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Quality Management System Requirements

Total questions: 39

Worksheet time: 9mins

Name
Class
Date
1.

Benefits of Integrated Management System.

a)

Cost reduction

b)

Common operational documentation

c)

Eliminating redundancies

d)

All of the above

2.

What organizations might be facing if they do not have proper documentation?

a)

Predictable result

b)

Transparency

c)

Product quality varies

d)

Streamline implementation

3.

Below are the meaning of interested parties:

a)

Regulators

b)

Any person/organization having an interest in the success of the organization.

c)

Suppliers

d)

Customers

4.

The policy of an organization shall be communicated through below channels except for:

a)

be available as documented information

b)

be communicated

c)

be available to interested parties

d)

Clarifies roles and responsibilities

5.

Below are 7 quality principles except for:

a)

Create an independent safety review process

b)

Leadership

c)

Improvement

d)

Relationship management

e)

Engagement of people

6.

ISO Standard consists of how many clauses?

a)

10

b)

9

c)

8

d)

6

7.

All ISO Standards including ISO 9001 will be revised every 5 years to maintain relevant and adapt to a changing word.

a)

TRUE

b)

FALSE

8.

The scope of the quality management system needs to be available and be maintained as documented information.

a)

TRUE

b)

FALSE

9.

Who is responsible to establish, implement and maintain a quality policy?

a)

Top Management

b)

Management Representative

c)

Quality Manager

d)

Quality Policy is everyone's responsibility

10.

The effect of uncertainty is called:

a)

Non Conformance

b)

Risk

c)

Effect

d)

Probability

11.

Below is related to Clause 7.2 Competence, EXCEPT:

a)

Determine the necessary competence of person(s) doing work under its control that affects its QMS performance.

b)

Did not have to retain appropriate documented information as evidence of competence.

c)

Ensure these persons are competence on the basis of appropriate education, training or experience.

d)

Take action to acquire the necessary competence and evaluate the effectiveness.

12.

ISO stands for ...

a)

International Organization for Standardization

b)

International Standardization of Organization

13.

PDCA stands for

a)

Plan, Do, Check, Act

b)

Plan, Deliver, Comply, Action

14.

Process approach is one of

a)

Quality Management System

b)

Quality Management Principle

15.

Clause 4.1

a)

Understanding organization and its context

b)

Risk Assessment and Quality Objectives

c)

Resource Planning and Support

d)

Continuous Improvement

16.

Clause 5.3

a)

Leadership and Commitment

b)

Organizational roles, responsibilities and authorities

c)

Planning of changes

d)

Operational planning and control

17.

Clause 6

a)

Design and development of products and services

b)

Risk Assessment form, Quality Objectives, planning of changes

18.

QMS is

a)

a way of defining how an organization can meet the requirements of its customers and other stakeholders affected by its work

b)

a system that allows the organization to work towards achieving the customers needs

19.

What is ISO 9001 ?

a)

Quality System

b)

International Organization for Standardization

c)

Quality Management System - requirements

d)

Audit Requirements

20.

Latest version of ISO 9001

a)

ISO 9001:2014

b)

ISO 9001:2005

c)

ISO 9001:2016

d)

ISO 9001:2015

21.

What verbal form of standard expresses a requirement?

a)

shall

b)

may

c)

should

d)

can

22.

Relationship between the result achieved and the resources used

a)

objective

b)

effectiveness

c)

target

d)

efficiency

23.

extent to which planned activities are realized and planned results are achieved

a)

objective

b)

effectiveness

c)

target

d)

efficiency

24.

Positive effect of risk

a)

issue

b)

opportunities

c)

problem

d)

risk

25.

How many auditable clauses are there in ISO 9001:2015

a)

10

b)

9

c)

8

d)

7

26.

The circumstances that form the setting for an event, statement, or idea, and in terms of which it can be fully understood

a)

context of the organization

b)

context

c)

interested parties

d)

risk and opportunities

27.

combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives

a)

context of the organization

b)

context

c)

interested parties

d)

risk and opportunities

28.

Which of these are 2 principles of the quality management

a)

Customer management

b)

Improvement

c)

Engagement of leadership

d)

Process approach

e)

Eat quality streets

30.
ISO 9001:2015 requires organizations to prepare a Quality Manual.
a)
true
b)
false
30.
ISO 9001:2015 requires organizations to prepare a Quality Manual.
a)
true
b)
false
31.
ISO 9001:2015 requires organizations to appoint a Management Representative.
a)
true
b)
false
32.
In ISO 9001:2015 there is no requirement related to Preventive Actions.
a)
true
b)
false
33.
Six mandatory procedures are required in ISO 9001:2015?
a)
true
b)
false
34.
In ISO 9001:2015 records and documents are now called documented information.
a)
true
b)
false
35.
ISO 9001:2015 has introduced the concept of risk based thinking in quality management.
a)
true
b)
false
36.
Intentions and direction of an organization as formally expressed by its top management is called:
a)
Vision
b)
Mission
c)
Policy
d)
Objective
37.
Which of the following is NOT the way to deal with the nonconforming outputs?
a)
Correction
b)
Preventive Action
c)
Informing the customer
d)
obtaining authorization for acceptance under concession
38.
Following are the actions required when the requirements for products and services are changed. Identify the WRONG statement from the following options.
a)
ensure that relevant documented information is amended
b)
change of requirements should not be permitted
c)
relevant persons are made aware of the changed requirements
39.
"Action to eliminate the cause of a nonconformity and to prevent recurrence" is called a:
a)
Correction
b)
Corrective Action
c)
Preventive Action
d)
Nonconformity