A Research About Chinese Medicine Hospital Executing ISO9000 Group

ISO, short for the International Organization For Standardization is aninternational federation comprised by organizations for standardization ofover 70 countries. Derived from English BS5750 standards and after 10 years` work of international organization for standardization, ISO9000 series/group set up and issued a set of scientific, systemic, advanced, practical,close "the standard of quality management and quality assurance"in 1987,that is, ISO9000 group Quality Management and Quality Assurance Systemwhich are the first international standards of scientific management. In 1994and in 2000, it was modified and republished, the standards of ISO9000group are being revised and added. Among the four core standards, ISO9001is appropriate for service trades, which stipulates 20 quality system elementsincluding management responsibility, design development, purchase processcontrol ect. and which is applicable for design, production, installation andservice and process supplier organization supplying quality assurance tocustomers.Thanks to the features of ISO9000 group—emphasis on systemicmanagement, customers as centers, prevention as main aim, emphasis onprocess management, sustainable improvement, focus on substantial resultsand emphasis on evidence and function of leaders, it is quickly adopted bycountries throughout the world, which accordingly makes it a uniform oneworldwide accepted on which supplier establishes quality assurance systemand execution of quality management system. In Oct. 1992, State Bureau ofTechnical Supervision declared that ISO9000 group was adopted and it is thefirst 'national grade'standard of scientific management of our country. BySep. 2000, over 20,000 enterprises of our country had received authentication.In recent years, some service trades and government department activelypush ISO9000 group standards to strengthen scientific internal managementand improve its own competitive power. In Aug. 1999, the No.2 Hospitalattached to Harbin Medicine University reformed the hospital management toexert ISO9000 first in China, followed by some comprehensive hospitals.Especially in ISO9000 group of the version of Year 2000, of the eightmanagement principles, "customers as center", "meeting customers ` needsand striving for surpassing anticipation of customers"are ISO qualitymanagement principles. Therefore, it is accepted as agreeing with the theory"customers as center"put forward by sanitation system now in China.The renovation of hospital management theory brings Chinese MedicineHospital with challenge as well as opportunities. Western Medicine Hospital`s executing management of standardization provided experience forreference for Chinese Medicine Hospital `s execution of ISO9000 group.Above all, it is required to set quality objective and all sections strive for thecommon objective. It is required to regularly test the condition where theobjective is being achieved. Then the relations between hospital and patients,between supplier and internal sections are to be harmonized, every processand requirement of quality management with medical treatment flow as basisis to be identified so that management of all grades can know explicitresponsibility, turning control by man to control by law. At an angle ofprinciple and flow, all the work of the hospital is ordained, makingmanagement principles in medical treatment, care and service standardizationand routinization, putting an end to and reducing doctors and nurses errorswith objective management method, improving the quality of doctors andnurses, avoiding medical malpractices and assuring that patients receive safeand satisfactory service. ISO9000 standards effectively and continuouslycontrol the direct or indirect service that hospitals offer to patients so that theneeds of patients for high quality service are met. The features of service ofhospitals determine that quality control is not realized by final test so keep alookout in advance. Therefore, a set of technique standards and progress withstrong utility must be constituted to control the existence of ineligibleproducts as for every link of medical service by reference to the developmentof medicine and past lessons. Otherwise, ISO9000, a series of precise qualitymanagement standards and all traditional technical standard and managementrules of Chinese Medicine Hospital bring out the best in each other."Customers as center"and "meeting customers ` needs and striving forsurpassing anticipation of customers"are principles of ISO9000 qualitymanagement principles, in line with "patients as center". Moreover, it focuseson process and doctors and nurses are required to do fastidiously inaccordance with technical procedures and operation rules and exert theutmost of clinical effect of every medical technique and avoid the medicalerrors. In that case medical treatment quality is improved, risk of medicalmalpractice is controlled, quality cost is reduced and competitive power rises.Combination with the active various technique standards andmanagement principles, transfer ISO9000 standard items to the process ofChinese Medicine Hospital supplying sanitary service products anddetermine the standard procedure put forward by Chinese Medicine Hospitalby means of 1. preparatory work: decision-making of top leaders,transformation of ideas and uniform opinion, determination of hospitalquality policy, appointment of management representative and internalauditor, choice of consultation organization and training; 2. setup of systemand compilation of document: consummation of basic work, compilation ofquality system documents including four parts i.e. quality manual, proceduredocument, work instructions document and quality record, approve and issueof documents; 3. application of Chinese medicine symptom classification andcode country standard; 4. strengthening training; 5. execution of qualitymanagement system: Document press conference marks the commencementof running of quality management system. During the running, there may beunreasonable document compilation. But the modification is subject to statedprocedure. 6. audit of internal quality management system: review theconformance and validity including internal audit and management audit ofthe hospital, hospital annual performance review of internal hospital, regularprocess check of every sections of hospital and of internal section office, thedetermination of special process of cooperation of hospital and section office.The determination is preventive check and the self-check of all the staff inhospital in work. This is basic and self-conscious check. 7. authorizationaudit: after a period of running and the audit of complete internal qualitysystem and management, authorization may be applied. In brief, theprocedure of running quality management system is the following quintette:...