As soon as Nonconformity is detected within the organization, it must be recorded. It must be written somewhere. The ISO 9001 Standard requires that any non conforming product would be identified and controlled. The purpose is to prevent using this product or delivering it to your customers. The process of identifying and controlling shall be documented within a procedure. The documentation of the treatment must include authorities and responsibilities. So far, his cousin the ISO 13485 Standard requires pretty much the same. But of course with some additional requirements. Otherwise we wouldn't be here…

When dealing with nonconforming products, the organization must refer to the next issues