Author Archives: greg

#111 – WHAT IS ISO 9001: 2015 AUDITABILITY? – GREG HUTCHINS

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Greg Hutchins pixThis is the #1 question for CB’s with the new revision of ISO 9001:2015 standard.  Most management experts acknowledge that ISO 9001:2015 is a significant change.

Auditability implies consistent outcomes from auditing management systems.  If outcomes are different among CB’s, then the quality of the assessment and the reliance on the outcomes may be called into question.   Continue reading →

#111 – FDA REQUESTS PUBLIC INPUT ON QUALITY METRICS GUIDANCE – OLIVER WOLF

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a cust-nl-writer-photo-oliver-wolf-largeIn line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule.  At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points. Continue reading →

#111 – WHAT IS QUALITY MANAGEMENT? – IAN WALKER

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aaa‘Quality Management’ is a generic term, and the word ‘Quality’ means nothing on its own.

‘Quality’ is an individual’s perception. Take a wrist watch for example. What is its purpose?

My first initial thoughts are to tell the time, however for others a wrist watch is much more than that it may often be viewed a piece of jewellery and the more expensive the exclusive the brand name the better. Continue reading →

#111 – ISO 9001:2015 IS OUT: WHAT NOW? – JAMES KLINE

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The ISO 9001.2015 standard is  out.  Two important questions are: How did we get here?  What happens now?  Greg Hutchins, a Risk and Quality Expert, in his book “ISO: Risk Based Thinking 2015 Edition”, says we have gotten here through an evolutionary process, which, because of VUCA (Volatility, Uncertainty, Complexity and Ambiguity), requires a greater assessment of the external environment than is the case with just a quality focus. Continue reading →