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New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
Torque testing is an important quality-control step in nearly every manufacturing sector. Properly testing rotary parts for torque with handheld or automated gages can prevent everything from un-openable bottle caps to loose fasteners. Or, in a grave example, if GM properly acted on failed rotational torque tests of ignition switches in some of its mid-2000s models, 13 lives would have been saved.
Air gages have been reliable tools for more than 70 years, providing accurate and repeatable measures of diameter, depth, parallelism, taper and flatness.
Quality management professionals focused their eyes on the big update to ISO 9001 in September, and changes in the standard will require top leadership to do the same moving into the new year and beyond.
Computed tomography (CT) scanners are a popular choice for inspecting both the external and internal geometry of parts — finding inclusions, voids and flaws that could cause failure or underperformance.
Army Trail Road, in Chicago’s western suburbs, is dotted with metal fabrication plants — production facilities offering high-tech manufacturing jobs at living wages.