[ISO 9001-2000 certification for refractive laser treatment]. / Certification ISO 9001-2000 des traitements réfractifs par laser cornéen.

ABSTRACT

PURPOSE: To obtain ISO 9001-2000 certification for laser corneal refractive treatment, never before sought in Europe. MATERIAL AND METHODS: The consulting firm Veritas led the certification process with the clinic's staff manager. This ISO norm is dedicated to the implementation of a quality management system. We assessed and optimized all necessary resources, evaluating customer satisfaction using patient and referring-physician surveys. We started quality rounds including surgeons, nurses, and technicians. Based on this preparation, we redefined and explained all processes including staff responsibilities and necessary resources in the quality manual. The procedure lasted 14 months with substantial involvement on the part of the management. RESULTS: Unconditional ISO 9001-2000 certification was granted by the independent audit firm, BVQI, in december 2003 for refractive laser treatment. CONCLUSION: The 2000 version of the new ISO 9001-2000 seeks to meet the demand for improving health care delivery in this field, most particularly by establishing a clear procedural orientation. Such certification enhances team work, stabilizes methodologies, and reinforces cohesion and self-audit. Patients notice that the center follows a consistent quality policy and are assured that the clinic respects rules and regulations. Certification is an advantageous alternative when accreditation cannot be considered. Our article discusses the steps taken in upper management, quality management, procedural guidance, as well as customer and staff counselling. It also discusses the project's cost/benefit ratio for the organization.