ISO 13485:2016 Certification

About IAS – the ISO 13485 Certification body in Latin America

Integrated Assessment Services (IAS) is one of the UQAS accredited ISO 13485 Certification bodies in Latin America regions. Incorporated in 2006, we have more than 13 years of professional experience in auditing and issuing management system certifications on various ISO standards. Our auditors are professional experts who have the best industry background experience will support the organization effectively to implement the requirements of the desired ISO standard

What is ISO 13485?

ISO 13485 provides requirements particularly for the organization’s quality management system to enhance the quality of medical devices and equipment. This international standard enables the organization to provide medical devices that satisfy customers and applicable legal requirements. The ISO 13485 standard is applicable to all sizes of the organizations that develop and provide medical devices and equipment. The requirements of this standard are also intended to apply equally to the associated services provided by the organizations.

ISO 13485:2016 Certification

ISO 13485 Certification ensures the effective implementation of the quality management system and as well as the improved performance medical devices and equipment. The ISO 13485 certification for medical devices improves customer satisfaction that certainly helps achieve more business opportunities. This is the most recognized certification to establish the high-level performance of the medical devices. This certification enhances the manufacturing process and also reduces the operational errors.

How does the ISO 13485 Certification benefit my organization?

  • The ISO 13485 Certification proves the continual improvement of QMS
  • Ensures the quality performance of medical devices and equipment
  • Enhances customers’ confidence
  • Helps meet applicable legal requirements
  • Also, it brings new business opportunities

Other services of IAS:

  • IAS is one of the globally recognized ISO 13485 Certification body in Latin America regions. Other than ISO 13485 Certification, we also offer numerous process certifications on various ISO management system standards such as ISO 14001, 27001, 50001, 45001, etc.
  • IAS is also an accredited platform for auditing and issuing product certification such as CE Marking, Kosher, BRC, Halal, cGMP, Green, RoHS, and GOST-R.
  • We are a famous ISO training body in Latin America. We offer lead auditor training, internal auditor training, and as well as awareness and foundation training courses against various ISO standards.
  • IAS provides ISO 13485 Certification Service not only in Latin American countries but also in plenty of countries including India, Malaysia, Singapore, Thailand, Vietnam, Philippines, Bangladesh, Oman, Qatar, Saudi Arabia, and so on.

For detail discussion over phone or in-person, kindly contact our executives through Mail: info@iasiso,com or Mobile:+91 9962590571