ISO 13485 certification

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Integrated Assessment Services (IAS) is one of the ISO 13485 certification bodies accredited by UQAS in Colombia

Integrated Assessment Services (IAS) is one of the ISO 13485 certification bodies accredited by UQAS in Colombia. Established in 2006, we have more than 13 years of professional experience in auditing and issuing management system certifications in various ISO standards. Our auditors are professional experts who have the best experience in the industry in conducting ISO 13485 QMS audits that will help the organization effectively implement the requirements of the desired ISO standard.

What is ISO13485?

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

ISO 13485:2016 certification

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

How does ISO 13485 certification benefit my organization?

  • ISO 13485 certification demonstrates the continuous improvement of the QMS
  • Ensure quality performance of medical devices and equipment
  • Improve customer confidence
  • Helps to comply with applicable legal requirements
  • In addition, it brings new business opportunities.

Other IAS services:

  • IAS is one of the globally recognized ISO 13485 certification bodies in the Latin American regions. In addition to ISO 13485 quality management system certification, we also offer numerous process certifications in various ISO management system standards, such as ISO 14001, 27001, 50001, 45001, etc.
  • IAS is also an accredited platform to audit and issue product certifications such as CE marking, Kosher, BRC, Halal, cGMP, Green, RoHS and GOST-R. certificación ISO 13485 en Colombia
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