Management at my AS9100D certified company has asked about adding ISO13485 certification.
The guides I can find online, including Elsmar, are either for older revisions, are broken links, or are focused on going from ISO13485 to 9100 or ISO9001 to 13485 rather than AS9100 to ISO13485. (I know AS9100 is all of 9001, but the added 9100 requirements may cover 13485 requirements 9001 does not.)
We are a contract manufacturer of electronics and do not do design. Most of our current customers are aerospace, so we are used to aerospace FOD controls, product preservation, etc.
We will avoid sterile products except possibly if the customer will take all responsibility for getting the product from commercially clean to sterile.
Labeling, if any, would be as required by the customer. Medical products would not be sold under our name.
Having taken a quick look at the latest rev of 13485 including Appendix B, I don’t immediately see any big changes required.
How practical are combined AS9100-ISO13485 audits?
How many more days would typically be added for a 100 person company?
Does anyone know of an up to date guide for adding 13485 to an established AS9100 quality system?
I would like to hear from people what areas we would likely have to update and what pitfalls we may encounter.