#21 – COULD YOUR PACEMAKER BE HACKED? – PAUL KOSTEK

Paul Kostek PixHack a pacemaker?  Is this a real problem?

Some recent experiments have been able to hack a pacemaker and other medical devices including an insulin pump.  The weakness of these systems was the analog sensors attached to the body to gather information. These analog inputs bypass the internal security and are converted directly to digital signals.  Continue reading

#20 – THE MANY UNCERTAINTIES OF RISK AS CURRENTLY STATED IN ISO 9001-2015 – JAMES LAMPRECHT

Jim LamprechtThe words “risk” or “risks” have been sprinkled throughout the 2015 revision of the ISO 9000 standard.  Although some “requirements” will be easy to satisfy using well-established process monitoring or capability techniques other references to risk are so vaguely stated as to be open to a myriad of interpretations and thus become meaningless.  Having read and re-read the current references to risk spread over several paragraphs I wonder if it would not have been better to address risk in one paragraph at the beginning of the standard.  I have “cut and paste” most of the current references to risk and included brief comments. Continue reading