ISO 9001 MCQs (FREE Multiple Choice Questions)

1: What does ISO stand for?

A. the Internal Standards Option

B. the International Standards Opportunity

C. the Internal Systems Organization

D. the International Organization for Standardization

2: The ISO 9001 standard requires planning from top management. What shall be measurable and consistent with the quality policy?

A. quality documents

B. quality manual

C. quality objectives

D. quality records

3: The ISO 9001 standard requires an organization to handle nonconforming product how?

A. as long as the nonconformity is low risk, deliver product and record as no action required

B. by taking action to eliminate the detected nonconformity

C. release product as long as it works as intended

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

4: The implementation of a organization's ISO 9001 management system is influenced by:

A. its products, processes, and size

B. the county of its physical location

C. the government

D. the IRS

5: The ISO 9001 standard requires the organization's quality manual to include:

A. a description of the size of the organization

B. the names of all top management

C. a description of the interaction between the processes of the quality management system

D. a definition of the organization's products

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

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

B. to ensure the organization isn't guilty of patent infringement

C. to ensure that the resulting product is capable of meeting all specified requirements and intended uses

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

A. statement of work

B. documented quality objective statement

C. non-disclosure agreement

D. confidentiality agreement

8: The ISO 9001 standard requires an organization to establish a quality manual that includes:

A. customer references

B. the number of employees

C. the justification for not documenting confidential processes

D. a justification of any exclusions to the requirements of the standard

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

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

B. measuring equipment shall be calibrated and/or verified

C. the equipment shall be maintained after every part has been measured

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

10: The ISO 9001 standard requires top management of an organization to ensure the quality policy includes what?

A. a definition of the responsibilities and authorities

B. a definition of the quality management system

C. a record of each change made to it

D. a commitment to continually improve the effectiveness of the quality management system

11: An organization shall conduct internal audits when?

A. once a month

B. per each process

C. annually

D. determined planned intervals

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?

A. stop all production to determine next steps

B. correction and corrective action shall be taken

C. rewrite the quality management system processes to achieve the planned results

D. inform the customer of the situation and ask them what should happen next

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

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

B. to patent the product design

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

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

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

A. a process that only one customer requires

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

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

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

15: The required documentation for the ISO 9001 standard can be:

A. only hard copy documentation

B. in any form or type of medium

C. only electronically filed

D. only filed offsite

16: How does an organization become ISO 9001 certified?

A. Through customer audits

B. The International Organization of Standardization certifies the organization meets the ISO 9001 standard requirements

C. The organization itself certifies it meets ISO 9001 standard requirements

D. Through an independent certification body that determines the product, service or system in question meets ISO 9001 standard requirements

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

A. re-verification to demonstrate conformity to the requirements

B. selected certification body approval

C. International Organization of Standardization approval

D. customer approval

18: Why would an organization implement a quality management system that meets ISO 9001 standard requirements?

A. the organization is required to by state laws

B. all customers require it

C. the International Organization of Standardization requires organizations to meet the ISO 9001 standard requirements

D. to improve the efficiency and effectiveness of company operations

A. the determined number of procedural changes for the year

B. the required semi-annual change to the quality policy

C. the process changes specific to the next 6 months

D. improvement of product related to customer requirements

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

A. competence

B. number of trained employees

C. number of training records to meet state laws

D. number of training classes to meet its requirements

21: The ISO 9001 standard requires an organization to review its quality management system at planned intervals. Why?

A. to ensure its continuing effectiveness

B. to ensure its not breaking any laws

C. to ensure it is profitable

D. to ensure its records are up to date

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

A. to ensure changes and current revision status of documents are identified

B. to dispose of obsolete documents

C. to update documents at point of use

D. to ensure that documents are all electronically available

23: ISO 9001 is considered compatible with what other ISO standard?

A. ISO 13485

B. ISO 17025

C. ISO 14001

D. ISO 14971

24: Who should the Management Representative be of an organization?

A. sales representative

B. outsourced consultant

C. member of the organization's management

D. trained employee

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

A. the processes they can affect down-stream from them

B. all statements of work

C. every written procedures of the organization

D. the established quality objectives

26: The ISO 9001 standard requires an organization to determine requirements specified by the customer to include requirements for what?

