ISO 9001 CHAPTER 2 Flashcards
What is the focus of Chapter 2 of ISO 9001?
The context of the organization and leadership, outlining how organizations should define their environment and establish leadership roles for a successful QMS.
What does “context of the organization” refer to in ISO 9001?
The external and internal factors that affect the organization’s ability to achieve its intended outcomes.
Why is understanding the context of the organization important in ISO 9001?
It helps identify opportunities and risks, ensuring the QMS is aligned with the strategic direction of the organization.
What are the two key factors to consider under “context of the organization”?
Internal factors (e.g., organizational structure) and external factors (e.g., market conditions, regulations).
What is the role of “interested parties” in ISO 9001?
Identifying the relevant stakeholders (e.g., customers, suppliers) whose needs and expectations influence the QMS.
What is leadership’s responsibility in ISO 9001?
Ensuring that the QMS is established, maintained, and integrated into the organization’s overall management processes.
How does ISO 9001 define “top management”?
The person or group of people who direct and control the organization at the highest level.
What is the leadership’s role in promoting customer focus?
Leaders must ensure that customer requirements are understood and consistently met, aiming to enhance customer satisfaction.
What does “quality policy” mean in ISO 9001?
A formal statement from top management outlining the organization’s commitment to quality and customer satisfaction.
What is the significance of the quality policy in ISO 9001?
It provides a framework for setting quality objectives and is a key part of leadership responsibilities.
How should a quality policy be communicated?
It must be communicated, understood, and applied throughout the organization.
What are quality objectives in ISO 9001?
Measurable goals set by the organization that support the achievement of the quality policy.
What role does leadership play in the planning of the QMS?
Leadership must ensure that the QMS is properly planned, including setting objectives, assessing risks, and allocating resources.
What is the importance of assigning roles, responsibilities, and authorities in ISO 9001?
To ensure that individuals at all levels understand their contribution to the QMS and the achievement of quality objectives.
Who is responsible for ensuring the QMS conforms to ISO 9001 requirements?
Top management must assign responsibility for ensuring that the QMS meets ISO 9001 requirements.
What is the role of a “management representative” in ISO 9001?
This role is no longer explicitly required in ISO 9001:2015, but organizations must still assign responsibilities for QMS conformity.
How does leadership demonstrate a commitment to the QMS?
By actively participating in QMS reviews, setting objectives, and promoting a culture of continuous improvement.
What is “risk-based thinking” in ISO 9001?
A strategic approach where organizations identify risks and opportunities to ensure the QMS achieves its intended outcomes.
What is the purpose of addressing risks and opportunities in the QMS?
To prevent undesired effects and enhance the ability to achieve QMS goals.
How should organizations address identified risks in ISO 9001?
By integrating risk management into the QMS planning and taking appropriate actions to mitigate risks.
What does the “support” clause in ISO 9001 address?
It outlines the resources, competence, awareness, and communication needed to support the QMS.
What is the significance of resource management in ISO 9001?
Leadership must ensure that sufficient resources (e.g., personnel, infrastructure) are available to implement the QMS effectively.
What is the importance of communication in ISO 9001?
Effective internal and external communication ensures that all relevant parties are informed about the QMS and its performance.
How is competence defined in ISO 9001?
Ensuring that employees are qualified, trained, and competent to perform tasks that affect the QMS.
What is the objective of ISO 9001’s requirement for awareness?
Employees should be aware of the quality policy, their roles in the QMS, and how they contribute to its success.
