What to do to keep ISO 13485 cert when medical device is not produced anymore?

D

DRDDO

Dear Team,
I am new comer, DRDDO = Dr. D Do.
My company is ISO 13485 certified. But now we stop produce Medical device.
Surveillance audit will be conducted next week.
How to protect the certificate?
Thanks,
DRDDO
 

Jim Wynne

Leader
Admin
Re: How to do if when audit medical device is stop produced anymore?,

Dear Team,
I am new comer, DRDDO = Dr. D Do.
My company is ISO 13485 certified. But now we stop produce Medical device.
Surveillance audit will be conducted next week.
How to protect the certificate?
Thanks,
DRDDO

Welcome to the Cove, DRDDO :D

I'm not an expert in this area, but it seems like this is a good question to ask your registrar. I'm assuming that you would want to claim ISO 9001 certification in the absence of manufacture of medical devices. The ISO website says this:
[ISO 13485] includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
[Emphasis added]
 

DannyK

Trusted Information Resource
It all depends on what are the plans of the company.If you are planning on producing a medical device in the future then it would be worthwhile to try to maintain. For the survaillance audit you could show evidence of the last several lots produced.

If you are also ISO 9001:2000 registered, then you can drop the ISO 13485 certificate.

You should be up front with the auditor and registrar and explain the situation. Maybe they can present you with a good alternative.
 
D

DRDDO

Dear Team,
My Audtor said, he will audit non MDD production line that quite similar to MDD production line, but Minor CAR will be raised, because it is not MDD.
For Next audit if still no MDD, Major will be Raised.
What do you think?
:thanx:
DRDDO
 

harry

Trusted Information Resource
Welcome Dr D Do,

I am also not an expert in this area. I am looking purely from the business and responsibility point of view.

First, what medical device do you manufacture? Is there a certain life span or do you have warranty responsibilities? My view is that until your responsibilities with regards to the device life span or warranty is over, no sane parties can take away your certification. The other way to look at it is that you still have responsibilities to discharge as required by the standards and good practice.

Meanwhile you can have time to look around/develop new Medical Device business.

Good luck.
 

Ajit Basrur

Leader
Admin
Great responses so far.

The decision to continue ISO 13485 totally rests with the Management Team. Discuss in the Mgmt Review Meeting.

If the decision is not to go forwards with medical devices, discontinue but if you want to have it in the future, maintain the system till the time you want to activate it. :)
 
R

Roland Cooke

Both for ISO13485, and (I would argue) MDD, I would look to see capability to restart manufacture (of medical devices/components) within a reasonable timescale. (That timescale can't be defined here because it can vary a great deal.)

If equipment has been appropriately mothballed, if personnel retraining process can be shown to be able to effectively implemented etc, I don't really have a problem.

What you describe is rare, but far from unknown, and certifications should support the real world not the other way around.

That said, it is usually very obvious when a company just wants to pay lipservice to the above, in a vague attempt to keep the frames hanging on the wall...
 

Marcelo

Inactive Registered Visitor
Well, you should really be worried about the expected service life of the device. Depending on the regulations you´re complying with, you have to keep your certifications in place (and even a lot of your systems in place, for example, your post-production information system) becasue your responsible for some time for the devices on the market.
 
D

DRDDO

To Roland SGS CE0120
You answer not specific!
If you were that auditor, you will Raised Minor CAR or not? and If Following Surveillance, Still no production, You will Raised Major or not?
Thanks.
DRDDO
 
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