ISO-9000 kalite güvencesi sistemi ve ISO-9000 standartlarının uygulanması için yapılan çalışmalar

Özer, Melih
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Fen Bilimleri Enstitüsü
Kalite güvencesi; en ekonomik, en kullanışlı ve tüketiciyi her zaman memnun eden kaliteli bir ürünü geliştirmek, tasarlamak, üretmek ve bakımını yapmak için uygulanan entegre bir sistemdir. İşletmeler için kalite, güven ve rekabet unsurudur. Kalite güvencesi sadece üretim hattında değil, tasarım/geliştirmeden satış sonrası servis faaliyetlerine kadar tüm aşamalarda gerçekleştirilmelidir. ISO-9000 Kalite Güvencesi standartları işletmenin tüm faaliyetle rinde kalite güvencesi sağlayan bir standartlar serisidir. Bu çalışmada, kalite güvencesi ile yakın ilgili olan genel kalite kontrolü kavramlarını, Toplam Kalite Kontrolü ile ISO-9000 Kalite güvencesi standartları incelenmektedir. Birinci bölümde; kalite kontrolünün gerekliliği ve birçok ülkede ve ülkemizdeki kalite kontrolü çalışmaları hakkında bilgi verilmiştir. İkinci bölümde; genel olarak kalite kavramları ile toplam kalite kontrol anlatılmıştır. Üçüncü bölümde; ISO-9000 Kalite Güvencesi Standartları hakkında geniş bilgi verilmiştir. Dördüncü bölümde ise; Türk Elektronik Sanayinin önde gelen kuruluşlarından PROFİLO-TELRA Elektronik Sanayi ve Ticaret A.Ş.'nin ISO-9001 Kalite Güvencesi Belgesini almak için yapılan çalışmalar anlatılmıştır.
Total Quality Management is to produce the product or service at one time with zero error and to satisfy the customer's requirements. Total Quality management can be taught as a process which contains all the activities from purchasing of the raw materials to the after sales services. The total quality management has been improved by Japanese who were very bad economical situation after World War II. In 19 50 the quality control experts from USA taught Japanese the principles of the statistical quality control. With the methods of the Quality Control, the Japanese have begun to control the production process and to decrease the costs by improving the quality. But the problems were not only on the production process. It can not be talked about the product in good quality if - the requirements of the customers are not known completely - the products are not designed according to customer's requirements - the production method are not chosen correctly - the produced goods are not well-marketed even if they are perfect. Therefore, in 19 54 it was understood that the quality could not be obtained only and completely in the production and not only the quality control department is responsible for the quality but also every department in the company especially top management is responsible for the quality. Thus the concept of the total quality management has been borned and implemented in Japan. In 1960s, it was also understood that it is not possible to produce undefected products unless the workers participate in the activity although the quality control has been accepted as management philosophy by all departments. Thus Quality Control Circles have been improved in order to join the workers and formen to the Total Quality System. - vii - In the beginning, the total Quality System contained General Manager, Managers, Personel, Formen, Workers and Salesman but in the last years, the contests of the total quality system has been expanded as including the subcontractors, distributor companies. The main aims of the total quality are ; - to improve the dynamism and the structure of the company - to obtain zero error in the production or in the service by establishing the quality assurance system which are based on the cooperation of all personnel - to gain the confidence of the customers - to reach the highest quality level in the world - to develop new products in order to realize these aims. The philosophy of the total quality management is based on some main principles. These principles are like below. 1. Reforming Speed 2. The Organizational Structure 3. Implementation of the Total Quality Management 4. Planning 5. Continious improvement 6. Definition of the problems 7. Whole participation 8. To obtain 100% quality 9. The application of appreciation 10. To meet the customer's requirements completely 11. To prevent the error before occuring instead of final inspection 12. Bureaucracy İt is easy for acompany which has got total Quality Management System to get ISO 9000 Quality Assurance Certificate. Because the total quality management system contains the principles of IS0-9000 standards. Five standarts in ISO-9000 series (ISO-9000, IS0- 9001, ISO-9002, ISO-9003, IS0-9004) were developed by Technical Comittee 176 of the ISO and approved in their present form in 1987. - vixi - ISO-9000 standards have gained increasing recognition as the international benchmark for