ISO 9000:2015

Question 1

Clause 2 - Fundamental concepts and quality Management principles

Answer 1

2.2. Fundamental concepts
2.3. Quality management principles
2.4. Developing the QMS using fundamental concepts and principles

Question 2

Clauses 3. Terms and Definitions

Answer 2

3:1. Terms related to person or people
3.2. Terms related to organization
3:3. Terms related to activity
3.4. Thens related to process
3.5. Terms related to system
3.6. Terms related to requirement
3.7. Terms related to result
3.8. Terms related to data, information and document
3.9. Terms related to customer
3.10. Terms related to characteristic
3.11. Terms related to determination
3.12. Terms related to action
3.13. Terms related to audit

Question 3

2.2. Fundamental concepts

Answer 3

2.2.1. Quality
2.2.2. Quality management system
2.2:3. Context of an organization
2.2.4. Interested party
2.2.5. Support

Question 4

2.3 Quality management principles

Answer 4

2.3.1 Customer focus
2.3.2 Leadership
2.3.3 Engagement of people
2.3.4 Process approach
2.3.5 Improvement
2.3.6 Evidence-based decision making
2.3.7 Relationship management

Question 5

2.4 Developing the QMS using fundamental concepts and principles

Answer 5

2.4.1 QMS model
2.4.2 Development of a QMS
2.4.3 QMS standards, other management systems and excellence models

Question 6

2.2.1 Quality

An organization focused on quality promotes a culture that results in the __,__,__and___ that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties.

Answer 6

behaviour, attitudes, activities and processes

Question 7

2.2.1 Quality

The quality of an organization’s products and services is determined by the ability to__ customers and the intended and unintended impact on __ __

Answer 7

Satisfy, relevant interested parties

Question 8

2.2.1 Quality

The quality of products and services includes not only their intended function and performance, but also their __ __ and benefit to the customer.

Answer 8

perceived value

Question 9

2.2.2 Quality management system

A QMS __ activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results.

Answer 9

comprises

Question 10

2.2.2 Quality management system

The QMS __ the interacting processes and resources required to provide value and realize results for relevant interested parties

Answer 10

manages

Question 11

2.2.2 Quality management system

The QMS __ top management to optimize the use of resources considering the long and short term consequences of their decision

Answer 11

enables

Question 12

2.2.2 Quality management system

A QMS __ the means to identify actions to address intended and unintended consequences in providing products and services.

Answer 12

provides

Question 13

Define which one of the 7 Quality management principles is being mentioned:

statement: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.

Answer 13

Clause 2.3.1 Customer Focus

Question 14

Define which one of the 7 Quality management principles is being mentioned:

Statement: ___ at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.

Answer 14

2.3.2 Leadership

___ = Leaders

Question 15

Define which one of the 7 Quality management principles is being mentioned:

Statement: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value.

Answer 15

2.3.3 Engagement of people

Question 16

Define which one of the 7 Quality management principles is being mentioned:

Statement

Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

Answer 16

2.3.4 Process approach

Question 17

Define which one of the 7 Quality management principles is being mentioned:

Statement

Successful organizations have an ongoing focus on improvement.

Answer 17

2.3.5 Improvement

Question 18

Define which one of the 7 Quality management principles is being mentioned:

Statement

___ based on the analysis and evaluation of data and information are more likely to produce desired results.

Answer 18

2.3.6 Evidence-based decision making

___ = Decisions

Question 19

Define which one of the 7 Quality management principles is being mentioned:

Statement

For sustained success, organizations manage their relationships with relevant interested parties, such as providers.

Answer 19

2.3.7 Relationship management

Question 20

Define which one of the 7 Quality management principles is being mentioned:

Keybenefits:
Some potential key benefits are:
— increased customer value
— increased customer satisfaction;
— improved customer loyalty;
— enhanced repeat business;
— enhanced reputation of the organization;
— expanded customer base;
— increased revenue and market share.

