ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device?

[gus0457]

I hope someone can answer my question pertaining to ISO 13485 certification: We are a small company in Florida and have been working to implement a QMS under 13485. We have not shipped a single unit yet. Can we still get the ISO 13485 certification prior to shipment of the device?

 

[shimonv]

That's how it usually works. but keep in mind that the development and manufacturing needs to be in accordance with ISO 13485. They will check it during certification.

 

[somashekar]

I hope someone can answer my question pertaining to ISO 13485 certification: We are a small company in Florida and have been working to implement a QMS under 13485. We have not shipped a single unit yet. Can we still get the ISO 13485 certification prior to shipment of the device?

You can. Talk with your CB and tell them your situation. You would have certainly addressed the customer related processes within your QMS.

 

[gus0457]

Thank you gentlemen. Good point on the design and development part, we are currently working in remediation activities (Reconstructing Design Controls). My struggle with this is that we will have no records (Objective evidence) that the procedures are being followed. For example we have inspection procedures and the corresponding forms (The form will be blank) as we will not have shipped any units on the day of the audit. Is the answer still Yes?

 

[Sidney Vianna]

My struggle with this is that we will have no records (Objective evidence) that the procedures are being followed. For example we have inspection procedures and the corresponding forms (The form will be blank) as we will not have shipped any units on the day of the audit. Is the answer still Yes?

During the Stage 1 audit, the CB auditor should ascertain if the state of implementation of the system substantiates the justification for progressing to Stage 2. In this day and age where certification has been commoditized and trivialized, I am sure you will find a CB that would agree to "certify" a system that cannot deliver evidence of performance, for being audited too early. As @howste brilliantly mentioned here in the past, we are in a world where no children is left behind no system is left uncertified.

 

[yodon]

We have not shipped a single unit yet.

The question popped up in my mind about where you're planning on shipping (distributing). If in the US, the FDA doesn't particularly care about 13485 certification. Distributing to the EU is a different story and Canada is yet another story.

 

[gus0457]

During the Stage 1 audit, the CB auditor should ascertain if the state of implementation of the system substantiates the justification for progressing to Stage 2. In this day and age where certification has been commoditized and trivialized, I am sure you will find a CB that would agree to "certify" a system that cannot deliver evidence of performance, for being audited too early. As @howste brilliantly mentioned here in the past, we are in a world where no children is left behind no system is left uncertified.

Understood its all business for some med devices. However coming from implant Class III devices, the commoditizing you are referring to does not exist.