ISO 9000 & AUDITS WORLD CONFERENCE
A Common Sense Approach to Risks and Opportunities
Presenter: Lorri Hunt, President, Lorri Hunt & Associates, Inc., Kansas City, MO, USA
Keywords: Risk, Annex L, Preventive Action
It has now been almost five years since the revision of ISO 9001:2015 was released. The “new: concept of risks and opportunities continues to be one of the requirements where organizations struggle with implementation yet in most cases are probably meeting the intent of the requirement. To best implement the requirement, it is important to understand where the requirement comes from.
Most users were never aware or have forgotten that the term risk was used in the clause for corrective action. ISO 9001:1987 states “initiating preventative actions to deal with problems to a level corresponding to the risks encountered.” In its infancy, the term risk was directly related to preventive actions.
Subsequent revisions did not use the word risk. ISO 9001 transitioned to use the term preventive action. This requirement had a tendency to confuse users, so during the development of Annex SL (now Annex L) the drafters evolved the standard to address what the requirement was always meant to do which was take actions to avoid a potential problem. The term risk was introduced along with the concept of opportunities. This has resulted in organizations not always understanding the intent of the requirement.
This lack of understanding or confusion could be for a variety of reasons. These reasons include over interpretation by the organization, too much influence by auditors, or trying to apply an approach for an organization that does not meet the needs of the organization.
This session will review the requirements for risks and opportunities and provide implementation solutions based on the needs of the organization. It will demonstrate how a common sense approach to addressing risks and opportunities provides the best option for an organization meeting the requirement.