J
I work for a pharmaceutical company that recently purchased a medical device product. I have been assigned to create a Quality Manual that complies with ISO 13485 and 21 CFR 820. However, management doesn't want this to impact the operations for thier pharmaceutical products. In other words, they want me to create a Quality Manual that only applies to this medical device product, not to the rest of their quality system. - Does anyone have any experience with this type of situation? How do auditors respond to the use of dual quality systems?
: