Greetings forum users,
I have previously worked for a medical device manufacturer with ISO 13485:2003 certification. Now wanting to start over with a new venture I was wondering how it would work if I wanted to start with ISO 13485:2003 certification right out of the gate. How would this work without any document history, etc? The auditor would have no history to look at to judge the effectivenes of the QMS. Has anyone attempted this or have thoughts about how this might work?
Thanks in advance for your time.

The auditor would look at your readiness to comply. For example, you may not have any complaints but the auditor will try to determine whether you will issue a corrective or preventive action for each complaint and if not, will you provide a justification.

Greetings forum users,
I have previously worked for a medical device manufacturer with ISO 13485:2003 certification. Now wanting to start over with a new venture I was wondering how it would work if I wanted to start with ISO 13485:2003 certification right out of the gate. How would this work without any document history, etc? The auditor would have no history to look at to judge the effectivenes of the QMS. Has anyone attempted this or have thoughts about how this might work?
Thanks in advance for your time.

Hi rthompson,

Pl help me clarify your question - are you looking for effectiveness of the ISO 13485 system back tracking from customer complaints ?

Hi Ajit,
Thanks for your reply. I'm looking for a more general answer regarding what the auditor would look for as far as evidence that the QMS was effective. Certainly customer complaints would be a large part of that. But really I'm looking to see if anyone on the forum has taken this approach with a new company and might have any insight regarding how the external audit might be different from an audit in which the company has been in business for years and is only now applying for ISO 13485. I hope that helps clarify. Thanks again for your thoughts.

Hello,

I have been in this situation on several occasions where the organization does not have objective evidence.

For example: There have been no sales so there are no customer complaints, no order reviews, no production, no Nonconformances.

It is important to do a thorough internal audit and have the system ready for the activities such as sales or production.

I have seen some registrars award the ISO 13485 certificate but insist on an additional visit within 6 months to verify the objective evidence. That is assuming that there will be more activity after the award of the certification.

At an initial phase, a NB will look at if you have everything in place and your current status of business process (may not have sales or process validation report). Some CAPA, change control, at leats one internal audit, one MR should be documented.

A follow-up audit in 6 month, followed by revision at 12 month from the initial audit may be scheduled to check the rest of processes and objective evidances.