Summary: ISS Solutions has obtained ISO 13485:2016 certification, confirming its adherence to quality management standards for medical devices and ensuring their safety and reliability.

Key Takeaways:

  • ISO 13485:2016 certification confirms ISS Solutions’ commitment to quality in medical device management and regulatory compliance.
  • The certification process positions ISS Solutions as a trusted partner for healthcare providers seeking reliable, safe medical device services.

ISS Solutions, a provider of customized technology lifecycle services for healthcare and other mission-critical industries, announced its achievement of ISO 13485:2016 certification. This internationally recognized certification demonstrates the company’s commitment to high standards of quality management systems (QMS) specific to medical devices and related services.

Global Standard for Medical Device Services

ISO 13485:2016 is the globally accepted standard for organizations involved in the design, production, installation, and servicing of medical devices. By achieving this certification, ISS Solutions affirms its dedication to consistently meeting customer expectations, regulatory requirements, and ensuring the safety and reliability of the medical devices it services.

“Achieving ISO 13485:2016 certification is a significant milestone for ISS Solutions,” said Barbara Maguire, vice president healthcare technology management of ISS Solutions. “This accomplishment underscores our unwavering commitment to delivering the highest quality services to the healthcare industry while ensuring the safety of patients and caregivers. We are proud to provide the peace of mind that comes with adhering to internationally recognized best practices.”

Rigorous Certification Process

The rigorous certification process involved a comprehensive review and audit of ISS Solutions’ quality management systems, operational processes, and commitment to continuous improvement. Achieving this certification positions ISS Solutions as a trusted partner for healthcare providers looking to enhance their medical device management and ensure compliance with the latest industry standards.

ISS Solutions offers a wide range of medical equipment services, including repair, preventive maintenance, and asset management, all backed by a commitment to quality and regulatory compliance, according to the company.