CE işareti ve Türk şirketlerine uygulanabilirliğinin analizi
CE marking and anaysis of the application to Turkish firms
- Tez No: 66507
- Danışmanlar: DOÇ. DR. SEÇKİN POLAT
- Tez Türü: Yüksek Lisans
- Konular: Mühendislik Bilimleri, İşletme, Engineering Sciences, Business Administration
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 1997
- Dil: Türkçe
- Üniversite: İstanbul Teknik Üniversitesi
- Enstitü: Fen Bilimleri Enstitüsü
- Ana Bilim Dalı: İşletme Mühendisliği Ana Bilim Dalı
- Bilim Dalı: Belirtilmemiş.
- Sayfa Sayısı: 96
Özet
ÖZET Bu çalışma, belli ürün yönetmeliklerine uygunluk gösteren mamullerin, Avrupa Birliği ülkelerine ihracatları yapılabilmesi için, üreticilerin iliştirmeleri gereken CE işaretini detaylı olarak inceliyerek, dört örnek yönetmelik üzerinde tüm aşamalar gösterilmiştir. CE işaretinin verilmesinde önemli bir rol oynayan harmonik normlara bu çalışmada açıklık kazandırılmak hedeflenmiş ve bu normların oluşturulmasında söz sahibi olan CENELEC, ETSI, ve CEN gibi organizasyonlar ele alınarak incelenmiştir. İkinci bölümde yönetmeliklere ilişkin özellikler incelenmiş ve daha sonra üçüncü bölümde CE işaretlemesindeki temel aşamalar analiz edilerek bazı temel kavramlar üzerinde durulmuştur. Bunun yanında yüksek riskli ürün grubuna dahil edilen ürünlerin kontrolünde bulundurulması gereken onaylanmış kuruluşlar ( notified body ) hakkında bilgi verilerek, CE işaretleme prosedüründeki yerleri belirtilmiştir. Üçüncü bölümde ayrıca CE işaretlemesinin uygunluk prosedürlerini kolaylaştırmak amacıyla oluşturulan A-H 'ye kadar olan modüler sistem üzerinde durularak, CE işaretlenmesindeki yeri akım şemaları ile belirtilmiştir. Genel teorik bilgilerin verilmesinin ardından dört yönetmelik seçilerek detaylı olarak incelenmişlerdir. Bunlar sırası ile Makine Yönetmeliği, Alçak Gerilim Yönetmeliği, Elektromanyetik Dayanım Yönetmeliği ve Yapı Sanayi Mamulleri Yönetmelikleridir. Bu dört yönetmeliğin seçilmesinin nedeni ise, herbiri için ayrı bir uygulama şeklinden kaynaklanmaktadır. Örneğin Alçak Gerilim Yönetmeliğinde sade üretici deklarasyonu yeterli olurken Yapı Sanayi Mamulleri Yönetmeliğine göre onaylanmış bir kuruluş çalışmalara dahil edilmelidir. Tezin son aşaması olan uygulama kısmında iki firma örneği verilerek, kalite departmanları incelenmiş. Kullandıkları kalite güvence sistemleri, laboratuarlarda kullanılan teçhizat ve Özellikle eğitim görmüşlük seviyeleri incelenerek daha kaliteli üretim yapabilmeleri için gereken unsurlar araştırılmıştır ve şirketler için ayrı ayrı bir değerlendirme sistemi oluşturulmuştur. Bu analizler yardımıyla Türk şirketlerin CE işareti alabilmelerindeki yerleri, bilgileri, imkanları irdelenmiş ve bu konuya daha iyi hakim olabilmeleri için önerilerde bulunulmuş. Ayrıca sanayici için önemli olan maliyet ve prosedür unsurları ele alınarak, sanayicimiz için bir gösterge oluşturulmak istenmiştir. viii
Özet (Çeviri)
SUMMARY (CE MARKING AND ANAYSIS OF THE APPLICATION TO TURKISH FIRMS ) Silice 1985, the European Commission has been publishing guidelines on different product groups. These guidelines determine the conditions of health, security, environment and consumer protection. European Union countries are obliged to transform these guidelines as their national laws in two years transaction cycle. Some necessity written above are valid for export of goods from non- European Union countries; like Turkey to European Union countries. At the end of a transaction cycle of a guideline, unavailable products cannot be imported to and marketed in European Union countries. Manufacturers put CE Marking on their products as sign of conformity by providing availability to guidelines either in European Union countries or in non-European Union countries. Up to now different guidelines for lots of product groups are published. Studies in European Union countries are going on to announce new guidelines in near future. In Table *A, there are some of them with their transaction cycle listed. Table - A Some of the guidelines with their transaction cycle IXNew standards are being prepared throughout Europe, aiming to direct manufacturers in ensuring the guideline conditions. These standards called Harmonic European Standards are combinations of national standards in European Union countries. European Norms (EN) are prepared by cooperation of European Standards Institutes; like CENELEC ( Electrical goods ), ETSI ( Telecommunication and information technology ) and CEN(other goods) and National Standardization Communities. Manufacturers are free to apply the standards meaning that they are only showing right directions EN Standards contain technical