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Quality Management
System- Requirements
(ISO 9001:2008) Revision
Dr. Eman Taher
QMS Certified Lead Auditor
TQM Professional
Choose the best answer – only
ONE answer is correct.
 1. Which of the following manufacturing
activities is value-added?
(A) Setup
(B) Process
(C) Calibration
(D) Inspection
 2. Before selecting a supplier as a partner, a
customer should do which of the following first?
(A) Conduct supplier surveys.
(B) Define its own needs.
(C) Determine which suppliers are industry
leaders.
(D) Get feedback from employees about how
various suppliers are performing.
 3. Which of the following departments
provides services primarily to external
customers?
(A) Human resources
(B) Purchasing
(C) Marketing
(D) Manufacturing
 4. According to ISO 9000, the activities that
establish the objectives and requirements for
quality and for the application of quality
system elements are defined as quality
(A) engineering
(B) planning
(C) assurance
(D) control
 5. To be effective, a company’s strategic quality
plan must be :
(A) developed by representatives from all levels of the
company
(B) free of cost and profit considerations
(C) an integral part of the overall company business
plan
(D) the foundation of the company’s quality manual
 6. An internal quality audit should be
designed primarily to answer which of the
following questions?
(A) “Is the process effective?”
(B) “What is the degree of management compliance?”
(C) “How can the process be made more efficient?”
(D) “What is the level of compliance?”
 7. When a product has a variety of customers
(such as purchaser, operator, and
maintenance worker), the product must
(A) be inexpensive to operate and maintain
(B) be able to perform multiple functions
(C) be highly reliable and easy to use
(D) have multiple quality characteristics
 8. A batch of product that is otherwise ready for
shipment does not meet 100% of the customer’s
specification. In this situation, which of the following
actions by the quality manager would NOT be
appropriate?
(A) Segregate and ship that portion that meets the
specifications.
(B) Initiate a request for deviation and ship the product.
(C) Submit the situation to the materials review board.
(D) Contact the customer to request a deviation.
 9. Which of the following groups should have
the primary role in establishing an
organization’s quality policies?
(A) All employees
(B) Middle managers
(C) The quality council
(D) The quality department
 10. A qualification test on a supplier product
evaluates:
a) The design of the product.
b) The production capability of the supplier on
the product.
c) Both "a" and "b".
d) Neither "a" not "b".
 11. According to Juran, anyone is a customer
of a product or service if that person
(A) purchases it
(B) uses it
(C) is affected by it
(D) produces it
 12. The main advantage of having quality
procedures online instead of in hard copy is that
(A) the current version can be the only one
available
(B) all personnel can input changes to the
documents
(C) the documentation review process is simplified
(D) an online document is easier to read
 13. What are two components of customer
satisfaction?
a) Durability and function.
b) Product features and freedom of deficiencies.
c) Ease of use and durability.
d) Features and benefits.
14. All of the following are Quality Management
Principles of ISO 9001:2008 EXCEPT:
A. Customer focus
B. Process approach
C. Quality system
D. Continual improvement
 15. All of the following are advantages that result
from building customer-supplier partnerships
EXCEPT:
(A) The supplier is offered longer-term financial
security.
(B) Both partners can learn new approaches to
teamwork.
(C) The customer can realize reduced inspection
costs.
(D) Prevention costs are shifted to the supplier.
 16. Customers are anyone who is impacted
by the product or process. These customers
consist of the following categories:
a) Producers, distributors, and end users.
b) External, internal, and suppliers.
c) Producers and consumers.
d) Upper, middle, and lower consumers
 17. Before a purchasing agent can send requisitions
to a supplier, the quality department must check the
purchase requisitions for code-related requirements.
Which of the following best describes the
relationship that supports this process?
(A) The quality department is an internal supplier to
the purchasing agent.
(B) The quality department is an adversary of the
purchasing agent.
(C) The purchasing agent is an internal supplier to the
quality department.
(D) The purchasing agent is the customer of an
external supplier.
 18. In a manufacturing company, the
machine shop is what kind of customer in
relation to the human resource department?
(A) Intermediate
(B) Hidden
(C) External
(D) Internal
 19. Which of the following is the final step in
the Juran Trilogy®?
(A) Quality control
(B) Quality planning
(C) Quality documentation
(D) Quality improvement
 20. The two U.S. consultants that worked
with the Japanese to integrate quality
throughout their organizations in the 1950s
were:
A. Juran and Crosby
B. Deming and Crosby
C. Deming and Juran
 21. Personnel performing work affecting
conformity to product requirements shall be
competent on the basis of:
A. Education & training.
B. Skills and Experience
C. Upper manager opinion
D. A and B
 22 . In general, employee empowerment has
been viewed as an effective practice for
customer-driven organizations that hold total
quality Management.
