My company is already ISO 9001 certified and we are working on ISO13485 regisrtation and certification.

Once the 13485 stardards are implemented here should ISO 9001 be considered obsolete, even though we maunfacture but medical and non medical devices?

Kind of a silly question but this is my first go around with 13485.

Certification to ISO 13485 doesn't include all of ISO 9001. If it were me, I'd maintain certification to both standards. People outside the medical device community may not know what ISO 13485 is.

That is what I was assuming but our "consultants" insisted that 9001 would be obsoleted. We have a dept here that has absolutely nothing to do with medical.

So I think that ISO9001 would still apply to that dept. granted most if not all of the documentation is the same.

Relevant discussion here:
What is Required to Switch from ISO 9001-2000 to ISO 13845
(http://elsmar.com/Forums/showthread.php?p=227156)

So seeing that 13485 is a bit more granular that 9001, should I bother to keep seperate 9001 procedures as live documents or just consider 9001 included in 13485.

I ask because there is a dept that has nothing to do with medical and I am curious if we should make a clear distintion bewteen them.

Personally I wouldn't distinguish them.

My philosophy is that we have a management system and operating procedures that are applicable to the business - some medical, other not. The specific ISO standards are only mentioned in the scope of our Quality Manual, as references. The system has been created to suit our business and just happens to align with ISO's standards :tongue in cheek:

It's a philosophy that helps me get support from the organization.

Makes sense.

Since the main difference between ISO 9001 and ISO 13485 is 9001 emphasis on continual improvement and 13485 specifically omits continual improvement, I can see the quandary.

The idea with 13485, of course, is the whole schtick about "harmonization" and being able to satisfy multiple regulatory bodies (with the notable exception of the US FDA) with one registration versus multiple registrations for each jurisdiction where a product is marketed or used. Those multiple jurisdictions do NOT want organizations "improving" [i.e. "changing"] ANY products, processes, or services without notifying them.

My own decision would depend on whether my non-medical device customers demanded ISO 9001 registration. It also depends on whether an organization has the same registrar for both registrations - sadly, not every registrar approved to issue 9001 registrations is also approved by many jurisdictions to issue 13485 registrations.

If one has the same registrar, perhaps the registrar can work a discount to maintain BOTH registrations.

If no customers demand 9001 registration, I'd say it was a no brainer to drop the 9001 registration and just maintain a "compliant" system for the non-medical aspect of the business - especially the "continual improvement" part! Other than a demand for registration, keeping BOTH registrations would need a definite market advantage to justify the expense for me.

If one has the same registrar, perhaps the registrar can work a discount to maintain BOTH registrations.

If no customers demand 9001 registration, I'd say it was a no brainer to drop the 9001 registration and just maintain a "compliant" system for the non-medical aspect of the business - especially the "continual improvement" part! Other than a demand for registration, keeping BOTH registrations would need a definite market advantage to justify the expense for me.
If a registrar wanted to charge any sizeable fee for maintaining certification to both ISO 13485 and ISO 9001, I'd have to question why. The audit won't take any longer than for ISO 13485 by itself. Maybe a small fee might be justified for additional paperwork, but that's about it. If it's a large enough fee to cause you to think about dropping ISO 9001, they're trying to milk you.

Customer satisfaction and continual improvement are the only things in ISO 9001 that are missing in ISO 13485. Any company that wants to stay in business should be paying attention to both of these anyway...

If a registrar wanted to charge any sizeable fee for maintaining certification to both ISO 13485 and ISO 9001, I'd have to question why. What about the scenario where an organization has one single medical device product line and 25 commercial (non-medical) product lines? And they want the commercial products covered under an ISO 9001 certification. Would that justify it?

Or should the CB make a certification decision for ISO 9001, based on an ISO 13485 audit that covered a small portion of the registrant's system?

What about the scenario where an organization has one single medical device product line and 25 commercial (non-medical) product lines? And they want the commercial products covered under an ISO 9001 certification. Would that justify it?

Or should the CB make a certification decision for ISO 9001, based on an ISO 13485 audit that covered a small portion of the registrant's system?
Good point. I made the assumption that the entire system would fall under the ISO 13485 certificate. It does sound like ISO 13485 will apply to a majority of the organization with the possible exception of one department.
...a dept that has nothing to do with medical...

In addition to the other reasons above, some companies make the same product that has both medical and non-medical uses (e.g. products for both human and veterinary uses), so keep both certs.

SGS doesn't charge extra for "adding/keeping" ISO9001. Some of our clients are keeping ISO9001 even if they don't strictly need it. An increasing number (over time) are dropping it, ISO13485 is well-recognised within the industry, customer-base, and supplier-base.

Even if you do drop ISO9001:2000, I would still invest a little time in understanding the extra bits (e.g continuous improvement / customer satisfaction), as well as the changes in ISO9001:2008.