information about product development and manufacturing and are enlarged detailed form of necessities of guidelines. In short, European Union guidelines point out which rules match with which product and EN standards show how this availability is provided. Manufacturers will have the right of using CE marking on their products after completing necessary rules of concerning guidelines in condition of products in low risk level. For products in high risk level; in addition to studies of producer examinations and tests should be done by notified bodies approved communities by European Union countries. CE is formed by the first letters of“ Conformite Europeenne ”which means conformity to Europe. CE marking which is not a quality sign determines the availability of guidelines standards of product while manufacturing and marketing. CE plays the role of passport for non-European countries such as Turkey during export. There is not such an authorized foundation giving CE Marking neither in European Union nor in non-European countries. In European countries there are notified bodies validating conformity procedures for high risk level products. For products rather than these, manufacturers put CE marking on their products after conformity procedures. Definitely these mean; CE marking cannot be given by notified bodies, every manufacturer does it on their own. CE marking should be put on products available to conditions of guidelines. Though for some product groups using of CE marking is simple to apply, for high risk level products notified bodies' existence is a must in order to do product tests; quality assurance system should be used by manufacturers. In previous years, consumers had to prove risky positions of products. But now, according to New Product Responsibility Law; if an accident occurs because of related product or if one of the European Union Countries proves that product is insufficient to fit CE marking conformity such as leak of security; manufacturer should have evidences to demonstrate the opposite. During studies about CE marking;“ Technical File ”pointed out in guidelines, is examined by commission and may determined sanctions to manufacturer and importer. So manufacturer must take into consideration that he has whole product responsibility and therefore should keep technical files in archives for ten years. Taking authorization of few guidelines means having whole responsibility of some modules for notified bodies. For example, givingapproval on machinery guideline or/and LV (low voltage ) or/and EMC(Electromagnetic compatibility) belongs to national authorized staff. Union countries should inform communities authorized by them to the commission. Expensive conformity procedures of manufacturers having higher risk level products should be completed by notified bodies in European Union countries. Notified bodies have two alternatives to approve conformity to guidelines; a ) examining technical file in detail b ) making necessary tests on sample of the product CE marking can only be attached to product in case öf conformity to the conditions of guidelines. According to properties of product, right guidelines should be chosen. Lots of products belong to low risk level considering security. After completing conformity procedures manufacturer publishes declaration of conformity proving security, health, environment and consumer protection and uses CE marking. Manufacturer declaration is not enough for high risk level products; examination and test controls are done by third parties. To ease investigation of conformity procedures, a modular system has been developed in European Union countries. This system consists of eight modules from A to H and informs manufacturer on what to follow and by whom to do. For every guideline there can be different modules. Below are some examples ; 1 ) for machinery guideline A and B modules 2 ) for EMC (Electromagnetic compatibility) and toy guideline, A, B and C modules 3 ) for active implantable medical devices guideline A, B, D, F and H modules. Excluding machinery guideline, for high risk level products, like heart batteries, every product supplied to market should definitely suit with security and health conditions. Therefore having maximum quality assurance system rescues manufacturers from making tests one by one. Neither high risk level nor low risk level products should match with EN standards which only give information about conformity to guidelines. Manufacturing high risk level products according to standards will ease notified bodies' conformity procedures. Though manufacturing according to guidelines is