Risky Business - Cruising to Success with ISO 9001-2015 and ISO 31000

Clark Leiphart, Senior Quality Engineer, Modular Mining Systems, Tucson, AZ, USA

Keywords: Risk Management,  IS0 31000, Management Review

Industry: All

Level: Intermediate


Even though 9001:2015 does not REQUIRE a formal risk management methodology, there is an opportunity to consistently use risk management throughout a company, on products and services offered to customers, as well as on internal operational processes. This presentation provides both a lightweight approach to documenting risk-based thinking within existing Internal Audit Planning, Corrective and Preventive Action, and Management Review, as well as a more robust framework that can be used within the framework of a higher level compliance-oriented structure such as ISO31000. Both approaches include generic Microsoft documents that can be used to jumpstart an improvement effort. Screenshots of a system implementation within a Microsoft SharePoint web-based Quality Management System will also be shown. The integration and management of risk across the organization should yield an increase in operational efficiency and a common internal vocabulary to pursue opportunities and reduce unintended consequences Participants will learn: How to add risk based attributes to existing ISO9001 procedures and related documented information How to review and assess these risk-enhanced procedure outputs at Management Review How to determine good and bad reactions to risk-enhanced information How to integrate risk-enhanced procedures into a corporate compliance risk management structure What a web-based system incorporating these concepts looks like What a document-based system incorporating these concepts looks like Participants will also be able to get several artifacts to help them with their internal transition efforts to ISO9001:2015, if desired. 

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Another month has passed and we’re all still concerned for the people impacted by the horrible events of the past month. From hurricanes to wildfires, mass shootings to sexual harassment in Hollywood...it’s very frustrating to watch the news these days. Fortunately, we work in a wonderfully people-oriented industry that has demonstrated many times that it’s capable of bringing people up, not letting them fall down. 

A Step-by-Step Guide to ISO 9001:2015 Transition

ISO 9001:2015
Management Training

“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013