The ISO 13485: 2016 standard is an international standard that has been created on the basis of the ISO 9001: 2008 standard and includes special requirements for Medical Devices. ISO 13485 is a system that Medical Device manufacturers can use when going for CE marking, and companies that prefer H module within the scope of CE marking must establish. Although it basically includes the ISO 9001: 2008 Quality Management System, it has been made a standard for medical device manufacturers, especially with additional requests at the design stage.

Based on the ISO 9001: 2008 process approach model, this standard covers more comprehensive and specific quality system requirements than ISO 9001, which should be followed by organizations that want to provide medical devices and related services, and to prove their ability to meet customer and regulatory requirements that are consistently applied to medical devices.

ISO 13485, a standard that defines the specific requirements of quality systems for organizations operating in the field of trade and manufacture of medical devices, can be applied by all organizations that include the project, production, installation, and supply phases of medical devices or their services.

What is the difference between EN ISO 13485: 2016 and ISO 13485: 2003?

Changes in the new EN ISO 13485: 2016 compared to the 2003 version are only for the foreword and Appendix Z. There has been absolutely no change in the Normative Text.

In the 2016 version of the standard, the new Annex Z provides further clarity on the applicability of the quality systems provisions of the three European Medical Device Directives (MDD, AIMD, and IVD) and ISO 13485.

Each Annex Z contains a different Annex for each Medical Directive. For example, Annex ZB of EN ISO 13485: 2016 shows the relationship between MDD 93/42 / EEC Annex II and the Full Quality Assurance clauses of ISO 13485.

Benefits of ISO 13485

• Providing a competitive advantage
• Increasing the awareness of quality among employees
• Adopting a process-oriented approach
• Creation of documentation (infrastructure) that will ensure standardization of business activities
• Increasing the organization's reputation in the market
• Ensuring global compliance of medical devices with quality rules
• Increasing the design, production, and service quality of medical devices
• Providing advantage especially in exports to European Union countries
• Increasing confidence in devices
• Due to the increase in the quality of the devices, protection of human health
Facilitating compliance with various laws and regulations on this subject

What is ISO 13485 Quality Management System for Medical Devices?

The ISO 13485 Quality Management System for Medical Devices, which is one of the ISO documents and is of utmost importance, is a parallel system with the ISO 9001 Quality Management System. ISO 13485, which is the adapted version of the ISO 9001 Quality Management System for medical devices, is an international standard. ISO 13485, one of the arguments required for medical device manufacturers to obtain CE certification, operates as a module of quality assurance.

What is the Purpose of ISO 13485 Quality Management System for Medical Devices?

The main purpose of this document is to determine the rules to be followed by companies that want to ensure that customer and regulatory requirements are met in the best way and to prove their capabilities. These rules, shaped within the framework of ISO 9001, include the requirements of a special quality management system. In this way, it is possible to produce and use medical devices, which are extremely important for human health, in a quality and reliable way.

What are the Benefits of ISO 13485 Quality Management System for Medical Devices?

There are some basic benefits of having this document for businesses. At this point, we can talk about the benefits that companies producing medical devices can gain by having this certificate as follows.

·         This document; It provides an opportunity for education, development and continuous improvement.

·         It ensures that the quality awareness of the companies that have this certificate is increased in the best way.

·         We can mention that the ISO 13485 document is of great importance in general medical device design, service levels and increasing production.

·         We can mention that this document is extremely important in terms of compliance with regulations and laws.

What Does ISO 13485 Quality Management System for Medical Devices Cover?

ISO 13485; ensures that companies and manufacturers operate within reliable and effective processes. At this point, it can be said that the quality management system has a great benefit in improving the business. We can state that these processes are designed to cover the life cycles of medical devices, to develop, produce, perform installation, prepare consistent designs, monitor, deliver, destroy and track. The reliable use of the medical devices in question for the intended purposes is possible with the existence of this document.

Why Obtain ISO 13485 Quality Management System Certificate for Medical Devices?

Companies apply to the aforementioned document in order to benefit from the above-mentioned purposes and benefits. It is very important that the production is carried out in accordance with ISO 13485 standards in order to produce medical devices in a much more reliable, professional and high quality manner.

Who Can Get ISO 13485 Quality Management System Certificate for Medical Devices?

This document is an important document that should be owned by all institutions and organizations that produce and sell products within the scope of medical devices and continue their service activities.

How to Obtain ISO 13485 Quality Management System Certificate for Medical Devices?

All ISO documents are submitted by certification bodies. If you apply for this document, your company will be examined whether it complies with the standards of the document. In case the company's production complies with the standards, the certificate in question can be submitted by the certification bodies.

Where to Get ISO 13485 Quality Management System Certificate for Medical Devices?

Our company has been continuing its activities in the best way for its customers since its establishment. At this point, you can reach ISO 13485 certificate and all other ISO documents through our company. You can get information about the said document and other ISO documents by contacting KiosCert, one of the certification bodies, and you can have these documents.

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