A. only refunds

B. only returns

C. delivery and post-delivery activities

D. only complaints

27: Audits are a vital part of ISO 9001's management system approach as they enable the organization to:

A. determine if they are profitable

B. determine if they have too many employees

C. check if they need to hire a certification body

D. check how far their achievements meet their objectives

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

A. inform the customer of the nonconformities

B. not hide its problems

C. be completely transparent with its issues

D. prevent recurrence

29: The ISO 9001 standard promotes the adoption of a process approach because:

A. this is the only approach that can work with ISO 9001

B. this approach is much easier to manage

C. this approach enhances customer satisfaction by meeting customer requirements

30: The ISO 9001 standard requires an organization to ensure records of evidence of conformity are what?

A. uploaded electronically

B. sent offsite for storage

C. approved and signed off by top management

D. legible, readily identifiable and retrievable

31: The ISO 9001 standard requires a organization to determine and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes what?

A. noise

B. weather

C. software and hardware

D. temperature and humidity

32: How does an organization monitor and measure customer satisfaction?

A. 0 complaints received

B. 0 returned product counts

C. repeat orders

D. customer data on delivered product quality

33: Per the ISO 9001 standard, an organization is required to plan an audit program that considers the results of what?

A. employee surveys

B. top management perceptions

C. sales of similar products from other suppliers

D. previous audits

34: The ISO 9001 standard refers to a methodology as PDCA. What does PDCA stand for?

A. Plan, Do, Check, Act

B. Procedures, Documents, Corrections, Actions

C. Process, Documents, Certification, Actions

D. Process, Data, Correct, Analyze

35: Per the ISO 9001 standard, documents required by the organization's quality management system shall be:

A. controlled

B. hard copy

C. approved

D. electronic

36: An organization must perform what to check how its quality management system is working?

A. customer audits

B. internal audits

C. management reviews

D. external audits

37: 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?

A. the need to determine what inputs will come from OSHA for product realization

B. the need to determine the required monitoring activities specific to the product

C. the need to specify the exact amount of documents that are required to meet product requirements

D. the need to determine the amount of customer visits that are required to meet product requirements

38: The ISO 9001 standard can be applied to:

A. only organizations that provide customers with products but not services

B. only manufacturing type of organizations

C. only larger organizations that have 100 employees or more

D. any organization, large or small, whatever its product or service and regardless of its sector of activity.

39: What purpose would an organization seek an ISO 9001 certification?

A. Because the organization is required to by city regulations

B. It's the law

C. Because OSHA requires organizations to be certified to ISO 9001

D. To provide the organization's customers assurance of consistent, good quality products or services

40: The ISO 9001 standard requires an organization to plan and implement the monitoring, measurement, analysis and improvement of processes needed to what?

A. determine if product can be exported to other countries

B. satisfy state laws regarding records of conformity

C. determine if employees are content with their jobs

D. continually improve the effectiveness of the quality management system

41: 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?

A. the effectiveness of the profit sharing estimates

B. the location of each record controlled

C. the effectiveness of the quality management system

42: ISO 9001 requires an organization to implement a quality management system to demonstrate:

A. the organization's ability to meet environmental regulations

B. the organization's ability to consistently provide product that meets customer requirements

C. the organization's ability to pay employees

D. the organization's ability to meet employment regulations

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

A. the non-intended use risks involved with the product

B. the stage at which no changes will be allowed during the design phase

C. the number of employees required to design the product

D. the design and development stages

44: 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?

A. the defined quality policy

B. the defined requirements

C. the changes requested by the certification body

D. the changes requested by an external auditor

45: The ISO 9001 standard requires an organization to implement effective arrangements for communicating what to customers?

A. all internal reorganizations

B. enquiries, contracts, or order handling including amendments

C. other customer audit findings

D. all redlines made to process documentation

46: The organization is required to determine and provide the resources needed to enhance customer satisfaction by what?

A. meeting top management expectations

B. meeting OSHA requirements

C. meeting customer requirements

D. meeting ISO 9001 standard requirements

47: When monitoring and measuring product, what type of records shall be maintained by the organization per ISO 9001?

A. a written approval record from the customer for each lot

B. an internal corrective action report for all issues found for each lot

C. an audit record per lot

D. evidence of conformity with the acceptance criteria

48: The recommendations for improvement is considered an input for what?

A. design review

B. customer audit

C. management review

D. external audit

49: How should auditors conduct internal audits per the ISO 9001 standard?

