Ensure You Have
When Considering Vendors
You might remember seeing a movie in 2013 titled, “We Are the Millers.” The movie contained some quite memorable scenes, particularly one in which the main character’s love interest shows up to meet the parents with a tattoo reading, “No Ragrets,” across his chest. (It should have read, “No Regrets,” of course). The boy clearly had no idea that it was so hilariously misspelled, but it did make me wonder… did the tattoo artist even realize the word was misspelled?
If this type of egregious mistake were to happen inside a regulated environment, our first reaction would be to check the vendor’s qualifications. We would ask questions like “Was that tattoo artist qualified to provide ‘tattoo artistry’ as a service?”
Thank goodness, this process has been made easier for use with the International Organization for Standardisation (ISO) 13485:2016 for Medical Devices. This updated version was published in March 2016 and has a transition period of three years. One of the key changes in the update is the “strengthening of supplier control processes” to be more harmonized with the United States (US) Food and Drug Administration’s (FDA) 21 Code of Federal Regulation (CFR) Part 820.50, Purchasing Controls. This means that manufacturers of “Conformité Européene” (CE)-marked, FDA cleared medical devices will need to ensure all supplier quality-related procedures are compliant to both requirements. Are you ready to dive into vendor qualification requirements?