CHAPTER 5 : ISO 9000

Question 1

a specialized agency for
standardization, the International Organization for Standardization (ISO), founded in 1946 adopted a series of written quality standards in ______ .

Answer 1

1987

Question 2

. It is an independent, non-governmental international organization with a membership of 169 national standards bodies.

Answer 2

International Organization for Standards

Question 3

ISO is a scientific term for _______ (as in isotherm lines on a weather map, which show equal temperatures).

Answer 3

equal

Question 4

documented agreements that include technical specifications or other precise
criteria to be used consistently as rules, guidelines, or definitions to ensure that materials, products processes, and services are fit for their purpose.

Answer 4

Standard

Question 5

ISO standards are internationally agreed by experts. Think of them as a _______ that describes the best way of doing something.

Answer 5

formula

Question 6

The standards required __________ for all processes affecting quality and suggest that
compliance through auditing leads to continuous improvement.

Answer 6

documentation

Question 7

A company could comply with the standards and still produce a poor-quality product as long as it did so consistently!

Answer 7

True

Question 8

family standards
focus on developing, documenting, and implementing procedures to ensure consistency of operations and
performance in production and service delivery processes, with the aim of continual improvement, and
supported by fundamental principles of total quality

Answer 8

ISO 9000

Question 9

standards originally were intended to be advisory in nature and to be used for two-party contractual situations (between a customer and supplier) and for internal auditing.

Answer 9

ISO 9000

Question 10

Recertification is required every ______ years

Answer 10

three

Question 11

ISO 9000 has three principal benefits

Answer 11

• It provides discipline.
• It contains the basics of a good quality system
• It offers a marketing program

Question 12

help businesses of any size and sector reduce costs, increase
productivity, and access new markets.

Answer 12

ISO International Standards

Question 13

provide specifications to ensure products and services work the way you expect them to.

Answer 13

ISO standards

Question 14

ISO and policy makers

Answer 14

Consistent, transparent, targeted

Question 15

SO standards help policy makers to:

Answer 15

• Open up world trade
• Stimulate solutions to national and international issues
• Save money
• Provide solutions to policy issues

Question 16

” A third-party company called a _________ is the only authorized entity that can award ISO 9001 certification.

They are accredited by an authoritative national body and are
contracted by companies to evaluate their quality management system to see if it meets the ISO 9001 standards

Answer 16

Registrar

Question 17

measures how effectively management determines the company’s overall quality policy, its objectives, and its responsibilities, as well as its quality policy
implementation.

Answer 17

Quality management

Question 18

an explicit requirement.

Answer 18

Customer Satisfaction

Question 19

few final steps worth taking before booking your certification audit:

Answer 19

• Get the QMS running (present schedule)
• Gap analysis (prove that customers are satisfied)
• Pre-certification audit (internal audit - if requirements are met)

Question 20

Do I have to certify?

Answer 20

If you’re happy simply gaining these benefits and are not too terribly worried about being able to demonstrate your credentials, then conformance may be
enough.

Question 21

Certification is an expensive disruption.

Answer 21

the length of the certification audit scales with the size of your organization,

Question 22

There’s so much documentation involved.

Answer 22

No, just make sure you have enough documentation to tell people how
the process works (a work instruction for the product/ service and for checking the product/service) where
it is needed and to check that they’re doing it correctly (such as a log or checklist).

Question 23

Certification won’t guarantee quality

Answer 23

Yes, because it focuses on compliance rather than improvement.

What certification does guarantee is that your organization is doing everything it can to ensure quality and
minimize customer dissatisfaction.

Question 24

Can’t my customers audit my quality processes instead of paying for a certification body?

Answer 24

if you have several customers who all want
validation of your quality credentials, then repeated audits by your customers is likely to become a significant burden and disruption

Question 25

The certification auditor is just looking for problems.

Answer 25

This is only true if you have a very bad auditor. Certification Body auditors are passionate about quality management and, like anyone passionate about something, they want to see it done right.

Question 26

Maintaining quality

Answer 26

Although a certification to ISO 9001:2015 is proof that your organization has implemented a management system that conforms to the specification, it is not proof that your organization continues to follow best practice.

