DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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68 BONEZONE • December 2016 Dust Off Your Drawing Board As you know, ISO 13485 has changed. The new standard radiates the concepts and requirements presented by the Medical Device Regulation (QSR), 21 CFR, Part 820. Still, there is more to this standard than meets the eye. The introduction to ISO 13485:2016 states the following in paragraph 0.4 - Relationship with ISO 9001: "While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015." Now what do we do? I get a headache just thinking about this shell game. Let's focus on transitioning to ISO 13485:2016 in this article, and somewhat minimize the suspense. Previous editions of ISO 13485 established a normative relationship with the ISO 9001 requirements. In other words, ISO 9001 served as the underpinning for the 13485 standard, i.e., to be compliant with ISO 13485 was to be compliant to ISO 9001 by association. Not true anymore. What a conundrum this has become, especially for companies that are only 13485 certified. "This 13485:2016 stan- dard excludes some of the requirements of ISO 9001 that are not appro- priate as regulatory requirements. Because of these exclusions, organizations with dual certifications whose quality management systems con- form to this international standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001:2015 (as well)." Have you seen the monster changes taking place with 9001? With the publication of ISO 9001:2015, what was previously eight sections has been scrambled into ten sections. Oh, and by the way, you don't even need a quality manual for certifi- cation to the new 9001 Standard, whereas a quality manual is still part of ISO 13485:2016. Flying straight is all about making adjustments, as I understand it. Imagine this. From this day moving forward, ISO 13485 is living on its own little isle. That is our starting point. The boat that brought you to the Isle of 13485:2016 is on its way back to the mainland and now you're challenged with build- ing a bridge that connects your present quality management system with the new, risk-based and regulatory-sensitive sce- narios. It will be a large undertaking, but frankly, we've been preparing for this for quite some time. Structural Background: What Changed and Why The easy answer for the change is that it was due. The ISO 13485 standard was updated to keep up with variability in the industry and to address changes in the underlying ISO 9001 standard. While some industry leaders expected the new ISO 13485 standard to use the latest ISO 9001:2015 standard, ISO Technical Committee 210 evidently felt that the older ISO 9001 standard better serves the needs of medical device sup- pliers, regulators and customers. This committee has always led the way for device regulation. It's been awhile since we've built a 21 CFR, Part 820-aligned structure. Yet, here we are. The new ISO 13485 standard is more flexible than the old standard. For instance, in the past, organizations could only exclude Sec- tion 7 requirements (concerning product realization), and then only if they could justify that deci- sion. Now, they can exclude any require- ment in Sections 6, 7 or 8 if they can justify the action based upon processes and product requirements. Also, the old standard expected you to establish a Qual- ity Management System (QMS) compliant with ISO 13485, whereas the new version now explicitly expects you to comply with all applicable regulatory requirements. The new standard expects you to apply a "risk based approach" to your organization's QMS processes. The old standard expected you to think about risk, but only during product realization (again, in Section 7). Now, you're expected to apply risk management methods and techniques to all QMS processes, including outsourced processes. Frankly, it's about time. Both ISO and FDA have been talk- ing about risk since 1994 (informally, before 1994). This major change will affect the culture of every company from start to finish. Decisions will be quantitatively-based, and not based on savviness. QUALITY MANAGEMENT Building Your Bridge to the Island of ISO 13485:2016 John Gagliardi MidWest Process Innovation, LLC Processes must be linked, risk must be accounted for and people need training. This is not an osmotic occurrence but, in fact, the culmination of a detailed plan with timelines and compotent resources.

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