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Writer's picturePierre Venter

Understanding ISO 9001:2015 Clause 7.1.6 – Organizational Knowledge

In the fast-paced world of business, staying competitive means staying informed. Clause 7.1.6 of ISO 9001:2015 addresses Organizational Knowledge, ensuring that businesses understand, maintain, and transfer the knowledge necessary to deliver quality products and services consistently. Let’s break this down, explain how to ensure compliance, and guide you on what to present during an audit.



What is Organizational Knowledge?

Organizational knowledge refers to the information, skills, and experience that a business uses to operate effectively. This could include:

  • Processes and best practices for producing goods or services.

  • Lessons learned from past successes or failures.

  • Customer preferences and expectations.

  • Industry standards and regulatory requirements.


Think of it as the intellectual backbone of your organization. Without it, you might struggle to meet customer expectations or adapt to changes in the market.


What Does Clause 7.1.6 Require?

ISO 9001:2015 requires organizations to:

  1. Determine the knowledge required for their operations and quality management system (QMS).

  2. Maintain and share this knowledge within the organization as needed.

  3. Update knowledge as external factors change, such as technology advancements or market shifts.


The focus is on ensuring the right information is available to the right people at the right time.


How to Ensure Compliance with Clause 7.1.6

Here’s a step-by-step approach to ensure compliance:

1. Identify Key Knowledge Areas

  • Document critical information about your products, services, and processes.

  • Map out the knowledge needed for roles across your organization.

  • Capture lessons learned during projects or problem-solving activities.


2. Store and Protect Knowledge

  • Use a centralized system, such as a document management system, to store knowledge securely.

  • Protect sensitive information through access controls.


3. Share Knowledge Effectively

  • Train employees regularly to ensure they understand and can apply the knowledge in their work.

  • Use tools like intranets, manuals, and workshops to disseminate information.


4. Adapt to Changes

  • Stay informed about industry trends, regulatory updates, and customer feedback.

  • Regularly review and update your documentation to reflect these changes.


5. Plan for Knowledge Retention

  • Ensure critical knowledge isn’t lost when employees leave by documenting processes and mentoring successors.


What to Have in Place for an Audit

To demonstrate compliance during an audit, you’ll need tangible evidence. Here’s what you should prepare:

  1. Documented Evidence

    • Procedures or policies related to knowledge management.

    • Records of training sessions, workshops, or meetings.

    • Updated process documentation or manuals.


  2. Knowledge Retention Plan

    • A strategy to retain critical knowledge during transitions or employee turnover.


  3. Examples of Knowledge Sharing

    • Minutes from meetings where lessons learned were discussed.

    • Communication records, such as emails or intranet posts, sharing updates with employees.


  4. Evidence of Monitoring and Updating Knowledge

    • Records of reviews or updates made to your knowledge base.

    • Feedback or suggestions from employees, customers, or suppliers.


Why Organizational Knowledge Matters

Effectively managing organizational knowledge benefits your business by:

  • Improving decision-making and reducing errors.

  • Enhancing employee performance and satisfaction.

  • Increasing your ability to adapt to change and innovate.


By complying with ISO 9001:2015 Clause 7.1.6, you create a more resilient and knowledgeable organization capable of delivering consistent quality.


In conclusion, organizational knowledge is not just a compliance requirement—it’s a cornerstone of sustainable success. By identifying, storing, sharing, and updating critical information, your business can ensure smooth operations and a competitive edge. Preparing well for an audit by keeping evidence of these efforts will demonstrate your commitment to quality management.


Got questions about implementing ISO 9001:2015 or managing organizational knowledge? Feel free to reach out to us for expert guidance!



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