set out for themselves, and whether it still continues to fit the ISO 9000 framework," Liberman adds. "We will always find some things, and it is good that we find them before [Joint Commission] does."
"Certification is global recognition that your organization absolutely inculcates a common foundation and structural framework that is nonindustry specific," Crago says. "In the [European Union], a majority of member states have adopted it for national accreditation."
Abnett, for one, is willing to give it a try. "I want to bring all the quality management opportunities and tools I can to our system," she says. "Let’s beef it up and take it to the next level."
Need more information?
For more information, contact:
• Kirill Liberman, Director, Business Development, TUV Management Service, 2149 Timberidge Court, West Bloomfield, MI 48324. Telephone: (248) 706-1740. Fax: (248) 706-1741. Internet: www.ISO9000healthcare.com.
• Michael Crago, PhD, Director of Health and Human Services, TUV Management Service, 2149 Timberidge Court, West Bloomfield, MI 48324. Telephone: (248) 706-1740. Fax: (248) 706-1741. Web site: www.ISO9000healthcare.com.
• Sandra L. Abnett, RHIT, CPHQ, Director of Quality Management, WellSpan Health System, WellSpan Health Office Center, 45 Monument Road, Suite 200, York, PA 17403. Telephone: (717) 851-5869. E-mail: [email protected].
• Judy Homa-Lowry, RN, MS, CPHQ, Homa-Lowry Healthcare Consulting, 7245 Provincial Court, Canton, MI 48187-2121. Telephone: (734) 459-9333.
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