ISO 13485 Certification : Quality Management Systems (QMS)

What is ISO 13485 Certification?

ISO 13485 is a set of standards that provides a framework for the quality management systems (QMS) for medical devices.

The ISO 13485 certification makes it easier for the designers, manufacturers, and suppliers of the medical devices to demonstrate compliance with the regulatory requirements and build confidence among the stakeholders about averting any risks. ISO 13485 emphasizes on risk-based thinking as well as stronger involvement at all levels.

What is the purpose of ISO 13485?

There are certain regulations of the land that are needed to be adhered to for the demonstration of commitment to the safety and quality of medical devices. Hence, with the adoption of ISO 13485, the manufacturers can become compliant to regulations such as, the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations. By identifying the customer’s requirements for QMS, and with the management support, you will need to begin the documentation of quality policies, quality objectives, and quality manual. These define the overall scope of your quality management system you will also need to create additional processes along with mandatory procedures for your organization to realize the desired outcomes.

Is ISO 13485 Certification mandatory?

Although none of the ISO certifications are mandatory, but ISO 13485 certification id usually demanded by the customers because of its ability to provide assurance of safety. By implementation of this standard, the process of manufacturing can meet the international criteria. This not only helps in implementation of the quality management system for medical devices, but also enables compliance to various legal and statutory requirements. By applying ISO 13485 standard in your organization, you also become compliant to the EU MDR regulation. It is also helpful if your organization goes for the CE mark for the products. For all such compliances, getting ISO 13485- Quality Management System for Medical Devices becomes very important.

Requirements of ISO 13485:2016

ISO 13485:2016 is the only standard that proves compliance with the regulatory requirements for quality management systems.

Following are the ways through which you can establish quality management system for your medical devices.

  1. Distinctly define quality policies, goals, and hierarch in your organization.
  2. Detailed description of the processes in your organization, which should cover the following requirements:

3. Appropriate allocation of financial and human resources, including a quality management deputy.
4. Follow the processes in order to achieve your objectives and maintain proper documentation.

Benefits of ISO 13485 Certification

  1. Global Recognition & Financial Benefits
  2. Improved satisfaction of the customer
  3. Increased effectiveness through improved processes.
  4. Better decision making by involving the top management.
  5. Better involvement of the workforce.

Who Awards ISO 13485 Certification?

ISO 20000 Certification is awarded by accredited certification bodies that are authorized to conduct audits and certify organizations against the ISO 13485 standard. These certification bodies must adhere to international accreditation standards to ensure the credibility and validity of the certification.

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