A. Every year a new auditor shall be selected to conduct internal audits

B. Auditors shall audit their own departments

C. Each auditor shall only audit once a year to maintain objectivity

D. Auditors shall not audit own work

50: Under 4.0, the ISO 9001 standard requires an organization to monitor, measure and analyze processes to determine if they are:

A. effective

B. all linked

C. correct

D. approved by the customer

51: Which should an organization use to continually improve the effectiveness of the quality management system per the ISO 9001 standard?

A. test equipment, calipers, microscopes

B. quality policy, management review, audit results

C. procedures, quality manual, nonconforming material reports

D. external auditors, customer surveys, supplier score cards

52: Who is responsible for establishing the quality policy of an organization?

A. quality manager

B. International Organization of Standardization

C. each employee

D. top management

53: A documented procedure for preventive actions shall be established to define requirements for what?

A. when an organization needs to report the potential nonconformities to the certification body

B. determining potential nonconformities and their causes

C. when an organization needs to report the potential nonconformities to the customer

D. the need of the products to be recalled due to the potential nonconformities

54: The ISO 9001 standard requires an organization to take action to eliminate the causes of potential nonconformities. What is this called?

A. corrective action

B. preventive action

C. management review

D. internal audit

55: The ISO 9001 standard requires the organization to determine and provide the resources needed to enhance customer satisfaction by meeting:

A. quality objectives

B. all scheduled reviews

C. customer requirements

D. all the requirements detailed in its quality manual

56: Preservation of product per the ISO 9001 standard includes:

A. packaging, delivery, and replacement

B. handling, packaging, and storage

C. handling, testing, and delivery

D. labeling, verification, and delivery

57: During the design and development planning within the ISO 9001 standard requirements, the organization is required to determine what?

A. all organizational employees' role within the product development cycle even if an employee doesn't have one

B. the responsibilities and authorities for design and development

C. how records will be maintained for the product life cycle

58: What should an organization do if a piece of measuring equipment is found out of conformance to requirements?

A. assess and record the validity of the previous measuring results

B. identify the product separately and sale product at a discount

C. dispose of all product ran through piece of equipment

D. rerun product through piece of equipment to verify conformance

59: A review of the design and development of product is required by the ISO 9001 standard. The review shall:

A. include personnel of all departments to determine the viability of the product

B. include an ISO certification representative to approve product design

C. identify any problems and propose necessary actions

D. include a customer representative to approve the design of the product

60: Confirmation of the ability of computer software to satisfy the intended application would typically include:

A. testing its configuration from an outside source

B. its verification and configuration management to maintain its suitability for use

C. a review from employees not directly related to the intended application for verification

D. a certificate from the software supplier to confirm the software's intended application

61: How does top management provide evidence of its commitment to meet the requirements of the ISO 9001 standard?

A. by organizing an annual organization communication

B. by ensuring the availability of resources

C. by attending organization all-hands meetings

D. by attending internal audits

62: 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?

A. Management Responsibility

B. Continual Improvement

C. Customer Requirements

D. Resource Management

63: The ISO 9001 standard requires control of production and service provisions under controlled conditions. Controlled conditions shall include:

A. an approval from top management for the release of the product before delivery

B. the availability of work instructions

C. a record documenting all personnel involved with the production of the product

D. a cleanroom environment

A. replacement activities after a re-sale of product

B. non-intended use of product

C. resale of product

D. final disposal

65: How does an organization verify purchased product required by the ISO 9001 standard?

A. the organization shall request a signed quality agreement from each supplier they purchase product from

B. the company will measure and test every purchased product to ensure it meets requested requirements

C. the organization shall establish and implement inspection activities

D. the organization shall audit every supplier to ensure they meet quality requirements

66: Certification is performed by external certification bodies, which are largely private. When choosing a certification body it is a good idea to:

A. make sure the certification body is not accredited

B. only use certification bodies that know he organization's specific product or service

C. only use certification bodies rated by the better business bureau

D. bear in mind that the cheapest could be more costly in the long run if its auditing is below standard

67: The ISO 9001 standard requires an organization to identify, verify, protect and safeguard what?

A. documented procedures

B. customer contracts

C. customer property provided for use

D. records of evidence

68: 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:

A. ensuring that all corrective actions taken were closed prior to release of the product

B. evidence that all suppliers used for purchased product were audited prior to release of product

C. customer satisfaction data

D. ensuring that at least one preventive action was issued prior to release of product

69: 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?

