ISO 13485 tıbbi cihazlar için kalite yönetim sisteminin ISO 9001 kalite yönetim sisteminden farklılıkları üzerine bir uygulama
An application on differences between ISO 13485 quality management system for medical devices and ISO 9001 quality management system
Yazar: ESRA AKDAĞ
Danışman: YRD. DOÇ. DR. GÖKHAN AKYÜZ
Akdeniz Üniversitesi / Sosyal Bilimler Enstitüsü / İşletme Ana Bilim Dalı
Derece: Yüksek Lisans, 2013
Konu: İşletme = Business Administration
Dizin: Antalya = Antalya ; ISO 13485:2003 = ISO 13485:2003 ; ISO 9001 = ISO 9001 ; ISO = ISO ; Kalite = Quality ; Kalite yönetim sistemi = Quality management system ; Tıbbi cihazlar = Medical devices

Özet:
Bu çalışmada ISO 13485 Tıbbi Cihazlar - Kalite Yönetim Sistemleri - Mevzuat Amaçları Bakımından Şartlar standardının bir kalite yönetim sistemi standardı olarak ISO 9001 Kalite Yönetim Sistemi - Şartlar standardından farklarının saptanması ve tıbbi cihazlar üreten bir kuruluşta uygulaması yapılarak bu standardı kullanan kişi ya da kuruluşlar için bir kılavuz görevi görmesi amaçlanmıştır.  ISO 13485'in amacı, yapısı, içeriği, tarihçesi, revizyonları ile gelen değişiklikler, belgelendirme koşulları, tıbbi cihaz direktifleri ile bağlantısı ve ISO 9001 standardından farklılıkları incelenmiştir. İki standard arasında saptanan farkların ortaya çıktığı maddeler tespit edilmiş, karşılıklı tablolarla farklılıkların gerekçesi analiz edilmiştir. Antalya Serbest Bölgesi / TÜRKİYE'de faaliyet gösteren ve ISO 13485 kalite yönetim sistemini yürüten bir tıbbi cihaz üretim işletmesinde bu maddelerin uygulaması yapılarak uygulamaya ilişkin veri toplanmıştır. Araştırma bulgularına göre ISO 13485 ile ISO 9001 arasında,

Abstract:
An Application on Differences Between ISO 13485 Quality Management System for Medical 
Devices and ISO 9001 Quality Management System". The study has been conducted with the aim 
of determining different aspects of "ISO 13485 Medical Devices – Quality Management Systems 
– Requirements for Regulatory Purposes" as a quality management system (QMS) standard from 
"ISO 9001 Quality Management Systems – Requirements" standard and constituting a guide for 
individuals and organizations who would intend to work according to this standard, by giving 
information that has been obtained from an application at a medical device manufacturing 
organization. Purpose, structure, content and history of ISO 13485, changes occurred with its 
revisions, requirements for certification, its relationship with medical device directives and 
different clauses from ISO 9001 standard has been examined. Data has been collected by doing an 
application of these clauses in QMS of a medical device manufacturing organization which 
operates in Antalya Free Trade Zone / TURKEY and implements ISO 13485 system. According 
to the findings of the research, two types of differences have been determined between ISO 13485 
and ISO 9001, named as "basic systematic differences" and "additional requirements for ISO 
13485". Scope and regulation difference, maintaining effectiveness principle of ISO 13485 
against continuous improvement principle of ISO 9001, providing of customer feedback purpose 
of ISO 13485 against customer satisfaction purpose of ISO 9001 and differences on exclusions are 
the basic systematic differences. Additional requirements for ISO 13485 are those: Higher number 
of procedures that should be documented and records should be kept and increased retention time 
of them, requirement of technical documentation, requirement of risk management through 
product realization, requirements related work environment – product cleanliness and 
contamination control, requirements related sterilization activities and validations of sterilization 
processes, additional requirements for installation and service activities and requirements for 
implantable and active implantable medical devices. On application phase, it is observed that 
QMS of the organization wanders off from the process approach structure because of 
organizational growth and is not operated effectively. Some correction necessities on 
documentation of the organization have been detected and carried out. It is detected that options 
presented under 7.5.1.2.1 Cleanliness of Product and Contamination Control clause are not 
eligible to reflect all procedures able to be applied for providing product cleanliness. ISO 14698 
Cleanrooms and Associated Controlled Environments–Biocontamination Control, an harmonized 
standard with MDD 93/42/EEC, does not present any numerical value to be used in order to 
compare biocontamination data.