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Medical devices industry has certain non-negotiable policies especially when it comes to safety and quality of the product. With the regulatory requirements getting stringent at every step of a medical product’s life cycle from manufacturing till delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. What is ISO 13485:2016 Certification? ISO 9001:2015 is designed to specify requirements for a quality management system wherein an organization needs: - To show its ability to provide medical devices and the relevant services that can consistently meet the customer requirements while complying with applicable statutory and regulatory standards. - To focus on customer safety by ensuring that the products they deliver fulfills the safety requirements while assuring the conformity of products based on the function it is intended to serve. All the requirements specified under ISO 13485:2016 are specific. This certification can be used by suppliers or external parties who are in medical devices business, including the ones providing services related to the quality management system. What are the benefits of having ISO 13485:2016 Certified QMS Software? Some of the benefits of having ISO 13485:2016 Certified QMS Software: Improved Brand Recognition and Credibility With an ISO 13485 Medical Devices QMS software like Qualityze implemented in your organization, you can reflect trustworthiness for your clients and customers to do business with you. A powerful ISO 13485 QMS software makes a great marketing tool since it has become a requirement for medical devices suppliers to showcase compliance in many countries. This enables you to attract more opportunities. Improved Decision-Making An important principle of quality management under ISO 13485 is that it focuses on evidence when it comes to decision-making. When you will use the data and facts to make informed decisions, you are likely to align them with your business objectives. What your instinct tells you will not always be right; it can put you in serious business troubles at times. The added bonus here is an insight into your business health as you can track every improvement done and their results. Better Processes ISO 13485 specifies organizations to use a process approach that makes it easier for you to identify new opportunities to improve. You can easily identify and eliminate the causes that could lead to rework and waste. You can also reduce the chances of errors in the process while fostering the greater efficiency in the organization and increase cost-savings. Increased Customer Satisfaction The ISO 13485 standard relies on certain quality management principles. One important principle highlights customer satisfaction. You need to achieve this principle by evaluating the needs and expectations of the customers and striving to meet them because today customers are more specific about their demands. Also, keeping customers satisfied will bring them back, and you will be able to sell your services to new customers. This is a direct implication for increased revenue. Employee Engagement When you will seek help from the employees to improve their own processes – they will not only provide the best insights, but also will be happier and more involved. The more will be your employees understanding of their roles to deliver quality product and services; the more will be their engagement. This directly implies for improved productivity. You can attain all the quality management principles for medical devices with Qualityze ISO 13485 Quality Management Software for Medical Devices has designed to align your company processes with the quality goals while complying with ISO requirements. It enables you to drive the culture of continuous improvement in the organization without any hassle. As you know, the medical device manufacturing vertical is highly regulated industry. The quality management system for medical devices industry must meet regulatory requirements which mandate the manufacturers to design and develop medical devices that are safe and fit for their intended use. ISO 13485 standard was designed to assist medical device manufacturers to develop and implement quality management systems that meet and exceed regulatory requirements. ISO 13485 is derived from the ISO 9000 family of standards set forth by International Organization for Standardization (ISO). Qualityze Solution Information Matrix for ISO 13485 Qualityze quality management software for medical devices is designed to help an organization to comply with 13485 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help: Related Links Compliance Management Software ISO 9001 Quality Management Software 21 CFR 820 Quality System FDA 21 CFR Part 11 Software AS 9100 Quality Management Software TS 16949 Automotive QMS Software
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ISO 13485:2003 Standardı, ISO 9001:2000-8 Standardı ile paralel bir standart olup ISO 9001:2000-8 Standardı temel alınarak hazırlanmıştır. ISO 9001:2000-8 Standardı'nın tıbbi cihazlara uyarlanmış ve bu alanda geliştirilmiş şeklidir. Tıbbi cihazlar için özel şartlar içeren uluslararası bir standarttır. ISO 13485, tıbbi cihaz üreticilerinin CE İşaretlemesine giderken de kullanabilecekleri en önemli argümanlardan biridir. CE İşaretlemesi kapsamında üretim kalite güvencesi modülünün seçilmesi halinde firmaların kurması gerekli olan bir sistemdir. Baz olarak ISO 9001:2000-8 Kalite Yönetim Sistemi'ni içermekle birlikte özellikle tasarım aşamasındaki ek istekleri ve steril tıbbi cihazlar için özel şartları ile tıbbi cihaz üreticilerine ait bir standart haline getirilmiştir. ISO 9001:2000-8 proses yaklaşımı modelini esas alan bu standart, tıbbi cihaz ve ilgili servisleri sağlamak, tutarlı bir biçimde tıbbi cihazlara uygulanabilir olan müşteri ve mevzuat şartlarını karşılayabilme kabiliyetini kanıtlamak isteyen kuruluşların uymaları gereken, ISO 9001'den daha kapsamlı ve özel kalite sistem şartlarını kapsar. Tıbbi cihazların ticareti ve imalatı alanında faaliyet gösteren kuruluşlara yönelik kalite sistemlerinin sağlaması gereken spesifik şartları tanımlayan bir standart olan ISO 13485, tıbbi cihazların ya da onlarla ilgili hizmetlerin proje, üretim, tesisat ve tedarik safhalarını içine alan bütün kuruluşlar tarafından uygulanabilmektedir. Sonuç olarak; ISO 13485 Tıbbi Cihazlar İçin Kalite Yönetim Sistemi'nin Faydaları Nelerdir? ISO 13485 Standardını Kimler Kullanabilir/Uygulayabilir? ISO 13485 Tıbbi Cihazlar İçin Kalite Yönetim Sistemi Standardı, tıbbi cihaz kapsamındaki bütün ürünlerin üretiminde ve servis faaliyetleri alanında çalışmalarını sürdüren bütün kurum ve kuruluşlara uygulanabilir.