What the clause requires
Clause 7.1.6 asks the company to determine the knowledge necessary for the operation of its processes and to achieve conforming products and services, to maintain that knowledge and to make it available to the extent needed. When new needs or new trends appear, the company considers the knowledge it currently holds and decides how to acquire or access whatever is missing. Note that this is about the knowledge of the organization, not the competence of individuals, which is dealt with separately in clause 7.2. It is a short clause that quietly covers one of the biggest operational risks a company carries.
Organizational knowledge is what the company knows, not only what each individual knows: lessons learned from failures and from successes, process recipes, machine settings, the particular habits of a given customer, the history of past projects. It can come from internal sources, such as experience and the analysis of nonconformities, and from external ones, such as standards, conferences, suppliers and customers. It is not about building a corporate library; it is about the things that would stop production tomorrow if they were forgotten today.
The risk this clause attacks is the loss of knowledge: the technician who knows how to set the machine retires and nobody else knows how. The practical answers are documenting the critical knowledge in instructions, technical sheets and lessons-learned records, training successors, rotating people between posts, and capturing what was learned from nonconformities and from projects. The auditor question is blunt: who are the irreplaceable people here, and what happens if one of them does not come in tomorrow?
What the auditor asks to see
- Critical knowledge identified by process or by function
- Lessons learned recorded from nonconformities, projects and customer complaints
- Instructions and technical sheets covering critical settings and recipes
- A succession plan or cross-training for the key roles in the company
- Access to the external knowledge needed, such as standards and specifications
Where companies most often get it wrong
- Critical knowledge held inside a single person's head and nowhere else
- Lessons never recorded after a serious problem, so the problem comes back
- A key employee leaving with no handover of what he or she knew
- Reference standards out of date or not accessible to the people who need them
Example of a nonconformity
- Requirement
- ISO 9001, 7.1.6: the necessary knowledge shall be maintained and made available to the extent necessary.
- Evidence
- The temperature setting of the tempering furnace for the special alloy is carried out only by technician A. Silva, with no written instruction; during his holiday in 01/2026, 3 batches were rejected for hardness outside the specification.
- Finding
- Knowledge necessary to the process is neither maintained nor available within the organization.
Ready-made templates for this clause
Frequently asked questions
Do I need a knowledge management system?
No. The standard asks for the necessary knowledge to be maintained and available. Instructions, lessons-learned records and cross-training solve it in most companies.
What is the difference between 7.1.6 and 7.2?
Clause 7.2 covers the competence of people. Clause 7.1.6 covers the knowledge of the organization, which has to survive people leaving.
How do I record lessons learned?
A "lesson learned" field when closing nonconformities and projects, reviewed periodically, already does the job well.