ISO 9000 kalite güvencesi sistemi ve yapılan yatırımın değerlendirilmesi
Quality assurance and total quality management
- Tez No: 46620
- Danışmanlar: PROF.DR. ETHEM TOLGA
- Tez Türü: Yüksek Lisans
- Konular: Endüstri ve Endüstri Mühendisliği, Industrial and Industrial Engineering
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 1995
- Dil: Türkçe
- Üniversite: İstanbul Teknik Üniversitesi
- Enstitü: Fen Bilimleri Enstitüsü
- Ana Bilim Dalı: Belirtilmemiş.
- Bilim Dalı: Belirtilmemiş.
- Sayfa Sayısı: 144
Özet
ÖZET Globalleşen sanayi ve ticaret beraberinde yoğun bir rekabeti getirmiş, bu ortamda da kalite en önemli rekabet unsuru olarak ortaya çıkmıştır. Yine bu günlerin ilgi odağı olan AT ISO 9000 standardını zorunlu hale getirmiş, bunun sonucunda ihracat yapan firmalar pazar paylarını kaybetmemek için kalite sistemlerinde bir iyileştirme gündeme getirmişlerdir. Bunun da ötesinde Türkiye'nin gümrük birliğine üyeliği yaklaşırken, iç piyasaya çalışan firmalar için kalite, bir tehdit unsuru olmaktadır. Çoğu organizasyon kaliteli üretimin bilincine varmış ve bu konuda çalışmalarım sürdürmektedir. Bu çalışma ISO 9000 kalite güvencesi uygulamasına yönelik yapılmış bir araştırmadır. Çalışmanın birinci ve ikinci bölümlerinde kalite kavramları üzerine bir literatür çalışması yapılmıştır. Aynı zamanda kalite maliyetlerini oluşturan kalemler belirlenmiş ve incelenmiştir. Üçüncü bölümde toplam kalite felsefesi irdelenmiş, kalite güvencesi standartları ile olan ortak özellikleri ve ayrıldıkları noktalar üzerinde durulmuştur. Dördüncü bölümde bir kalite güvencesi standardı olan ISO 9000'in uygulanması sırasında gözden geçirilmesi gereken ve aşağıda belirtilen 20 ana madde detaylı bir şekilde anlatılmıştır : 1- Yönetim Sorumluluğu 2- Kalite Sistemi 3- Sözleşmenin/Gözden Geçirilmesi 4- Tasarım Kontrolü 5- Doküman Kontrolü 6- Satmalma 7- Alıcının Temin Ettiği Ürün 8- Ürün Tanımı ve İzlenebilirliği 9- Proses Kontrolü 10- Muayene ve Deney 1 1- Muayene, Deney ve ölçme Teçhizatı 12- Muayene ve Deney Durumu 13- Uygun Olmayan Ürünün Kontrolü 14- Düzeltici Önlem 15- Taşıma, Depolama, Ambalajlama, Saklama ve Dağıtım 16- Kalite Kayıtlan 17- Dahili Sistem Denetimi 18- Eğitim 19- Servis 20- İstatistiksel Teknikler Beşinci bölümde ISO 9000 belgesine sahip olmak isteyen firmaların izlemesi gerek adımlar ve hazırlamanması gereken belgelere örnekler yer almaktadır. Altıncı bölümde ise ISO 9000 yatırımının geri ödeme süresi üzerine bir uygulama mevcuttur. Sonuç bölümünde, değişik enflasyon ve net karlılık değerlerine göre yapılan uygulamaya ait yorumlar ve ISO 9000 üzerine Türkiye çapında gerçekleştirilen bir anket yeralmaktadır.
