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ISO 13485 Certification

ISO 13485 Certification

What is ISO 13485 standard?

Enhance the quality, enjoy the reputation

ISO has developed a specific standard ISO 13485 for improving the quality of medical devices and equipment. It provides requirements to ensure consistency in the quality of medical devices and equipment. It also helps improve the Quality Management System performance of the organizations. This international standard not only monitors and improves the quality of medical equipment but also ensures continual improvement in the associated services provided by the organizations. The ISO 13485 has a similar connection with ISO 9001 standard, but it also includes specific requirements to maintain and implement the performance of medical devices. So, it is easy to implement at any organization that produces and delivers medical devices and related services.

About ISO 13485 Certification and its importance

ISO 13485 Certification ensures the organizations’ commitment to delivering quality medical devices and services to the customers. This globally recognized certification certainly helps you achieve a constant position in the international business market and also creates new business opportunities even from overseas. ISO 13485:2016 ensures the manufacturers to follow the best practices in the development of medical equipment as well as its related services that take your business to the international standard. Even though the ISO 13485 Certification for medical equipment is obtained for satisfying the customer requirement, it also supports organizations to increase their productivity and profitability.

What are the benefits of ISO 13485 Certification?

The ISO 13485 Certification:
  • Ensures consistency in the quality of medical devices and equipment
  • Helps organizations to meet legal quality requirements
  • Ensures employees safety
  • Reduces waste as well as saves cost
  • Satisfy customer requirements
  • Boosts stakeholders’ confidence
  • Helps achieve global recognition
  • Increases credibility
  • Also, it develops the organizations’ reputation

Who are we?

IAS (Integrated Assessment Services) is one of the most recognized ISO 13485 Certification Bodies in Israel. We are a UQAS approved certification body for providing management system certifications and product certifications. Incorporated in 2006, we have two decades of professional experience in auditing and providing ISO certification against ISO 13485.

We also audit and issue ISO certification against various ISO management system standards such as ISO 14001, 45001, 22000, 22301, 50001, 9001, etc.

By carefully analyzing the trend of the local market, we guide our clients effectively to meet the requirements of the desired ISO standard.

We have professionally trained IRCA certified lead auditors to support the organizations to achieve the required implementation for standardization.

Want to know more about the ISO 13485 certification and as well as its auditing processes? Kindly contact us!