The Beginning of the End for Fake ISO 13485 Certificates
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.
When it comes to detectors for dangerous chemicals, toxins, or nefarious germs, smaller and faster is better. But size and speed must still allow for accuracy, especially when measurements by different instruments must give the same result.
Taiichi Ohno, the father of the Toyota Production System, once said, “Where there is no standard [process], there can be no kaizen [improvement].”
‘It’s all about the process,” says MIT professor Warren Seering. He’s referring to his product design and development class (identified as Course 2.739), but he could easily be talking about product development itself.
Toward the end of summer, I was part of an assembled mass of governors and manufacturers at a Walmart-led summit in Florida. My boss, the Secretary of Commerce (or most accurately, my boss’s boss’s boss’s boss) was there, too.
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