Özet (Çeviri)
SUMMARY QUALITY ASSURANCE AND TOTAL QUALITY MANAGEMENT ISO 9000 İs one of three International Standards dealing with quality system requirements that can be used for external quality assurance purposes. The quality assurance models, set out in the three International standards listed below, represent three distinct forms of quality system suitable for the purpose of a supplier demonstrating its capability, and for the assessment of such supplier capability by external parties. - ISO 9001 Quality systems- Model for quality assurance in design, development, production, installation and servicing. For use when conformance to specified requirements is to be assured by the supplier during design, development, production, installation and servicing. - ISO 9002 Quality systems- Model for quality assurance in production, installation and servicing. For use when conformance to specified requirements is to be assured by the supplier during production, installation and servicing. - ISO 9003 Quality systems- Model for quality assurance in final inspection and test. For use when conformance to specified requirements is to be assured by the supplier solely at final inspection and test. It is emphasized that the quality system requirements specified in this International Standard, ISO 9002 and ISO 9003 are complementary to the technical (product) specified requirements. They specify requirements which determine what elements quality systems have to encompass but it is not the purpose of these International Standards to enforce uniformity of quality systems. They are generic, independent of any specific industry or economic sector. The design and implementation of a quality system has to necessarily be influenced by the varying needs of an organization, its particular objectives, the products and services supplied and the processes and specific practices employed. It is intended that these International Standards will normally be adopted in their present form but on occasions they may need to be tailored by adding or deleting certain quality system requirements for specific contractual situations. ISO 9001-1 provides guidance on such tailoring as well as selection of the appropriate quality assurance model, ISO 9001, ISO 9002 or ISO 9003.The International Standard, scope, specifies quality system requirements for use where a supplier capability to design and supply conforming product needs to be demonstrated. The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through to servicing. The following standards contain provisions which constitute provisions of the International Standards, normative references. 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. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8402 : Quality Management and Quality Assurance- Vocabulary. For the purpose of the International Standards the definitions given in ISO 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 fulfill requirements for quality. XllQUALITY 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. 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. 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 general and cross- functional activities. Written Procedures : Documented and authorized guide lines for handling and carrying out a certain activity or series of operations. XIIIInstruction : 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 authorized description of requirements to be fulfilled and followed a specific operation or task. As a summary, quality system requirements of ISO 9000 standards can be written as follows: 1. Management Responsibility 2. Quality system 3. Contract review 4. Design control 5. Document and data control 6. Purchasing 7. Control of customer supplied product 8. Product identification and trace ability 9. Process control 10. Inspection and testing 1 1. Control of inspection, measuring and test equipment 12. Inspection and test status 13. Control of nonconforming product 14. Corrective and preventive action 15. Handling, storage, packaging, preservation and delivery 16. Control of quality records 17. Internal quality audits 18. Training 19. Servicing 20. Statistical Techniques. Companies are beginning to recognize that ISO 9000 registration is a virtual necessity for competing at the international level. They are also discovering that implementing a quality system that meets ISO 9000 requirements can be confusing, costly and time consuming. Fortunately, the road to ISO 9000 registration has been paved by companies willing to share their proven methods for implementing effective quality systems. These companies have demonstrated that there are many right ways to satisfy the requirements of the ISO 9000 standards and their experiences can be a valuable learning tool for organizations just beginning the journey. Organization seeking registration often use the services of professional ISO 9000 consultant and trainers. It takes 12-18 month for most companies to achieve registration. This time frame is only an approximation; the actual time depends on the initial status of quality system, the presence of the management commitment and the degree of involvement of every member in the organization. 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 xivISO 9000 process requires not only the involvement of the leaders, but also the resources that only they can allocate. Once the organization's leaders have decided to pursue registration, they must develop a strategic plan for implementing ISO 9000. The plan should include the scope of registration, an initial assessment of the organization, the resource requirements, and a tentative time line. The next step is to establish an infrastructure that includes a management representative, steering group, and area coordinators. The management representative has the authority and responsibility for ensuring that the ISO 9000 standards' requirements are implemented and maintained. He or she can delegate activities but must manage the overall effort. Since the implementation of a quality system is not a one-person job, the steering group is essential to help guide the effort and make strategic decisions. Led by the management representative, the relatively small team should include leaders from a cross section of functions within the organization. Every area involved in the ISO 9000 pursuit needs a coordinator who provides input to and of the strategic directions of the steering group. The people assigned to all three of these jobs need to know about the standards' requirements and how they apply to their own functions. A two-day interactive seminar should be sufficient to provide the necessary knowledge and skill for implementation. As the registration effort gets under way, the organization needs to determine its starting point to continuously measure progress. Internal quality audits are an effective measurement tool. The initial round of internal audits compares the current quality system- including documentation, policies and practices- to the requirements of the appropriate ISO 9000 standard. The result is a thorough report on the areas that need to be upgraded or improved to implement an effective quality system that meets the ISO 9000 standard's requirements. From these audit results the management representative and steering group can set priorities based on business needs and develop a more detailed implementation plan. In addition, many areas will likely need to upgrade their documentation or develop new documentation where none exists. Area coordinators should set up teams to work on these tasks as needed. Internal quality audits will identify the areas in which standard practices are missing or areas in which practices exist but are not documented. New or updated procedures that match current practices