The differences between FDA and ISO 9001 Audits

[taitaichicken]

Can someone please help explain the different between FDA and ISO audits(Especially, on the "Incoming Inspection, Nonconforming and calibration areas)?

Thanks

[chris1price]

The main difference is that ISO audits cover a small part of the QMS and build up a picture over a period of time, whereas FDA audits tend to cover the complete QMS at one hit. FDA audits are much more thorough when looking into records and documentation. FDA audits also tend to be an adversarial process whereas ISO audits are generally cooperative. Have a read through the QSIT manual on the FDA web site and also at 483 reports to see what NCs they observed.

http://www.fda.gov/ora/inspect_ref/igs/qsit/

[Ajit Basrur]

Originally Posted by taitaichicken

Can someone please help explain the different between FDA and ISO audits(Especially, on the "Incoming Inspection, Nonconforming and calibration areas)?

Thanks

Welcome to the Cove.

I would say the main difference between ISO and FDA is - you will have to pay money to ISO (for them to do audit) to give you NCRs while FDA give you for FREE

[Randy]

Yeah, with an ISO audit a result of not doing what you are supposed to do can get you a non-conformance and with a FDA audit it can get you shut down.

[Aaron Lupo]

I think Chris said it best. ISO is a snap shot of how the system is performing at the time a sampling of the system. You know when they are coming well in advance, you can give your auditors lunch, some you can even joke around with.

FDA will generally look at your entire system, they will try to give you a 2 week notice before they come in, they will dig as far back as they want to, you can't give them lunch water or even a crumb, most times you will find you can't even joke around with them.

As Randy said, FDA can lock your doors and put you in prison, ISO could pull your cert. and send you a big bill.

[GStough]

Originally Posted by Aaron Lupo

...FDA will generally look at your entire system, they will try to give you a 2 week notice before they come in, they will dig as far back as they want to, you can't give them lunch water or even a crumb, most times you will find you can't even joke around with them.

As Randy said, FDA can lock your doors and put you in prison, ISO could pull your cert. and send you a big bill.

While they try to give a 2 week notice prior to coming, that is not always the case. The last time I was involved in a FDA inspection, I was on vacation and got a frantic phone call from my boss late in the afternoon. She wanted me to come in to the office that night and help them get ready (records, documentation, etc.) because the FDA had called and they had an investigator/inspector on her way to our place and would arrive the very next day.

In spite of one manager's penchant for trying to argue with this FDA investigator/inspector over one issue, we did not receive a single 483 during that inspection.

[Ajit Basrur]

Originally Posted by GStough

While they [U][B] In spite of one manager's penchant for trying to argue with this FDA investigator/inspector over one issue, we did not receive a single 483 during that inspection.

Gidget, so your last minute rush was very beneficial.