Kalite güvencesi ISO 9000
Quality assurance and ISO 9000
- Tez No: 75304
- Danışmanlar: PROF. DR. İRFAN SAYGILI
- Tez Türü: Yüksek Lisans
- Konular: Makine Mühendisliği, Mechanical Engineering
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 1998
- Dil: Türkçe
- Üniversite: İstanbul Teknik Üniversitesi
- Enstitü: Fen Bilimleri Enstitüsü
- Ana Bilim Dalı: Makine Mühendisliği Ana Bilim Dalı
- Bilim Dalı: Konstrüksiyon Bilim Dalı
- Sayfa Sayısı: 183
Özet
ÖZET Belirli bir kalitenin sağlanması ve güvence altında tutulması için yapılan faaliyetlere eskiden kalite kontrolü deniliyordu. Günümüzde ise bu faaliyetlerin tümü kalite güvence sistemi ve toplam kalite yönetimi gibi kavramlarla ifade edilmektedir. Kalite güvence sistemi, bir işletmede çeşitli departmanların gösterdiği kaliteyi geliştirme, koruma, iyileştirme, tüketicinin tam beğenisini kazanma ve en ekonomik düzeyde bir üretim ve hizmet sağlamayı amaçlayan faaliyetlerin bütünüdür. Kalite güvence sistemi ile ilgili olarak birçok ülkede sistem modelleri üzerinde çalışmalar yapılmıştır. Geliştirilen bu modellerden yararlanılarak, İngiliz, Kanada, A.B.D., Almanya, Fransa ve Japonya gibi endüstrileşmiş ülkelerin standart hazırlama kuruluşları ulusal nitelikte, kendi ülkeleri için kalite sistem standartları düzenlemişlerdir. Kalite güvence sistemlerinden ISO 9000 (Uluslararası Standartlar Örgütü) 1980 yılı içinde başlattığı çalışmalarının sonucunda ISO 9000 serisi olarak anılan, kalite güvence sistemlerinin kurulmasına yönelik standartları 1987 yılı içinde yayınlamıştır.. Bu tarihten itibaren, özellikle pazar potansiyellerini kaybetmek istemeyen firmalar için ISO 9000 zorunlu hale gelmiştir, özellikle ihracata yönelik çalışan firmalar bu sistemin eksikliğini oldukça büyük bir şekilde hissetmişlerdir. Bu çalışmada, işletmeler için kalitenin güvence altına alınmasının ve ISO 9000 standartlarının önemi araştırılmıştır. Çalışmanın birinci ve ikinci bölümünde kalite kavramları üzerinde durulmuş ve kalitenin yapısı incelenmiştir. Üçüncü bölümde toplam kalite konusu incelenmiş, dördüncü bölümde ise kalite güvence sistemlerine değinilmiştir. Beşinci bölümde, ISO 9000 standartları açıklanmış ve standardın uygulanması için yerine getirilmesi gereken 20 ana madde detaylı bir şekilde anlatılmıştır. Altıncı bölümde ise, kalite güvence sisteminin kurulmasına yönelik çalışmalar, daha sonra konu hakkında çıkarılan sonuçlar ve öneriler ele alınmıştır. Ek A bölümünde Otosan Fabrikaları'nın kalite ilkesi ve ISO 9000 standartlarına bakışı, Ek B bölümünde ise Otosan Fabrikalarında uygulanan S.P.C. kontrol sistemlerine yer verilmiştir.