are not only required by ISO 9000, they are necessary for the effective operation of a quality system. The quality manual is an important aspect of documentation because it describes the policies and principles by which the organization manages quality. Before the actual audit takes place it is important to establish a relationship with a third-party register. The organization should be accredited to ensure that the registration provided will be recognized by customers. The initial visit enables the registrar to learn about the organization and to better plan the resources needed for the assessment. Since practices vary among registrars it is wise to use this first meeting to gain an understanding of the XVregistrar's process. Sometimes prior to the actual assessment, at least one management review should be performed. The pre-assessment is basically a dress rehearsal for the official assessment. It is optional, but many organizations find it is valuable in pinpointing weaknesses. It is likely that pre-assessment will point out some remaining discrepancies in the quality system. These might be ISO 9000 requirements that have not been addressed or aspects of a documented system that are not being followed. Any discrepancies must be corrected prior to the registration assessment. The registration assessment is performed by the registrar several months after a quality system is completely documented and implemented. This allows the registrar to find objective evidence that the organization's actions comply with its quality system and with ISO 9000 standard. The registration assessment follows the same format as the pre- assessment, with an opening meeting, an interview/investigation period, and a closing meeting. The assessment outcome is available before the registrar leaves the facility. The outcome is either a recommendation for or against registration. If the outcome of the assessment is a recommendation for registration the organization will receive a certificate in several months. If the registrar found minor discrepancies the organization will have about four to eight weeks to correct them. Major discrepancies will preclude registration and will require a partial or complete re-audit of the system. Registration is really just the beginning of the ISO 9000 process; it serves as the foundation for ongoing quality and business improvements. An organization must continue its internal audits, management review and corrective actions. The registrar will return periodically to conduct surveillance audits to ensure that the quality system is still in compliance. Almost every industrialized nation has adopted ISO 9000 as its national quality system standard, making it increasingly important to secure registration. In addition to preserving competitive advantage, ISO 9000 can improve productivity, reduce costs, enhance product and service quality, and institutionalize continuous improvement across an entire business. ISO 9000 might not be the path to TQM but it could be a path to TQM. ISO 9000 as the path to TQM is uncompleted. For example ISO 9000 does not have a sufficient customer focus, does not address how good a product or service is, doesn't focus on continues improvement and the scope of the support systems and processes needed for continues improvement and doesn't call for an ongoing evaluation and improvement of quality system elements. These however are not deficiencies. The intent is not to include these elements because ISO 9000 serves a different purpose. It is designed to ensure the adequacy of a given quality system and to use audits to ensure its adherence to it. TQM requires and assumes that an effective quality assurance system exist and is followed. Unfortunately this is not always a valid assumption. Any organization starring a TQM afford should asses the adequacy of its underlying quality system. It becomes a base üne 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 xviperiodic evaluation of the quality system. Since a successfiil TQM effort will continuously force change in the quality system this advantage could become a long term critical success factor. An alternative is to integrate the ISO 9000 standard in to TQM from the start. The quality system could be restructured in to an ISO 9000 system as part of an initial assessment. The goal would be to use this activity to identify key processes or project for improvement. It also could serve as the method to start a goal oriented team activity by deciding to flow chart the procedure and instruction s part of ISO 9000 restructuring, teams can be directed to improve how the process flows. It would be simple to have the teams identify the required resources and the task cycle times for a complete flow analysis. They could even be assigned quality improvement goals. The internal auditing requirement also could become the ongoing evaluation and improvement process for the TQM process itself. This integrated approach could accelerate the TQM process. It would give quality consuls immediate strategic plans. It could also provide greater assurance of early successes and help simplify the cultural acceptance of change. The integration should result in a mutual strengthening of both effort and ensure that neither effort detract from the other. It would be a particularly excellent path for those companies that have made significant accusations, such as adding new locations with different systems and cultures. It could bring a universal language to amalgamate the separate operations in to a consistent cooperate system and culture. If a company is just starting in TQM or reexamining its TQM effort it should consider integrating an ISO 9000 assessment in to the program. Companies seeking ISO 9000 registration that already have a successful TQM system can manage the activity by making it a quality improvement project. They can develop and implement ISO 9000 procedures and instructions to be consistent with their TQM initiatives. If a company has no TQM initiative and has no reason to seek ISO 9000 registration, it should still consider doing an ISO 9000 assessment of its quality system and modifying it as appropriate. Unless a company has supreme confidence in the adequacy of its present quality system and has recently confirmed it, an assessment is a critical to its health as a financial audits. Although the exercise will not be a complete path to TQM, it should increase quality awareness and the need for a solid quality system This exercise just might result in the enlightenment needed to start a TQM program. xvu
Benzer Tezler
- Gıda sektöründe kalite güvence sistemleri ve fayda-masraf analizi
Quality assurance systems in the food sector and cost-benefit analysis
ŞULE ULUSOY
- ISO-9000 kalite güvencesi sistemi ve ISO-9000 standartlarının uygulanması için yapılan çalışmalar
ISO 9000 qualıty assurance standarts and studies being done for these standarts
MELİH ÖZER
Yüksek Lisans
Türkçe
1993
Endüstri ve Endüstri Mühendisliğiİstanbul Teknik ÜniversitesiPROF.DR. AHMET FAHRİ ÖZOK
- TS-150 9000 standartları ve kalite güvencesi sistemi
Başlık çevirisi yok
HASAN ATAŞ
Yüksek Lisans
Türkçe
1996
Makine MühendisliğiUludağ ÜniversitesiMakine Mühendisliği Ana Bilim Dalı
PROF. DR. SEDAT ÜLKÜ
- Kamu sektöründe ISO-9000 ve bir sağlık kuruluşunda uygulaması
ISO-9000 in state controlled sector and the application in a health foundation
ABDULKADİR YILDIRIM
- Türk inşaat firmalarında ISO 9000 sertifikasından beklentiler ve memnuniyet 'sertifikalı inşaat firmalarında alan araştırması'
ISO 9000 certification process of the Turkish construction firms and a survey research about expectation and satisfaction from ISO 9000
SEYMAN TAYİBE
Yüksek Lisans
Türkçe
2003
Mimarlıkİstanbul Teknik ÜniversitesiMimarlık Ana Bilim Dalı
DOÇ. DR. AHMET MURAT ÇIRACI