#104 – QUALITY RISK MANAGEMENT – PRETESH BISWAS

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AAA1Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmaceutical, pharmacovigilance, and by agencies regulating these industries. Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Continue reading

#103 – CONSULTANT QUESTIONS FOR ISO 9001: 2015 TRANSITION – GREG HUTCHINS

Greg Hutchins pixConsultants are going to be challenged with Risk Based Thinking and risk requirements in ISO 9001:2015.  Why?  Most ISO management system consultants are not risk consultants or understand RBT.  RBT and risk based auditing are so new that most ISO management system consultants have not done a risk based, process, and effectiveness audit.   Continue reading

#103 – ISO 9001 – 2015 TRANSITION THOUGHTS – TOM BACUS

Bacus_4385-webA couple of thoughts concerning your overall ISO 9001:2015 transition strategy can be found below:

For 2015 actions:

1.  For the organization’s ISO team and / or leadership team, conduct a detailed overview of all the significant changes to the standard so that you better understand the implications for your organization (Sept – Dec). Continue reading

#102 – LIVING WITH RISKS – GREG HUTCHINS

Greg_Hutchins_pixHarvard Business Review this month published an article on ‘How to Live with Risks.’  The essence of the piece is that we are looking for risk in all the wrong places:

“Risk management has historically focused more than half its time on legal, compliance, and financial reporting functions.  That’s starting to change as companies realize that most big hits to shareholder value come from strategic and operating risks.”[i]

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