Özet (Çeviri)
SUMMARY QUALITY ASSURANCE AND ISO 9000 In Today's marketplace the rivalry among business firms is very strong. The life of a firm depends on customer satisfaction much more and quality is the main factor of this satisfaction. Firms should apply quality assurance system to establish customer satisfaction, for to get the continuation of the quality and for to increase their power of rivalry. The quality can be described as appropriateness of the using aim. If the product is produced approitely to user aim, it can be described as high- quality. Quality is not meaning the best absolutely. A product quality is depended on its function or using aim and price. Quality also is depended on quality of raw and auxiliary material, sources and technology. In the second chapter, quality functions are explained. Total quality management requires and assumes that an effective quality assurance system exist and is followed. Unfortunately this is not always a valid assumption. Any organisation starting a total quality management afford should asses the adequacy of its underlying quality system. It becomes a base line from which to start quality improvement activities. Using an ISO 9000 standard for this assessment would provide excellent measurement criteria and a structured approach to periodic evaluation of the quality system. Since a successful total quality management effort will continually force change in the quality system this advantage could became a long term critical success factor. As the European Community moved toward the European free trade agreement, which went into effect at the end of 1992, quality management became a key strategic objective. To standardise quality requirements for European countries within the common market and those wishing to do business with those countries, a specialised agency for standardisation, the International Organisation, founded in 1946 and composed of representatives from the national standards bodies of 91 nations, adapted a series of written quality standards in 1987. The standards have been adapted in the United States by the American National Standards Institute (ANSI) with the endorsement and co-operation of the American Society for Quality Control (ASQC). The U.S. Standards are called the ANSI/ASQC Q90- 1987 series. The standards are XIrecognised about 100 countries, including Japan. In some foreign markets, companies will not buy from noncerfied suppliers. The ISSO 9000 series of standards are different from the traditional nation of a standard. They are not engineering standards for measurement, terminology, test methods, or product specifications. They are quality system standards that guide a company's performance of specified required in the areas of design, production, installation, and service. In the fourth chapter, Quality Assurance System's functions are explained. All International Standards about ISO 9000 Quality Assurance was prepared by Technical Committee ISO/TC176, quality management and quality assurance. From International Standard models, ISO 9004 can be used for internal quality management purposed and ISO 9001, ISO 9002 and ISO 9003 series of other standards used for external quality assurance purposes. ISO 9000 :Quality management and quality assurance standards. ISO 9001 :Quality systems - Model for quality assurance in design/development, production, installation and servicing. ISO 9002 :Quality systems - Model for quality assurance in production and installation. ISO 9003 :Quality systems - Model for quality assurance in final inspection and test. ISO 9004 :Quality management and quality system elements - Guidelines. ISSO 8402:Quality - Vocabulary All standards are subject to revision and parties to agreements based on these International Standards are encouraged to investigate the possibility of applying the most recent addition of the standards indicated below. For the purpose of the International Standards the definitions given in ISO 8402 apply as follows: -Quality The totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs. -Product or servicesUnless otherwise stated the result of activities or process or an activity or process such as the provision of a service or the execution of a production process. -Quality Policy The overall quality intentions and direction of an organisation as regards quality, as formally expressed by top management. -Quality Management That aspect of overall management function that determines and implements the quality policy. -Quality Assurance All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. -Quality Control The operational techniques and activities that are used to fulfil requirements for quality. -Quality System The organisational structure, responsibilities, procedures, processes and sequence of activities relevant to a particular product, service, contract or project. -Quality Manuel A document setting forth the general quality policies, procedures and practices of an organisation. -Quality Audit A systematic and independent examination to determine whether quality activities and related result comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. -Inspections Activities such as measuring, examining, testing, gauging one or more characteristics of a product or service and comparing these with specified requirements to determine conformity. -Traceability The ability to trace the history, application or location of an item or activity or similar items or activities by means of recorded identification. -Nonconformity The nonfulfillment of specified requirements. -SpecificationThe document that prescribes the requirements to which the product or service has to conform: Procedure :A methodology for carrying out a certain activity or series of operations. Procedures basically cover general and crossfunctional activities. Written Procedures :Documented and authorised guide line for handling and carrying out a certain activity or series of operations. Instruction :A description of how to execute a specific operation. An instruction generally covers one or some of several specific operations included in a written procedure. Written Instruction :A documented and authorised description of requirements to be fulfilled and followed a specific operation or task. The standards focus on 20 key requirements; quality system requirements of ISO 9000 standards can be written as follows: 1 ) Management Responsibility, 2) Quality System, 3) Contact Review, 4) Design 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) Control of Non conforming product, 14) Corrective Action, 15) Handling, Storage, Packaging and Delivery, 16) Quality Records, 17) Internal Quality Audits, 18) Training, 19) Servicing, 20) Statistical Techniques, In the fifth chapter, detailed knowledge about ISO 9000 standards is given. International Standards can be beneficial to certificate companies as they can compete on an equal footing with competitors on a world wide basis while, at the same time satisfying the customers requirements. The need to achieve certification is voluntary but buyers may specify compliance as a requirement. This has been the case with numerous large governmental purchasers including Defence Ministries in the United Kingdom andSingapore and the Department of the Navy in the United States. They have required contract suppliers to have ISO 9000 registration. The ISO 9000 standards are not an end in themselves they are tools to be used to meet objectives, total quality improvement being the principal objective Business enterprises have recognised that quality improvement is being pursued by all levels in today's society and, accordingly, those who intend to remain in a competitive position have to shift emphasis from the price to the quality side of the equation, especially in the global markets.
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