Do we need our Notified Body to be SCC (Standards Council of Canada) accredited?

[Beth Workman]

We are certified to ISO 13485:2003. Our current Notified Body is SCC accredited, however, we are looking at changing to a Notified Body that reviews the QMS at our parent company, with an eventual plan to have one collaborative QMS.
The new company we are looking at is not SCC accredited and the cost is significantly lower (perhaps because of this), which is incredibly appealing to the powers that be.
We are not a finished device manufacturer, only components, so I don't believe that it will affect our ability to do business with potential customers in Canada, but that may be a matter of opinion based on the customer.
I want to help my company make the right decision on this without selling ourselves short. I would appreciate any thoughts that might bring attention to potential concerns or contradictions to my understanding of the differences between the 2 companies.

Thanks!

[Chance]

What do you mean by SCC?

[Beth Workman]

Standards Council of Canada accredits our Notified Body.

http://www.scc.ca/en/accreditation/management-systems

[Jennifer Kirley]

Good day Beth,

This subject has been discussed in threads such as Accredited/Unaccredited Certification - The Credibility of some Certification Bodies and the related threads linked at the bottom of the page that the link opens.

I suppose the answer to the question is also the answer to the question "Which matters more to us - price or credibility?" ...as the accreditation process is really all about credibility, value for the money. Accreditation bodies supervise the CBs through reviews of audit records and "shadowing" to see the CB auditors in action.

Certainly you can go the other way if you choose. I have seen one outfit - I forget who it is just now - that went to the effort of advertising its accreditation to an outfit which shared the same IP address! 100% conjured... though it would be easy to set up the facade web sites I go to enough trouble in my work to not be associated with them because I feel pretty sure that customers do care.

[DannyK]

In Reply to Parent Post by Beth Workman

We are certified to ISO 13485:2003. Our current Notified Body is SCC accredited, however, we are looking at changing to a Notified Body that reviews the QMS at our parent company, with an eventual plan to have one collaborative QMS.
The new company we are looking at is not SCC accredited and the cost is significantly lower (perhaps because of this), which is incredibly appealing to the powers that be.
We are not a finished device manufacturer, only components, so I don't believe that it will affect our ability to do business with potential customers in Canada, but that may be a matter of opinion based on the customer.
I want to help my company make the right decision on this without selling ourselves short. I would appreciate any thoughts that might bring attention to potential concerns or contradictions to my understanding of the differences between the 2 companies.

Thanks!

Since you do not have any medical device licenses, it is not a requirement for your notified body or registrar to be accredited by SCC. If you were selling medical devices in Canada, you would not have a choice.

I work with many companies in Canada that have ISO 13485 and have critical suppliers that are not with SCC. What is important is that these NBs are accredited by a known accreditation body such as UKAS.

[Beth Workman]

This is what I was wondering. Nothing that we make requires licensing.

Thanks!

[Chrisx]

Health Canada guidance GD210 section 2.3.2.4 describes the process a Health Canada Recongized Registrar must go thru when determining if they must conduct an audit of critical suppliers/outsourced processes. One component of this is a certificate from a Health Canada Recognized Registrar. All Health Canada Recognized registrars must have SCC accreditation, but the converse is not necessarily true. It may be that one of your customers has device licenses. Their Health Canada Recognized Registrar may determine that an audit of your facility is required, because you no longer hold an SCC accreditated ISO 13485 certificate. There is the possibility that by changing registrars, you may be burdened with additional audits. Your customers may be unhappy due to the additional cost of these audits. GD210 is available for free off the Health Canada website.