Answer 20

Clause 2:3 Customer Focus

Question 21

Define which one of the 7 Quality management principles is being mentioned:

Possible actions:
Possible actions include:
— recognize direct and indirect customers as those who receive value from the organization;
— understand customers’ current and future needs and expectations;
— link the organization’s objectives to customer needs and expectations; — communicate customer needs and expectations throughout the organization;
— plan, design, develop, produce, deliver and support products and services to meet customer needs and expectations;
— measure and monitor customer satisfaction and take appropriate actions; — determine and take action on relevant interested parties’ needs and appropriate expectations that can affect customer satisfaction;
— actively manage relationships with customers to achieve sustained success.

Answer 21

Clause 2:3 Customer Focus

Question 22

Define which one of the 7 Quality management principles is being mentioned:

Rationale: Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.

Answer 22

2.3.2 Leadership

Question 23

Define which one of the 7 Quality management principles is being mentioned:

Key benefits:
Some potential key benefits are:
— increased effectiveness and efficiency in meeting the organization’s quality objectives;
— better coordination of the organization’s processes;
— improved communication between levels and functions of the organization; — development and improvement of the capability of the organization and its people to deliver desired results.

Answer 23

2.3.2 Leadership

Question 24

Define which one of the 7 Quality management principles is being mentioned:

Possible actions:

— communicate the organization’s mission, vision, strategy, policies and processes throughout the organization; — create and sustain shared values, fairness and ethical models for behaviour at all levels of the organization;
— establish a culture of trust and integrity;
— encourage an organization-wide commitment to quality;
— ensure that leaders at all levels are positive examples to people in the organization;
— provide people with the required resources, training and authority to act with accountability;
— inspire, encourage and recognize the contribution of people.

Answer 24

2.3.2 Leadership

Question 25

Define which one of the 7 Quality management principles is being mentioned:

Rationale: In order to manage an organization effectively and efficiently, it is important to respect and involve all people at all levels. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization’s quality objectives

Answer 25

2.3.3 Engagement of people

Question 26

Define which one of the 7 Quality management principles is being mentioned:

Key benefits:
Some potential key benefits are:
— improved understanding of the organization’s quality objectives by people in the organization and increased motivation to achieve them;
— enhanced involvement of people in improvement activities;
— enhanced personal development, initiatives and creativity;
— enhanced people satisfaction;
— enhanced trust and collaboration throughout the organization;
— increased attention to shared values and culture throughout the organization.

Answer 26

2.3.3 Engagement of people

Question 27

Define which one of the 7 Quality management principles is being mentioned:

Possible actions:

Possible actions Possible actions include:
— communicate with people to promote understanding of the importance of their individual contribution;
— promote collaboration throughout the organization;
— facilitate open discussion and sharing of knowledge and experience; — empower people to determine constraints to performance and to take initiatives without fear;
— recognize and acknowledge people’s contribution, learning and improvement; — enable self-evaluation of performance against personal objectives;
— conduct surveys to assess people’s satisfaction, communicate the results and take appropriate actions.

Answer 27

2.3.3 Engagement of people

Question 28

Define which one of the 7 Quality management principles is being mentioned:

Rationale

The QMS consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.

Answer 28

2.3.4 Process approach

Question 29

Define which one of the 7 Quality management principles is being mentioned:

Keybenefits
Some potential key benefits are:
— enhanced ability to focus effort on key processes and opportunities for improvement;
— consistent and predictable outcomes through a system of aligned processes; — optimized performance through effective process management, efficient use of resources and reduced cross-functional barriers;
— enabling the organization to provide confidence to interested parties related to its consistency, effectiveness and efficiency.

Answer 29

2.3.4 Process approach

Question 30

Define which one of the 7 Quality management principles is being mentioned:

Possible actions
Possible actions include:
— define ojectives of the system and processes necessary to achieve them;
— establish authority, responsibility and accountability for managing processes;
— understand the organization’s capabilities and determine resource constraints prior to action;
— determine process interdependencies and analyse the effect of modifications to individual processes on the system as a whole;
— manage processes and their interrelations as a system to achieve the organization’s quality objectives effectively and efficiently;
— ensure the necessary information is available to operate and improve the processes and to monitor, analyse and evaluate the performance of the overall system;
— manage risks which can affect outputs of the processes and overall outcomes of the QMS.

