Most organizations meet Clause 7.1.6 by writing a paragraph in a manual and moving on. That passes the audit and misses the point entirely. The clause is the standard's acknowledgement that what your people know is a resource — and that when they leave, it walks out with them.
What the clause actually requires
ISO 9001:2015 introduced Clause 7.1.6, "Organizational Knowledge." It asks you to determine the knowledge needed to operate your processes and achieve conformity, to maintain that knowledge, and to make it available where needed. Crucially, it asks you to look ahead: when needs change, how will you acquire the additional knowledge you'll need?
Tacit vs. explicit — the distinction that matters
The knowledge that's already written down is the easy part. The dangerous part is tacit knowledge — the judgement your most experienced operator uses to tell when a process is "about to go wrong," the relationship history your account manager carries in her head. The Nonaka–Takeuchi model describes how organizations convert tacit knowledge into explicit, shareable form. Clause 7.1.6 is, in effect, asking you to run that conversion deliberately.
Compliance asks "is it documented?" Culture asks "would we survive if this person left tomorrow?"
A practical sequence
- Map it. List the knowledge each critical process depends on, and where it lives — in a document, a system, or a single person's head.
- Find the single points of failure. Any process that depends on one undocumented person is a succession risk.
- Capture from the experts before they leave. Structured interviews, recorded walkthroughs, paired work.
- Make it findable. Knowledge nobody can locate isn't maintained — it's buried.
- Anticipate. What will the next product line, regulation, or market require that you don't yet know?
Why it connects to culture
Clause 7.1.6 doesn't live alone. It links to Clause 7.2 (competence), 7.3 (awareness), 7.4 (communication) and 10.3 (continual improvement). Together they decide whether your quality management system is compliance-driven — surviving on procedures and checklists — or culture-driven, where improvement is something people do rather than something the auditor checks.
Go deeper on knowledge & quality culture
My ISO 9001 course turns Clause 7.1.6 from a vague obligation into a knowledge map, a culture-maturity assessment, and a twelve-month roadmap you can actually run.
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Is Clause 7.1.6 auditable?
Yes. An auditor can ask how you determined required knowledge, how you maintain it, and how you plan for future needs. A one-line manual entry rarely satisfies a thorough auditor.
Does this require a knowledge-management system?
No specific tool is mandated. A simple, maintained knowledge map plus a capture routine satisfies the clause far better than expensive software nobody updates.