Industry Trends for ISO 13485

What we found out was that Glenn was not only a consultant, but he had also managed manufacturing organizations so he understood the issues faced by manufactures today. He reinforced the training by hands on activities.... we as a management team was learning to think out of the conventional box - move away from existing paradigms, and we began to look a new and better ways of conducting our business. In summary, our management team is better equipped to deal with the increasing cost of doing business. We are learning to move away from conventional thinking to now examining new and different ways to do our business. The training was awesome - an eye opener and I recommend it to anyone who is serious about surviving in the US economy as it is today.

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Issues and Trends

The purpose of ISO 13485 certification is sometimes misunderstood. ISO 13485 certification does not fulfill the requirements of 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers. As previously mentioned, the standard is in part meant to serve as a means to the creation of a management system that aligns with the requirements of various regulators.

Phillip C. Dobyns, technical manager for Wayne, PA-based HSB Registration Services, elaborating on this idea, says, “The ISO 13485 accomplishes a harmonization by writing specific medical device requirements in a generic framework that allows any specific or unique needs of local regulation to be addressed.”

Medical device manufacturers also should realize the importance that risk management bears in a 13485 management system. “A lot of places typically look at risk management only at the design and development function and they don’t carry it through the entire lifecycle of the product or process,” says Nadia Perreault, medical device technical manager for National Quality Assurance USA (NQA, Acton, MA). “People think that it is just a little snippet in time during the design and development phase.”

While Perreault points out that medical device manufacturers are not giving risk management its due gravity in their management systems, IBS’ Ridge reports that the recognition of the need for thorough enterprise-wide risk management practices is growing. “Risk assessments have become a key activity that manufacturers perform throughout the product lifecycle, whether they are designing new products, choosing suppliers, inspecting finished goods or performing corrective actions based on customer complaints,” says Ridge. A combination of increased regulation and technological advances is forcing medical device manufacturers to couple their management systems with enterprise-wide risk management programs.

ISO 13485 is no longer thought of as pertaining solely to finished medical device manufacturers. Today, such manufacturers are requiring their sub-tier suppliers to also attain 13485 certification. Of this phenomenon, Arlen Chapman, quality systems director for NQA, notes, “Medical device manufacturers want to realize better products and better services. I see it more from the financial standpoint for them—for cost savings, making sure they have good suppliers that they’re communicating with them properly and managing them properly.” This is risk management enacted to establish supplier quality, as it is difficult for a manufacturer to single-handedly regulate the quality programs of its suppliers.

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