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Test answers for ISO 9001 2016

(74) Last updated: January 27
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74 Answered Test Questions:

1. What does ISO stand for?

Answers:

• the Internal Systems Organization

• the Internal Standards Option

• the International Organization for Standardization

• the International Standards Opportunity

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

Answers:

• the number of employees required to design the product

• the non-intended use risks involved with the product

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

• the design and development stages

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

Answers:

• assess and record the validity of the previous measuring results

• identify the product separately and sale product at a discount

• dispose of all product ran through piece of equipment

• rerun product through piece of equipment to verify conformance

4. How does an organization verify purchased product required by the ISO 9001 standard?

Answers:

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

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

• the organization shall establish and implement inspection activities

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

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

Answers:

• by ensuring the availability of resources

• by attending organization all-hands meetings

• by organizing an annual organization communication

• by attending internal audits

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

Answers:

• customer contracts

• records of evidence

• documented procedures

• customer property provided for use

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

Answers:

• the responsibilities and authorities for design and development

• how records will be maintained for the product life cycle

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

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

Answers:

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

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

• its verification and configuration management to maintain its suitability for use

• testing its configuration from an outside source

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

Answers:

• other customer audit findings

• enquiries, contracts, or order handling including amendments

• all internal reorganizations

• all redlines made to process documentation

10. How should auditors conduct internal audits per the ISO 9001 standard?

Answers:

• Auditors shall not audit own work

• Auditors shall audit their own departments

• Each auditor shall only audit once a year to maintain objectivity

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

11. Preservation of product per the ISO 9001 standard includes:

Answers:

• handling, packaging, and storage

• handling, testing, and delivery

• labeling, verification, and delivery

• packaging, delivery, and replacement

12. Who is responsible for establishing the quality policy of an organization?

Answers:

• quality manager

• International Organization of Standardization

• each employee

• top management

13. An organization must perform what to check how its quality management system is working?

Answers:

• management reviews

• external audits

• internal audits

• customer audits

14. How does an organization monitor and measure customer satisfaction?

Answers:

• repeat orders

• 0 complaints received

• 0 returned product counts

• customer data on delivered product quality

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

Answers:

• sent offsite for storage

• uploaded electronically

• legible, readily identifiable and retrievable

• approved and signed off by top management

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

Answers:

• Process, Data, Correct, Analyze

• Plan, Do, Check, Act

• Procedures, Documents, Corrections, Actions

• Process, Documents, Certification, Actions

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

Answers:

• be completely transparent with its issues

• inform the customer of the nonconformities

• not hide its problems

• prevent recurrence

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

Answers:

• customer approval

• re-verification to demonstrate conformity to the requirements

• selected certification body approval

• International Organization of Standardization approval

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

Answers:

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

• to improve the efficiency and effectiveness of company operations

• all customers require it

• the organization is required to by state laws

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

Answers:

• employee surveys

• sales of similar products from other suppliers

• previous audits

• top management perceptions

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

Answers:

• the required semi-annual change to the quality policy

• the determined number of procedural changes for the year

• improvement of product related to customer requirements

• the process changes specific to the next 6 months

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

Answers:

• all statements of work

• every written procedures of the organization

• the processes they can affect down-stream from them

• the established quality objectives

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

Answers:

• number of trained employees

• number of training classes to meet its requirements

• competence

• number of training records to meet state laws

24. 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?

Answers:

• stop all production to determine next steps

• correction and corrective action shall be taken

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

• rewrite the quality management system processes to achieve the planned results

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

Answers:

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

• the equipment shall be maintained after every part has been measured

• measuring equipment shall be calibrated and/or verified

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

26. An organization shall conduct internal audits when?

Answers:

• per each process

• determined planned intervals

• once a month

• annually

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

Answers:

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

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

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

• a process that only one customer requires

28. How does an organization become ISO 9001 certified?

Answers:

• 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

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

Answers:

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

• to patent the product design

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

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

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

Answers:

• a definition of the quality management system

• a record of each change made to it

• a commitment to continually improve the effectiveness of the quality management system

• a definition of the responsibilities and authorities

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

Answers:

• to ensure its records are up to date

• to ensure it is profitable

• to ensure its continuing effectiveness

• to ensure its not breaking any laws

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

Answers:

• the number of employees

• the justification for not documenting confidential processes

• customer references

• a justification of any exclusions to the requirements of the standard

33. The ISO 9001 standard requires an organization to handle nonconforming product how?

Answers:

• by taking action to eliminate the detected nonconformity

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

• release product as long as it works as intended

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

34. ISO 9001 is considered compatible with what other ISO standard?

Answers:

• ISO 14001

• ISO 14971

• ISO 17025

• ISO 13485

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

Answers:

• documented quality objective statement

• statement of work

• non-disclosure agreement

• confidentiality agreement

36. The required documentation for the ISO 9001 standard can be:

Answers:

• only filed offsite

• in any form or type of medium

• only hard copy documentation

• only electronically filed

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

Answers:

