The Importance of Total Quality Management Practices on Quality Performance in the Medical Device Manufacturing Industry: A Literature-Based Review

Ali Köstepen; Ceren Aytar

Makale detayları

The Importance of Total Quality Management Practices on Quality Performance in the Medical Device Manufacturing Industry: A Literature-Based Review

Yazarlar:

Ali Köstepen | Ceren Aytar

Yayıncı:

Manisa Celal Bayar University

Ana Başlıklar:

Kalite Yönetimi

Dergi:

Manisa Celal Bayar Üniversitesi Sosyal Bilimler Dergisi Vol.22 Issue 4, pp.491-501

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001336092

pISSN:

1304-4796

Anahtar kelimeler:

Özet:

 This study is to conduct a literature research on in the role of Total Quality Management TQM practices in increasing the quality performance of medical devices within the medical device manufacturing industry. Medical devices range from simple instruments like gloves to complex devices like pacemakers and MRI machines, have a direct impact on patient health and safety, making quality management a critical aspect of their production. The study adopts research, combining past research on manufacturers and commentary from industry experts. Key TQM practices identified include customer focus, employee involvement, process management, supplier quality management, continuous improvement, employee training and development. According to research reveal that there are significant positive relationships between TQM practices and quality performance indicators such as defect reduction, regulatory compliance, customer satisfaction and operational efficiency. To further improve quality performance in the medical device industry, the long-term impact of Total Quality Management practices should be investigated.

 This study is to conduct a literature research on in the role of Total Quality Management TQM practices in increasing the quality performance of medical devices within the medical device manufacturing industry. Medical devices range from simple instruments like gloves to complex devices like pacemakers and MRI machines, have a direct impact on patient health and safety, making quality management a critical aspect of their production. The study adopts research, combining past research on manufacturers and commentary from industry experts. Key TQM practices identified include customer focus, employee involvement, process management, supplier quality management, continuous improvement, employee training and development. According to research reveal that there are significant positive relationships between TQM practices and quality performance indicators such as defect reduction, regulatory compliance, customer satisfaction and operational efficiency. To further improve quality performance in the medical device industry, the long-term impact of Total Quality Management practices should be investigated.

 This study is to conduct a literature research on in the role of Total Quality Management TQM practices in increasing the quality performance of medical devices within the medical device manufacturing industry. Medical devices range from simple instruments like gloves to complex devices like pacemakers and MRI machines, have a direct impact on patient health and safety, making quality management a critical aspect of their production. The study adopts research, combining past research on manufacturers and commentary from industry experts. Key TQM practices identified include customer focus, employee involvement, process management, supplier quality management, continuous improvement, employee training and development. According to research reveal that there are significant positive relationships between TQM practices and quality performance indicators such as defect reduction, regulatory compliance, customer satisfaction and operational efficiency. To further improve quality performance in the medical device industry, the long-term impact of Total Quality Management practices should be investigated.

 Bu çalışma, tıbbi cihaz üretim endüstrisinde Toplam Kalite Yönetimi TKY uygulamalarının tıbbi cihazların kalite performansını artırmadaki rolü üzerine bir literatür araştırması yapmaktır. Eldiven gibi basit aletlerden kalp pili ve MRI makineleri gibi karmaşık cihazlara kadar uzanan tıbbi cihazlar, hasta sağlığı ve güvenliği üzerinde doğrudan bir etkiye sahiptir ve bu da kalite yönetimini üretimlerinin kritik bir yönü haline getirmektedir. Çalışma, üreticiler üzerinde yapılan geçmiş araştırmaları ve sektör uzmanlarının yorumlarını bir araya getiren bir araştırmayı benimsemektedir. Belirlenen temel TKY uygulamaları arasında müşteri odaklılık, çalışan katılımı, süreç yönetimi, tedarikçi kalite yönetimi, sürekli iyileştirme, çalışan eğitimi ve gelişimi yer almaktadır.Araştırmaya göre TKY uygulamaları ile hataların azaltılması, mevzuata uyum, müşteri memnuniyeti ve operasyonel verimlilik gibi kalite performans göstergeleri arasında önemli pozitif ilişkiler bulunmaktadır. Tıbbi cihaz sektöründe kalite performansını daha da iyileştirmek için Toplam Kalite Yönetimi uygulamalarının uzun vadeli etkisi araştırılmalıdır.

Makale detayları

The Importance of Total Quality Management Practices on Quality Performance in the Medical Device Manufacturing Industry: A Literature-Based Review

Yazarlar:

Ali Köstepen | Ceren Aytar

Yayıncı:

Manisa Celal Bayar University

Ana Başlıklar:

Kalite Yönetimi

Dergi:

Manisa Celal Bayar Üniversitesi Sosyal Bilimler Dergisi Vol.22 Issue 4, pp.491-501

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001336092

pISSN:

1304-4796

Total Quality Management

Medical Device Manufacturing

Regulatory ComplianceToplam Kalite Yönetimi

Tıbbi Cihaz Üretimi

Hukuki Uygunluk

Sayı

Makale detayları

The Importance of Total Quality Management Practices on Quality Performance in the Medical Device Manufacturing Industry: A Literature-Based Review

Yazarlar: Ali Köstepen | Ceren Aytar

Yayıncı: Manisa Celal Bayar University

Ana Başlıklar: Kalite Yönetimi

Dergi: Manisa Celal Bayar Üniversitesi Sosyal Bilimler Dergisi Vol.22 Issue 4, pp.491-501

Belge Tipi: Makale

Yayın Tarihi: 12/2024

Belge Dili: İngilizce

Document ID (Org No.): 2001336092

pISSN: 1304-4796

Total Quality Management

Medical Device Manufacturing

Regulatory ComplianceToplam Kalite Yönetimi

Tıbbi Cihaz Üretimi

Hukuki Uygunluk

Sayı

Yazarlar:

Ali Köstepen | Ceren Aytar

Yayıncı:

Manisa Celal Bayar University

Ana Başlıklar:

Kalite Yönetimi

Dergi:

Manisa Celal Bayar Üniversitesi Sosyal Bilimler Dergisi Vol.22 Issue 4, pp.491-501

Belge Tipi:

Makale

Yayın Tarihi:

12/2024

Belge Dili:

İngilizce

Document ID (Org No.):

2001336092

pISSN:

1304-4796