ISO 9001:2026 organizational knowledge: retain, apply, share

What changes

The change sounds editorial but has a clear direction: a wiki nobody uses no longer meets 7.1.6. What matters is that knowledge survives staff changes, is actually used in the work and flows between people and departments.

Which knowledge is meant

It is the knowledge the organization needs to operate its processes and deliver conforming products and services. It is specific to your company and usually comes from experience. Typical examples:

• lessons from complaints, errors and projects that are not in any textbook,
• settings, tricks and inspection methods of individual specialists,
• customer-specific knowledge about expectations, contacts and particularities,
• knowledge about suppliers and their strengths and weaknesses,
• external knowledge from standards, conferences, customers and literature.

How to implement 7.1.6

1. 1

   Identify critical knowledge

   Ask for each process: what knowledge would we lack if this person left tomorrow? Focus on the answers with a large impact on results.

2. 2

   Retain

   Capture critical knowledge, for example in work instructions, lessons-learned entries, checklists or videos, or secure it through deputies.

3. 3

   Apply

   Make sure the knowledge reaches the place where work is done: in the current instruction, in onboarding, in inspection.

4. 4

   Share

   Create fixed occasions for exchange, such as error reviews, project close-outs or expert rounds, and make knowledge searchable.

5. 5

   Act on departures

   Plan a structured handover for resignations and retirements. That is the most common moment when knowledge gets lost.

6. 6

   Check effectiveness

   Watch indicators such as recurring errors after staff changes or long onboarding times and discuss them in management review.

A practical example

A manufacturer of injection-moulded parts has an experienced setter who has known for twenty years which tools need readjusting in humid weather. That knowledge is not in any instruction. When she moves to part-time work, scrap rises on two machines.

Under 7.1.6, the company should have identified this knowledge as critical beforehand. A sensible approach: the setter documents the key setting rules together with the quality team, a colleague learns them in a pairing set-up, and the rules go into the work instruction. After three months, the scrap rate shows whether the knowledge is actually applied. This chain of retaining, applying, sharing and checking is exactly what the new wording requires.

Evidence for the audit

• an overview of critical knowledge per process or role,
• lessons-learned entries from complaints, deviations and projects,
• onboarding plans and handover records for staff changes,
• evidence that knowledge is used, such as instructions updated after an insight,
• interviews: people know where to find knowledge and how to pass on experience.

Common mistakes

• Treating 7.1.6 as training planning under 7.2. Competence concerns people, knowledge concerns the organization.
• Introducing a knowledge portal without creating occasions to fill and use it.
• Not transferring insights from CAPAs into instructions and onboarding.
• Noticing the departure of experienced staff only when errors occur.

Implementation in docxpert

Approved documents are centrally findable in docxpert, and the AI knowledge assistant answers questions based on your documents with source references. That way, retained knowledge is applied faster. Insights from CAPA management flow into instructions through change control.

For the 2026 edition, the “Competence, training and awareness” template has a section on awareness and organizational knowledge. You record onboarding and briefings in training management. In the transition area, 7.1.6 belongs to the “awareness” step; the transition check gives an overview of all changes.