A. record keeping

B. verification

C. documentation

D. testing

A. changes to orders

B. customer ship to address

C. if personnel had been trained appropriately to build the order

D. re-verification of purchase price

71: The ISO 9001 standard requires an organization to identify what by suitable means throughout its realization?

A. procedures

B. records

C. processes

D. product

72: The ISO 9001 standard requires "document procedures" to how many specific elements in an organization's quality management system?

A. 2

B. 10

C. 6

D. 8

73: Although ISO does not perform certification, what committee has produced a number of standards that relate to the certification process?

A. ISO 9001 Audit Committee

B. Committee to Quality Management System Certification

C. CASCO (Committee on Conformity Assessment)

D. Committee of the Audit Process for ISO 9001

74: The ISO 9001 standard requires an organization to review its quality management system at planned intervals. What "inputs" shall management review records include?

A. resource needs

B. improvements to the quality management system processes

C. improvement of product related customer requirements

D. changes that could affect the quality management system

75: Whose satisfaction is necessarily to be monitored and measured?

A. Employees

B. Customer

C. Owners

D. Producers

76: ISO9001 aims to enhance the satisfaction of :

A. Employees

B. Stake holders

C. Customers

D. Employers

E. Management

77: Out of the given quality management principles, which one emphasizes on understanding & meeting requirements, and also obtaining effective results?

A. customer focus

B. process approach

C. system approach to management

D. continual improvement

78:
Special Instructions:The following question may have more than one correct answer options
According to ISO9001, Monitoring and Measurement is required for:

A.

Delivery

B.

Process

C.

Product

D.

None of the above

79: ___________ is the technical committee of Environmental Management Systems.

A. ISO/TC 207

B. ISO/TC 206

C. ISO/TC 205

D. ISO/TC 204

80: In case any element cannot be applied to an ISO system due to the nature of an organization, it can be considered for exclusion as per:

A. Clause 8

B. Clause 6

C. Clause 7

D. Clause 9

81:
Special Instructions:The following question may have more than one correct answer options

Documented procedure for control of records must define controls for their:

A.

identification

B.

storage and protection

C.

retention and retrieval

D.

none of the above

82:
Special Instructions:The following question may have more than one correct answer options

ISO9001 certified organization is permitted to use an approved logo of the certifying body on its following items:

A.

Stationery

B.

Product

C.

Advertising Material

D.

Anywhere

83: ISO9001 can be applied to any organization irrespective of its size, structure and nature of the product.

A. True

B. False

84: ________ is required to analyze and compare the adequacy of the system resources in order to improve and achieve product quality.

A. quality audit

B. quality assurance

C. quality conformance

D. quality evaluation

85: Out of the given quality management principles, which one emphasizes on understanding & meeting current and future needs of the customers?

A. Customer focus

B. Process approach

C. System approach to management

D. Continual improvement

86: The work that the organization goes through to develop, manufacture, and deliver the finished goods or services is called

A. manufacturing

B. product validation

C. product planning and control

D. product realization

87: An activity of using resources to transform inputs into outputs is called:

A. Method

B. Process

C. Procedure

D. System

88: According to ISO9001 specifications, the product status needs to be identified:

A. only before dispatching to the customer

B. suitably throughout production process

C. only while planning the production process

D. only while determining the cost of the product

89: According to ISO specifications, customer property, if any, either used for production or incorporation

A. need not be identified

B. can not be used for production

C. must be identified prior to use

D. should not be used for more than one year

90: Monitoring and measurement equipment must be calibrated or validated

A. during production process

B. as and when required

C. before using the equipment

D. only before ISO audit

91: Which ISO standard sets guidelines for auditing Quality Management Systems and Environmental Management Systems?

A. ISO 9000:2005

B. ISO 19011:2002

C. ISO 14001:9000

D. ISO 14001:9001

92: In PDCA cycle P stands for Plan, D stands for Do, A stands for Act. What does C stand for?

A. Control

B. Co-ordinate

C. Check

D. Create

93: Appropriate records of education, training, skills and experience of the employees of the organization should be maintained by:

A. quality assurance department

B. external quality auditors

C. accounts department

D. personnel department

94: During an audit, which step is used to check if a product meets the initial product specification requirements?

A. product verification