ISO 9001:2026 | Todo lo que DEBES saber sobre la nueva versión
Changes in ISO 9001:2026 Explained
Overview of ISO 9001:2026
- The speaker introduces the changes in the new version of ISO 9001:2026, which focuses on implementing best practices for quality management systems within organizations.
- Emphasizes that all ISO standards are based on the Plan-Do-Check-Act cycle, with the 2026 version incorporating risk-based thinking.
Key Concepts and Structure
- The process approach allows organizations to plan their processes and interactions effectively to deliver products or services that meet customer needs.
- The goal is to enhance customer satisfaction by providing products that align with expectations, highlighting the importance of a quality management system.
Requirements Breakdown
Context of the Organization (4.1)
- Organizations must identify internal and external issues relevant to their quality management system, including considerations like climate change. Monitoring updates related to this understanding is essential.
Understanding Stakeholder Needs (4.2)
- Engaging with stakeholders is crucial for planning a quality management system based on their expectations and requirements, including potential climate-related concerns from these parties.
Determining Scope (4.3)
- Clarification of the scope for the quality management system is necessary; justifications are required when certain requirements do not apply. No significant changes were noted here compared to previous versions.
System Operation (4.x)
- After determining scope, organizations need to establish how their quality management system will function while maintaining continuous improvement through established processes and interactions as per standard requirements. Documentation must support operations and provide evidence of compliance with planned processes.
Leadership Commitment (5.x)
- Leadership plays a critical role in ensuring effective implementation of quality policies and integration of standard requirements into the management system, emphasizing resource allocation and communication about quality's importance for achieving desired outcomes. A focus on promoting a culture of quality and ethical behavior has been added as part of leadership responsibilities in this version.
Leadership and Customer Focus in Quality Management
Leadership Commitment to Customer Focus
- The leadership must demonstrate commitment to customer focus, ensuring that customer requirements and applicable statutory regulations are systematically determined, understood, and met.
- Emphasis is placed on understanding and fulfilling these requirements based on the "Yuran Trilogy," which discusses effective communication of these requirements to customers.
Addressing Risks and Opportunities
- The customer focus requirement mandates identifying risks and opportunities that could impact product conformity and enhance customer satisfaction.
- Continuous improvement should be maintained without significant changes; policies must align with organizational purpose, provide a framework for quality objectives, and ensure stakeholder communication.
Roles and Responsibilities in Quality Management
- Senior management is responsible for assigning roles clearly, ensuring compliance with good practices in quality management systems (QMS), and promoting a customer-focused approach throughout the organization.
- Integration of QMS should be ensured during planning and implementation of changes while maintaining standardization regardless of any modifications.
Risk Management Changes in Quality Systems
Importance of Risk Identification
- A notable change emphasizes addressing opportunities alongside risks; organizations must understand their context to effectively manage both aspects.
- Actions to address risks should be established through processes that determine, analyze, and evaluate potential adverse effects on the QMS's capability.
Strategic Planning for Quality Management
- Organizations need to implement actions within their QMS processes after evaluating identified risks. This involves strategic planning aligned with the Plan-Do-Check-Act cycle.
Opportunities in Quality Management
Establishing Processes for Opportunities
- Organizations are required to establish processes for identifying opportunities that can positively affect their ability to consistently deliver conforming products/services.
Action Plans for Improvement
- Actions addressing opportunities may include adopting new practices or technologies, exploring new markets, or forming partnerships. These strategies aim at enhancing organizational capabilities.
Quality Objectives Planning
Setting Measurable Goals
- While there are no major changes regarding quality objectives planning, it remains crucial that goals are coherent, measurable (if feasible), relevant to product/service conformity, communicated effectively, monitored regularly, updated as necessary, and documented appropriately.
Quality Management System Planning
Importance of Customer Satisfaction and Relevant Objectives
- The discussion emphasizes the significance of customer satisfaction in establishing relevant objectives for product or service compliance and improvement.
- It highlights the need to set goals that align with the organization's offerings, pushing for a focus on quality management.
Planning Quality Management Objectives
- Key questions are raised regarding the planning process: Who will execute the objectives? What resources are necessary? Who is responsible for implementation?
- The importance of determining completion timelines and evaluation methods for results is stressed as part of effective planning.
Managing Changes in Quality Management Systems
- The transcript discusses how changes within the quality management system should be planned to ensure effective implementation and desired outcomes.
- Considerations during change planning include understanding the purpose and consequences of changes, maintaining system integrity, resource availability, responsibility allocation, and evaluating change effectiveness.