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Question:* What does ISO stand for?

Answer: the International Organization for


Standardization

Question:* Design and Development of


product requires planning per the ISO 9001
standard. What should the organization
determine during planning of design and
development?
Answer: the design and development stages

Question:* What should an organization do


if a piece of measuring equipment is found
out of conformance to requirements?
Answer: assess and record the validity of the previous
measuring results

Question:* How does an organization verify


purchased product required by the ISO
9001 standard?
Answer: the organization shall establish and implement
inspection activities
Question:* How does top management
provide evidence of its commitment to meet
the requirements of the ISO 9001 standard?
Answer: by ensuring the availability of resources

Question:* The ISO 9001 standard requires


an organization to identify, verify, protect
and safeguard what?
Answer: customer property provided for use

Question:* During the design and


development planning within the ISO 9001
standard requirements, the organization is
required to determine what?
Answer: the responsibilities and authorities for design
and development

Question:* Confirmation of the ability of


computer software to satisfy the intended
application would typically include:
Answer: its verification and configuration management
to maintain its suitability for use

Question:* The ISO 9001 standard requires


an organization to implement effective
arrangements for communicating what to
customers?
Answer: enquiries, contracts, or order handling
including amendments

Question:* How should auditors conduct


internal audits per the ISO 9001 standard?
Answer: Auditors shall not audit own work

Question:* Preservation of product per the


ISO 9001 standard includes:
Answer: handling, packaging, and storage

Question:* Who is responsible for


establishing the quality policy of an
organization?
Answer: top management

Question:* An organization must perform


what to check how its quality management
system is working?
Answer: internal audits
Question:* How does an organization
monitor and measure customer
satisfaction?
Answer: customer data on delivered product quality

Question:* The ISO 9001 standard requires


an organization to ensure records of
evidence of conformity are what?
Answer: legible, readily identifiable and retrievable

Question:* The ISO 9001 standard refers to


a methodology as PDCA. What does PDCA
stand for?
Answer: Plan, Do, Check, Act

Question:* The ISO 9001 standard requires


an organization to take action to eliminate
the causes of nonconformities in order to
what?
Answer: prevent recurrence

Question:* When nonconforming product is


corrected, it shall be subject to what?
Answer: re-verification to demonstrate conformity to the
requirements

Question:* Why would an organization


implement a quality management system
that meets ISO 9001 standard
requirements?
Answer: to improve the efficiency and effectiveness of
company operations

Question:* Per the ISO 9001 standard, an


organization is required to plan an audit
program that considers the results of what?
Answer: previous audits

Question:* The ISO 9001 standard requires


the output from the management review
shall include any decisions and actions
related to what?
Answer: improvement of product related to customer
requirements

Question:* The ISO 9001 standard requires


a organization to ensure its personnel are
aware of what?
Answer: the established quality objectives

Question:* The ISO 9001 standard requires


the organization to provide training, where
applicable, or take other actions to achieve
the necessary what?
Answer: competence

Question:* 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?
Answer: correction and corrective action shall be taken

Question:* The ISO 9001 standard requires


an organization to establish processes to
ensure that monitoring and measuring
equipment is controlled. This includes:
Answer: measuring equipment shall be calibrated and/or
verified
Question:* An organization shall conduct
internal audits when?
Answer: determined planned intervals

Question:* How does the ISO 9001


standard define an "outsourced process?"
Answer: a process that the organization needs for the
quality management system and which the organization
chooses to have performed by an external party

Question:* How does an organization


become ISO 9001 certified?
Answer: Through an independent certification body that
determines the product, service or system in question
meets ISO 9001 standard requirements

Question:* What does product design and


development verification of the ISO 9001
standard require?
Answer: to ensure the outputs have met the input
requirements of the design and development

Question:* The ISO 9001 standard requires


top management of an organization to
ensure the quality policy includes what?
Answer: a commitment to continually improve the
effectiveness of the quality management system

Question:* The ISO 9001 standard requires


an organization to review its quality
management system at planned intervals.
Why?
Answer: to ensure its continuing effectiveness

Question:* The ISO 9001 standard requires


an organization to establish a quality
manual that includes:
Answer: a justification of any exclusions to the
requirements of the standard

Question:* The ISO 9001 standard requires


an organization to handle nonconforming
product how?
Answer: by taking action to eliminate the detected
nonconformity

Question:* ISO 9001 is considered


compatible with what other ISO standard?
Answer: ISO 14001
Question:* Clause 4.2 of the ISO 9001
standard requires a organization's quality
management system to include a:
Answer: documented quality objective statement

Question:* The required documentation for


the ISO 9001 standard can be:
Answer: in any form or type of medium

Question:* What does product design and


development validation of the ISO 9001
standard require?
Answer: to ensure that the resulting product is capable
of meeting all specified requirements and intended uses

Question:* Who should the Management


Representative be of an organization?
Answer: member of the organization's management

Question:* The implementation of a


organization's ISO 9001 management
system is influenced by:
Answer: its products, processes, and size
Question:* Under 4.0, the ISO 9001
standard requires an organization to
control required documents. One of these
controls is:
Answer: to ensure changes and current revision status of
documents are identified

