The 2015 revision of ISO 9001 adds the concept of “Risk-based Thinking” to quality management systems (QMS) requiring registered organizations to “determine the risks and opportunities” needed to ensure that the QMS achieves expected results and improvement. Clause 6.1, (Actions to address Risks and Opportunities), is one of several clauses created by ISO’s new “high level structure” designed to produce a common format and base level text within its catalog of management systems standards. The addition of risk-based thinking is a welcome addition to ISO 9001, currently the largest selling standard in the world and applicable to any organization seeking third party registration of their products and/or services in the marketplace. Continue reading →