Question
One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 certificate, do they simply refresh their company location / address in their ISO 9001 certificate with the Notified Body or they actually need to go through a full scale quality system audit by the NB?
Answer
Yes. They do need to have a full scale audit. The reason is very simple, a business is a system. When you change the environment, you alter that system. A full audit will be an adequate representation of the scope and magnitude of the change, and will indicate if this supplier is still a reliable manufacturer. Think about your most recent home move, the family is the same, your belongings are the same; however, everything is different at the same time.
For more on this topic, please visit ASQ’s website.
I agree because it will be an audit to show an adequate controls over the suppliers QMS. And it is beneficial to maintain an ongoing conformance to the process that yields the excellent customer requirements.