Karen Boyd, ASQ CQA Somashekar - Industry-specific differences between ISO 9001 and ISO 13485 alone (aside from revision level changes), are the reason these two standards cannot be equated with each other. (There is much more than 'context of the organization' and 'relevant interested parties needs and expectations' that distinguishes medical device manufacturing QMS requirements from "generic" industry QMS requirements.)

Somashekar BV Karen... I happened to read the white paper about the expected changes brought out by BSI. I did not see anything so substantial but for some of the FDA 21 CFR 820 requirements reworded or taken directly. I do not see any love towards this new revision from the regulators either. There is not 13485 without considerations to regulatory requirements, and therefore the basic QMS aka the 9001 + the applicable regulatory requirements in its entirety will work far better than this half backed medical device regulation that none care for seriously. The regulators are also playing around with the MDSAP pilot separately, which at mid point level has shown a very poor industry response.
So will the new 13485 hold any water ?

Karen Boyd, ASQ CQA Yes, it will and does hold water (ISO 13485), IMO, along with the governmental and product-relative regulatory requirements (e.g. FDA, EU MDD, CMDCAS, etc.), as relevant and applicable.
Of course, all (or most) industry-specific ISO standards use the basis of 9001 for their foundation of requirements.
It is not just reading the standards, but practicing and implementing them into QMS where the real distinguishing features are apparent.

Somashekar BV Unlike Automotive or Aerospace where the industry look to AS or the TS with purpose since these are the accepted system standards, the medical regulators have so far never looked at the 13485 on the same lines. They have always played the card safe with the region GMP being the only accepted system. The big question that you must ask yourself at this juncture when the 13485 is taken up for revision after 12 years is why the regulators forum from many regions (IMDRF) are accepting the MDSAP as a voluntary scheme along with their own scheme of regulatory inspection. Why is it that the device manufacturers have failed to recognize and adopt the same.
There is a lot of duplication in the various regulatory GMP documents as well as specifics. Every region regulatory is in deep love with their own GMP. A FDA inspector does not care if you have a 13485, as long as you are good with the 21 CFR 820 inspection.
In countries where there is no complete medical device regulation, like in India for example, what the buyer looks for is the ISO 9001 and / or the CE and / or the FDA approval. There is no mention of the 13485 in the government tenders for buying medical devices.
The ISO and the Medical device Regulatory do not see eye to eye and with a purpose. There is no trust on the ISO scheme of things on medical devices, less on the ISO 13485 CB's.

Karen Boyd, ASQ CQA Harmonization is the goal. Agree to disagree, Somashekar.

Somashekar BV Always respect your opinion Karen ~~~~

Anil Bhalani ISO 9001 is a general quality system. ISO 13485 is specific to the medical device industry. AS/TS 9001 is specific to automotive/aerospace and so on. A company in the medical device industry should be using ISO 13485 and not ISO 9001. The registrars and notified body will certify a medical device company to ISO 9001, which in my opinion is wrong but the registrar and notified bodies make money of every registration and there is nothing illegal that prevents them from certifying a company to ISO 9001 or both. But they should not be certifying a non-medical device company (or IVD) company to ISO 13485.

For a medical device company, certification to ISO 13485 is not mandatory even if you sell a product in the USA. Complying to the Medical Device Directive is mandatory, which requires a quality system and FDA QSR is an acceptable quality system. However, certification to ISO 13485 will reduce arguments with a notified body. Besides if you sell in Canada, Health Canada mandates ISO 13485 certification issued by a CMDCAS registrar. I would strongly recommend a company operating in the USA to stick to ISO 13485: 2003, because FDA was involved in its writing and once recognized by the FDA. It is not the same but closest to FDA QSR compared to all the later revisions.

Edwin Bills, ASQ Fellow, RAC A new release of ISO 13485 will be coming soon. The FDIS will shortly be published and, if accepted, the new standard will be released in early 2016. It is similar to the 2003 edition, but has some differences. It does continue to be harmonized with FDA 21 CFR 820. The transition process is still to be resolved, but it may not be the simple 3 years. There is discussion about no new certificates being issued after 2 years to the old version, even though the transition period may be stated as 3 years.

ISO 9001:2015 will be released soon, and is being trumpeted as being "100% accepted". The large number of abstentions in the voting are not being publicized and the dissatisfaction by some major national committees is being swept under the rug, though rumblings continue to be heard.

Karen Boyd, ASQ CQA Great info, Edwin. Thanks for sharing those updates on the revisions.

John F. Bielski Why 13485? Because all you get to publish from the FDA is the number of 483's and they spent so many days here so many years ago. Yes you can get a redacted copy of an inspection report, but you may not want your potential customer to know too much about the customer you were making something for when the FDA popped in. ISO-13485 is first and foremost a marketing tool, just like ISO-9001. With enlightened management you don't need to pay a penny to any registrar to have a fully functioning effective QMS, but who is going to believe you?

Somashekar BV John ... 13485, a marketing tool ? How on earth is this.
If indeed it was a marketing tool, the first customers buying in must be the regulatory, not the manufacturers. Where the regulatory presence is existing and strong, the ISO does not seem to have any stand. Where is the regulatory is existing and not strong., OR not existing, they lean on the stronger regulatory approvals to believe and register your medical devices. The only place where the 13485 sells perhaps is with the contract manufacturers, because the principle manufacturer wants the CM to be 13485 certified which gives them more belief than the 9001 certification. Yet the principles do not let just with the 13485. They schedule their own periodic audits at the CM.
Now coming about to your marketing tool...... yes, its a marketing tool for the CM's who seen big principle customers, for the entry only. Sustaining comes from performance and their own audit processes. Not from the 13485.
So either way, 13485 is only an ALSO and not the PRIME for the real medical device guys.

John F. Bielski You are absolutely right. My company is a contract manufacturer who sells to both big name and just past start-ups Device companies. Even with the big names, who will eventually come in and do their own audits, the 13485 does give you a leg up on getting on the bid list to begin with. And with the smaller players, the 13485 is all they are concerned with. Since my company is also registered to ISO/TS-16949, we need the 13485 to show the customers that we aren't just and automotive supplier, we also make good Medical Device components along with Over the Counter Drugs and military components in the same building..

Ee Bin Liew if you add Anil and John's comments together and have a ponder, it's logical. so thank you both for your comments. For that matter 9001 is also considered to be a marketing tool or a specific customer requirement. Ideally as john said, with enlightened management you can still ensure a fully functional QMS that helps the organisation dole out great products and services.

Edwin - the transition period is officially 3 years and by the 2nd year one may not be able to be certified to the 2003 version. it was posed to be 3 years in view of organisations' certification cycle. Voting is open and transparent and it's dependent on the number of participating and observing members for the Standard - just like any other - if countries are not an O or P member then ISO can't force them . we recently had meetings in Denver and in Wokingham to sort all comments out and respond to each and every one officially so nothing is to be swept under the rug per se. the WG is responsible to accept or reject comments, and all are done with justifications documented in the working drafts.

Cheers,
Ee Bin