Tag Archives: T. Dan Nelson

#48 – WHAT DOES ISO ‘RISK BASED THINKING’ REALLY MEAN? – T. DAN NELSON

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T. Dan NelsonISO is promoting ‘Risk-Based Thinking’ in all of its standards – even ISO 9001:2015 its flagship Quality Management System standard.  What does this really mean for companies?

IRISK AS PART OF QUALITY
Risk is recognized (finally?) as being part of quality management—which is nothing new.  Risk is involved with every activity in life—some will likely knee-jerk react with an over-blown response to the inclusion of risk-based thinking among ISO 9001 requirements.  To clearly comply with the requirement to apply ‘risk-based thinking’, some companies will no doubt be tempted to raise a ‘Risk Management’ process and maybe even hire a ‘Risk Manager,’ even though neither is necessary to implement ‘risk-based thinking’ or to comply with requirements to apply ‘risk-based thinking.’ Continue reading →

#47 – AS 9101 E – BEST YET – T. DAN NELSON

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T. Dan NelsonAS9101 is the audit companion to AS9100.  A sector scheme of ISO 9001, AS9100 is used in the aerospace and defense industries.  Certifying bodies (CBs) use AS9101 as a guide for auditors using AS9100. AS9101E, released just this month, seems to offer a vast improvement over all previous versions of AS9101.

Revision E removes the temptation to use AS9101 as stage 2 audit criteria, while at the same time further promoting a process approach to auditing, being clear about the importance of stage 1 auditing. Continue reading →

#46 – A BRIGHT FUTURE FOR QUALITY PROFESSIONALS – T. DAN NELSON

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T. Dan NelsonPDCA ON DISPLAY
When we see an athlete perform at the Olympics, we are looking at someone who has become intimately familiar with plan-do-check-act (PDCA) in its simplest form.

Each Olympian has measured every possible aspect of his or her ability to perform.  Each has done everything in his or her power to improve in an effort to be the best.  It’s not only the drive to win that makes them winners, it’s the effective application of PDCA.  To win, they can’t just want to be better, they need to be better.  Every Olympic event is PDCA in action and under pressure to deliver. Continue reading →

#45 – ISO 9001: ONE SHORT OF INFINITY! – T. DAN NELSON

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T. Dan NelsonPlenty of companies got the idea that ISO 9001 certification was about proving conformity to requirements.  We can tell by all of the QMS documentation designed to do just that.  Sure, ISO 9001 certification certainly does involve demonstrating conformity to requirements.  There are an infinite number of ways organizations could choose to define QMSs meeting ISO 9001 requirements.

ONE SHORT OF INFINITY
To define a QMS, there are infinity minus one ways, actually.  The one way of demonstrating conformity to requirements that isn’t acceptable per ISO 9001: documenting the system according to the requirements of ISO 9001 (or, using a standard-based approach). Continue reading →

#44 – IT’S ALL RISKY BUSINESS – T. DAN NELSON

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T. Dan Nelson
Risk is everywhere.  It impacts every aspect of life, including one’s work life.  Whether or not management is aware of it, they have been managing risk for years.  They were managing quality years before ISO 9001 came along, and they were managing risk long before ISO 9001 includes risk among its requirements.  Continue reading →