The Commons 4425 Old Ridge Road Williamson, New York 14589 Phone: 315-589-2800 Fax: 315-589-4420	ISO 9002 Certification To manage our orthopaedic practice, it is necessary to simultaneously and continuously analyze and adjust organization mission and vision, patient satisfaction initiatives, external standards and accreditation statutes, financial and budgetary constraints, outcome management and data reporting, and information systems, all while maintaining and attempting to improve patient satisfaction. In 1998, we decided we needed a system that would organize and monitor these initiatives without interrupting the patient care delivery process every time there was a change or reduction in the fee schedule, management, personnel, or equipment. We were not aware of a model with origins in the private practice sector of health care. ISO 9002, a product of the International Organization for Standardization, is an industry-based system containing 20 requirements for quality management and assurance. This generic core of standards is applicable to a broad range of organizations. The system defines the elements, but not how they are implemented. Because of its versatility, we chose ISO as our quality system model. With the help of ISOHealth® and overcoming the industrial/medical language barriers, our practice management system was molded to fit the 20 ISO requirements, and was audited on-site by an official ISO registrar (SGS International). Our practice was in compliance with the ISO standard, and we were awarded certification early in 1999.
In the 9 months leading to certification, there was an 8% improvement in patient satisfaction, and a 20% reduction in systems errors related to billing. The money saved by these and other system changes covered the cost of certification, even before the certification was actually achieved. In addition, in the first year, the presence of a recognized quality system led to new business, resulting in new revenue streams for the practice. The development of WRO practice policies and procedures under the ISO system will continue in areas of management leadership, clinical outcomes improvement, telemedicine, formal strategic planning, profit improvement, clinical treatment leadership, participation in the formation of health care public policy, increased employee involvement, and good old-fashioned continuous improvement in overall patient satisfaction. We believe the short-term benefits already realized by our practice are only a small part of the anticipated continued benefits of ISO certification.
4.1 Management Responsibility 4.2 Quality Systems 4.3 Contract Review 4.4 Design Control 4.5 Document and Data Control 4.6 Purchasing 4.7 Control of customer supplied product 4.8 Product identification/traceability 4.9 Process Control 4.10 Inspection and Testing 4.11 Control of Inspection, Measuring, and Test Equipment 4.12 Inspection and Test Status 4.13 Control of Nonconforming Product 4.14 Corrective and Preventative Action 4.15 Handling/Storage/Packaging/Preservation/Delivery 4.16 Control of Quality Records 4.17 Internal Quality Audits 4.18 Training 4.19 Servicing 4.20 Statistical Techniques	Related References "The Search for Quality: Why an Orthopaedic Practice Became ISO 9002 Registered." Frederick A. Kaempffe, IV, MD, Frederick A. Kaempffe, III, BS. Quality Progress, Volume 32, Number 11, November 1999: pp. 110-117.   "In Search of Quality: Why Our Practice Became ISO-9000 Certified." Frederick A. Kaempffe, MD, Frederick A. Kaempffe, III, BS. American Society for Quality ISO 9000 Conference, Atlanta, Georgia, March 1999. HCMR Group ISO/JCAHO Seminar, Atlanta, Georgia, May 1999. American Academy of Orthopaedic Surgeons, 67th Annual Meeting, Orlando, Florida, March 2000.
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