Workshop #2

QMS Documentation, ISO 9001: 2000

1.01 Under certain circumstances it may be permissible to exclude the following

activities:

a. monitoring of customer satisfaction .

b. training.
c. purchasing.
d. all of the above.
e. none of the above.

1.02 Which of the following is a requirement of ISO 9001?

a. to have a quality plan for each product.

b. to have a documented procedure for measuring quality system-related costs.
c. to have a documented quality policy.
d. all of the above.
e. none of the above.

1.03 "Action to eliminate the cause of a detected nonconformity or other undesirable

situation" is called

a. management review.
b. document and data changes.
c. corrective action.
d. all of the above.
e. none of the above.

1.04 Changes in the organization must be:

a. approved by the authorized person .

b. allowed to occur as necessary .
c. controlled to preserve the integrity of the quality system.
d. all of the above.
e. none of the above.

1.05 ISO 9001 requires organizations to:

a. set documented processes for each department

b. monitor the performance of processes
c. flowchart all the organization’s processes
d. all of the above.
e. none of the above.
1.06 ISO 9001 standard includes requirements for :

a. health and safety.

b. quality planning.
c. quality costing.
d. all of the above.
e. none of the above.

1.07 A system based on the requirements of ISO 9001 aims to

a. achieve customer satisfaction.

b. demonstrate an organization’s ability to consistently supply conforming product.
c. prevent non conformity.
d. all of the above.
e. none of the above.

1. 08 The process approach to a quality management system seeks to help

organizations:

a. manage numerous linked activities.

b. understand and fulfill applicable requirements .
c. continually improve the processes.
d. all of the above.
e. none of the above.

1.09 The extent of documentation of the quality system should be determined by:

a. the complexity of processes and their interactions.

b. the expectations of auditors.
c. the culture of the quality department.
d. all of the above.
e. none of the above.

1.10 The documents generated outside the organization and used within the quality
management system must be :
a. re-approved by the organization prior to use
b. identified and their distribution is controlled
c. prevented from unintended use
d. all of the above
e. none of the above
1.11 the quality manual shall include as a minimum :
a. a copy of the quality policy
b. a copy of the organization chart
c. the quality objectives
d. all of the above
e. none of the above

1.12 changes to quality management system documents must be ;

a. re-approved prior to document release
b. entered into a document changes log
c. inhibited in order to ensure consistency of performance.
d. all of the above
e. none of the above

1.13 processes referred to in clause 4.1 of ISO 9001 standard are :

a. only those processes related to product realization activities and measurements
b. processes related to management activities
c. processes related to resources management
d. all of the above
e. none of the above

1.14 the quality policy of the organization must be :

a. signed by a member of the top management
b. known by hard by every body within the organization
c. reviewed for continuing suitability
d. all of the above
e. none of the above

1.15 all the quality system procedures must be :

a. included as a part of the quality manual
b. ensure the effective planning , operation and control of organization’s processes
c. updated annually
d. all of the above
e. none of the above