ISO 9000 kalite güvencesi sistemi

Abstract

Yakın zamana kadar firmalar yoğun ve kıyasıya bir rekabetin yaşandığını bildikleri uluslararası sanayi ve ticaret piyasasına girip girmeme kararını kendileri belirtiyordu. İç piyasa koşullarını uygun bulan birçok işletme, korumacılığında etkisi ile dış pazarlara açılmayı düşünmüyordu. Ancak sanayi ve ticarette globalleşmenin yaşanması ve gümrük duvarlarının kaldırılmaya başlanması ile şirketler kendilerini, sahip oldukları üretim ve yönetim sistemlerinin yeterliliğinin ölçüleceği zorlu bir sınavın ortasında buldular. Böyle bir ortamda rekabet ve başarının en önemli unsuru olan kalite belirleyici rol oynamıştır. Günümüzde iç piyasaya yönelik üretim yapan firmalar açısından kalite, adeta tüm dünya pazarlarının bir araya gelmesi ile birlikte bir handikap olmuştur. Ürettiği ve müşerinin kullanımına yansıyan ürün ya da hizmetteki her hata artık işletmelerin geleceğini belirleyecek bir öneme sahiptir. Kalitesizlik mevcut müşterilerin kaybedilmesinin yanında potansiyel müşterilerinde kaçırılmasına sebep olmaktadır. Artık, kaliteli ürün veya hizmet üretmenin yanısıra müşterinin güvenini kazanacak bir sistem kalitesine sahip olmanın da önemli olduğu aşikardır. Müşteri ihtiyaçlarını onların beklentlerinin de üzerinde sağlayan; yönetim ve üretim sisteminin tümünü sürekli olarak kontrol eden ve yenileyen; verimliliği, ekonomikliliği ve kaliteyi amaç edinmiş kuruluşların önünde parlak bir gelecek durmaktadır. Bu hedefe ulaşmak yine firma yönetimlerinin elindedir. Günümüzde yaygınlığı tüm dünyayı sarmış olan ISO 9000 kalite güvencesi sistemi, bu yolda ip uçları veren bir yön göstericidir. Kalite güvencesi sistemi ve ISO 9000 belgelerine sahip olmak amaç değil araç olmalı ve bunun sadece bir başlangıcın sonu olduğu unutulmamalıdır. Bu çalışmanın temelini ISO 9000 Kalite Güvencesi Sistem uygulaması oluşturmaktadır. Çalışmanın birinci ve ikinci bölümlerinde kalitenin günümüze kadar olan gelişimi ve kavramlarının açıklanmasına yer verilmiştir. Yine bu bölümde tüm çalışanların kaliteye katkısının önemini vurgulayan Toplam Kalite Yönetimi açıklamıştır. Üçüncü bölüm, Kalite Güvence Sistemine ayrılmış, tanımı ve tarihsel gelişminin ardından verimlilikle ilişkisi irdelenmiştir. Dördüncü bölümde ISO 9000 Kalite Güvencesi Modelleri tanıtılmış ve ISO 9001 uygulanması sırasında önem verilmesi gereken maddeler ayrıntılı bir şekilde açıklanmıştır. Beşinci bölümde kalite güvence sitemi kurulmasına yönelik bir uygulama mevcuttur. Altıncı bölümde ise çalışma sonuçlarının yorumlanması ve konu hakkındaki öneriler yer almaktadır. Kalite Güvence Sistemi kurulmasına yönelik uygulamada gerçekleştirilen dokümantasyon çalışmaları, ekler bölümünde verilmiştir. EK A. Kalite El Kitabı, EK B. Prosedür Örnekleri, EK C. Talimat Örnekleri, EK D. Görev Tanımları ve EK E. Kalite Planı; ekler bölümünde yer almaktadır.

