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What will the regulators do in response to the 2016 changes? How do we revise our supplier controls? When will the standard be harmonized with the EU directives? In one of my previous announcements a couple of people responded to my announcement indicating which aspects of ISO 13485:2016 they thought were of concern. I maintain my opinion that the changes are minor, but I make this statement in the context of much more radical changes to the EN version of ISO 14971 where the 7 deviations contradict the content of the standard. As another example, ISO 9001:2015 is not just restructured, but the requirement for “procedures” is replaced by “documented requirements”, preventive actions are eliminated and corrective actions are combined with nonconformities. There are lots of changes to ISO 13485 in the 2016 version, but the overall structure is the same and the only significant new requirement is specific to complaint handling (i.e., the new Clause 8.2.2). I’m building my presentation slide decks for a training next week, and I’d love to know what questions you are most concerned about. Software validation has always been required. Software applies in several places in the QSR and standalone software devices are becoming more important. I believe the general intent was to emphasize the applicability of the Standard to software in specific places where the committee felt it was important. Does this keep you up at night? Please send emails to my suggestion box (http://medicaldeviceacademy.com/suggestion-box/) or add a comment to our LinkedIn posting with what you are MOST worried about. ++++++++++ Patient clinical design input can reduce the burden, improve retention and increase efficiency. Such significant gains should be captured with smarter involvement of patient feedback. To help you incorporate patient input from the outset, you’re invited to a free webinar with senior leaders Craig Lipset, Head of Clinical Innovation at Pfizer and Faye O’Brien, Associate Director, Clinical Development at AstraZeneca. It is March 30th at 3pm CET/2pm GMT (9am EST) for the online webinar to discuss how to: Sign up here to ensure you don’t miss out: http://bit.ly/co-create-trials Group member Dave Gallup prepared GMPs for Medical Devices, a video-based training program for manufacturing medical device personnel at http://medgroup.biz/GMPs. It provides all the instructions a trainer or program facilitator needs to ensure a successful implementation. At the end of this program, you’ll be able to: That link again: http://medgroup.biz/GMPs. source: https://www.linkedin.com/groups/2070960/2070960-6115897851110318084 Marked as spam
 Posted by Asked on March 16, 2016 12:00 am
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Private answer
Dan Brown
Rob: My opinion is that the changes are fairly minor for fully FDA compliant OEMs. However, I believe that the changes are MAJOR for component suppliers and contract manufacturers. 1) Risk management: these companies have done this all along, but typically limited to processing risk and the ability to conform to customer requirements. Supplier's to the OEMs now are required to discuss patient impacts with their customers and assess how processing errors can impact the end users - this is a very significant change and I question the willingness of the OEM customers to open up and share this information. I wonder how the registrar auditors of the OEMs will respond if they don't share this information.
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Anil Bhalani
Rob: Why would I update my ISO 13485:2003 to the newer version? The fact is that most ISO 13485:2003 compliant companies get a FDA 483. Bur rarely does an FDA QSR company get a violation from a ISO audit. MDD only requires a quality system. It does not require an ISO 13485 certification. This statement I believe by Kim Trautman of the FDA who was on the ISO 13485:2003 committee that harmonized this version of the standard to cGMPs is very buried within the system that none of us thousands of consultants and millions of ISO registrars will bring out lest we loose the millions we make from companies in the name of compliance.
The new EU rules of unannounced audits by notified bodies is already making millions for the notified bodies. No sooner than they were made effective, one of my contract manufacturers received a 2 day audit in January by a single person followed by a $10,000 bill. And the irony is that they were scheduled for a surveillance audit in April, which still happened. Marked as spam
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Rob Packard
With regard to Anil's comment, the ISO 13485 certification is required for Canadian Licensing. All other countries, except the USA, recognize it as one method for meeting the requirements. Kim Trautman's comments are reflective of the lack of training for many auditors on how to audit to both the ISO standard and QSR simultaneously. Your comments about the unannounced audits are also not a surprise to anyone. The EU Commission required the unannounced audits in order to identify fraud, but none of the Notified Bodies thought it would be an effective method. I trained one of the Notified Body auditing teams to use the same techniques the FDA inspectors use to help them identify fraud, but the audits are only as good as the auditor's skill.
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Rob Packard
Dan's comments are very important to understand. Ideally a contract manufacturer is the expert with regard to the process controls and raw material controls implemented. They should know best practices in their industry and use a risk-based approach in implementing these controls. Suppliers still need input from the customer, but typically that is part of the quotation process for each new product.
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Dan Brown
Thanks, Robert. Unfortunately, in my experience the OEM's rarely share more than a print to their suppliers with "give me a quote for 1,000 of these." Actual requirements aren't shared until AFTER the PO is sent when the supplier goes "WHAT?!?!" and realizes that they are S.O.L. for making any money on the project because they didn't put any riders on the quote for changes in requirements and are afraid of losing future work if they refuse to honor their low-bid quote. Not only are requirements withheld until the PO is sent, often requirements aren't shared until the first job is rejected. Where's the FAI report? This has unacceptable scratches! This isn't the shade of green we expected. Etc. I typically ask auditees how they qualify new opportunities and what risk assessments do they perform on quote requests from potential new customers. You'd be surprised by the blank looks I've received.
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Private answer
Dan Brown
Another major impact for non-OEM's is software validation for QMS software. All suppliers are familiar with validating machine programs, CMM's, etc. but very few have validated their ERP system, and almost none have validated calibration and maintenance tracking (but it has to be valid, I purchased it to do this!) or other QMS software.
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