Unleashing Organisational Knowledge: ISO 9001:2015 Requirements

oragnisational knowledge ISO 9002:2015The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledge accurately and consistently over time within teams and between individuals. 

In fact, this practice is regarded as so central to the effective management of a business that ISO 9001:2015 7.1.6, has made it a requirement for those seeking to obtain the quality standard.

What is organisational knowledge in ISO 9001:2015?

According to ISO 9001:2015 Organisational Knowledge is the information that is needed, used and shared within an organisation to meet operational goals and to make an organisation more effective.

In its supporting notes the standard expands on this definition, showing how it can be based on:

Internal Sources, which might include: knowledge gained from experience, intellectual property, lessons learned from failed and successful projects, undocumented knowledge and experience of workers, the results of improvements in processes, products and services


External Sources, which might include regulation, standards, industry networking, feedback from customers or information from external suppliers.

In classic knowledge theory, the different kinds of knowledge covered above are labelled variously as ‘tacit’ and ‘explicit’.  Information which is understood and retained by certain individuals, that which is ingrained but not necessarily documented or regularly analysed is dubbed ‘tacit’.  On the other hand, that knowledge which is often stated, well documented, published and made commonly available within an organisation is labelled ‘explicit.

But defining what constitutes organisational knowledge is one thing.  Extracting that information from those who possess it, then transmitting it across the organisation and into the future, while allowing for its controlled change and evolution, is quite another.

What outcomes does ISO 9001:2015 7.1.6 require?

While the standard is clear about the outcomes organisations should be aiming for, it is notably vague about how exactly a company should achieve them. 

“The organisation shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

  • This knowledge shall be maintained and be made available to the extent necessary.
  • When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.”

When it comes to delivering on these requirements, therefore, the first challenge is converting the ‘tacit’ or undocumented knowledge into ‘explicit’ or documented knowledge within an organisation. The second challenge is ensuring that it is disseminated and propagated effectively within an organisation, augmented with external learning, and subject to ongoing review and optimisation.

How's your quality management - ad hoc, analytical or chaordic?

How the ‘knowledge creation spiral’ functions

Making this happen has been a central concern of quality managers and theorists for years, notably in the work of Nonaka and Takeuchi who introduced the SECI model in 1996; the model known as the ‘knowledge creation spiral’.  

This model describes how knowledge can be passed on: 

The Knowledge Creation Spiral
  1. Tacitly through socialisation (demonstration, imitation and replication)
  2. Then explicitly through externalisation (the preparation and sharing of the documentation which describes it)
  3. By augmenting or combining it with other kinds of knowledge sources (external documents) 
  4. Finally, by worker's ingesting and internalising it in its modified form and using it to optimise their existing tacit knowledge.

Moving from ‘tacit’ to more ‘explicit’ organisational knowledge

All this should result in a virtuous spiral of ever-increasing knowledge and ingrained expertise, and it’s a model which ISO 9001:2015 7.1.6 clearly aspires to.  

But it’s been the movement from ‘tacit to explicit’ and the subsequent internalisation and optimisation of best practice that has been regarded by organisations as the most difficult or even impossible to achieve.

However, we would argue that the traditional approach and tools used to address these specific challenges has been part of the problem here.

How QMS solutions have historically failed

Organisations who needed to document and formalise their Quality Systems, often chose digital approaches that had the effect of setting certain business behaviours in stone - in very unhelpful ways.   

Historically, the whole process of selecting and installing an eQMS over several months, having a QA team observe and ‘document’ the future ‘rules’, then train an entire organisation to follow them, has been a recipe for a moribund and ineffective quality function.  

Box ticking and other inspect and fail compliance paradigms, are the ways more prescriptive QMS attempt to impose quality - identifying, correcting and ‘trapping’ tacit knowledge once and once only.

But as Plato, the father of Western philosophy himself put it:

“Knowledge which is acquired under compulsion obtains no hold on the mind”

And he may have been on to something when it comes to quality management, too.

Towards a more collaborative QMS

These rigidly structured and highly formalised systems do not easily permit workers to contribute to their creation and maintenance, they insist on particular processes and procedures operating in particular ways (especially those developed for highly regulated industries).

We would argue that what’s needed in a more agile commercial world, is a more flexible type of QMS, a digital framework in which you can build out visualisations of the business processes and procedures that are unique to your business.  Visualisations which are designed collaboratively, locked for editing but accessible by all via an intranet, and subject to continual review.  Visualisations that are easy to edit by non-coders and underpinned by solid, version controlled, document management tools.

ISO 9001:2015 7.1.6 requires a Quality Management System that functions as a ‘Knowledge Creation Spiral’ in its own right.  If you choose the right tools, you can rid yourself of restrictive quality practices and replace them with a system that drives improvements from within, helping tacit knowledge become explicit and optimising the way it is implemented.


Tags: Compliance

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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