Question 27

select an appropriate process approach

Answer 27

You should be sure that it has a cyclical structure * Plan-Do-Check-Act Cycle * DMAIC

Question 28

“The quality of an organization’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties”, which makes it a function of the organization’s ability to do business with its customers and other interested parties.

Answer 28

Quality

Question 29

This is a broad idea, encompassing the organization’s business environment, industry, major partners and suppliers, legal requirements and so on. Also consider the organization itself - want to achieve

Answer 29

Context of the organization

Question 30

comprises all forms of documentation: policies, procedures, work instructions, records and so on.

Answer 30

Documented information

Question 31

As such, the documented information you choose to develop (or where your organization’s‘context’ requires it) should be an accurate ___________ of the actual quality processes you have in place

Answer 31

reflection

Question 32

By staying aware of the importance of inputs and outputs when designing or formalizing your QMS processes, it is much simpler to make sure that they are appropriately identified, measured, and tracked.

Answer 32

Inputs and outputs

Question 33

people and organizations with some interest in your organization and its activities. By default, this will include customers and suppliers, regulatory bodies and so on.

Answer 33

Interested parties

Question 34

effect of uncertainty

Answer 34

risk

Question 35

represents potential events that have consequences for the organization, which should either be planned for (to limit the effect and/or compensate when they occur) or prevented.

Answer 35

Risk

Question 36

The Standard comprises ten clauses of which seven (Clauses 4–10) specify the requirements for a QMS

Answer 36

4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement

Question 37

directed almost solely at “top management”, which is the “person or group of people who directs and controls an organization at the highest level”. This focus makes sure that the QMS is led by individuals able to provide the resources and authority to establish, implement, maintain, and improve the management system.

Answer 37

Clause 5 – Leadership

Question 38

which declares the organization’s dedication to and perspective on quality.

Answer 38

quality policy

Question 39

required to assign appropriate roles, responsibilities, and authorities relating to quality and the QMS.

Answer 39

top management

Question 40

focused on risk, quality objectives and change, which are interrelated functions within the QMS

Answer 40

Clause 6 – Planning

Question 41

Supporting the QMS by providing the necessary resources and organizational structures is critical to the success of any management system.

Answer 41

Support

Question 42

The Standard broadly divides support into

Answer 42

resources, competence, awareness, communication, and documented information.

Question 43

covering people, infrastructure, environment in which the processes are operated, measuring and organizational knowledge.

Answer 43

resource

Question 44

The organization should establish methods of identifying the actual requirements, assessing whether the appropriate individuals meet those requirements, and how to develop the necessary ____________

Answer 44

competence

Question 45

“ability to apply knowledge and skills to achieve intended results

Answer 45

Competence

Question 46

apply to all persons doing work under the organization’s control, which can include people who are not ordinary employees of the organization, such as contractors, suppliers’ employees and so on.

Answer 46

awareness

Question 47

both internal and external communications, communication procedures should not be difficult

Answer 47

communication

Question 48

This is one of the more demanding parts of the Standard because many organizations do not document their processes or take the time to properly manage what documentation they do keep.

Answer 48

documented information

Question 49

the organization needs to make sure that any QMS documents describe what you actually do, and that what you are actually doing is sufficient to meet your quality objectives

Question 50

responsibility for quality largely resides in the organization’s day-to- day operations

Answer 50

Clause 8 – Operation

Question 51

The subclause e 8.5.5 requires the organization to preserve outputs during production and service provision, which makes sure that there is an ____________ following the product/service through its production lifecycle.

Answer 51

auditable trail

Question 52

There are three core practices involved in performance evaluation:

Answer 52

* monitoring, measurement, analysis, and evaluation * internal audit * management review

Question 53

planned assessments that focus on the functioning of the QMS, its conformity with the organization’s own requirements and those of ISO 9001.

Answer 53

internal audits

Question 54

process by which the organization’s top management formally assesses the QMS and determines any necessary changes.

Answer 54

management review

Question 55

improving the processes that govern quality management will naturally improve the quality of products and services

Question 56

means that it recurs regularly; it is something that is repeated frequently

Answer 56

* Continual

Question 57

means that it occurs without interruption

Answer 57

* Continuous

Question 58

organization must make sure that it continually examines opportunities for improvement (to both the QMS and to quality in general) and implements those that are viable