Certification and regulatory compliance verification can be key for medical field customers.
Organizations involved in the production of textiles used in medical applications may wish to become certified to ISO 13485 in order to ensure the effectiveness of their processes and demonstrate to customers their commitment to safe products, as well as compliance with regulatory and legal requirements. Those who are already certified should be aware of changes made to the 2003 standard and the three-year time frame to transition to the 2016 standard.
ISO 13485 covers companies involved in the design and development, production, storage and distribution, installation and servicing of medical devices (defined to include wound dressings and implantable fibers). The updated standard broadens its applicability to include all entities involved in the life cycle of a medical device, greater alignment with regulatory requirements, greater focus on post-market surveillance and complaint handling, and greater emphasis on infrastructure and risk management.
Companies certified to the 2003 standard should work with their third-party certifiers on making any necessary changes to comply with the 2016 version.
“As they make the changes, they need to ensure their internal audit program is examining the changes and that they are implemented effectively,” says Eamonn Hoxey, former chair of the technical committee that developed the standard. “The certification body is likely to be able to do the certification audit as part of a scheduled recertification or surveillance assessment.”
Those who do not make the transition will lose their certification to ISO 13485. For more information, visit www.iso.org/iso/certification.
Janice Kleinschmidt is a freelance writer and magazine editor based in San Diego, Calif.