Notified Body Unresponsive - Cancelled ISO Cert Early

[Donetta]

We ended our contract with our notified body mid-cycle. Our notified body canceled our 13485:2016 certificate effective 31st March 2023 in a letter dated 3rd April 2023. The 13485:2016 certificate was valid from 06 July 2022 until 16 October 2024 subject to satisfactory surveillance audits. The last satisfactory surveillance audit was dated 6/8/2022.

How long should our certificate have been good for and where would this be documented? Logically and from what we paid, shouldn't it be valid for at least a year from our last surveillance audit or even until October 2023? I can't get any response from anyone at our NB about this.

 

[Ed Panek]

Why would you cancel your NB prior to acquiring a replacement? You can use their ISO certificate as long as they legally permit it to be used. Usually, that is included in your contract. Usually, the agreement includes unannounced onsite inspections but since thats off the table they may no longer want you to use their certificates since the contract is breached.

 

[Donetta]

Why would you cancel your NB prior to acquiring a replacement? You can use their ISO certificate as long as they legally permit it to be used. Usually, that is included in your contract. Usually, the agreement includes unannounced onsite inspections but since thats off the table they may no longer want you to use their certificates since the contract is breached.

It was a CO decision. We let our NB know as soon as we decided so we wouldn't have to pay for the $13,150+travel+per diems for the year for the last audit expenses in the contract (we canceled our CE surveillance, accreditation, and unannounced audit with our NB as well and they don't specify how much of that is for ISO and how much is for our CE mark). Their contract is a 2 pager with the pricing schedule and a reference to their conditions online - with a link that doesn't work directly and you have to use the search bar to find them. They have raised prices each year by sending us pricing adjustments and they've booked travel last minute - increasing the costs we pay for our audits as we are responsible for all their travel costs and per diems. They also denied our requests for remote audits to reduce these travel and per diem costs.

 

[Sidney Vianna]

How long should our certificate have been good for and where would this be documented? Logically and from what we paid, shouldn't it be valid for at least a year from our last surveillance audit or even until October 2023? I can't get any response from anyone at our NB about this.

The certificate is the property of the issuing organization. The moment you informed them you were canceling the contractual relationship, the CB/NB obviously wants to avoid any uncompensated risk, what your certification becomes when they no longer can perform any type of oversight activities onto your organization. You might want to look at the fine print on the actual certificate itself because it normally lists the general conditions for maintenance of it’s validity.

As a side note, I am surprised with the validity period of the (now cancelled) cert. When issued, they are normally listed as valid for 3 years; yours wasn’t.

 

[Ed Panek]

It was a CO decision. We let our NB know as soon as we decided so we wouldn't have to pay for the $13,150+travel+per diems for the year for the last audit expenses in the contract (we canceled our CE surveillance, accreditation, and unannounced audit with our NB as well and they don't specify how much of that is for ISO and how much is for our CE mark). Their contract is a 2 pager with the pricing schedule and a reference to their conditions online - with a link that doesn't work directly and you have to use the search bar to find them. They have raised prices each year by sending us pricing adjustments and they've booked travel last minute - increasing the costs we pay for our audits as we are responsible for all their travel costs and per diems. They also denied our requests for remote audits to reduce these travel and per diem costs.

OK, I See. As Sydney says they own the cert.

A few comments. The medical device space is very challenging to operate within primarily because of $$. The extra work required to meet strict regulations has a cost. This is a disadvantage of the medical space but its also a barrier for competitors to compete with you. As you are aware a new partnership may have similar pricing and requirements so just canceling your agreement may get you nowhere better than additional costs for a new partner.


As of now, it seems you sell a medical device without a valid ISO 13485 cert. Is it on your website or PowerPoint presentations? In any supplier agreements?

 

[Randy]

Self inflicted wound, your CO obviously made a decision about something he/she lacked the competency or adequate knowledge to do so. Tell that person to enjoy the complete recertification process and all the extra time & expense involved beyond what you would have paid had some minor reaseach been done beforehand.

Caveat emptor!