AIV has implemented the ISO 13485:2016 certification one year ahead of the March 2019 deadline. It is required that all ISO 13485 companies be certified to the newest standard by March 2019. BSI issued AIV’s certificate on February 13, 2018.
AIV’s quality and regulatory department conducted a detailed review of the company’s entire quality management system, including the quality manual, quality systems procedures and applicable forms. All new requirements outlined in ISO 13485:2016 were added to the quality management system prior to AIV’s January 2018 re-certification and transition audit.
According to the International Organization for Standardization, ISO 13485:2016 specifies requirements for a quality management system where the organization needs to demonstrate the ability to provide medical devices and related services that consistently meet customer’s needs and regulatory requirements. The new ISO 13485:2016 standard requires the application of a risk-based approach to quality management systems. Some of the updates from the ISO 13485:2003 standard include design control and development changes, product handling and storage, the evaluation of safety and performance of products, and the associated training of the end user.
AIV was initially certified to ISO 9001 and upgraded to ISO 13485:2003 on March 29, 2006. Choosing to implement ISO 13485 was a requirement for the company to address the European Medical Device Directives, regulations and responsibilities, and for the safety and quality of medical devices. It also ensures the consistent design, development, production, and delivery of medical devices and replacement parts manufactured by AIV.
The transition to the newest quality standard included the review of AIV’s entire quality management system, including the Quality Manual, Quality Systems Procedures and applicable forms which provide evidence that documented procedures are being followed. Auditors were impressed with the maturity of AIV’s quality system and manuals and felt AIV’s technicians knew their jobs. The auditor felt that she could perform the explained tasks with the work instructions and little guidance.
Renee Gould with Global Regulatory Compliance, AIV’s internal auditor, commended the achievement saying, “the AIV team is passionate and focuses on meeting customer and regulatory requirements. This is demonstrated by AIV planning, implementing and achieving ISO 13485:2016 certification one year prior to the deadline. This is a significant achievement. Congratulations!”
AIV’s ISO 13485:2016 Quality Management System complies with the requirements for the following: The design, manufacture, service and distribution of ultrasound and toco dynamic fetal monitor transducers, components for infusion pumps, pulse oximeters and fetal monitor transducers, patient monitoring devices and ventilation devices; the service only of infusion pump, pulse oximeters and fetal monitor transducers.
© 2018, TechNation Magazine. Site designed by MD Publishing, Inc.