In many companies, knowledge exists but is not managed. It is stored “in the heads” of a few experienced employees, in old email threads, in personal folders, or in informal agreements between departments. As long as key people remain in place, the system seems to work. But as soon as an employee goes on vacation, resigns, or moves to another role, it suddenly becomes clear that part of the important know-how, settings, customer-specific details, or technological nuances is no longer available to the organization.
That is exactly why ISO 9001 introduced a separate topic: organizational knowledge. The standard treats knowledge as one of the resources required for stable process operation and for ensuring that products and services meet requirements. This is an important idea: knowledge is not an abstract “intellectual value,” but a resource just like people, infrastructure, equipment, and monitoring and measuring resources.
For a mature quality management system, knowledge management is a way to protect the organization from loss of know-how, improve process resilience, and support process improvement. For organizations going through QMS implementation, it is also a practical answer to the question: how can we make sure the system does not critically depend on one or two “irreplaceable” employees?
What It Is
Organizational knowledge usually means the knowledge a company needs in order for its processes to function and for required results to be achieved.
This is not limited to documents and instructions. Knowledge may be:
formalized
informal
internal
external
technical
managerial
project-based
customer-related
production-related
organizational.
Put simply, organizational knowledge is everything that helps the company perform work correctly, consistently, and predictably.
For example, this may include:
work instructions
process settings and parameters
lessons learned from past mistakes
experience in solving unusual problems
customer-specific expectations
knowledge about suppliers and supply risks
templates for effective solutions
quality control methods
best practices for performing operations
results of previous improvements
project experience accumulated over time.
It is very important to understand that knowledge is not only “what is written down.” In many organizations, the most valuable knowledge is not documented at all. And that is exactly where the greatest risk lies.
Requirements of the Standard
In ISO 9001:2015, the topic of organizational knowledge is covered in clause 7.1.6.
If we translate the meaning of this requirement into practical language, the standard expects three things from the organization.
First, the company must determine what knowledge it needs for the operation of its processes and for ensuring the conformity of its products and services.
Second, that knowledge must be maintained and made available when needed.
Third, when needs, processes, products, services, or working conditions change, the organization must understand what knowledge is missing and decide how to obtain new knowledge or update existing knowledge.
This is where many companies make a mistake. They assume the requirement is fulfilled if they have a folder of procedures or a database of regulatory documents. But the logic of the standard requirements is broader. The standard is not just about documents. It is about the organization’s ability to use and preserve knowledge that is actually needed by its processes.
In practical terms, this requirement was introduced to protect the company from knowledge loss caused by:
staff turnover
weak transfer of experience
lack of systematization
poor accessibility of information
process changes
new tasks and new risks.
Why Knowledge Management Matters for the QMS
In the context of a quality management system, knowledge is especially important for several reasons.
The first reason is process stability. If a process depends on verbal agreements and the personal experience of one specialist, the performance of that process is always at risk.
The second reason is consistency of quality. A company should ensure that results depend on a managed system, not on luck or individual memory.
The third reason is risk reduction. Loss of knowledge often leads to mistakes, delays, defects, customer disputes, and repetition of known problems.
The fourth reason is development and change. When an organization launches a new product, changes equipment, implements a new IT system, or redesigns processes, it needs not only new resources, but also new knowledge.
The fifth reason is the internal audit and management review. If the organization truly manages knowledge, it becomes visible: processes become more stable, new employees ramp up faster, repeated mistakes decrease, and improvement actions become more meaningful.
What Knowledge Usually Needs to Be Identified
In practice, it is better not to try to “describe all knowledge in the company,” but to identify the knowledge without which processes cannot work effectively.
Most often, it makes sense to look at knowledge in the following groups.
1. Knowledge about products and services
This includes requirements, characteristics, technical parameters, quality criteria, rules of use, limitations, and typical mistakes.
2. Knowledge about processes
How the process is performed, what key steps and control points it has, what risks it contains, what records are required, and how departments interact.
3. Knowledge about customers and the market
Customer requirements, contract specifics, past complaints, service expectations, and important agreements.
4. Knowledge about suppliers and external parties
Supplier reliability, features of purchased materials, typical issues, external standards, and industry changes.
5. Knowledge about past mistakes and improvements
Root causes of recurring problems, actions taken, lessons learned, successful solutions, and the results of changes.
6. Expert knowledge held by employees
Equipment adjustment, non-standard troubleshooting methods, setup nuances, experience in performing complex operations, and knowledge of weak points in a process.
How It Works in Practice
In practice, knowledge management rarely exists as one separate “knowledge process.” More often, it is a set of mechanisms embedded into different QMS processes.
