ISO 9000 & AUDITS WORLD CONFERENCE
Objectives and Measures Under ISO 9001:2015 and ISO 13485:2016
Presenter: Nancy Pasquan, Principal, Eyes On, Inc., Escondido, CA, USA
Keywords: Objectives, Measures, Metrics, Process Control
Objectives and Measures are both required for quality management systems under ISO 9001:2015 and related standards. The two requirements are often treated as the same thing, and confusion exists about the differences and relationship between the two. This presentation will define the terms and describe how, when used correctly, they can guide an organization to desired achievements while simplifying management decisions. Examples of good and less than good measures and their usage are provided. These lessons learned come from ISO certification audits and supplier assessments over the past 10 years.
Objectives are sometimes thought of as what an organization wants to be ‘when we grow up’, are often overly financial (versus quality) or are focused on the negative. When objectives are achievable but challenging, time limited, and communicated, they can motivate an organization to really move forward.
Processes are established to help the organization achieve the established objectives. Measuring those processes allows management to focus on the important things, having confidence that the measure will let us know when there is trouble brewing. Measures are frequently confused with objectives when applied to processes, but are also often the things we want to avoid or are temporary.
Process measures are admittedly trickier to identify than objectives or product measures. Sometimes there are too many metrics and the idea of a KEY process indicator (KPI) is lost. How the process in question interacts with its fellow processes is sometimes ignored or poorly understood.
Understanding both objectives and measures allows managers to focus on what matters both to their own processes and the organization overall.
Used correctly, the requirements from the ISO standards can be used to guide an organization to desired achievements and simplify management decisions. The time to establish objectives (aka goals) is now. The time to evaluate performance toward those objectives is daily, weekly, monthly and or annually. The data for goal vs actual performance may come from the process measures (ergo the confusion), or may be tracked via traditional business data collection.
This presentation provides definitions for measures and objectives and through example and story demonstrates how they can provide focus and improvement across an organization.