A. True
B. False
 23. In the context of total quality, companies
need to make long term commitments to
which of the following stakeholders?
a. employees
b. customers
c. suppliers
d. all of the above
 24. In the Quality System Documentation the
document that determines Responsibility,
Authority, Reporting and interfacing
relationship of the employee is the:
A. Quality Policy
B. Work Instructions
C. Job descriptions
D. Reference Documents.
 25. All of the following are mandatory
documented procedures, EXCEPT:
A. Control of documents
B. Control of records
C. Purchasing Procedure
D. Internal Audit
 26. When a product or service completely
meets a customer’s requirements:
A. Quality is achieved
B. The cost of quality is high
C. The cost of quality is low
D. The customer pays the minimum price.
 27. To what does the following definition refer?
"A member of the organization’s management
appointed by top management who shall have
responsibility and authority that includes ensuring that
processes needed for the quality management system
are established, implemented and maintained?”
A. Chief Executive Officer
B. Management Representative
C. Quality Assurance Manager
D. Quality Specialist
 28. To what does the following definition refer?
“Ensure that the design outputs have met the
design input requirements?”
A. Design and Development Verification
B. Design and Development Validation
C. Design Requirements
D. Design Audit
 29. To what does the following definition refer?
“An action to eliminate the root cause?”
A. Internal Audit
B. Correction
C. Preventive Action
D. Corrective Action
 30. To what does the following definition
refer? “Making an audit by us on them such
as supplier audit?”
A. Internal Audit
B. 1st Party Audit
C. 2nd Party Audit
D. 3rd Party Audit
 31. Quality is:
A. Meeting and exceeding the customer’s
expectations
B. Adding extras to make the customer happy
C. The degree to which the product meets
requirements
D. Conformance to management's objectives
Answers:
1. B 9. C 17. A 25. C
2. B 10. C 18. D 26. A
3. C 11. C 19. D 27. B
4. B 12. A 20. C 28 . A
5. C 13. B 21. D 29. D
6. D 14. C 22. A 30. C
7. D 15. D 23. D 31. A
8. B 16. B 24. C

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ISO 9001 Quality Management System Requirements Guide

  • 1. Quality Management System- Requirements (ISO 9001:2008) Revision Dr. Eman Taher QMS Certified Lead Auditor TQM Professional
  • 2. Choose the best answer – only ONE answer is correct.
  • 3.  1. Which of the following manufacturing activities is value-added? (A) Setup (B) Process (C) Calibration (D) Inspection
  • 4.  2. Before selecting a supplier as a partner, a customer should do which of the following first? (A) Conduct supplier surveys. (B) Define its own needs. (C) Determine which suppliers are industry leaders. (D) Get feedback from employees about how various suppliers are performing.
  • 5.  3. Which of the following departments provides services primarily to external customers? (A) Human resources (B) Purchasing (C) Marketing (D) Manufacturing
  • 6.  4. According to ISO 9000, the activities that establish the objectives and requirements for quality and for the application of quality system elements are defined as quality (A) engineering (B) planning (C) assurance (D) control
  • 7.  5. To be effective, a company’s strategic quality plan must be : (A) developed by representatives from all levels of the company (B) free of cost and profit considerations (C) an integral part of the overall company business plan (D) the foundation of the company’s quality manual
  • 8.  6. An internal quality audit should be designed primarily to answer which of the following questions? (A) “Is the process effective?” (B) “What is the degree of management compliance?” (C) “How can the process be made more efficient?” (D) “What is the level of compliance?”
  • 9.  7. When a product has a variety of customers (such as purchaser, operator, and maintenance worker), the product must (A) be inexpensive to operate and maintain (B) be able to perform multiple functions (C) be highly reliable and easy to use (D) have multiple quality characteristics
  • 10.  8. A batch of product that is otherwise ready for shipment does not meet 100% of the customer’s specification. In this situation, which of the following actions by the quality manager would NOT be appropriate? (A) Segregate and ship that portion that meets the specifications. (B) Initiate a request for deviation and ship the product. (C) Submit the situation to the materials review board. (D) Contact the customer to request a deviation.
  • 11.  9. Which of the following groups should have the primary role in establishing an organization’s quality policies? (A) All employees (B) Middle managers (C) The quality council (D) The quality department
  • 12.  10. A qualification test on a supplier product evaluates: a) The design of the product. b) The production capability of the supplier on the product. c) Both "a" and "b". d) Neither "a" not "b".