Below are the most practical forms.
Work instructions and procedures
This is the most obvious tool. If knowledge can be described clearly and unambiguously, it is best to record it in an instruction, standard, process sheet, or procedure.
Checklists
These are especially useful where it is important not to miss critical steps, checks, or conditions for starting work.
Training programs
Some knowledge is better transferred through training, onboarding, workshops, and mentoring rather than documents alone.
On-the-job transfer of experience
Some knowledge is too “live” to be turned into text. In that case, mentoring, job shadowing, hands-on training, and guidance from experienced employees are essential.
Knowledge base
This may be an internal knowledge base, electronic archive, corporate wiki, library of templates, lessons-learned register, or catalog of standard solutions.
Lessons learned register
This is a very useful tool for projects, changes, CAPA, and recurring problems. The company records: what happened, what was learned, and what should be taken into account in the future.
Communities of practice and expert directories
In some organizations, it is useful not only to store information, but also to know who carries specific knowledge.
Practical Example
Imagine a manufacturing company where critical equipment setup has for years been handled by one master technician. He knows the optimal parameters, can hear the first signs of deviation from the sound of the machine, understands which materials are difficult, and knows how to stabilize the process quickly. Formally, there are instructions, but a significant part of the real knowledge exists only “in his head.”
As long as he is present, the system seems stable. But when he goes on vacation, the defect rate rises, setup time increases, and younger employees begin trying different settings by trial and error.
If we look at this situation through ISO 9001, it is a typical example of unmanaged knowledge.
A mature approach here would be:
identify what knowledge is actually critical
record part of it in instructions and checklists
document typical settings and limitations
organize experience transfer through mentoring
introduce a lessons log for non-standard cases
include the topic in training for new employees
periodically review whether the knowledge remains current.
As a result, the organization reduces dependence on one individual and makes the process more resilient.
Typical Mistakes
The most common mistake is treating only documents as knowledge. In practice, a large share of critical knowledge is not documented at all.
The second mistake is starting with a huge and heavy knowledge base without understanding which knowledge is actually critical to the processes.
The third is assuming that if a storage system is created, employees will immediately start using it. Without habit and culture, this usually does not happen.
The fourth is failing to connect knowledge with change. The company changes a process, product, or structure, but does not think about what new knowledge is required.
The fifth is failing to see the risk of knowledge loss when key employees leave, move, or become overloaded.
The sixth is not reviewing knowledge after mistakes, projects, CAPA, and audits. And those are exactly the situations where the most valuable lessons often appear.
Practical Tips
It is better to begin not with “all company knowledge,” but with the question:
what knowledge is critical for the stable operation of our processes and the quality of the result?
A good practical sequence may look like this:
Identify key QMS processes.
Determine what knowledge is needed for their stable operation.
Understand where that knowledge currently resides.
Assess the risks of loss or inaccessibility.
Decide which method of retention and transfer is most appropriate.
Assign responsibility for maintaining and updating it.
Periodically review knowledge after changes, audits, and problems.
It is also very useful to connect knowledge management with existing mechanisms such as:
personnel training
documented information management
nonconformity analysis
CAPA
project work
change management
internal audit.
Then the topic of knowledge does not remain a separate initiative “about a knowledge base,” but becomes part of real quality management.
And one more important point: knowledge must not only be stored, but also accessible. If valuable information sits in a complex archive that nobody knows about, the requirement has not been met in substance.
How to Know the System Is Working
Organizational knowledge management can be considered effective if:
critical knowledge has been identified
it is not tied to a single person
employees know where to find needed information
new employees become effective faster
lessons from mistakes are actually used
during changes, the company understands what knowledge is missing
knowledge is updated regularly
repetition of the same mistakes decreases.
This is no longer just formal compliance with ISO 9001, but real support for processes and decisions.
Conclusion
Organizational knowledge management in ISO 9001:2015 is not an additional “fashionable topic,” but a practical requirement for process resilience and for the maturity of the quality management system.
The standard expects the organization to:
determine what knowledge it needs
ensure that this knowledge is maintained and available
acquire new knowledge when needs change.
In practice, this means the company must recognize its critical knowledge not only in documents, but also in people’s experience, lessons learned from mistakes, best practices, project solutions, and customer-specific know-how.
If knowledge management is set up correctly, the organization gains several benefits at once: less dependence on individual employees, more resilient processes, faster training of new staff, stronger process improvement, and a more mature QMS overall.
That means the topic of knowledge is not a formal clause in the standard, but a very practical tool that helps make QMS implementation more meaningful, supports the internal audit, and truly fulfills the standard requirements.