compulsory and to standards is optional the most available and secure way is to manufacture according to standards. Especially this concern is important for high risk level products. Generally compulsory conditions explained in guidelines are for finished products but also valid for pieces of finished products. This means CE marking can be used on hydraulic press as well as on hydraulic mechanism of office chair. xiA product can be in scope of one guideline while another can be of few other guidelines. After announcing guidelines, a transaction cycle of 2-4 years is accepted. In this period European Union countries are obliged to transform these guidelines to national laws. If some changes occur in guidelines, last version of them should be applied. CE marking is used on finished products matching with guidelines. This does not mean that manufacturers for nothing for manufactured units and systems in sub - industry. They have to ensure all their responsibilities such as providing conditions of guidelines, preparing technical files and publishing manufacturer declaration prove conformity of their products with CE marking; but mustn't use CE marking on products. Manufacturers having whole responsibility of finished goods, should demand“ Manufacturer Declaration ”for systems and units of sub-industry. Otherwise manufacturer can't prove the conformity to standards and guidelines. Therefore manufacturer of finished goods should demand“Manufacturer Declaration”from the sub - industry. By putting“ Manufacturer Declaration ”in technical files, they are able to demonstrate health, security, environment and consumer protection of their products. Now let us list the basic levels of having the CE marking; * Conformity Appraisal Procedure * Preparing the Technical Files * Preparing the Conformity Declaration * CE Marking Also the CE marking is affecting the Turkish economy in some ways. This will be clear, when import and export data for European Union countries from and to Turkey are examined. After entering to the Customer Union, the European market getting more attractive for Turkish manufacturers because of descending the taxes to a minimum level. Also the Turkish market becomes an attractive one but the European manufacturers were prepared to a situation like this. Especially Spain, Austria and France has increase their import to Turkey. With 91% increasing in import Austria obtains the first place in this competition. We can demonstrate these better with Figure - A. The customer union is a very important subject for the Turkish economy. If the Turkish manufacturer profit more from this advantage so the image of Turkey would increase respectively. As explained before the CE marking is not a quality sign, it is only a passport for products coming from non-European Union countries. But without quality, it is very dangerous to mark the products with the CE sign. Therefore it is important to produce according to some standards and rules. With reference to these, two of Turkish firms are analyzed according to their quality department and with the firm T.Ü.V. Quality Auditing and Supervision the results are appraised. Xllc/3.c 3 O e o c o. s 3 W J3 -o eö ı-> H c SP 'S t-l o CO V, 3 H 3 00. ??M X111
Benzer Tezler
- Yükseköğretim kurumları işbirliğinde meydana getirilen buluşlarda yapılan sözleşmeler ve hak sahipliği olgusu
Inventions créées dans des contrats avecla coopération d'établissementsd'enseignement supérieur et le fait de lapropriété des inventions
ÖMER FARUK ŞENGÖR
Yüksek Lisans
Türkçe
2022
HukukGalatasaray ÜniversitesiÖzel Hukuk Ana Bilim Dalı
DOÇ. DR. FÜLÜRYA YUSUFOĞLU BİLGİN
- Makro ihtiyati politika ve finansal istikrar ilişkisi: Türkiye'de konut sektörüne yönelik araçların etkinliği
The relationship between macro prudential policy and financial stability: Effectiveness of tools for the housing sector in Turkey
MURAT SARI
Yüksek Lisans
Türkçe
2022
EkonomiGalatasaray Üniversitesiİktisat Ana Bilim Dalı
DR. ÖĞR. ÜYESİ ZEHRA YEŞİM GÜRBÜZ
- Analysing the relationship between integrated marketing channels and born global companies
Entegre pazarlama kanalları ile doğan küresel şirketler arasındaki ilişkinin incelenmesi
HAJAR DAGHMI
Yüksek Lisans
İngilizce
2023
İşletmeİstanbul Aydın Üniversitesiİşletme Ana Bilim Dalı
PROF. DR. İLKAY KARADUMAN
- CE süreci-medikal sektöründe uygulamalar ve Türk firmalarının bu süreçteki durumu
CE process-applications in medical sectors and condition of Turkish firms in this process
YUSUF ÇAKABEY MENGİ
Yüksek Lisans
Türkçe
2005
Endüstri ve Endüstri Mühendisliğiİstanbul Teknik ÜniversitesiEndüstri Mühendisliği Ana Bilim Dalı
Y.DOÇ.DR. UFUK CEBECİ