bpritts, thank you for your response. I am curious if the suppliers you have audited in Asia were also currently registered under 13485? I am very suspect of some of the vendors in Asia due to a cases of fraud where you are shown a facility that you are told your product is manufactured at however you later find that is not the case and it is actually manufactured in a factory down the street. I also agree with another wwho previously stated some of the auditors are not as diligent as others, however with NSAI, I have not encountered an inept auditor. When I audit facilities that have ISO registration I feel confident in the fact they are in compliance with the QS they have implemented. I still look at records but I focus more on product records for what is manufactured for my company. I will also check their ASL shipping receiving storage training etc. but feel they do not need to air their dirty laundry. I will also review NCMRs and CAPAs related to my batch records or any product/equipment I inspected and observed there was a NC cited.