ISO 9001 CHAPTER 3 Flashcards
(27 cards)
What is the main focus of Chapter 3 of ISO 9001?
Planning for the Quality Management System (QMS), including setting objectives, identifying risks, and determining actions to achieve the desired outcomes.
What does ISO 9001 require organizations to consider when planning for the QMS?
The context of the organization, the needs and expectations of interested parties, and the scope of the QMS.
What are “quality objectives” in ISO 9001?
Specific, measurable goals aligned with the quality policy and focused on improving the QMS and customer satisfaction.
How should quality objectives be established according to ISO 9001?
They must be measurable, communicated, and regularly reviewed to ensure they are being met.
What does ISO 9001 require in terms of planning to achieve quality objectives?
Organizations must determine what will be done, the resources required, who will be responsible, and how results will be evaluated.
What is “risk-based thinking” in the context of QMS planning?
A proactive approach to identifying and addressing risks and opportunities that could impact the QMS and its objectives.
What is the purpose of addressing risks in QMS planning?
To prevent or reduce undesired effects and ensure that the organization can meet its quality objectives.
What are “opportunities” in the context of ISO 9001 planning?
Potential positive impacts or improvements that can be identified and leveraged to enhance the QMS or achieve better outcomes.
How does ISO 9001 suggest organizations address risks and opportunities?
Through risk assessments, preventive actions, and strategies to exploit opportunities to enhance performance.
Why is it important to integrate actions to address risks and opportunities into the QMS processes?
To ensure they are part of everyday operations and are aligned with organizational goals.
What should organizations do when risks are identified during the planning phase?
Take appropriate actions to mitigate risks and ensure the QMS remains effective.
What is the role of “change management” in QMS planning?
Organizations must plan and implement changes to the QMS in a controlled manner to ensure continued conformity to ISO 9001 requirements.
What factors should be considered when planning for changes in the QMS?
The purpose of the change, the potential consequences, resource availability, and the impact on responsibilities and authorities.
What is meant by “resource planning” in ISO 9001?
Ensuring that the organization has sufficient resources (e.g., personnel, infrastructure) to meet the quality objectives.
How should organizations ensure the availability of resources for the QMS?
By identifying the resources needed, allocating them effectively, and monitoring their usage to ensure quality objectives are achieved.
What is “competence” in the context of ISO 9001 planning?
Ensuring that employees have the necessary skills, training, and qualifications to perform their roles within the QMS.
How does ISO 9001 address the need for competence in QMS planning?
Organizations must determine the necessary competencies for each role and ensure that employees receive appropriate training.
What is the role of “awareness” in QMS planning?
Ensuring that employees are aware of the quality policy, their contribution to the QMS, and the importance of their roles in meeting quality objectives.
What is the significance of “internal communication” in QMS planning?
It ensures that relevant information about the QMS is effectively communicated within the organization.
What should organizations communicate internally regarding the QMS?
The importance of meeting customer requirements, the quality policy, quality objectives, and the outcomes of QMS performance evaluations.
What role does “documented information” play in QMS planning?
Documented information supports the QMS by providing evidence of conformity to ISO 9001 requirements and effective operation.
What is the requirement for “control of documented information” in ISO 9001?
Organizations must establish controls for the creation, updating, and management of documented information to ensure it remains accurate and available.
Why is it important to monitor and review the QMS plan?
To ensure that the planned actions are effective and the organization is on track to meet its quality objectives.
