CERM Risk Insights #49

Hello Readers:
We were talking with a quality consultant the other day on the incorporation of risk into ISO 9001:2015.  Here’s his logic flow:
ISO 9001:9001 incorporates risk.  ISO 31000 is the risk guideline for ISO 9001.  ISO 31000 is an Enterprise Risk Management (ERM) standard.  So, ISO 9001:2015 is moving towards ERM standard.  And now, he reasoned that ALL families of ISO standards are moving to ERM.  Sound far-fetched.  What do you think?
We hope you enjoy this issue.  We look forward hearing from you.  Best
Greg Hutchins PE CERM | Quality + Engineering | CERM Academy | 800.COMPETE | 503.233.1012
Future of Quality: Risk®
 
Being Anticipatory by Daniel Burrus.  Think that being lean, agile, and executing well are today’s most critical business attributes.  Wrong.  It’s all about being anticipatory.  Learn about ‘soft’ and ‘hard’ trends and how you can capitalize by identifying them early.  Read more at Life@Risk.
 
Don’t Hear What I’m Not Saying by Mark Moore.  Studies indicate the #1 risk to project success is poor communications.  Find out why and what you can do about it.  Read more at Projects@Risk.
Process Approach in C Major by T. Dan Nelson.  Process management is coming in ISO 9001:2015.  Don’t fret.  You can now design your registration around your quality and business processes.  Read more at ISO9001:2015@Risk.
 
Auditing Risk Auditors by Umberto Tunesi.  ISO 9001 auditors have a difficult time conducting quality compliance audits.  How are they going to audit the new risk requirements in ISO 9001;2015 standard?  Read more at Quality@Risk.
 
Correcting and Detecting CAPA Horrors by Peter Knauer.  About 30% of FDA warning letters are issued for CAPA problems.  Find out why and what you can do to mitigate them.  Read more at Pharma@Risk.
 
ISO 31000 and ISO 9001:2015: Thoughts on the Future by Alex Dali.  ISO 9001:2015 references ISO 31000.  Alex is the founder and chair of the biggest Linkedin ISO risk community.  Hear his thoughts on the future of quality risk.  Read more at ISO9001:2015@Risk.
 

IT Application Guidelines by Ed Perkins.  There is much more interest in cyber security.  The US is developing new guidelines to deter hacking.  Read more at Software@Risk.

 

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