ISO 9001 CHAPTER 1

Question 1

What does ISO stand for?

Answer 1

International Organization for Standardization.

Question 2

What is ISO 9001?

Answer 2

ISO 9001 is an international standard for quality management systems (QMS).

Question 3

What is the main purpose of ISO 9001?

Answer 3

To ensure that organizations consistently meet customer and regulatory requirements.

Question 4

Which organization is responsible for developing ISO 9001?

Answer 4

The International Organization for Standardization (ISO).

Question 5

What does QMS stand for?

Answer 5

Quality Management System.

Question 6

What is the key principle of ISO 9001?

Answer 6

A focus on customer satisfaction through the continuous improvement of processes.

Question 7

How often is ISO 9001 updated?

Answer 7

Approximately every 5–7 years.

Question 8

What is the current version of ISO 9001?

Answer 8

ISO 9001:2015.

Question 8

What is the Plan-Do-Check-Act (PDCA) cycle in ISO 9001?

Answer 8

A four-step model for continuous improvement of processes.

Question 9

What does the “Plan” stage in PDCA involve?

Answer 9

Establishing objectives and processes necessary to deliver results in accordance with customer requirements.

Question 10

What does the “Do” stage in PDCA involve?

Answer 10

Implementing the processes as planned.

Question 11

What does the “Check” stage in PDCA involve?

Answer 11

Monitoring and measuring processes and product/service results to ensure objectives are met.

Question 12

What does the “Act” stage in PDCA involve?

Answer 12

Taking action to continually improve process performance.

Question 13

What are the 7 Quality Management Principles in ISO 9001?

Answer 13

Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, relationship management.

Question 14

What is the customer focus principle?

Answer 14

Understanding and meeting customer needs and striving to exceed expectations.

Question 15

What is the leadership principle?

Answer 15

Leaders at all levels establish unity of purpose and direction to ensure alignment with the QMS.

Question 16

What is the process approach principle?

Answer 16

Managing activities as interconnected processes to achieve consistent and predictable results.

Question 17

What is the importance of risk-based thinking in ISO 9001:2015?

Answer 17

To address potential risks and opportunities, ensuring processes can achieve desired outcomes.

Question 18

What is the scope of ISO 9001?

Answer 18

It applies to any organization, regardless of size or industry, that wants to improve its QMS.

Question 19

What is “documented information” in ISO 9001?

Answer 19

Information that must be controlled and maintained, including procedures, records, and documented processes.

Question 20

What are internal audits in ISO 9001?

Answer 20

Regular assessments conducted to ensure the QMS is effective and meets ISO 9001 requirements.

Question 21

What is nonconformity in ISO 9001?

Answer 21

A failure to meet a requirement of the ISO 9001 standard.

Question 22

What is a corrective action in ISO 9001?

Answer 22

Steps taken to eliminate the cause of nonconformity to prevent recurrence.

Question 23

How does ISO 9001 relate to continual improvement?

Answer 23

It emphasizes ongoing improvement of processes and the QMS to increase effectiveness and efficiency.

Question 24

What is “context of the organization” in ISO 9001?

Answer 24

Understanding internal and external factors that can affect the QMS and organizational goals.