What Are ISO 13485:2016 Validation Requirements?
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Validation of computer systems is a legal requirement within a number of life science industries,
including ISO 13485
Inside Quality Digest Live for July 7, 2017
In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations.
Dual Status Hospitals: Beware of IRS Compliance Audits
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The IRS is ramping up compliance audits of governmental hospitals who are exempt under 501(c)3 (dual status).
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
Applying Risk-Based Thinking to Operations
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Hazard equals risk times exposure. One alligator... two alligators... three alligators...
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
Understanding AS9100 Revision D
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Transition Planning for AS9100 Revision D
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Credit: NASA
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New Language in AS9100 Revision D
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Credit: NASA
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Same Old Routine With FMEA?
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Scratches: Product failure or process failure?
Credit: Stef
Replacing the Risk Priority Number
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How much risk is too much depends on many factors
Risk-Based Thinking in Planning (6.0): Using the Business Operating System Approach
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(Credit: Guinness World Records)
In the 1990s, Omnex worked with Ford Motor Co. to develop the Ford quality operating system methodology, which with maturity and broad experience has evolved into Omnex’s business operating system (BOS) process.