ISO 9001 : 2015

ISO 9001 : 2015 is an international standard for Quality Management Systems (QMS). It provides a framework and guidelines for organizations to ensure they meet customer requirements and enhance overall satisfaction by improving processes, products, and services. Here are the key features and changes introduced in the 2015 version.

• Context of the Organization : Organizations are required to understand their internal and external environments, the needs and expectations of interested parties (such as customers, suppliers, regulators), and how these affect their QMS.
• Leadership : Greater emphasis on leadership commitment. Top management must be actively involved in implementing and maintaining the QMS, not just delegate it. The standard emphasizes customer focus and ensuring the alignment of quality objectives with business strategies.
• Planning : Organizations must assess risks and opportunities to ensure the QMS can achieve its intended outcomes, prevent or reduce undesired effects, and ensure continual improvement. Quality objectives must be measurable and aligned with the strategic goals of the organization.
• Support : This includes the availability of resources (such as people, infrastructure, and technology) necessary for the effective operation of the QMS. Emphasis is placed on competence, awareness, and communication.
• Operation : Organizations must plan, implement, and control the processes needed to deliver products and services that meet customer requirements and ensure quality. A focus on managing change and making decisions based on evidence.
• Performance Evaluation : There is an increased emphasis on monitoring, measuring, analyzing, and evaluating the performance of the QMS. This includes both customer satisfaction and internal audits to identify areas for improvement.
• Improvement : A continuous improvement approach is central to the standard. Organizations should identify opportunities for improvement, take corrective actions when needed, and manage changes to ensure consistent quality performance.

• Structure Alignment with Other Standards : The 2015 version adopts the "High-Level Structure" (HLS), which aligns it with other management system standards (like ISO 14001 : 2015), making it easier for organizations to integrate multiple management systems.
• Risk-Based Thinking : There is a stronger focus on risk-based thinking throughout the standard. Organizations are required to identify risks and opportunities that could impact the achievement of quality objectives.
• No Requirement for Preventive Actions : In previous versions, organizations were required to have preventive actions. In the 2015 version, the focus is more on risk-based thinking, and preventive actions are now considered part of the planning process.
• Leadership Engagement : The 2015 revision places more emphasis on the role of top management. Top leaders are expected to demonstrate leadership and commitment to the QMS, and their involvement is critical in setting the direction for quality objectives.
• Documentation Flexibility : The 2015 version allows more flexibility regarding documentation. The requirement for a Quality Manual and prescribed documented procedures has been removed. Organizations can use any format or method that best suits their needs, provided they meet the requirements of the standard.

• Improved Efficiency and Productivity : By refining processes and focusing on continual improvement.
• Customer Satisfaction : Consistently meeting customer needs leads to improved loyalty and satisfaction.
• Risk Management : By focusing on risk and opportunities, organizations can proactively prevent issues.
• Market Competitiveness : The ISO 9001 certification can improve an organization's credibility and increase business opportunities.

• To become certified, an organization must implement the ISO 9001 : 2015 standard, undergo an internal audit, and then pass an external audit conducted by a third-party certification body.
• Recertification and surveillance audits typically occur every 1-3 years.

In conclusion, ISO 9001 : 2015 aims to create a culture of continuous improvement, customer satisfaction, and effective quality management throughout an organization.