The modern approach to quality and reliability concerns excellence; excellence when the product is designed, excellence when the product is made, excellence as the product is used, and excellence throughout its lifetime. Excellence does not result without effort, and products and services of superior quality and reliability require an appropriate combination of statistical, engineering, management, and motivational effort. This effort can be directed for maximum benefit only in light of timely knowledge approaches, and methods that have been developed and are available in these areas of expertise. Create, control, correct and improve quality and reliability are cost effective, that enhance productivity, and create a motivational atmosphere that is constructive. International Standard Organization (ISO) 9000 series has come from various sources; domestic and foreign customers, corporate headquarters, and overseas subsidiaries or sales representatives. ISO 9000 is one of three international standards dealing with quality system requirements that can be used for external quality assurance purposes. The ISO 9000 series consists of five documents; three core quality system documents which are models of quality assurance, namely 9001, 9002, and 9003 and two supporting guidelines documents, 9000 and 9004. The documents' title clearly indicate their purpose. ISO 9000 Quality Management and Quality Assurance Standards: Guidelines for Selection and Use. 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. Recognizing that at the heart of most customer - supplier relationships are contractual obligations, the international committee chose to organize the ISO quality assurance documents into three broad categories; 9001, 9002 and 9003. IX ISO 9001 is applicable in contractual situations when "conformance to specified requirements is to be assured during several stages which may include design/development, production, installation, and servicing". Moreover; a) The contract requires design effort and the product requirements are stated principally in performance terms or they need to be established, b) Confidence in product conformance can be attained by adequate demonstration of certain supplier's capabilities in design, development, production, installation, and servicing. ISO 9002, the standard often adopted by the process industries, as well as other industries, is applicable in contractual situations when; a)The specific requirements for the product are stated in terms of an established design or specification, b) Confidence in product conformance can be attained by adequate demonstration of certain supplier's capabilities in production and installation. ISO 9003, which has been applied to small shops, distributors or divisions within an organization, is applicable in contractual situations when; The conformance of the product to specified requirements can be shown with adequate confidence providing that certain supplier's capabilities for inspection and tests conducted on the product supplied can be satisfactorily demonstrated on completion. For the purpose of the International Standards the definitions given in ISO 8402 (Quality Management and Quality Assurance Vocabulary) 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 Services Unless otherwise stated the result of activities or processes 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 organization 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 organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Quality Plan A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, service, contract or project. Quality Manual A document setting forth the general quality policies, procedures and practices of an organization. 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. Inspection 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. Traceabilitv The ability to trace the history, application or location of an item or activity or similar items on activities by means of recorded identification. Nonconformity The nonfulfillment of specified requirements. Specifications The 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 genera and cross-functional activities. Written Procedure: Documented and authorized guidelines 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. xi Written InstructionDocumented and authorized description of requirements to be fulfilled and followed a specific operation or task. The ISO 9001 standard is the most comprehensive of all three models for quality assurance. It consists of twenty paragraphs, some of which are broken down into as many as eight sub paragraphs. 1. Management Responsibility Quality Policy Responsibility and Authority Verification Resources and Personnel Management Representative Management Review 2. Quality System 3. Contract Review 4. Deign Control General Design and Development Planning Activity Assignment Organizational and Technical Interfaces Design Input Design Output Design Verification Design Changes 5. Document Control Document Approval and Issue Document Changes/Modifications 6. Purchasing General Assessment of Sub-contractors Purchasing Data Purchasingerification of Purchased Product 7. Purchaser Supplied Product 8. Product Identification and Traceability 9. Process Control General Special Processes 10. Inspection and Testing Receiving Inspection and Testing In-Process Inspection and Testing Final Inspection and Testing Inspection and Test Records 1 1. Inspection, Measuring, and Test Equipment 12. Inspection and Test Status 13. Control of Nonconforming Product 14. Corrective Action 15. Handling, Storage, Packaging, and Delivery General Handling Storage Packaging Delivery 16. Quality Records 17. Internal Quality Audits 18. Training 19. Servicing xii 20. Statistical Techniques The primary scope of the 9001 standard is to ensure that a supplier can demonstrate that his quality assurance system is organized in such a way has to prevent the occurrence of nonconformities across all stages from deign to servicing. There tends to be some confusion or occasional philosophical disagreements when someone tries to compare the ISO 9001, 9002 or 9003 series of quality assurance standards with the principles of Total Quality Management (TQM). When people realize that a significant portion of the implementation efforts required to achieve registration consist of documenting what you say you do, some individual develop an allergic reaction to ISO. To them, the real issue is total quality management. To achieve that objective everyone must be involved to solve a multitude of problems which may have accumulated over several years. Some even go as far as suggesting, with some sarcasm, that registration to one of the ISO standards "does not even guarantee that firms will make good products". Low-growth economics, the rise of third-sector industries, and the movement of society to higher technology makes competition in the domestic and international markets increasingly severe. Companies are searching for strategies to cope with this increasingly difficult situation. The survival of companies does not depend merely on careful planing by managers and supervisors; a concerned effort by all company members is essential. Total Quality Control developed primarily in the manufacturing industries, but has quickly extended itself to construction, service, banking and finance, electrical power, and retail industries. TQC activities allow companies to develop products that meet the needs of the world, to make cost reductions, and to provide goods and services with true international competitiveness. TQC activities also give companies the ability to endure whatever changes occur in the business environment. There are four specific points included in TQC;. Everyone participates.. All division perform it.. It is practiced at all stage of bringing the product to market.. It is systematically executed. ISO 9000 series intended to provide a vehicle to foster interaction of the elements of the modern approach to quality, including statistical applications, quality and reliability engineering, management and motivational aspects.