It’s now too late to update your QMS to either ISO 9001:2015 or AS9100 Revision D. You have to resign to this, which is actually exactly what you need to do to improve your QMS over the long term.
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Beyond CR Bard, multiple other companies cited by the FDA for medical device quality system violations were found to hold ISO 13485 certifications from a number of accredited registrars.
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IAQG wants Oxebridge to oversee updating the OASIS database now.
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Cage match! Certificate mill operator Daryl Guberman battled IAQG genius Buddy Cressionnie, and neither man came out smarter than when they went in.
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If you’re a reader of the Oxebridge website, you must be conflicted and possibly confused....
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