ISO 9001:2008 POST-TEST

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Name: E#: Date

1. Which of the following is considered as a non- 6. The release of product and delivery of service to
compliance? the customer shall not proceed until the planned
arrangements have been satisfactorily com-
a) Test equipment is found to be out of calibration pleted, unless otherwise ___________ by a rele-
but it is evident that an actions for recall has vant authority and, where applicable, by the cus-
been taken by the Storekeeper.
tomer.
b) Company decided to do their vendor perform-
ance evaluation only once a year. a) waived
c) An urgent order production lot had been re- b) agreed
jected by the QA. However, nobody reported
c) approved
this to the Sales Department to inform the cus-
tomer. d) warrant
d) Internal Quality Audit carried out by the own
7. It is important for the Organization to ensure ef-
Department Head, according to the MR, he is
fective review of the customers’ requirements
the only person who knows about the whole
and to ensure that the organization has the capa-
production process in the company. bility to fulfill the requirements. Which clause of
the ISO Standard addresses the above require-
2. The term “management responsible for the area
ments?
being audited” in Clause 8.2.2 Paragraph 5 is re-
ferred to a) 7.1

a) Supervisor b) 7.2

b) Manager c) 5.2

c) QMR d) 8.2.1

d) Process Owner 8. The organization shall continually improve the

effectiveness of the quality management system
3. Where an organization chooses to _____________
through the use of the followings, except
any process that affects product conformity to
requirements, the organization shall ensure con-
a) audit results
trol over such processes.
b) management review
a) employ c) quality management system planning
b) purchase d) training needs analysis
c) acquire
9. Personnel performing work affecting conformity
d) outsource to product quality requirements shall be compe-
tent on the basis of appropriate....
4. A single document may address the require-
ments for one or more procedures. a) education
b) qualifications
a) True
c) skills
b) False
d) competencies
5. Conformity to product requirements can be af-
fected directly or indirectly by __________ per- 10. Can a requirement for a documented procedure
forming any task within the quality management be covered by more than one document.
system
a) Yes.
a) operator b) No.
b) clerk
c) inspector
d) personnel
ISO 9001:2008 POST-TEST
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Name: E#: Date

11. When ________________ product is corrected it 17. "Conformity to product requirements can be af-
shall be subject to re-verification to demonstrate fected directly or indirectly by personnel perform-
conformity to the requirements. ing any task within the quality management sys-
tem." Which clause of the ISO Standard ad-
a) rejected dresses the above requirements?
b) noncompliance
c) nonconforming a) 6.2.1 Paragraph 1
d) defective b) 6.2.1 Note
c) 6.2.2 a)
12. Preservation shall also apply to the constituent d) 6.2.2 b)
parts of a product.
18. A documented procedure shall be established to
a) True define the controls needed to ensure that docu-
b) False ments of external origin determined by the or-
ganization to be necessary for the planning and
13. Where identification is a requirement, the organi- operation of the quality management system are
zation shall control and record the unique identi- identified and their distribution controlled.
fication of the product
a) True
a) True
b) False
b) False
19. An action that defines to eliminate the causes of
14. The organization shall ______________ any proc- nonconformities in order to prevent recurrence is
esses for production and service provision where known as
the resulting output cannot be verified by subse-
quent monitoring or measurement. a) Remedial action
b) Corrective action
a) verify c) Preventive action
b) validate d) No action
c) inspect
d) control 20. Records shall remain ________________,
_______________ and _______________.
15. A document specifying the processes of the qual-
ity management system (including the product a) legible, identifiable and retrievable.
realization processes) and the resources to be b) fileable, identifiable and retrievable.
applied to a specific product, project or contract, c) legible, readily identifiable and retrievable.
can be referred to as a ______________. a) legible, identifiable and traceable.

a) Quality Plan
b) Quality Control Plan
c) Quality Assurance Plan
d) All of the above

16. "When used in the monitoring and measurement

of specified requirements, the ability of computer
software to satisfy the intended application shall
be confirmed." Which clause of the ISO Standard
addresses the above requirements?

a) 7.5.2 Paragraph 1
b) 7.5.2 Paragraph 2
c) 7.6 Paragraph 1
d) 7.6 Paragraph 6