  • 13.  11. According to Juran, anyone is a customer of a product or service if that person (A) purchases it (B) uses it (C) is affected by it (D) produces it
  • 14.  12. The main advantage of having quality procedures online instead of in hard copy is that (A) the current version can be the only one available (B) all personnel can input changes to the documents (C) the documentation review process is simplified (D) an online document is easier to read
  • 15.  13. What are two components of customer satisfaction? a) Durability and function. b) Product features and freedom of deficiencies. c) Ease of use and durability. d) Features and benefits.
  • 16. 14. All of the following are Quality Management Principles of ISO 9001:2008 EXCEPT: A. Customer focus B. Process approach C. Quality system D. Continual improvement
  • 17.  15. All of the following are advantages that result from building customer-supplier partnerships EXCEPT: (A) The supplier is offered longer-term financial security. (B) Both partners can learn new approaches to teamwork. (C) The customer can realize reduced inspection costs. (D) Prevention costs are shifted to the supplier.
  • 18.  16. Customers are anyone who is impacted by the product or process. These customers consist of the following categories: a) Producers, distributors, and end users. b) External, internal, and suppliers. c) Producers and consumers. d) Upper, middle, and lower consumers
  • 19.  17. Before a purchasing agent can send requisitions to a supplier, the quality department must check the purchase requisitions for code-related requirements. Which of the following best describes the relationship that supports this process? (A) The quality department is an internal supplier to the purchasing agent. (B) The quality department is an adversary of the purchasing agent. (C) The purchasing agent is an internal supplier to the quality department. (D) The purchasing agent is the customer of an external supplier.
  • 20.  18. In a manufacturing company, the machine shop is what kind of customer in relation to the human resource department? (A) Intermediate (B) Hidden (C) External (D) Internal
  • 21.  19. Which of the following is the final step in the Juran Trilogy®? (A) Quality control (B) Quality planning (C) Quality documentation (D) Quality improvement
  • 22.  20. The two U.S. consultants that worked with the Japanese to integrate quality throughout their organizations in the 1950s were: A. Juran and Crosby B. Deming and Crosby C. Deming and Juran
  • 23.  21. Personnel performing work affecting conformity to product requirements shall be competent on the basis of: A. Education & training. B. Skills and Experience C. Upper manager opinion D. A and B
  • 24.  22 . In general, employee empowerment has been viewed as an effective practice for customer-driven organizations that hold total quality Management. A. True B. False
  • 25.  23. In the context of total quality, companies need to make long term commitments to which of the following stakeholders? a. employees b. customers c. suppliers d. all of the above
  • 26.  24. In the Quality System Documentation the document that determines Responsibility, Authority, Reporting and interfacing relationship of the employee is the: A. Quality Policy B. Work Instructions C. Job descriptions D. Reference Documents.
  • 27.  25. All of the following are mandatory documented procedures, EXCEPT: A. Control of documents B. Control of records C. Purchasing Procedure D. Internal Audit
  • 28.  26. When a product or service completely meets a customer’s requirements: A. Quality is achieved B. The cost of quality is high C. The cost of quality is low D. The customer pays the minimum price.
  • 29.  27. To what does the following definition refer? "A member of the organization’s management appointed by top management who shall have responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?” A. Chief Executive Officer B. Management Representative C. Quality Assurance Manager D. Quality Specialist
  • 30.  28. To what does the following definition refer? “Ensure that the design outputs have met the design input requirements?” A. Design and Development Verification B. Design and Development Validation C. Design Requirements D. Design Audit
  • 31.  29. To what does the following definition refer? “An action to eliminate the root cause?” A. Internal Audit B. Correction C. Preventive Action D. Corrective Action
  • 32.  30. To what does the following definition refer? “Making an audit by us on them such as supplier audit?” A. Internal Audit B. 1st Party Audit C. 2nd Party Audit D. 3rd Party Audit
  • 33.  31. Quality is: A. Meeting and exceeding the customer’s expectations B. Adding extras to make the customer happy C. The degree to which the product meets requirements D. Conformance to management's objectives
  • 34. Answers: 1. B 9. C 17. A 25. C 2. B 10. C 18. D 26. A 3. C 11. C 19. D 27. B 4. B 12. A 20. C 28 . A 5. C 13. B 21. D 29. D 6. D 14. C 22. A 30. C 7. D 15. D 23. D 31. A 8. B 16. B 24. C