Apparently ISO management standards are continuing to evolve. They show evidence of intelligent design – ingesting new practices to claim as their own.
For the ISO 9001:2015 revision, it’s risk assessment and a management dashboard for those letters beloved of unimaginative chief executives -S.M.A.R.T. (Specific, Measurable, Actionable, Realistic, Time-bound).
You can already see how much better quality is going to be. It will be unrecognisably better than the unmeasurable improvements brought by the earlier standards.
ISO Standards Evolution
The latest revision of ISO 9001 (ISO 9001:2015) follows the same overall structure as other ISO management systems (known as High-Level Structure), which makes it easier for anyone using multiple systems (e.g., ISO 9001 and ISO 22000). This is a major change in the latest 9001 revision.
Another big change is the focus on risk-based thinking. Basically, the latest version of the standard makes risk management, which has always been implicit (or implied), explicit (no longer optional.) Now there is the need in the standards to make critical and often-ignored implicit components of application, such as planning and change activities, explicit in implementation. As an example, now explicit in these activities is the application of risk-based decision making, control measures for change and risk application, and the specific use of data-driven measurement and analysis.
A third change is the key explicit requirement for formal evaluation and activity in assessing the objectives for chosen benchmarks in the business using quality-driven criteria with chosen alternatives for meeting such objectives. S.M.A.R.T. (Specific, Measurable, Actionable, Realistic, Time-bound) driven objectives must have regular dashboard review by cross-functional teams in an improvement strategy with the application of critical thinking skills as a process-based approach for quality and safety of products and services (e.g., quality consulting and auditing).
Why is this intelligent? Because it necessitates lots more unnecessary work to be inspected. Lots more food for those who like to waste time on micro-management, collection of unhelpful data and inspection.
Haeckel’s ideas were once believable and fashionable too.
When the risk assessment and SMART are imposed on laboratories, will the certain risk of colossal waste in accreditation have to be accounted for?
Will the “improvement” in quality have to be quantified to be really SMART?