ISO 9001 CHAPTER 1 Flashcards
(25 cards)
What does ISO stand for?
International Organization for Standardization.
What is ISO 9001?
ISO 9001 is an international standard for quality management systems (QMS).
What is the main purpose of ISO 9001?
To ensure that organizations consistently meet customer and regulatory requirements.
Which organization is responsible for developing ISO 9001?
The International Organization for Standardization (ISO).
What does QMS stand for?
Quality Management System.
What is the key principle of ISO 9001?
A focus on customer satisfaction through the continuous improvement of processes.
How often is ISO 9001 updated?
Approximately every 5–7 years.
What is the current version of ISO 9001?
ISO 9001:2015.
What is the Plan-Do-Check-Act (PDCA) cycle in ISO 9001?
A four-step model for continuous improvement of processes.
What does the “Plan” stage in PDCA involve?
Establishing objectives and processes necessary to deliver results in accordance with customer requirements.
What does the “Do” stage in PDCA involve?
Implementing the processes as planned.
What does the “Check” stage in PDCA involve?
Monitoring and measuring processes and product/service results to ensure objectives are met.
What does the “Act” stage in PDCA involve?
Taking action to continually improve process performance.
What are the 7 Quality Management Principles in ISO 9001?
Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, relationship management.
What is the customer focus principle?
Understanding and meeting customer needs and striving to exceed expectations.
What is the leadership principle?
Leaders at all levels establish unity of purpose and direction to ensure alignment with the QMS.
What is the process approach principle?
Managing activities as interconnected processes to achieve consistent and predictable results.
What is the importance of risk-based thinking in ISO 9001:2015?
To address potential risks and opportunities, ensuring processes can achieve desired outcomes.
What is the scope of ISO 9001?
It applies to any organization, regardless of size or industry, that wants to improve its QMS.
What is “documented information” in ISO 9001?
Information that must be controlled and maintained, including procedures, records, and documented processes.
What are internal audits in ISO 9001?
Regular assessments conducted to ensure the QMS is effective and meets ISO 9001 requirements.
What is nonconformity in ISO 9001?
A failure to meet a requirement of the ISO 9001 standard.
What is a corrective action in ISO 9001?
Steps taken to eliminate the cause of nonconformity to prevent recurrence.
How does ISO 9001 relate to continual improvement?
It emphasizes ongoing improvement of processes and the QMS to increase effectiveness and efficiency.
