ISO ( 2 )

Question 1

What is the purpose of ISO 9001:2015?

Answer 1

To specify requirements for a quality management system (QMS) that consistently provides products and services meeting customer and regulatory requirements, and enhances customer satisfaction.

Question 2

What is the PDCA cycle and why is it important in ISO 9001?

Answer 2

Plan-Do-Check-Act; it’s the model ISO 9001 uses to structure continual improvement.

Question 3

What are the 7 Quality Management Principles?

Answer 3

Customer focus, Leadership, Engagement of people, Process approach, Improvement, Evidence-based decision making, Relationship management.

Question 4

How many main clauses are in ISO 9001:2015 (excluding scope, normative, terms)?

Answer 4

7 (Clauses 4–10).

Question 5

Which clause is about Leadership?

Answer 5

Clause 5.

Question 6

Which clause covers Planning?

Answer 6

Clause 6.

Question 7

Which clause covers Performance Evaluation?

Answer 7

Clause 9.

Question 8

Which clause focuses on Context of the Organization?

Answer 8

Clause 4.

Question 9

What does Clause 4.1 require organizations to determine?

Answer 9

Internal and external issues relevant to its purpose and strategic direction.

Question 10

What does Clause 4.2 cover?

Answer 10

Needs and expectations of interested parties.

Question 11

What is required in Clause 4.3?

Answer 11

Determining the scope of the QMS.

Question 12

What does Clause 4.4 require?

Answer 12

Establishing the QMS and its processes.

Question 13

What must top management demonstrate under Clause 5.1.1?

Answer 13

Leadership and commitment to the QMS.

Question 14

What does Clause 5.2 require?

Answer 14

Establishing, maintaining, and communicating a quality policy.

Question 15

What’s the role of organizational roles, responsibilities, and authorities (5.3)?

Answer 15

To ensure accountability and authority for the QMS.

Question 16

What does 6.1 require organizations to address?

Answer 16

Risks and opportunities.

Question 17

What does 6.2 require?

Answer 17

Setting quality objectives and planning to achieve them.

Question 18

What does Clause 7.2 cover?

Answer 18

Competence of personnel.

Question 19

What does Clause 7.5 require?

Answer 19

Documented information to be controlled and maintained.

Question 20

What is Clause 8.5 about?

Answer 20

Production and service provision.

Question 21

What is required in Clause 8.7?

Answer 21

Control of nonconforming outputs.

Question 22

What is Clause 9.2 about?

Answer 22

Internal audits.

Question 23

What is Clause 9.3 about?

Answer 23

Management review.

Question 24

What does Clause 10.2 require?

Answer 24

Corrective action for nonconformities.

Question 25

What is the emphasis of Clause 10.3?

Answer 25

Continual improvement of the QMS.