ISO 9001

Question 1

What is the main purpose of Clause 1 in ISO 9001:2015?

Answer 1

To define the scope and applicability of the standard to organizations.

Question 2

What does ISO 9001:2015 aim to achieve?

Answer 2

Consistent product and service quality and enhanced customer satisfaction.

Question 3

Is ISO 9001:2015 applicable to all types and sizes of organizations?

Answer 3

Yes, it is designed to be generic and applicable to any organization.

Question 4

What must an organization demonstrate to conform to ISO 9001:2015?

Answer 4

Its ability to meet customer and regulatory requirements.

Question 5

What is the normative reference for ISO 9001:2015?

Answer 5

ISO 9000:2015 – Fundamentals and vocabulary.

Question 6

Why is ISO 9000:2015 important in the context of ISO 9001:2015?

Answer 6

It provides definitions and terminology needed to understand the standard.

Question 7

Where are the terms and definitions for ISO 9001:2015 specified?

Answer 7

In ISO 9000:2015.

Question 8

Why is using standard terminology important in ISO 9001:2015?

Answer 8

For consistent understanding and implementation of requirements.

Question 9

What must an organization determine about its context?

Answer 9

Internal and external issues affecting its QMS.

Question 10

Why should interested parties be identified?

Answer 10

Their needs can affect the QMS’s ability to deliver quality.

Question 11

What must organizations determine about interested parties?

Answer 11

Their relevant needs and expectations.

Question 12

What inputs are required to determine QMS scope?

Answer 12

Context, interested parties, products, and services.

Question 13

What should the documented scope of the QMS include?

Answer 13

Types of products/services and justification for non-applicable requirements.

Question 14

What does Clause 4.4 require regarding QMS processes?

Answer 14

They must be established, implemented, maintained, and improved.

Question 15

What is required from top management under Clause 5?

Answer 15

Leadership and commitment to the QMS.

Question 16

What must the quality policy align with?

Answer 16

The organization’s context and strategic direction.

Question 17

What should top management promote?

Answer 17

Process approach and risk-based thinking.

Question 18

What is the role of leadership in customer focus?

Answer 18

Ensuring customer needs are understood and met.

Question 19

What must top management assign?

Answer 19

Roles, responsibilities, and authorities within the organization.

Question 20

What must an organization address during planning?

Answer 20

Risks and opportunities that affect the QMS.

Question 21

What should quality objectives be?

Answer 21

Measurable, consistent with policy, and regularly updated.

Question 22

What does Clause 6.3 cover?

Answer 22

Planning of changes in a controlled manner.

Question 23

What resources must be provided for the QMS?

Answer 23

People, infrastructure, environment, and organizational knowledge.

Question 24

What does Clause 7.2 focus on?

Answer 24

Competence of personnel.

Question 25

What should employees be aware of regarding the QMS?

Answer 25

Policy, objectives, and their contribution to effectiveness.

Question 26

What is the purpose of internal communication?

Answer 26

To ensure people are aware of their role in the QMS.

Question 27

What is required for documented information?

Answer 27

It must be controlled, maintained, and available when needed.

Question 28

What does Clause 8 cover?

Answer 28

Operational planning and control to meet product/service requirements.

Question 29

What is required before accepting a customer order?

Answer 29

A review of customer and statutory requirements.

Question 30

What is included in design and development controls?

Answer 30

Planning, inputs, outputs, verification, and changes.

Question 31

What does Clause 8.4 cover?

Answer 31

Control of externally provided processes, products, and services.

Question 32

What is the purpose of post-delivery activities?

Answer 32

To meet customer and legal obligations after product delivery.

Question 33

When can products/services be released to the customer?

Answer 33

After verification of conformity to requirements.

Question 34

What must be done with nonconforming outputs?

Answer 34

Identify, control, and correct them.

Question 35

What does Clause 9 require about performance?

Answer 35

Monitoring, measurement, analysis, and evaluation.

Question 36

What must be done with customer feedback?

Answer 36

It must be collected and analyzed to gauge satisfaction.

Question 37

What is the purpose of internal audits?

Answer 37

To check QMS conformance and effectiveness.

Question 38

What should management reviews evaluate?

Answer 38

Performance, risks, customer feedback, and improvement needs.

Question 39

What is the focus of Clause 10?

Answer 39

Continual improvement of the QMS.

Question 40

What triggers corrective actions?

Answer 40

Nonconformities and complaints.

Question 41

What should the organization aim to improve?

Answer 41

Products, services, and the QMS itself.

Question 42

What evidence must be retained for corrective actions?

Answer 42

Description of nonconformities and actions taken.