ISO 9000 standartları ve belge almış firmalarla anket çalışması

Abstract

Son yıllarda, II. Dünya Savaşından sonra hızlanıp günümüzde en üst düzeylere ulaşmış olan kalite devriminin Türkiye yansımalarını izlemekteyiz. Ticari anlamda sınırların kalktığı, tüm dünyanın ortak bir pazara dönüştüğü rekabet ortamında, pek çok Türk firması da bu kalite devrimi sürecine girmişlerdir. Kalite devrimi, Toplam Kalite Yönetimi, İstatistiksel Proses Kontrol, Sürekli Gelişim, Deming Kuralları, Tam Zamanında Üretim gibi pek çok boyuta sahiptir. Bu boyutlardan biri de kaliteli üretimi sağlamak için tüm organizasyonu kapsayan bir standartlar kümesi olan ISO 9000 Kalite Güvence Sistemleri 'dir. ISO 9000 Sistemini diğerlerinden ayıran en önemli özellik, kurulan sistemin bir üçüncü tarafsız kuruluş tarafından denetlenmesidir. 1990 'lı yıllardan itibaren, ülkemizde öncelikle büyük şirketler ISO 9000 Sistemine geçmiş ve daha sonra da yan sanayiyi ISO sistemine zorlamıştır. ISO 9000 Standartları sadece üretim süreciyle ilgilenmeyip tüm organizasyonu kapsayan yapısal gelişmeler sağlaması ve belgeleme sistemiyle bir alt yapı oluşturmasıyla işletmelerde, uzun vadede gelişmelere ve yeni çalışmalara temel oluşturmuştur. Bu çalışmada, kalite ve Kalite Güvence Sistemleri incelenmiş ve ISO 9002 Standardının açıklaması yapılmıştır. Projenin son bölümünde yapılmış olan uygulama, ISO 9000 sistemine geçmiş şirketleri kapsayan bir anket çalışması içermektedir. Projenin ikinci bölümünde Kalite kavramı ve Kalitenin tarih boyunca gelişimi incelenmiştir. Aynı bölümde kalite maliyetleri ve kalitesizlik riski açıklanmıştır. Birinci bölümün son kısmında istatistiksel proses kontrol yöntemleri üzerinde durulmuştur. Üçüncü bölümde Kalite Güvence Sistemi ve ISO 9000 Standartları incelenmiştir. Bölüm 4, 19 maddelik ISO 9002 Standart gerekleri açıklanmasını içermektedir. ISO 9000 Kalite Güvence Sistemi kurma aşamaları beşinci bölümün birinci kısmında anlatılmıştır. İkinci kısımda ISO 9000 sisteminden etkin olarak faydalanmak için bazı yöntemler sunulmuştur. Son bölüm olan yedinci bölümde, ISO 9000 sistemine geçmiş toplam 30 şirket üzerinde gerçekleştirilmiş anket çalışması ve değerlendirilmesi sunulmuştur.

The ISO 9000 series of international quality standarts was first published in 1987. Five basic quality system documents were released. Since their introduction to a somewhat questioning user base, these standarts have become one of the most significant influences on the advance of the global quality movement. The world's business community is becoming a true global economiy. Many companies are now buying and selling products and sevices through-out the world. Even those companies with current domestic market limitations have plans for future woldwide competition. With a potantial worldwide marketplace, each company must aggressively assert its position by establishing and maintaining a quality-based strategy. In this study, Quality Assurance System Standart-ISO 9002 is introduced and its requirements are explained. The last chapter of the study, to learn more about ISO 9000 implementation, a survey was conducted with ISO 9000 certified organization. In the first chapter (Chapter 1), basic quality terms, quality costs and statistical quality control are explained. The Quality can be described as appropriateness of the using aim. If the product is produced approitely to user's aim, it can be described as high-quality. Quality is not the meaning the best absulutely. A quality is depended on its function or using aim and price. Quality also is depended on quality of raw and auxiliary material, source and technology. In chapter 2, detailed knowledge about quality assurance system and ISO 9000 Standarts is given. Quality Assurance System provides to guarantee to the customer, not to buying any noncomforming product. This action can be done by means of controlling process, insted of controlling product. So, defect is caught during the production process and corrective action is beginned immediately. After correcting the defect, the product process can be continioued by means of giving permission. All International Standarts about ISO 9000 Quality Assurance was prepared by Technical Committee ISO / TC 176, Quality management and quality assurance. From International Standard models, ISO 9004 can be used for internal quality management purposes and ISO 9001, ISO 9002 and ISO 9003 series of other standarts used for external quality assurance purposes. It is not to purpose of this series of International Standard to standardize quality systems implemented by organizations. ISO 9000: Quality management and quality assurance standards-Guidelines for selection and use. The purpose of this model are, a) To clarify the distinctions and interrelationship among the principal quality concepts, b) To provide guidelines for the selection and use of a series of International Standards on quality systems. ISO 9001: Quality system -model for quality assurance in design, development, production, installation and servicing. This model is used when conformance to specified is to be assured by the supplier (customer) during several stages which may include design/development, production, installation and servicing. ISO 9002: Quality system-model for quality assurance in production, installation and servicing. XI This model is used when conformance to specified requirements is to be assured by the supplier during production and installation. ISO 9003: Quality system-model for quality assurance in final inspection. This model is used when conformance to specified requirements is to be assured by the supplier solely at final inspection and test. ISO 9002 standard and its nineteen requirements examined in Chapter 3. This niniteen requirements are; 1) Management Responsibility 2) Quality System 3) Contract Review 4) Document and Data Control 5) Purchasing 6) Control of Customer-Supplied Product 7) Product Identification and Traceability 8) Process Control 9) Inspection and Testing 10) Control of Inspection, Measuring and Test Equipment 11) Inspection and Test Status 12) Control of Nonconforming Product 13) Corrective and Preventive Action 14) Handling, Storage, Packaging, Preservation and Delivery 15) Control of Quality Records 16) Internal Quality Audits 17) Training 18) Servicing Xll 19) Statistical Techniques In Chapter 4 ten step are explained to set up quality assurance system in a firm. The first step to ISO 9000 registration begins with management making an informed decision to implement an effective quality system. This commitment is essential because the ISO 9000 process requires not only the involment of the leaders, but also the resources that only they can allocate. The next step is to establish an infrastructure that includes a management representative, steering group and area coordinators. The third step is definition of quality policies. The quality policies should be relevant to the supplier's organizational goals and expectations and needs of customer. After definition policies training about ISO 9000 is began. It can be done like a campaign to maintain organizational motivation. Next, activities in organization are defined. The next step is including documentation effort. These document are procedures, quality manual, control plans, work instructions and records. After the documentation, document and data are reviewed and approved for adequacy by authorized personel prior to issue. The eighth step is internal quality audits. After all the firm is registered. Registration is really just the begining of the ISO 9000 process, it serves as the foundation for on going quality and business improvement. An organization must continue its internal audits, management reviews and corrective actions. The second part of the Chapter 4 is including some ways to rise effectiveness of ISO 9000. In the fifth Chapter, the relation between Total Quality Management and ISO 9000 was examined. Total Quality Management which has been powered by Japanese culture and ISO 9000 which reflects the systematical base of West Countries were compared. The last Chapter (Chapter 6) is including the survey made with 30 registired company. The survey consisted of eight opended questions. The survey questions focused on the various aspects of seeking and obtaing registration, including reasons why it was desired, the time of registration period, life after registration etc., xm An important result of the survey is the reasons to implement ISO 9000 are demands or requests from customer. The other important result of the survey is the companies are happy to use ISO 9000 Quality Assurance System.