Question:* The ISO 9001 standard


promotes the adoption of a process
approach because:
Answer: this approach enhances customer satisfaction by
meeting customer requirements

Question:* Audits are a vital part of ISO


9001's management system approach as
they enable the organization to:
Answer: check how far their achievements meet their
objectives

Question:* The ISO 9001 standard requires


an organization to determine requirements
specified by the customer to include
requirements for what?
Answer: delivery and post-delivery activities
Question:* The ISO 9001 standard requires
the organization's quality manual to
include:
Answer: a description of the interaction between the
processes of the quality management system

Question:* The ISO 9001 standard requires


an organization to plan and implement the
monitoring, measurement, analysis and
improvement of processes needed to what?
Answer: continually improve the effectiveness of the
quality management system

Question:* The ISO 9001 standard can be


applied to:
Answer: any organization, large or small, whatever its
product or service and regardless of its sector of activity.

Question:* The ISO 9001 standard requires


top management to ensure that appropriate
communication processes are established
within the organization and that
communication takes place regarding
what?
Answer: the effectiveness of the quality management
system

Question:* ISO 9001 requires an


organization to implement a quality
management system to demonstrate:
Answer: the organization's ability to consistently provide
product that meets customer requirements

Question:* The ISO 9001 standard requires


a organization to determine and maintain
the infrastructure needed to achieve
conformity to product requirements.
Infrastructure includes what?
Answer: software and hardware

Question:* Per the ISO 9001 standard,


documents required by the organization's
quality management system shall be:
Answer: controlled

Question:* The organization is required to


conduct a review prior to the commitment
to supply a product to the customer and
shall ensure that the organization has the
ability to meet what?
Answer: the defined requirements

Question:* Clause 7.0 of the ISO 9001


standard is Product Realization. The
standard requires a organization to plan
and develop the processes needed for
product realization. What does planning
product realization include?
Answer: the need to determine the required monitoring
activities specific to the product

Question:* The organization is required to


determine and provide the resources
needed to enhance customer satisfaction by
what?
Answer: meeting customer requirements

Question:* The recommendations for


improvement is considered an input for
what?
Answer: management review

Question:* When monitoring and


measuring product, what type of records
shall be maintained by the organization per
ISO 9001?
Answer: evidence of conformity with the acceptance
criteria

Question:* What purpose would an


organization seek an ISO 9001
certification?
Answer: To provide the organization's customers
assurance of consistent, good quality products or services

Question:* The ISO 9001 standard requires


planning from top management. What shall
be measurable and consistent with the
quality policy?
Answer: quality objectives

Question:* Under 4.0, the ISO 9001


standard requires an organization to
monitor, measure and analyze processes to
determine if they are:
Answer: effective

Question:* Which should an organization


use to continually improve the effectiveness
of the quality management system per the
ISO 9001 standard?
Answer: quality policy, management review, audit
results

Question:* The ISO 9001 standard requires


an organization to take action to eliminate
the causes of potential nonconformities.
What is this called?
Answer: preventive action

Question:* The ISO 9001 standard requires


the organization to determine and provide
the resources needed to enhance customer
satisfaction by meeting:
Answer: customer requirements

Question:* A documented procedure for


preventive actions shall be established to
define requirements for what?
Answer: determining potential nonconformities and their
causes
Question:* A review of the design and
development of product is required by the
ISO 9001 standard. The review shall:
Answer: identify any problems and propose necessary
actions

Question:* The ISO 9001 standard requires


control of production and service provisions
under controlled conditions. Controlled
conditions shall include:
Answer: the availability of work instructions

Question:* The model of a process-based


quality management system illustrates
process linkages based on the ISO 9001
standard clauses 4 - 8. What process plays a
significant role in determining inputs?
Answer: Customer Requirements

Question:* Certification is performed by


external certification bodies, which are
largely private. When choosing a
certification body it is a good idea to:
Answer: bear in mind that the cheapest could be more
costly in the long run if its auditing is below standard
Question:* The ISO 9001 standard requires
an organization to identify what by suitable
means throughout its realization?
Answer: product

Question:* The organization is required by


the ISO 9001 standard to collect and
analyze appropriate data to demonstrate
effectiveness of the quality management
system. This analysis of data shall include:
Answer: customer satisfaction data

Question:* The ISO 9001 standard requires


an organization to determine post-delivery
activities related to product. This might
include:
Answer: final disposal

Question:* The ISO 9001 standard requires


an organization to review requirements
related to product prior to supplying the
product. What should this review include?
Answer: changes to orders
Question:* Conformity assessment is the
process used to show that a product, service
or system meets specified requirements.
The main forms of conformity assessment
are certification, inspection and what?
Answer: testing

Question:* The ISO 9001 standard requires


"document procedures" to how many
specific elements in an organization's
quality management system?
Answer: 6

Question:* Although ISO does not perform


certification, what committee has produced
a number of standards that relate to the
certification process?
Answer: CASCO (Committee on Conformity
Assessment)

Question:* The ISO 9001 standard requires


an organization to review its quality
management system at planned intervals.
What "inputs" shall management review
records include?
Answer: changes that could affect the quality
management system