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Get Serious About ISO 13485:2003

“Quality Management” is one of those terms that’s often casually spoken or written about in the electronics industry. In many instances, it is so casually used that it sounds highly promotional just to get the OEM’s attention, and hopefully get that OEM’s business.

But when it comes to medical electronics, quality management is quite serious and has the utmost backing of highly respected industry standards, like ISO 9001:2008 and ISO 13485:2003. In particular, the hallmarks that OEMs focus on are quality, reliability, and repeatability as set forth by ISO 13485:2003, the quality management standard for medical electronics devices.

Fig 1 --Advanced X-Ray on PCB Assembly FloorSavvy OEMs first determine whether or not ISO 13485 is well established within a vendor organization. But even more important, they thoroughly check out a contract manufacturer (CM) or EMS Provider to find out first hand whether or not a quality mindset and culture permeate throughout that vendor’s organization.

There are several signs or indications to look for when finding out how serious a CM or EMS Provider is about ISO 13485-quality management. Here are a few tips to check out, but for a more detailed evaluation read our in-depth article in Medical Design Briefs Magazine.

  • Learn about their assembly floor equipment. Is it advanced, up-to-date, or is it a few generations old? For example, leading-edge x-ray looks for defects and assures all joints are proper, even on small PCBs loaded with micro packages, (see Fig. 1 above).
  • Also, how complacent are they about implementing ISO 13845? Are they taking a proactive or reactive approach toward quality management systems?
  • How well can they fully support your risk management?
  • Do their quality control (QC) measures and checks and balances meet ISO 13485 requirements?
  • Are you, the OEM, keeping a disciplined track of first pass yields and data matrices?
  • Are the right test strategies being deployed to meet specific medical electronics sub-assemblies?

These are just a few tips and hints to investigate how well you are being supported according to ISO 13485. One way to look at this is: Having a proactive mindset is a huge asset when it comes to top quality assembly and manufacturing. Once it is clearly adopted, it pays large dividends to both medical electronics OEM and to the partner CM or EMS Provider.

This means program management on the assembly floor is highly aware and on alert to anticipate potential issues when building a medical electronics product. In effect, it’s out-of-the-box thinking that opens the door to a clear mind full of “what if’s and how to resolve them ahead of time. Also, that positive attitude and thinking allow a CM or EMS Provider to proactively collaborate with customer OEMs to anticipate and resolve issues as well as put checks and balances into the project ahead of time.