quality- assurance. ISO-9000 is a series of standards and guidance material for establishing and maintaining quality management systems. The intent of the series is to provide a single, harmonized system which will be appropriately used across world industry. ISO-9000 Series standards and registration process are rapidly gaining acceptance worldwide to meet customer or regulatory requirements, position the organization in the market and to establish internal quality improvement. Three powerful forces; customer pressure, market pressure and regulatory pressure are combining to push ISO-9000 series standards into the spotlight worldwide. Now ISO- 9000 Series standards become the most important factor for doing business in Europe as an EC requirements since EC will require their suppliers to be audited and registered under EN 29000 series standards which are technically identical to ISO-9000 series. ISO-9000 Series of standards focus on systems for managing quality rather than on products themselves. ISO-9000 Quality Standard consists of five sets of standards. The first standard, ISO-9000 is a quide that provides basic definitions and explains how to select and use other standards in the series. The IS0-9001, 9002 and 9003 standards are for quality assurance purposes in contractual situations. These are the standards which are used to register the suppliers quality systems. The choice of each standards depends on the scope and complexity of a company's operations. These three standards are generic, they do not specify the technologies to be used in implementing the various quality-system elements. There are two aspects of the IS0-9000 standards; quality system concepts and contractual guidance. The contractual standards are contained in IS0-9001, IS0-9002 and IS0-9003 quality can not be manded like morality and truth. So the contractual standards contain those concepts needed to protect the customer but they do not guarantee goodness. ISO 9000 standards do not include many concepts of Total Quality Management such as continuous improvement, statistical tools and focus on the customer. ISO-9000 standards are generic. The series does not define quality but they documents the quality system elements to maintain an efficient quality system in a company. - ix - The definition of ISO-9000 standard series are like below; - ISO 9000 is a quide to selection and the use of appropriate part of ISO-9000 series - ISO 9001 is a specification for desing, develop ment, production, installation and servicing - ISO 9002 is a specification for production and installation - ISO 9003 is a specification for final inspection and test - ISO 9004 is a quide to quality management and quality system elements. The elements of Quality System of IS0-9001 can be classified like below ; 1. Management responsibility 2. Quality system 3. Contract review 4. Desing control 5. Document control 6. Purchasing 7. Purchaser supplied product 8. Product identification and traceability 9. Process control 10. Inspection and testing 11. Inspection, measuring and test equipment 12. Inspection and test status 13. Corrective action 14. Control of non conforming material/product 15. Handling, storage, packaging and delivery 16. Quality records 17. Internal quality audits 18. Training 19. Servicing 20. Statistical Techniques In order to apply ISO 9000 program successfully, there are some minimum requirements which should be met. These requirements are ; Management commitment and responsibility Documented quality policy Documented processes and controls Evidence that pratice, theory System of internal quality audits Appropriate education and training. - x - The companies which manage to maintain ISO 9000 quality assurance system and get ISO 9000 Certificate gain some benefits. These benefits are ; - Satify customers and current market environment - Meet regulatory/mandatory requirements - Foundation for a total quality management program - Gain external racognition of quality commitment - Prepare for future market requirement - Reduction in rejects and rework - Reduction in customers complaints and wide product acceptance - Increased quality awareness, motivation, cooperation, workanship and consciousness in the company - Improved communication - Documented quality system. Now IS0-9000 series standards are very important standards for Turkish companies which export their products to EC Countries since EC accepted the ISO 9000 Series Standards as a Community standards from Jan 1,1993. Therefore Turkish companies should have ISO 9000 certifi cate in order to improve their market share in export and domestic market.
Tez (Yüksek Lisans) -- İstanbul Teknik Üniversitesi, Fen Bilimleri Enstitüsü, 1993
Anahtar kelimeler
ISO 9000, Kalite güvence sistemi, Rekabet, ISO 9000, Quality assurance system, Competition