ISO 9001:2015 Clause 7.1.6

What is ISO 9001:2015 Clause 7.1.6?

Clause 7.1.6 of ISO 9001:2015 is titled “Organizational Knowledge.” This clause emphasizes the importance of managing organizational knowledge to enhance the organization’s ability to achieve its intended outcomes, maintain and improve its quality management system, and foster innovation.

Key points outlined in Clause 7.1.6 include:

Determining Knowledge Requirements:

The organization is required to determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

Maintaining Knowledge:

The organization should maintain the knowledge it has determined to be necessary, and this knowledge can include both explicit (documented) and tacit (in the minds of individuals) knowledge.

Ensuring the Availability of Knowledge:

The organization is expected to ensure that the necessary knowledge is available when and where it is needed.

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Updating and Sharing Knowledge:

• There is a focus on continually updating organizational knowledge to reflect changes in the external and internal context.
• The organization is encouraged to share knowledge within the organization to facilitate effective decision-making and improve overall performance.

Applying Knowledge:

The organization is expected to apply its knowledge to achieve conformity of products and services, address risks and opportunities, and support innovation.

Capturing and Sharing Lessons Learned:

The standard encourages the organization to capture and share lessons learned from past experiences, both positive and negative, to facilitate improvement.

Training and Awareness:

Organizations are required to ensure that employees are aware of the importance of conformity with the quality management system requirements and the potential consequences of not conforming.

Documenting and Communicating Knowledge:

While the standard does not prescribe a specific documentation requirement, organizations are expected to document and communicate relevant knowledge where necessary.

The intent of Clause 7.1.6 is to emphasize the role of organizational knowledge in the effectiveness of the quality management system. By actively managing and leveraging knowledge, organizations can enhance their ability to adapt to changes, make informed decisions, and continuously improve their processes and products/services.

Other ISO 9001:2015 Clauses:

• The Complete Clause 7
• Clause 7.1.1
• Clause 7.1.2
• Clause 7.1.3
• Clause 7.1.4
• Clause 7.1.5
• Clause 7.2
• Clause 7.3
• Clause 7.4
• Clause 7.5
• Clause 7.5.1
• Clause 7.5.2
• Clause 7.5.3

How does a Company comply with Clause 7.1.6?

Compliance with Clause 7.1.6 of ISO 9001:2015, which focuses on “Organizational Knowledge,” involves implementing processes and practices that effectively manage and leverage knowledge within the organization. Here are steps and considerations to help a company comply with this clause:

Identify Knowledge Requirements:

Determine the knowledge necessary for the operation of your processes and for achieving conformity of products and services.

Document Knowledge:

Document explicit knowledge, such as procedures, guidelines, and instructions, that is essential for the effective operation of processes.

Capture Tacit Knowledge:

Recognize the importance of tacit knowledge, which is often held by individuals, and implement mechanisms to capture, share, and transfer this knowledge within the organization.

Maintain a Knowledge Repository:

Establish a central knowledge repository or system where relevant organizational knowledge is stored and easily accessible to those who need it.

Continuous Updating:

Regularly update the knowledge repository to reflect changes in the external and internal context, ensuring that the information remains current and relevant.

Sharing Knowledge:

Create a culture that encourages the sharing of knowledge among employees. Use platforms, meetings, and communication channels to facilitate knowledge exchange.

Lessons Learned Process:

Implement a process for capturing and sharing lessons learned from both positive and negative experiences. Ensure that these lessons inform decision-making and improvements.

Training and Awareness:

Provide training to employees to enhance their awareness of the importance of conformity with the quality management system requirements. Make employees aware of the potential consequences of non-conformance.

Incorporate Knowledge into Decision-Making:

Encourage the application of organizational knowledge in decision-making processes. Ensure that knowledge is used to address risks and opportunities and to support innovation.

Measure and Monitor Knowledge Management:

Establish metrics or key performance indicators (KPIs) to measure the effectiveness of knowledge management processes. Monitor these metrics to identify areas for improvement.

Feedback Mechanisms:

Implement feedback mechanisms to gather input from employees regarding the effectiveness of knowledge management processes. Use this feedback to make continuous improvements.

Integrate with QMS Processes:

Integrate knowledge management processes with other processes within the quality management system to ensure a cohesive and coordinated approach.

While ISO 9001:2015 does not prescribe specific documentation requirements for organizational knowledge, it emphasizes the need for effective knowledge management practices. The focus should be on practical measures that help the organization leverage its collective knowledge to achieve its objectives and continually improve its performance. Compliance with Clause 7.1.6 is not a one-time activity but requires ongoing attention and adaptation to changing circumstances.

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