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ISO 13485 Certification

ISO 13485 Certification

ISO 13485 Certification is the commonly used certification to represent the Quality Management System of medical devices and equipment. This certification is applicable for all the organizations that manufacture/supply medical devices. It enhances the confidence of the consumers in your products and services. Moreover, the ISO 13485 Certification demonstrates the effective implementation of the medical devices and equipment.

ISO 13485 Certification

About ISO 13485 Standard

ISO 13485 is also one of the Quality Management System standards so you can easily implement it in your organizations. It has similar requirements as ISO 9001 and also includes its additional requirements. Both the standards are focused only in the development of high-quality products. But the major difference is, the ISO 9001 ensures customer satisfaction with quality products and services whereas the ISO 13485 standard includes requirements to improve the quality of medical devices and equipment.

The ISO 13485 standard provides guidelines for the manufacturers to improve the quality of medical devices from the manufacturing process, installation to servicing process. Also, it ensures the medical devices are safe and are made for their intended purpose.

What is the importance of ISO 13485 Certification?

ISO 13485 Certification ensures the quality performance of the medical devices. This certification not only satisfies the customer expectation but also ensures employees’ safety. It reduces the waste and operational costs. Also, the ISO 13485 certification improves consistency the quality of medical equipment and enhances reputation of your organization.

Benefits of the ISO 13485 Certification

  • The ISO 13485 Certification establishes the quality of medical devices and equipment
  • Increases visibility and helps to achieve quality-conscious customers
  • Improves customers confidence in product quality and services
  • Reduces customer compliance
  • Inspires the manufactures to produce high-quality equipment
  • Improves the profitability
  • helps to gain new business opportunities

 About IAS

Integrated Assessment Services (IAS) is one of the ISO Certification Bodies in UAE (United Arab Emirates). We have several representatives in various Gulf countries including Qatar, Kuwait, Saudi Arabia, etc. We have branches in India, Malaysia, Singapore, Bangladesh, Thailand, and so on.

IAS is a versatile platform for management system certifications and product certifications. We offer management system certification on ISO 13485 and also on various ISO standards.

IAS is also a leading training platform for ISO 13485 lead auditor training, ISO 13485 internal auditor training and awareness and foundation training courses.

Also, kindly contact us for detailed information about the certification process and auditing procedure.