ISO 9001:2015. Capítulo N° 6. Planificación (interpretación)

Actions to Address Risks and Opportunities in Quality Management System Planning

This section discusses the importance of considering the organization and its context, as well as the needs and expectations of stakeholders when planning a quality management system. It also emphasizes the need to determine risks and opportunities.

Determining Risks and Opportunities

• Risks can be identified by avoiding or assuming them, pursuing opportunities, eliminating sources of risk, changing probability or consequences, and making informed decisions.

• Opportunities can be identified by adopting new practices, launching new products, opening new markets, engaging with new customers, establishing partnerships, and utilizing new technologies.

Objectives of Quality Management System Planning

• The organization should plan actions related to risks and opportunities.

• These actions should be integrated into processes and evaluated for effectiveness.

• Quality objectives should be established in line with the quality policy.

• Objectives should be measurable, relevant to product/service conformity and customer satisfaction.

• Objectives should be monitored, communicated, updated as necessary, and documented.

Planning How to Achieve Organizational Objectives

This section focuses on planning how to achieve organizational objectives within a quality management system. It highlights the importance of determining actions, required resources, responsibilities, timelines, and evaluation methods.

Planning Organizational Objectives

• Determine what needs to be done to achieve organizational objectives.

• Identify required resources.

• Assign responsibilities for each task.

• Establish timelines for completion.

• Define evaluation methods for assessing results.

Planning Changes in Quality Management System

This section discusses the planning process for changes in a quality management system. It emphasizes considering the purposes and potential consequences of changes while maintaining the integrity of the system.

Planning Changes

• Consider the purposes and potential consequences of changes.

• Analyze resource availability.

• Assign responsibilities and authorities accordingly.