Hi,
We are manufacturers of Medical Devices and have ISO 13485 certification from a very prestigious NB ..... we recently were sold to another company that is change in constitution / ownership of the firm . All the staff technical and commercial , manufacturing process and machinery remains the same The NB says it has to be taken as a fresh new application as there has been a change in ownership. They also say that they can take up the job but actual certificate will be issued after onsite audit which they are unable to do at the moment due to pandemic.
They estimate it may take another 3 to 4 months to do the audit .... so do we stop manufacturing ??
What is the solution ?
Recently for the same site during pandemic the same NB had done a surveillance audit remotely ( Before the sale happened ) so why can't they rely on their own audits for the same site The NB has already done more than four onsite audits for the same site before and the current certification is still valid.
Would request comments , suggestions and advice.
Thanks
Michelle
We are manufacturers of Medical Devices and have ISO 13485 certification from a very prestigious NB ..... we recently were sold to another company that is change in constitution / ownership of the firm . All the staff technical and commercial , manufacturing process and machinery remains the same The NB says it has to be taken as a fresh new application as there has been a change in ownership. They also say that they can take up the job but actual certificate will be issued after onsite audit which they are unable to do at the moment due to pandemic.
They estimate it may take another 3 to 4 months to do the audit .... so do we stop manufacturing ??
What is the solution ?
Recently for the same site during pandemic the same NB had done a surveillance audit remotely ( Before the sale happened ) so why can't they rely on their own audits for the same site The NB has already done more than four onsite audits for the same site before and the current certification is still valid.
Would request comments , suggestions and advice.
Thanks
Michelle