ISO 13485 Certificate Scope modified by Notified Body

[rcjpedro]

Hello Forum!

My NB is changing the scope on our current 13485 certificate based on a proposed scope from "maintenance and marketing" to "Service and Sales" based on "current scope guidance" as stated in our latest Audit Report.
Does anyone has any experience with similar situation?
Thanks in advance

 

[chris1price]

Hi, the contents of the scope are always a discussion with the notified body and I'm sure you can push back if you think its appropriate.

"Servicing" is the term used in ISO13485 and so may be a better description than "Maintenance". I'm not sure there is a difference between the two terms and could be used interchangeably.

However, "Marketing" is different from "Sales".... ask any sales person! If you are actually selling the devices, then Sales is probably a better term.

Chris

 

[Drazenka]

I have a similar situation in my company. We were applying for certification according to Design, development, production, and sale of the medical device scope. We have done all our documentation according to this scope, and when the auditor came, he changed it, by cutting out the sale part, because we are not selling the device yet, although we have all processes and procedures established. We can not sell our device without CE mark, and we can not get CE mark without 13485 certificates, and we can not certify without sale part if we are going for CE mark after... So, I'm confused still. Can somebody help me, or give me some advice how to continue?

 

[Ronen E]

I have a similar situation in my company. We were applying for certification according to Design, development, production, and sale of the medical device scope. We have done all our documentation according to this scope, and when the auditor came, he changed it, by cutting out the sale part, because we are not selling the device yet, although we have all processes and procedures established. We can not sell our device without CE mark, and we can not get CE mark without 13485 certificates, and we can not certify without sale part if we are going for CE mark after... So, I'm confused still. Can somebody help me, or give me some advice how to continue?

Sounds ridiculous to me because CE marking is all about placing devices on the market = “sales”. I don’t think that “sale” should be on any EC certificate scope because it’s obvious. Additionally, there is no regulatory requirement for actual sales in order to CE mark.

 

[Golfman25]

I have a similar situation in my company. We were applying for certification according to Design, development, production, and sale of the medical device scope. We have done all our documentation according to this scope, and when the auditor came, he changed it, by cutting out the sale part, because we are not selling the device yet, although we have all processes and procedures established. We can not sell our device without CE mark, and we can not get CE mark without 13485 certificates, and we can not certify without sale part if we are going for CE mark after... So, I'm confused still. Can somebody help me, or give me some advice how to continue?

Well if you can't sell it, your doomed. I'm not sure it's for the auditor to change unilaterally. Certainly should be in accordance with the CB.

 

[pkost]

I agree that it sounds ridiculous to remove sales and I would push back, however in reality, what is the consequence? I can't see anyone challenging you on it

 

[Drazenka]

Well, it is so ridiculous, especially when you in the process of certification. The notified body that we are working with is rude because when we were in negotiation with them, they were so cooperative and nice, and after the stage 1 (as soon s we paid), they literally force us to do the lab tests in their laboratory, and if we don't do that, they don't even want to look at our documentation, and they don't accept other tests report.
We were shocked because that is not by any directive, standard etc. So, we didn't want to accept the blackmails from them (and they are too expensive), and we choose the laboratory by ourselves (which is also accepted by EU, and has all the certification needed), and now they don't what to answer our mail, and approve our scope, including the sales part.
With this step, they force us to get extra hours of certification when we are going to do the CE certification and to pay them extra money (this were not our agreement at all).
I am so disappointed and sad, I didn't expect this from this important notified house. They should be ashamed.

 

[locutus]

They should be ashamed.

Notified Bodies and Registrars ... and reading this discussion about Scope of the QMS ... I will not even start giving any comments - because I will be banned . The only comment I would make is that Notified Bodies/Registrars should follow their own quality system requirements - especially when requiring their customers to - NB Code of Conduct should be Code of Ethics :shrugs:.

 

[pkost]

Notified bodies are critical to the smooth running of a medical device company, its important to have a good relationship with them, that being said some of them don't help matters!

It's worth noting that for issues relating to the application of the directive you can appeal through their processes and eventually seek appeal through the competent authority. As previously noted, they have to follow their own procedures and comply with the regulation/standards

With regards to ignoring calls, hopefully your contract has service levels or something that requires them to respond to you in a timely manner. In this case it is more of a contractual breach which you can use against them


If all else fails, you can move notified body!

 

[Drazenka]

Yes, of course, I fully agree with you. We will consider replacing the notified body in the nearest future, for sure. Thank you