Rob Packard Several of my clients have dropped their ISO 9001 certificate with essentially no impact other than reduced cost and no more need for internal auditing of 9001. My biggest recommendation is to drop the ISO 9001 before your next recertification audit, because if you recertify you will also pay for a new certificate you won't need for very long.

Karen Boyd, ASQ CQA Organizations having scopes including and beyond medical devices may elect or necessitate continuation of both ISO 9001 and ISO 13485 registration; it depends on the business portfolio and customers.

Jonathan Wacks Why does a medical device manufacturer need ISO 9001? To be perfectly frank, why does any company need ISO 9001?

Karen Boyd, ASQ CQA Organizations whose QMS scopes extend beyond medical devices (integrated systems) may need to retain ISO 9001 (plus any other applicable standards) and transition to ISO 9001:2015 and ISO 13485:2016

David P Norby, PhD, CQE (ASQ) At a minimum, you should assess the requirements of the markets where you intend to distribute your products. If your markets accept ISO 13485 compliance certification in lieu of ISO 9001, then you can consider dropping the ISO 9001 certification. But if any of your current or anticipated markets require ISO 9001 certification, then you should consider the impact on your business and current customers of the loss of access to that market - including possible decline of your company's perception and reputation in other markets.

Even if you do decide to drop the pursuit of formal ISO 9001 certification, I would highly recommend that you maintain compliance to its requirements. If you, your management and co-workers consistently view the guidance of the ISO standard as wisdom pointing toward the highest profitability and deepest market penetration, and the fewest headaches then the organization will consistently pursue this as a valued end in itself - not just "something we gotta do."

This is my experience also. It is not necessary to hold certification in both ISO 9001 and ISO 13485. I only put my clients through ISO 13485. Not one customer (end user or distributor) has ever commented on the lack of ISO 9001, nor has there been any comments regarding the lack of ISO 9001 from the notified bodies at certification or re-certification. ISO 13485 trumps ISO 9001 for medical device companies.

Jose O Cotta I had recommended our clients to start using only ISO 13485. Those who chose this approach found it streamlines and simplifies the maintenance. Internal audit is a requirement of ISO 13485:2016. In addition the internal audit has lots of advantages in organizations but requires few trained quality auditors as auditors shall not audit their own work. I have used the audit findings and brain storm as a group. Robert is quite correct about reducing cost. The impact of the change has been well received by external customers and suppliers.

Ruud Lans If e.g. 13485: 2016 cover the ISO 9001: 2015 which it will do as this standard is now without required/ mandaten written procedures. But take care: Medical companies with offices only e.g. sales, marketing as ' internal service center' should Better keep the 9001 only.

Cezar Lucki Yes only ISO 13485 applies to medical devices. You do not apply 9001. QSR and ISO 13485 are near mirror images. I believe 9001's were replaced in early 2000s.

As of now both ISO 9001:2008 along with ISO 13485:2012 is necessary for medical device manufacturers...this topic is fairly under discussion as none of manufacturers have transitioned to ISO 13485 till date...

Any organization dealing in medical devices can go for ISO 13485 only...ISO 9001:2008 certification is an additional burden for medical device industry

Steve Bixby What about the reverse? Is it possible for a medical device company to only have ISO 9001? As 13485 keeps getting more expensive (as anyone who has gone through the unannounced audit knows), could a company use 9001 with a broad scope and make devices?

ISO 13485 specifically concentrates on medical devices manufacturing and distribution process conformity to required standards, which would cover ISO 9001 whole concepts.

As ich a Medical device Company you need ISO13485. ISO9001 has been a "nice to have" add-on, sometimes useful for governmental contracts and PR to non-medical stakeholders.
As the two ISO standards were very similar, the additional efforts & Costs were low to maintain both standards.
As the structure of ISO9001:2015 has changed completely and differs significantly to ISO13485 now, it will. E more expensive to Jeep both standards and I guess many MD companies will get

Jonathan Wacks One pursues ISO certification to make money.
If you are in the global medical device market, to sell into 1st-World countries, as well as many developed nations, it is a requirement. The US requires compliance to US 21 CFR 820 QSR. Many med device suppliers also secure certification. ISO 9000 has no part in this process, and will not make you money