• to ensure the organization isn't guilty of patent infringement

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

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

38. Who should the Management Representative be of an organization?

Answers:

• sales representative

• member of the organization's management

• outsourced consultant

• trained employee

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

Answers:

• the government

• its products, processes, and size

• the IRS

• the county of its physical location

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

Answers:

• to dispose of obsolete documents

• to ensure changes and current revision status of documents are identified

• to ensure that documents are all electronically available

• to update documents at point of use

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

Answers:

• this approach is much easier to manage

• this approach enhances customer satisfaction by meeting customer requirements

• this is the only approach that can work with ISO 9001

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

Answers:

• determine if they are profitable

• check how far their achievements meet their objectives

• determine if they have too many employees

• check if they need to hire a certification body

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

Answers:

• only returns

• only refunds

• delivery and post-delivery activities

• only complaints

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

Answers:

• a description of the interaction between the processes of the quality management system

• a description of the size of the organization

• a definition of the organization's products

• the names of all top management

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

Answers:

• continually improve the effectiveness of the quality management system

• determine if employees are content with their jobs

• determine if product can be exported to other countries

• satisfy state laws regarding records of conformity

46. The ISO 9001 standard can be applied to:

Answers:

• only manufacturing type of organizations

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

• only larger organizations that have 100 employees or more

• only organizations that provide customers with products but not services

47. 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?

Answers:

• the location of each record controlled

• the effectiveness of the quality management system

• the effectiveness of the profit sharing estimates

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

Answers:

• the organization's ability to pay employees

• the organization's ability to meet environmental regulations

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

• the organization's ability to meet employment regulations

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

Answers:

• weather

• software and hardware

• temperature and humidity

• noise

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

Answers:

• controlled

• electronic

• approved

• hard copy

51. 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?

Answers:

• the defined requirements

• the defined quality policy

• the changes requested by an external auditor

• the changes requested by the certification body

52. 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?

Answers:

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

• the need to determine the required monitoring activities specific to the product

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

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

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

Answers:

• meeting OSHA requirements

• meeting customer requirements

• meeting ISO 9001 standard requirements

• meeting top management expectations

54. The recommendations for improvement is considered an input for what?

Answers:

• management review

• customer audit

• external audit

• design review

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

Answers:

• evidence of conformity with the acceptance criteria

• an internal corrective action report for all issues found for each lot

• an audit record per lot

• a written approval record from the customer for each lot

56. What purpose would an organization seek an ISO 9001 certification?

Answers:

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

• It's the law

• Because OSHA requires organizations to be certified to ISO 9001

• Because the organization is required to by city regulations

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

Answers:

• quality manual

• quality records

• quality documents

• quality objectives

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

Answers:

• all linked

• effective

• correct

• approved by the customer

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

Answers:

• quality policy, management review, audit results

• procedures, quality manual, nonconforming material reports

• test equipment, calipers, microscopes

• external auditors, customer surveys, supplier score cards

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

Answers:

• internal audit

• corrective action

• management review

• preventive action

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

Answers:

• quality objectives

• all the requirements detailed in its quality manual

• customer requirements

• all scheduled reviews

62. A documented procedure for preventive actions shall be established to define requirements for what?

Answers:

• the need of the products to be recalled due to the potential nonconformities

• determining potential nonconformities and their causes

• when an organization needs to report the potential nonconformities to the customer

• when an organization needs to report the potential nonconformities to the certification body

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

Answers:

• include an ISO certification representative to approve product design

• include personnel of all departments to determine the viability of the product

• identify any problems and propose necessary actions

• include a customer representative to approve the design of the product

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

Answers:

• a cleanroom environment

• the availability of work instructions

• a record documenting all personnel involved with the production of the product

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

65. 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?

Answers:

• Management Responsibility

• Customer Requirements

• Resource Management

• Continual Improvement

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

Answers:

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

• only use certification bodies rated by the better business bureau

• make sure the certification body is not accredited

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

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

Answers:

• procedures

• records

• product

• processes

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:

Answers:

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

• customer satisfaction data

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

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

69. The ISO 9001 standard requires an organization to determine post-delivery activities related to product.  This might include:

Answers:

• final disposal

• replacement activities after a re-sale of product

• resale of product

• non-intended use of product

70. The ISO 9001 standard requires an organization to review requirements related to product prior to supplying the product.  What should this review include?

Answers:

• customer ship to address

• re-verification of purchase price

• changes to orders

• if personnel had been trained appropriately to build the order

71. 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?

Answers:

• testing

• verification

• record keeping

• documentation

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

Answers:

• 6

• 8

• 10

• 2

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

Answers:

• Committee to Quality Management System Certification

• CASCO (Committee on Conformity Assessment)

• ISO 9001 Audit Committee

• 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?

Answers:

• changes that could affect the quality management system

• improvement of product related customer requirements

• resource needs

• improvements to the quality management system processes