How to avoid ISO 13485 certification

I'm QA in a Canadian logistic centre that is deals with health products. The company has recently taken over another Canadian medical device company (MD class II). We will then transfer the license to our company name. Upper management wants us to avoid getting ISO certified. Is there anyway around having to be ISO 13485 certified?

If we own the other company that manufactures the device, can we declare ourself as a Private Label Manufacturer?

Thanks in advance for your help.

CT

Re: How to avoid ISO 13485 certification?

ctran said:

The company has recently taken over another Canadian medical device company (MD class II). We will then transfer the license to our company name. Upper management wants us to avoid getting ISO certified.

Click to expand...

Sounds like they screwed up when they decided to buy the second company.

Is there anyway around having to be ISO 13485 certified?

Click to expand...

If we own the other company that manufactures the device, can we declare ourself as a Private Label Manufacturer?

Click to expand...

Sort of.

You could contract with another medical device maker to be the Manufacturer, and your company could make the devices as a contract supplier to them. They would have to hold a Class II license for the device, and so would you. They would sell the devices back to you, and you would distribute them as a Private Label Manufacturer. Because you didn't have an ISO 13485-CMDCAS QMS, you would be subject to HC inspection regarding compliance with SOR/98-242.

That would be rather convoluted and inefficient, but it's the only way that comes to mind to me for you to avoid Manufacturer responsibility.

Re: How to avoid ISO 13485 certification?

Note that in a Class 2 (and above) CMDCAS medical device application , a QMS certificate is a required document. You may want to check with Health Canada whether a license holder MUST be ISO 13485 CMDCAS certified or not.

Q

Re: How to avoid ISO 13485 certification?

I guess the question I have is why do you want to avoid it?

Re: How to avoid ISO 13485 certification?

Qara123 said:

Note that in a Class 2 (and above) CMDCAS medical device application , a QMS certificate is a required document. You may want to check with Health Canada whether a license holder MUST be ISO 13485 CMDCAS certified or not.

Click to expand...

I believe the Manufacturer must have ISO 13485 and CMDCAS as a prerequisite for their license, but a Private Label Manufacturer has the option of either those certifications, or non-certified compliance with a subset of HC rules plus HC inspections, to obtain their license.

Certainly being sure by checking with HC would be a good idea.

Re: How to avoid ISO 13485 certification?

If the manufacturer has a Canadian license, you can piggyback on their license as a private label medical device.

I have processed the paperwork for the application for several companies and it usually took about 2-3 weeks to receive the license.

Re: How to avoid ISO 13485 certification?

DannyK said:

If the manufacturer has a Canadian license, you can piggyback on their license as a private label medical device.

I have processed the paperwork for the application for several companies and it usually took about 2-3 weeks to receive the license.

Click to expand...

Yes, and both you and the other company must keep the licence renewed annually and for this the other company (manufacturer) must be CMDCAS ISO 13485 certified.
The other company is your company now ... so where are you escaping from and where are you escaping to ... ?

I would also look at any other costs and benefits before getting into PLM licence. Do you have a brand image that perhaps will enhance your sales and turnover ? By becoming a PLM do you have see an increase in sales which covers your PLM costs and its annual maintenance ?
Owning a company is more a business and commercial deal. Its sometimes better to let and keep the other bought over company continue and maintain its regulatory obligations, while many other steps can be taken to improve market position. The company can still get a good improvement to reflect into the balance sheet.

Re: How to avoid ISO 13485 certification?

My company wants to avoid ISO 13485 certification for the obvious reason that they don't want to spend the time or money to get registered. So I am trying to find a solution that will keep us in compliance and get the product out the door as soon as possible.

Anyone know what is the process of transferring the ISO certificate from company that's being taken over to ours? If we adopt their entire QMS, does the transfer still involve the whole process of auditing from the registrar?

Thanks.

Re: How to avoid ISO 13485 certification?

ctran said:

Anyone know what is the process of transferring the ISO certificate from company that's being taken over to ours?

Click to expand...

Sure. Contact the prior company's registrar and tell them the circumstances.

If the prior company still exists as a nominally arms'-length party that's owned by your company, the registrar might be willing to continue the existing certificate, or maybe re-issue it with a name change depending on the relevant legalities.

If the prior company was dissolved into your company, probably the registrar will cancel the prior certificate, and--if you contract with them--schedule an initial audit to qualify your company for its own certificate. That however would involve things you don't want to do.

If we adopt their entire QMS, does the transfer still involve the whole process of auditing from the registrar?

Click to expand...

If you're talking about your company adopting the prior company's QMS, with only one company existing, the answer is yes. The point of an audit is to verify that what you say is true (i.e. you have a compliant QMS, and that's how you operate) is in fact true. Since the prior QMS would have existed in the context of a different company, that history would be irrelevant. Your QMS would be in effect entirely new.

In order to transfer your ISO 13485 certificate, the registrar will want to schedule an audit visit to verify if the system is in place at the new location and whether any of the changes has had anny effect to the QMS.

In order to transfer the Health Canada license, Health Canada will ask for a copy of the updated ISO 13485:2003 certificate (CMDCAS registrar logo has to be on the certificate) with the new address.