Quality Management: Key To Medical Electronics Assembly and Manufacturing
No other industry in the US is under more pressure than medical electronics, and those pressures continue mounting each year for greater innovation and products that are faster, better, at lower cost, and in total compliance with regulatory standards. Those standards are becoming more stringent and more demanding of medical electronics OEMs each year.In short, those standards are in place and precisely monitored to assure the highest level of quality when it comes to medical electronics product assembly and manufacturing. No mistakes or excuses are allowed. There are no “ifs,” “ands,” or “buts.” Plus, in some instances, to assure the highest possible quality, 100 percent operational conditions are fitted with multiple redundancies in case something unexplained happens.
As these demands continue escalating, veteran medical electronics OEMs further embrace and work closely with their contract manufacturer (CM) or electronics manufacturing services (EMS) provider partners if they’re successfully complying with standards and regulations. If not, they search out newer, more aggressive and savvier CM or EMS provider assembly and manufacturing talent that does meet those requirements. The chart shows a listing of the top characteristics to look for. In short, the hallmarks OEMs look for are quality, reliability, and repeatability as set forth by the ISO 9001:2008 and ISO 13485:2003 Standard, which is the quality management standard for medical electronics devices.
Experience counts, no question about it. But even more important in this outsourcing scenario is determining if ISO 13485 is well instituted within an organization. And even as important is whether or not a quality mindset permeates throughout the entire CM or EMS provider organization. When it embodies the right culture, quality, and mindset, the CM or EMS provider is steadily and frequently analyzing the process of manufacturing under a magnifying glass. This mode of operation permits them to determine if and when improvements need to be made.
Thus, quality, culture, and that positive mindset bring to the table highly invaluable assets and eliminate complacency with manufacturing practices and policies. That same quality thinking and actions must be foremost among top echelons of management and particularly, on the assembly floor with such personnel as process engineers and technicians responsible for creating the exact thermal profiles for a medical electronics printed circuit board (PCB).
In addition, an assortment of advanced systems and equipment assure quality and reliability. Automatic optical inspection or AOI is used to ensure consistency. X-rays provide assurances that all joints are proper. (See Figure 1) First article inspection makes inspection and quality control (QC) more reliable, repeatable, and faster. The more use of automation, using precise machinery, the less human intervention is required, thus eliminating the possibility of human error.
A Disciplined Setting
ISO 13485 provides a specific and disciplined setting within the assembly and manufacturing structure. It is critical because all the manufacturing instructions are to be developed, written, and implemented according to the Standard and directly linked to it.
Moreover, ISO 13485 provides the CM or EMS partner the certification to assure medical electronics OEMs that protocols have been created and tested, correct fixtures and process improvements are in place, and incoming, operational, and process qualifications are well established. Also, as part of the failure mode and effects analysis aspects of ISO 13485, procedures and policies are put in place to assure all manufacturing and assembly equipments are properly calibrated and maintained as per manufacturers’ specifications — all under the umbrella of quality management.
Quality management systems or QMS for medical electronics manufacturing encompass a trio of certifications. Today, the ISO 9001:2008 Standard is a given, and medical electronics OEMs assume a CM or EMS provider has this Standard under their belt. But on top of that, it’s critical to have ISO 13485. Also, in some cases, US Food and Drug Administration (FDA) certifications are necessary, depending on the product being manufactured.
So, by making greater inroads and successfully progressing along from ISO 9001:2008 to ISO 13485 and then on to FDA certifications, a top notch CM or EMS provider is expected to progress from successfully producing high quality sophisticated to extremely sophisticated products, meaning tolerances continue to get tighter, quality continues dramatically growing, and the numbers of checks and balances increase to assure high quality products.