ISO 9001:2000 in the Healthcare Sector

By John Sedlak

Several months ago, as a result of a mishap, I found myself facing the need for rotator cuff surgery. Through the process of networking with friends and acquaintances, I selected a surgeon. He told me the surgery would be performed on an outpatient basis.

On the appointed day, I arrived at the hospital and quite rapidly got caught up in hospital routine. It wasn’t long before I found myself laying on a pre-op gurney, waiting my turn to go into the operating room. Soon, there I was, in the OR, looking up at the huge array of lights and becoming aware of the many people in the room. Just before I succumbed to the anesthesia, I distinctly remember thinking to myself, “Boy, I sure hope they have an effective quality system here.”

Many of us never find ourselves in an operating room. Most of our excursions into the medical world are limited to office calls to the family doctor and the local pharmacy. Based on my limited personal experience, there is a high level of professionalism at the individual level. But, like any business, those working in the healthcare industry are subject to a myriad of challenges, such as person- to-person hand-offs, outside pressures from insurance companies, legal requirements, internal staffing pressures, personnel issues, and so on.

So, the question becomes, “How can the healthcare profession assure defect-free, safe delivery of service in this environment?”

I believe the answer lies in the implementation of a quality management system that conforms to the requirements of ISO 9001:2000 which, when implemented, offers any organization improved connectivity, sustainability and the opportunity for continual improvement.

“Wait a minute.” you say. “Aren’t hospitals accredited and licensed? Doesn’t this provide the assurance needed?” The answers are “yes” to the first question, and “maybe” to the second question. Here is why. Accreditation standards rightly and very thoroughly focus on clinical issues. Like the 1994 revision of ISO 9001, each accreditation requirement can be looked at in isolation. What seems to be lacking is what ISO 9001:2000 has to offer – the requirement to link the various processes together (read, sequence and interaction of processes.) Also lacking are the requirements for internal audits (assessing the implementation and effectives of the systems and processes), management review (looking at the big picture from the perspective of top management) and continuous improvement (getting better after “good” is achieved – anything else is corrective action).

Recently, SQA certified its first hospital, Licking Memorial Hospital located in Newark, Ohio, to ISO 9001:2000. The top management of this accredited hospital wanted to go beyond accreditation and licensure. They wanted to focus on improvement. They evaluated several approaches, including Malcolm Baldridge and six sigma, settling on ISO 9001:2000. Licking decided to take the additional step of achieving certification to gain independent validation and assurance of the effectiveness of their quality management system. They wanted to improve the quality of patient safety and patient care. The results of the assessment, coupled with my interviews with the management of this hospital, convinced me that the healthcare professionals of Licking Memorial Hospital fully understand the benefits of certification and how it will enable them to take the multiple inputs required by accreditation requirements and use them as a means to continually improve their processes. And this, in turn, will help them to improve their performance in areas like patient care, patient safety and community relations.

Today, the certification of hospitals to ISO 9001:2000 is a rarity. But this is changing. There is a good deal of discussion among healthcare professionals on healthcare quality and safety issues. Many are looking at traditional quality tools such as SPC, six sigma, theory of constraints, design of experiments, and others. Quality professionals in the commercial sector recognize these are all good tools. However, it is important to also realize that these tools, applied in the wrong environment, often result in a waste of time and valuable resources.

There are ways to provide assurance that these tools are effective, and one of the most effective ways is to create a management system that is culturally focused on improvement – starting with top management. And, with no surprise, ISO 9001:2000 offers the structure for this to happen. I encourage anyone in the quality profession to work further to educate those in the healthcare profession regarding what you already know – that quality, as defined by defect free work delivered on time, is a natural by-product of a robust and effective management system. Certification to ISO 9001:2000 can provide this. If anyone would like to discuss this further, you are free to call me directly.

Thank you,

John Sedlak
Vice President, COO

P.S. The surgery was a great success!