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The Revitalized ISO 13485: Ready for Business

ISO 13485 was updated to keep up with movements in industry and to address the changes to ISO 9001:2008, the foundation standard for ISO 13485. The old 13485 Standard was based upon ISO 9001:2000, while the new 13485 is based upon ISO 9001:2008. Industry expected the new 13485 to use the latest 9001 (2015) Standard, but Technical Committee 210 felt that the older ISO 9001 Standard better serves the needs of medical device suppliers, regulators and clients.

   

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Anyway, the new changes to 9001 are revolutionary in comparison to the new 13485. Not only is the format different, but the expectation for using risk management in both standards is renowned. The medical device industry doesn’t move that fast, nor does it “turn the corner” for changes that could upset some rather steadfast industry norms. In a few years, this will give the next change to ISO 13485 a chance to catch up and use the ISO 9001:2015 to modernize and re-develop another revision in a more meticulous and deliberate fashion.

The new ISO 13485 is applicable across the whole supply chain and will address the entire life cycle of a medical device. The final standard is expected to be published in March 2016. Some of the demonstrative changes include:

• Harmonization of regulatory requirements
• Inclusion of risk management throughout the QMS (and with outsourcing)
• Additional transparency with regard to validation, verification and design activities
• Strengthening of supplier control processes
• Increased focus regarding feedback processes
• Software Validation

Flexibility
The new ISO 13485 is more flexible than the old standard. You can now, with proper justification and explanation, exclude any requirements in sections six, seven or eight; as opposed to just section seven. This change alone will make a marked difference on the waythat small companies approach their QMS in terms of using the appropriate and applicable sections for operations that demand a “lean and mean” rather than a cumbersome, multi-level situation. I work with small as well as large companies, and they often wonder why requirements that deal with resources and measurement/analysis/improvement can’t be reduced for ease of manageability and applicability.

Risk Management
The update’s largest impact will pertain to risk management. Much like ISO 9001:2015, the new 13485 expects you to apply a “risk-based approach” to your company’s QMS processes. The old 13485 expected you to think about risk only during product realization (Section 7.1). Now you are expected to apply risk management methods and techniques to ALL QMS processes, including subcontracted ones. ISO 14971 (Risk Management) had a recent update and the industry is still reeling from the ALARP to ALAP (“as low as reasonably possible” to “as low as possible”) mentality for improvement, corrective action and mitigation. If your company is confused about how to assimilate risk management into your way of life, don’t be dismayed. Companies are struggling with this encompassing change, and many do not understand the big picture when it comes to dealing with uncertainties throughout and concerning just about every process initiative.

In a related way, product quality terminology has been replaced with product safety and performance, which is much like FDA’s safety and efficacy requirements for medical devices in the marketplace. Reading between the lines, the old 13485 implied product safety and performance, but now it is not only emphasized but more explicit. I am sorry to belabor this point, but risk management plays a huge role in making sense out of moving forward in a way that impedes uncertainty and increases assurances.

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