Setting the Knowledge of the Organization in a Knowledge Base – chapter 7.5.1
The ISO standard takes finally the Knowledge seriously as it deserves. The 2008 requires “only” determination of resources required to maintain the QMS effectively. Knowledge required for realization of the product is definitely a resource. The ISO 9001:2015 refers to knowledge as a critical resource and requires a clear definition of needed knowledge for maintaining the quality management effectively.
The 2015 elaborates and adds that knowledge is related to the assurance of conformity of goods and services and achievement of customer satisfaction. Another aspect is the management of the knowledge; the ISO 9001:2015 refers to knowledge as resource with value that must be managed, protected and be available to the appropriate people at the appropriate time and place.
With the 2008 we,
- define the required knowledge and skills of an employee in a specific role
- manage a certification program that ensures that new employees will be well integrated,
- we suggest a yearly training plan that would enrich our workers, and
- we evaluate their work and performance. According to the evaluation we decide whether an additional training is needed.
With the 2015 it all comes down the process approach – the definition of knowledge that must be determined according to the processes that combine the quality management system. This definition will be based on the process inputs, processing actions interrelation with other processes and outputs. We need to
- define for each process the right knowledge required for operating this process (again the process approach raises its challenging head)
- define the knowledge required to achieve customer requirements and enhance its satisfaction
- assure that employees acquire this knowledge
- find a method to protect, manage and make this knowledge available to the appropriate persons
If you ask me this is the new challenge with resource management is finding a way to turn the knowledge of your organization into a feasible manageable knowledge base? The easiest way I can think of is documentation. Another way that requires more investment is setting up a training center.
Another point is assessing changes and trends (see Management Review) – this assessment must refer to changes required in the knowledge base of the organization or new needs for knowledge. The medical device industry provides a good example. In this industry the QMS is planned according to regulatory requirements. These requirements derive knowledge of product realization. Once a regulatory requirement was updated or changed the organization must assess whether the related knowledge is now sufficient or update is required.
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