Introduction

Occupational health clinic managers and clinicians are currently facing significant performance challenges in providing the highest level of safe patient care, optimizing services to delight customers, and creating economic efficiencies in operations by integrating efficacy of care processes with business processes. However, we can only effectively achieve such outstanding performance results by sustaining an organizational healthcare delivery system that effectively manages risk by preventing potential patient care and business process disconnects.

In an effort to achieve these necessary performance outcomes, it would be of great value if there were a universally recognized and available international quality management platform that rationally synthesized how to establish and sustain management system quality and an organizational culture committed to continual improvement and customer satisfaction. There is such a platform, and it is the universally accepted foundation and structural framework for management system quality that has been long embraced across the international manufacturing and services industry landscape. It is called the ISO 9000 Quality Management System.

The International Organization for Standardization (ISO) is a non-governmental entity that was founded in 1947 by 25 countries as a way to develop voluntary technical standards for businesses. Its intent was to provide consensus for an approved methodology that could ensure consistency in the manufacturing of materials and products, by ensuring standardization of processes and services in accordance with customer requirements. Now, the ISO membership is comprised of over 140 National Standards Bodies, one from each affiliated country, of which the U.S. representative is the American National Standards Institute (ANSI).¹

The ISO 9000 Quality Management System was originally created in 1987 to non-prescriptively provide a management system quality standard for non-technical business functions. It was later perfected in 1994 and released as three distinct standards (ISO 9001, 9002, and 9003) in an effort to better generically differentiate design, development, production, installation, and servicing processes. The latest solution, ISO 9001:2000, was fielded as a consolidated framework on December 15, 2000.²

The ISO 9001:2000 principles inculcate a customer focus, leadership, involvement of personnel, a process approach, a system approach to management, continual improvement, a factual approach to decision making, and mutually beneficial supplier relations. Its structural methodology non-prescriptively requires you to describe your quality management system,
management responsibility, resource management, service realization, and measurement, analysis, and improvement methods.

[top]

There are six required documented procedures: control of documents, control of records, internal audits, control of non-conformances, corrective actions, and preventive actions.³

The ISO 9000 Quality Management System allows the healthcare organization to design and implement a management system with integrated and synchronized patient care and business processes. Establishing and achieving management system quality with ISO 9001:2000 is the essential core change strategy for achieving a seamless and transparent organizational system for quality.⁴

Any time you are able to improve delivery of care and delight your patient beneficiaries, you enhance your clinic’s reputation and improve your market position. As we all know, the quality of the patient/employer experience critically factors into an employer’s willingness to continue a relationship with a clinic facility. Companies registered to ISO 9000 have reported significant reductions in customer complaints, improved client relations, and reductions in operating costs. Other well recognized returns on the investment have been an increased demand for services, increased market share, and increased profits. Additionally, achieving management system quality will positively engage your clinic staff with better working conditions by integrating and synchronizing workflow process control. Improving this aspect of your practice, alone, can help to reduce stress among your staff, thereby favorably enhancing the caregiver/patient interface and reducing staff turnover.

How to Implement ISO 9000?

Once an organization has made the commitment to implement the ISO 9000 Quality Management System, a logical series of steps is taken to move forward towards validation and certification of the healthcare organization’s management system quality. The following simple steps offer an overview for how to earn ISO 9000 registration:⁵

[top]

What is the Application of ISO 9000 to Occupational Health?

Why use ISO 9000, as opposed to other quality management models? Many, if not most, employers for whom you currently provide healthcare are themselves ISO 9000 certified. As such, they are demonstrating a strong commitment to process management quality and outcomes excellence in order to maintain and improve their respective market positions and market shares. Clearly, one of the best ways to have your clients understand your commitment to quality and service is to "speak their language" by becoming an ISO 9000 registered clinic; an achievement that they can truly respect and appreciate. Earning registered status for your quality management system through ISO 9000 certification is the "gold standard" that most employer organizations themselves seek to achieve.

There is a second important consideration. American employers spend billions of dollars every year to purchase healthcare benefits for their employees. You should know that healthcare cultural change agents like the National Business Coalition for Healthcare are seeking to empower employer stakeholders to require their healthcare providers to adopt the same high standard business practices that they require of themselves and their other suppliers. This means that healthcare providers may soon be required to demonstrate that they too, as suppliers, have certified ISO 9000 quality management systems in place. The employer intent is to require proof that healthcare providers are process managing and improving their services to assure safer and more cost-effective patient care delivery. In other words, in the near future healthcare networks and organizations may have no choice but to adopt ISO 9000 certification, or lose their revenue streams to healthcare competitors who have had the vision to do so. For hospital-based networks, it is possible and may be easier to obtain the certification initially for just the occupational health clinics.

Is There a Relationship Between Accreditation and ISO Certification?

One must first differentiate accreditation from certification. Accreditation, by its very nature, is only intended to "prescribe minimum requirements," whereas the ISO Quality Management System culturally moves the organization far beyond minimums by establishing the foundation and structural framework for "non-prescriptive management system quality." For this very reason, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Senior Vice President, Dr. Paul M. Schyve, stipulated that the solution to preventing medical mistakes is "to change the systems and processes within which people work." He concluded that accreditation and ISO 9000 can fit well together and complement one another.⁶

It should be noted that the ISO 9000 is not intended to prescriptively validate efficacy of patient care nor the effectiveness of the clinician, other than in terms of management system quality and the inter-connectivity of the organization’s stated management processes and procedures.⁷

Where Do We Go From Here?

ISO 9000 ensures congruent control of the healthcare organization’s management system and its processes, and assures deliverable service quality. Optimizing, as caregivers, our patients’ experience through safe and cost-effective patient care outcomes, is what we should all be striving for in our occupational health practices. Both the injured and healthy worker, as our trusting customers, should be able to expect that we will endeavor to do both the "right things" and the "smart things." The ISO 9000 Quality Management System is the sensible and rational alternative to move your healthcare practice from inconsistent or substandard practices toward improved patient safety, financial performance, and both provider and consumer morale.

[top]

Footnotes

1. International Organization for Standardization (ISO) web site, "About ISO—What is ISO?" www.iso.ch/iso/en/aboutiso/introduction/whatisISO.html, April 2002.

2. Ibid.

3. ISO 9001:2000(E), Quality Management Systems–Requirements, Third Edition, December 2000.

4. Crago, M. "Partnering to Improve Process Management," American College of Physician Executives On-line Magazine, Click, Volume 3, Issue 1, February 2002, www.acpe.org/click.

5. Kurtus, R. "Steps to Achieve ISO Registration" (Modified), School for Champions e-Learning web site, www.school-for-champions.com/iso9000/isosteps.htm, March 2001.

6. Schyve, P. "A Trio for Quality: Accreditation, Baldridge and ISO 9000 Can Play a Role in Reducing Medical Errors." Quality Progress. June 2000.

7. Crago, M. "Partnering to Improve Process Management," American College of Physician Executives On-line Magazine, Click, Volume 3, Issue 1, February 2002, www.acpe.org/click.