ISO 9001:2015 introduces a new structure, referred to as the "high-level structure" (HLS), which is designed to streamline the integration of quality management systems with other management standards. This structure makes it easier for organizations to adopt multiple management systems simultaneously. In this article, we break down the ISO 9001:2015 structure and how it impacts the transition process from ISO 9001:2008.

What is the High-Level Structure?

The High-Level Structure (HLS) is a standardized framework for management system standards, designed to make it easier for organizations to align and integrate various management systems. It consists of a common set of clauses that are shared across ISO management standards. The new structure in ISO 9001:2015 includes the following key sections:

• Context of the Organization: Identifying internal and external issues that affect the QMS.
• Leadership: Emphasizing the need for top management to take ownership of the QMS and its effectiveness.
• Planning: Identifying risks and opportunities, setting quality objectives, and aligning resources.
• Support: Managing resources, competence, awareness, and communication.
• Operation: Controlling operations and processes effectively.
• Performance Evaluation: Monitoring, measuring, analyzing, and evaluating performance.
• Improvement: Driving continual improvement of the QMS.

Benefits of the High-Level Structure

The adoption of the HLS offers several benefits for organizations transitioning to ISO 9001:2015:

• Streamlined Integration: Organizations that are implementing multiple ISO standards (e.g., ISO 14001, ISO 45001) will find it easier to integrate their systems.
• Improved Efficiency: A more standardized structure means reduced duplication of efforts and better alignment of resources.
• Clearer Structure: The high-level structure provides a more logical and clear framework for organizations to follow, making it easier to understand and implement.

Conclusion

The introduction of the high-level structure in ISO 9001:2015 makes the transition from ISO 9001:2008 smoother and more efficient. By understanding the structure and its components, organizations can streamline the implementation process and ensure compliance with the new standard. For more details on the transition process and the high-level structure, visit QMII's registration page.