Do I look like the kind of guy who takes risks?

I’m just another boring oldster who’s waiting around to start collecting social security. What was this great risk I just took? I had a flu shot at my local CVS. Actually, it’s labeled: FLUARIX QUAD 2016-2017 SYRINGE. I have NO CLUE what’s in there. NO idea who BERNSTEIN, S. is either (prescriber, it says on … Continue reading “Do I look like the kind of guy who takes risks?”

What is the new Risk-Based Thinking in ISO 9001?

Risk-based thinking is a central theme which is newly introduced in ISO 9001:2015. The authors of this standard intended to replace the old ‘Preventive Action’ clause from ISO 9001:2008 with this simpler and more practical feature. Their intent was not to include the entire gamut of Risk Management such as can be found in the … Continue reading “What is the new Risk-Based Thinking in ISO 9001?”

What other standards are related to ISO 31000 and Risk Management?

Many of the ISO standards now include requirements related to risk and some reference ISO 31000 for further information. Some of the better known standards are: ISO 9001 – Quality Management Systems ISO 13485 – Medical Device Quality Management Systems ISO 14001 – Environmental Management Systems ISO 27001 – Information Security Management Not Mandated Although … Continue reading “What other standards are related to ISO 31000 and Risk Management?”

What is ISO 31000?

ISO 31000:2009 is the international risk management standard. It is different than the many existing, industry/sector-based standards in that it is completely generic and can easily be applied to any organization of any size. It also differs greatly from standards which place an emphasis on compliance. ISO 31000 is objectives-centric, i.e. it is focused on … Continue reading “What is ISO 31000?”