Answer 30

2.3.4 Process approach

Question 31

Define which one of the 7 Quality management principles is being mentioned:

Rationale

Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

Answer 31

2.3.5 Improvement

Question 32

Define which one of the 7 Quality management principles is being mentioned:

Keybenefits
Some potential key benefits are:

— improved process performance, organizational capability and customer satisfaction;
— enhanced focus on root cause investigation and determination, followed by prevention and corrective actions;
— enhanced ability to anticipate and react to internal and external risks and opportunities;
— enhanced consideration of both incremental and breakthrough improvement;
— improved use of learning for improvement;
— enhanced drive for innovation.

Answer 32

2.3.5 Improvement

Question 33

Define which one of the 7 Quality management principles is being mentioned:

Possible actions
Possible actions include:

— promote establishment of improvement objectives at all levels of the organization;
— educate and train people at all levels on how to apply basic tools and methodologies to achieve improvement objectives;
— ensure people are competent to successfully promote and complete improvement projects;
— develop and deploy processes to implement improvement projects throughout the organization; — track, review and audit the planning, implementation, completion and results of improvement projects;
— integrate improvement consideration into development of new or modified products and services and processes;
— recognize and acknowledge improvement.

Answer 33

2.3.5 Improvement

Question 34

Define which one of the 7 Quality management principles is being mentioned:

Rationale

__-__ can be a complex process and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision making.

Answer 34

2.3.6 Evidence-based decision making

__-__ = Decision-making

Question 35

Define which one of the 7 Quality management principles is being mentioned:

Keybenefits
Some potential key benefits are:

— improved __-__ processes;
— improved assessment of process performance and ability to achieve objectives;
— improved operational effectiveness and efficiency;
— increased ability to review, challenge and change opinions and decisions;
— increased ability to demonstrate the effectiveness of past decisions.

Answer 35

2.3.6 Evidence-based decision making

__-__ = decision making

Question 36

Define which one of the 7 Quality management principles is being mentioned:

Possible actions
Possible actions include:

— determine, measure and monitor key indicators to demonstrate the organization’s performance;
— make all data needed available to the relevant people;
— ensure that data and information are sufficiently accurate, reliable and secure;
— analyse and evaluate data and information using suitable methods;
— ensure people are competent to analyse and evaluate data as needed;
— make decisions and take actions based on evidence, balanced with experience and intuition.

Answer 36

2.3.6 Evidence-based decision making

Question 37

Define which one of the 7 Quality management principles is being mentioned:

Rationale

Relevant interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. __ __ with its provider and partner networks is of particular importance.

Answer 37

2.3.7 Relationship management

__ __ = Relationship management

Question 38

Define which one of the 7 Quality management principles is being mentioned:

Keybenefits
Some potential key benefits are:

— enhanced performance of the organization and its relevant interested parties through responding to the opportunities and constraints related to each interested party;
— common understanding of objectives and values among interested parties;
— increased capability to create value for interested parties by sharing resources and competence and managing quality related risks;
— a well-managed supply chain that provides a stable flow of products and services.

Answer 38

2.3.7 Relationship management

Question 39

Define which one of the 7 Quality management principles is being mentioned:

Possible actions
Possible actions include:

— determine relevant interested parties (such as providers, partners, customers, investors, employees or society as a whole) and their relationship with the organization;
— determine and prioritize interested party relationships that need to be managed;
— establish relationships that balance short-term gains with long-term considerations;
— gather and share information, expertise and resources with relevant interested parties;
— measure performance and provide performance feedback to interested parties, as appropriate, to enhance improvement initiatives;
— establish collaborative development and improvement activities with providers, partners and other interested parties;
— encourage and recognize improvements and achievements by providers and partners.

Answer 39

2.3.7 Relationship management

Question 40

Define which one of the 7 quality management principles are being mentioned:

Rationale: Sustained success is achieved when an organization attracts and retains the confidence of customers and other relevant interested parties. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to the sustained success of the organization.

Answer 40

2.3.1 Customer Focus

Question 41

Clause 3 Terms and definition

Answer 41

3.1 Terms related to person or people
3.2 Terms related to organization
3.3 Terms related to activity
3.4 Terms related to process
3.5 Terms related to system
3.6 Terms related to requirement
3.7 Terms related to result
3.8 Terms related to data, information and document
3.9 Terms related to customer
3.10 Terms related to characteristic
3.11 Terms related to determination
3.12 Terms related to action
3.13 Terms related to audit.