IWC operates under the guidelines of an US Food and Drug Administration (FDA) certified quality management system which follows both ISO 13485 and ISO 9001. Most folks have heard of ISO 9001, but many do not know that ISO 13485 is an International Standards Organization (ISO) standard published in 2003 that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. A quick Google search will tell you that IWC is one a very small number of healthcare casegoods manufacturers that have ISO 13485 certification.
IWC manufactures maternity bassinets for one of our customers. These bassinets are regulated as Class II medical devices under FDA guidelines.
While ISO 13485 is a stand-alone standard, it is based on ISO 9001. A primary difference is that 13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. Another difference is that ISO 13485 requires that the certified organization demonstrate its quality system is effectively implemented and maintained, while ISO 9001 requires the organization to demonstrate continual improvement in processes. Again, IWC carries both of these certifications.
Many companies in the healthcare furnishings industry shy away from Class II medical devices like bassinets. We have embraced them. By following FDA guidelines, our overall quality standards are raised for every product that IWC manufactures. When you choose to work with IWC, you are choosing higher quality.
Our customers also audit and monitor our quality and performance and provide feedback. The 5 year average for quality and on-time delivery is 99%.
- Understanding ISO 13485 http://www.qualitymag.com/articles/85096-understanding-iso-13485
- ISO Catalogue: ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=36786
- FDA: Overview of Device Regulation http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm
If you have questions about IWC’s ISO 13485 Quality Management System or healthcare furniture design regulatory requirements , please contact us.