Risk Based Thinking in and Beyond ISO 9001:2015

Duration: 60 Minutes
Clause 6.1 of ISO 9001:2015 requires the organization to implement "actions to address risks and opportunities" relevant to (1) understanding the organization and its context and (2) understanding needs and expectations of interested parties. These considerations are mandatory conditions of achieving ISO 9001:2015 certification, but they might not be sufficient to ensure world-class performance or even survival. We must look beyond the standard's stated requirements if we want the standard to be our servant rather than our master.
ISO 9001:2015
Product ID: 501502
Objectives of the Presentation
  • Know how ISO 9001 evolved from military quality standards that recognized explicitly that many quality risks originate from complex systems rather than poor individual craftsmanship
  • Understand that "actions to address risks and opportunities" is among the biggest changes in ISO 9001:2015
  • Know the definition of risk as a function of the consequences of the undesirable event and the probability of its occurrence, but go beyond the traditional failure mode effects analysis (FMEA) definition to include the frequency of exposure to the risk
  • Know that the Army's Risk Management Process is an off the shelf and public domain resource that can be modified for civilian applications to help support the requirements of ISO 9001:2015
  • Know where to look for risks and opportunities beyond those covered by ISO 9001:2015, and address them to achieve world class performance rather than mere compliance with the standard
Why Should you Attend
General Patton once warned that it is what we do not say that can destroy us and, in the context of industrial quality, it is generally what we don't do right rather than what we do wrong that can destroy us. Risks of omission (failure to recognize and exploit an opportunity) can be far more costly than the well-known risks of poor quality, but the costs are invisible to the cost accounting system; we cannot write off an opportunity cost (money we fail to make) on an income statement or tax return. This Webinar will therefore focus on risks of omission that might not even be auditable under ISO 9001.

Areas Covered
  • Complex business systems create risks that are unrelated to individual performance. (Compare to traditional crafts such as blacksmithing in which quality was entirely under the craft worker's or master's control)
  • Clause 6.1, "Actions to Address Risks and Opportunities" of ISO 9001, and also "context of the organization" and "needs and expectations of interested parties"
  • Risk assessment according to the Army's public domain Risk Management Process
  • Benefits of recognizing opportunities and risks not covered explicitly by ISO 9001:2015
  • Historical examples of missed opportunities, and the consequences
Who can Benefit
Quality professionals including auditors, as well as executives in service and manufacturing industries

Topic Background
Risk-based thinking, as now required explicitly by ISO 9001:2015, relates to identification of risks and opportunities that affect the business' performance. A comprehensive understanding of this topic is necessary to take full advantage of this provision, and gain competitive advantages that are not available through mere compliance with the letter of the standard.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, ISO/Lean Six Sigma World Conference, and others.


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