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ISO 9001 Exam

Question No. 1

What does ISO stand for?

the Internal Standards Option

the International Standards Opportunity

the Internal Systems Organization

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the International Organization for Standardization

Question No. 2
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The ISO 9001 standard requires planning from top management. What shall be
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measurable and consistent with the quality policy?

quality documents
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quality manual

quality objectives
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quality records
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Question No. 3

The ISO 9001 standard requires an organization to handle nonconforming product

how?

as long as the nonconformity is low risk, deliver product and record as no

action required

by taking action to eliminate the detected nonconformity

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release product as long as it works as intended

by asking the customer if they will take the product as is

Question No. 4

The implementation of a organization's ISO 9001 management system is

influenced by:

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its products, processes, and size

the county of its physical location

the government

the IRS
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Question No. 5
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The ISO 9001 standard requires the organization's quality manual to include:
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a description of the size of the organization

the names of all top management

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a description of the interaction between the processes of the quality

management system

a definition of the organization's products

Question No. 6

What does product design and development validation of the ISO 9001 standard
require?

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to ensure the customer has approved all documents used to build the product

to ensure the organization isn't guilty of patent infringement

to ensure that the resulting product is capable of meeting all specified

requirements and intended uses

Question No. 7

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Clause 4.2 of the ISO 9001 standard requires a organization's quality management
system to include a:

statement of work

documented quality objective statement

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non-disclosure agreement

confidentiality agreement
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Question No. 8
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The ISO 9001 standard requires an organization to establish a quality manual that
includes:
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customer references

the number of employees

the justification for not documenting confidential processes

a justification of any exclusions to the requirements of the standard

Question No. 9

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The ISO 9001 standard requires an organization to establish processes to ensure
that monitoring and measuring equipment is controlled. This includes:

only one employee is allowed to use the equipment per customer order

measuring equipment shall be calibrated and/or verified

the equipment shall be maintained after every part has been measured

the equipment is only allowed to be programmed for one type of product

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Question No. 10

The ISO 9001 standard requires top management of an organization to ensure the
quality policy includes what?
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a definition of the responsibilities and authorities

a definition of the quality management system

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a record of each change made to it

a commitment to continually improve the effectiveness of the quality

management system
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Question No. 11

An organization shall conduct internal audits when?

once a month

per each process

annually

determined planned intervals

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Question No. 12

The ISO 9001 standard requires an organization to apply suitable methods for
monitoring and measuring the quality management system processes and shall
demonstrate the ability to achieve planned results. When planned results are not
achieved, what should happen?

stop all production to determine next steps

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correction and corrective action shall be taken

rewrite the quality management system processes to achieve the planned

results

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inform the customer of the situation and ask them what should happen next
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Question No. 13

What does product design and development verification of the ISO 9001 standard
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require?

to ensure the customer has approved all processes required to build the
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product

to patent the product design

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to ensure the outputs have met the input requirements of the design and
development

to ensure the product does not look like any other customer's product already
sold

Question No. 14

How does the ISO 9001 standard define an "outsourced process?"

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a process that only one customer requires

a process that the organization defines as "optional" and the process is better
performed by an external party

a process that does not "fit" within the organization's quality management
system

a process that the organization needs for the quality management system and
which the organization chooses to have performed by an external party

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Question No. 15

The required documentation for the ISO 9001 standard can be:

only hard copy documentation .c

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in any form or type of medium

only electronically filed

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only filed offsite

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Question No. 16

How does an organization become ISO 9001 certified?

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Through customer audits

The International Organization of Standardization certifies the organization

meets the ISO 9001 standard requirements

The organization itself certifies it meets ISO 9001 standard requirements

Through an independent certification body that determines the product,

service or system in question meets ISO 9001 standard requirements

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Question No. 17

When nonconforming product is corrected, it shall be subject to what?

re-verification to demonstrate conformity to the requirements

selected certification body approval

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International Organization of Standardization approval

customer approval

Question No. 18 .c
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Why would an organization implement a quality management system that meets
ISO 9001 standard requirements?

the organization is required to by state laws

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all customers require it

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the International Organization of Standardization requires organizations to

meet the ISO 9001 standard requirements

to improve the efficiency and effectiveness of company operations

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Question No. 19

The ISO 9001 standard requires the output from the management review shall
include any decisions and actions related to what?

the determined number of procedural changes for the year

the required semi-annual change to the quality policy

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the process changes specific to the next 6 months

improvement of product related to customer requirements

Question No. 20

The ISO 9001 standard requires the organization to provide training, where
applicable, or take other actions to achieve the necessary what?

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competence

number of trained employees

number of training records to meet state laws

number of training classes to meet its requirements

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Question No. 21
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The ISO 9001 standard requires an organization to review its quality management
system at planned intervals. Why?
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to ensure its continuing effectiveness

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to ensure its not breaking any laws

to ensure it is profitable

to ensure its records are up to date

Question No. 22

Under 4.0, the ISO 9001 standard requires an organization to control required
documents. One of these controls is:

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to ensure changes and current revision status of documents are identified

to dispose of obsolete documents

to update documents at point of use

to ensure that documents are all electronically available

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Question No. 23

ISO 9001 is considered compatible with what other ISO standard?

ISO 13485

ISO 17025
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ISO 14001

ISO 14971
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Question No. 24
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Who should the Management Representative be of an organization?

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sales representative

outsourced consultant

member of the organization's management

trained employee

Question No. 25

The ISO 9001 standard requires a organization to ensure its personnel are aware
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of what?

the processes they can affect down-stream from them

all statements of work

every written procedures of the organization

the established quality objectives

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Question No. 26

The ISO 9001 standard requires an organization to determine requirements

specified by the customer to include requirements for what?

only refunds
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only returns

delivery and post-delivery activities

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only complaints
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Question No. 27
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Audits are a vital part of ISO 9001's management system approach as they enable
the organization to:

determine if they are profitable

determine if they have too many employees

check if they need to hire a certification body

check how far their achievements meet their objectives

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Question No. 28

The ISO 9001 standard requires an organization to take action to eliminate the
causes of nonconformities in order to what?

inform the customer of the nonconformities

not hide its problems

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be completely transparent with its issues

prevent recurrence

Question No. 29
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The ISO 9001 standard promotes the adoption of a process approach because:

this is the only approach that can work with ISO 9001
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this approach is much easier to manage

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this approach enhances customer satisfaction by meeting customer

requirements
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Question No. 30

The ISO 9001 standard requires an organization to ensure records of evidence of

conformity are what?

uploaded electronically

sent offsite for storage

approved and signed off by top management

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legible, readily identifiable and retrievable

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