ISS Solutions, Inc., a leader in healthcare technology management and clinical engineering services, is proud to announce that it has been awarded the ISO 13485 certification for its Quality Management System (QMS). This prestigious certification recognizes the company’s commitment to providing high-quality products and services that consistently meet customer and regulatory requirements in the medical device and healthcare industries.
What is ISO 13485?
ISO 13485 is an internationally recognized standard that outlines the requirements for a comprehensive quality management system specific to the medical device industry. This standard ensures that organizations can consistently design, develop, produce, and deliver medical devices that are safe for their intended purpose. The certification process involves rigorous auditing by an independent third party to verify that the company’s processes and practices meet the stringent criteria set by ISO 13485.
The Certification Process
The journey to achieving ISO 13485 certification is an extensive one. ISS Solutions undertook a thorough review and enhancement of its existing quality management practices, ensuring alignment with the standard’s requirements. The certification process included:
- Gap Analysis: An initial assessment to identify areas requiring improvement to meet ISO 13485 standards.
- Documentation and Implementation: Developing and documenting procedures that align with the standard and ensuring their effective implementation.
- Internal Audits: Conducting internal audits to verify compliance with documented procedures and identify any areas for further improvement.
- Management Review: Involving senior management in reviewing the QMS to ensure its suitability, adequacy, and effectiveness.
- External Audit: A thorough assessment by an accredited certification body to confirm compliance with ISO 13485 requirements.
Benefits of ISO 13485 Certification
Achieving ISO 13485 certification brings numerous benefits to ISS Solutions and its stakeholders, including:
- Enhanced Customer Confidence: Customers can be assured of the company’s commitment to quality and regulatory compliance.
- Improved Risk Management: A robust QMS helps identify and mitigate potential risks associated with medical devices and services.
- Operational Efficiency: Streamlined processes and continuous improvement initiatives lead to increased efficiency and value to our customers.
- Regulatory Compliance: Ensures adherence to national and international regulatory requirements, facilitating market access.
- Competitive Advantage: Differentiates ISS Solutions in the market as a provider of high-quality, reliable services.
Commitment to Excellence
“Our achievement of ISO 13485 certification underscores our unwavering dedication to quality and excellence in everything we do,” said Barbara Maguire, Vice President Healthcare Technology Management of ISS Solutions, Inc. “This milestone reflects our team’s hard work and commitment to providing the highest standards of service to our clients. It also positions us to better serve the evolving needs of the healthcare industry and reinforces our role as a trusted partner in healthcare technology management.”
About ISS Solutions, Inc.
ISS Solutions, Inc., a wholly-owned subsidiary of Geisinger Health, provides customized technology lifecycle management, clinical engineering, and biomedical services. With a focus on improving healthcare outcomes through innovative solutions and exceptional service, ISS Solutions partners with healthcare providers to manage and maintain critical medical technology. The company’s comprehensive service offerings include equipment maintenance, asset management, IT support, and consulting services.
Future Outlook
The ISO 13485 certification is a significant achievement for ISS Solutions, but it is just one step in the company’s ongoing commitment to excellence. ISS Solutions will continue to prioritize quality, innovation, and customer satisfaction as it expands its services and capabilities to meet the dynamic needs of the healthcare industry.
