ISO 9001:2015 clause 4.1 is about understanding the context of an organization.
What external and internal issues are relevant to the organization’s purpose and strategic direction? What external and internal issues can affect, either positively or negatively, the organization’s ability to achieve the intended results of its quality management system (QMS).
We saw in Part I that intended results of a QMS is something that is a function of who are chosen as the relevant interested parties. So, we cannot expect to determine internal and external issues correctly without having in mind who are relevant interested parties and what are their relevant needs and expectations.
One of these mornings I read:
"Le scénario se répète pour la quatrième année consécutive. Les défaillances d'entreprises vont continuer d'augmenter en 2020 à l'échelle mon-dialeAnd at another one I read:
...
Un zoom géographique montre une prédominance de l'Asie dans les faillites, avec la Chine en première ligne
...
Si la France s'en sort mieux que ses voisins européens, 2020 devrait marquer un tournant. C'est la première année depuis 2016 que les défaillances ne baissent pas. Elles devraient stagner, contre une hausse de 3 % en Allemagne et au Royaume-Uni, de 4 % en Italie et de 5 % en Espagne."
And then I thought of a number of companies I work or worked with that depend heavily on sales to the German market.German exports drop adds to country’s gloomy prospects https://t.co/2Ld8Rr3Mt1— Financial Times (@FT) January 9, 2020
What have I mentally done?
I selected an external event that can't be controlled by and organization and related it to an internal issue a particular organization:
Because of the strategic choices of the organization - bet on export to demanding German customers - one can say that both the external event and the internal issue have a negative connotation.
What will probably happen when we join the external event with that internal vulnerability? We determine a negative risk!
That risk will affect needs and expectations of a relevant interested party: the capital owners of the organization
One can also imagine internal events that can't be controlled by and organization:
Resignation of a critical worker will undermine our ability to respond to development requests, which will undermine our ability to capitalize on a boom in demand for co-created solutions.
In this case we have a positive external trend in motion that clashes with an internal negative event that the organization's top management cannot control.
The product of that clash is another risk - undermining of our ability to capitalize on a boom in demand for co-created solutions.
That risk will affect needs and expectations of different relevant interested parties: the capital owners of the organization and the potential customers searching for competent suppliers of co-created solutions.
These two examples illustrate the exercise I try to do with organizations to determine context-based risks and opportunities, using interested parties needs and expectations as a factor in assessing the importance of risk or opportunity.
What sources do I bring to the table to determine external issues? Normally, I use Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) to trigger the brainstorming of external issues.
When determining internal issues I ask people things like:
- What issues keep appearing in your internal meetings and reports?
- What issues keep appearing about overall performance of the organization, persons, resources, governance, ...?
Each combination is a possible risk or opportunity.
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