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ISO 14001 Test

This document appears to be a knowledge review test for employees of Zakfas Pharmaceuticals on their Quality Management System which complies with ISO 9001:2008. The 20 multiple choice questions cover topics such as the requirements of an ISO-compliant Quality Management System, responsibilities of management and staff, internal audits, corrective and preventive action, problem solving techniques, and the components and flow of a process-based quality management model.

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978 views3 pages

ISO 14001 Test

This document appears to be a knowledge review test for employees of Zakfas Pharmaceuticals on their Quality Management System which complies with ISO 9001:2008. The 20 multiple choice questions cover topics such as the requirements of an ISO-compliant Quality Management System, responsibilities of management and staff, internal audits, corrective and preventive action, problem solving techniques, and the components and flow of a process-based quality management model.

Uploaded by

usman javaid
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Zakfas Pharmaceuticals (Pvt.) Ltd.

KNOWLEDGE REVIEW OF QUALITY MANAGEMENT SYSTEM (ISO 9001:2008)


Name: ____________________________ Designation: ___________________________
Department: _______________________ Duration: 30 Minutes
---------------------------------------------------------------------------------------------------------------------
Total Marks: 28 Marks Obtained: _____________ %age: ___________
------------------------------------------------------------------------------------------------------------------
Kindly Encircle / Tick The True Option.
1. ISO 9001 is a:
a) Quality control standard b) Quality management system
c) Cost reduction program d) Quality improvement program
2. Which of the following do NOT need to be discussed during the management review:
a) Results of audit b) Record of complaints c) Quality Compliance d) Details of personal
records
3. The quality management system documentation shall include
a. documented statements of a quality policy and quality objectives
b. a quality manual
c. documented procedures and records required by this International Standard
d. documents, including records, determined by the organization to ensure the effective planning,
operation and control of its processes
e. All of the Above
4. Who will ensure that the quality policy is appropriate to the purpose of the organization:
a. Management Representative b. ISO Co-ordinator
c. Top Management d. All of above
5. The organization shall plan and implement the monitoring, analysis and improvement
processes needed:
a. To demonstrate conformity to product requirements.
b. to ensure conformity of the quality management system
c. Both a and b.
d. None of above
6. Who is responsible to maintain the QMS in organization:
a. MR b. Top Management c. ISO Co-ordinator d. External Party
4. Common factors between ISO 9001 and ISO 14001:
a. Policy b. Objectives and Targets c. Continual Improvement d. All of the above
7. Who is responsible to conduct the audit of an organisation:
a. Internal Auditor b. Top Management c. Customer d. None of above
8. Which one is not a part of internal communication:
a. Internal Newsletter b. Policies and Procedures c. Internet d. Memos
9. Throughout the text of ISO International Standard, wherever term “product” occurs, it can
also mean:
a. Batch b. Lot c. Service d. All of the above
10. According to ISO 9001 the quality policy must be:
a. Relevant to the organization
b. Contain objectives and targets
c. Contain results of internal audits
d. None of above
11. Quality Management System is:
a. Customer Requirement b. Legal Requirement c. International Requirement
d. None of above
QMS Knowledge Review 1
Zakfas Pharmaceuticals (Pvt.) Ltd.

12. Quality Policy shows commitment towards:


a. Prevention b. Improvement c. Compliance d. All of above
13. Quality Management Program comprises of:
a. Timeframe b. Responsibility c. Methods and Resources d. All of Above
14. What is the difference between corrective and preventive action:
a. Corrective action relates to the product and preventive action is concerned with the process
b. Corrective action implies direct action to rectify the problem and preventive action relates to
taking actions to prevent the problem from occurring
c. Corrective action is initiated by the workers and preventive action is initiated by the manager
a. All of the above
15. Arrange the steps involved in problem solving in sequence:
a. Identify the problem b. Propose solutions c. Implement solutions
d. Investigate the root causes e. Evaluate the effectiveness of solution
16. Arrange the main steps of internal audit in sequence:
a. Audit Reporting b. Audit Planning c. Audit Execution d. Corrective action and Follow up
---------------------------------------------------------------------------------------------------
Note: From Now each question is of 4 marks
17. Show the level of following documents:
Sr. # Documents Level
i- Work Instructions
ii- Manual
iii- Daily Report
iv- System Operating Procedures
18. Management System is:

iv i

19. Model Progress


Figure 1 -Model of a Process based Quality Management
System iii ii
Continual Improvement of the quality
management system

R S
E A
C Q C
4 T
U U U I
S I S S
T R T F
O E O
1 3 A
M M M C
E E E T
R N R
Output I
S T Input S
2 O
S Product
N
Value-adding activities
Information flow 10

QMS Knowledge Review 2


Zakfas Pharmaceuticals (Pvt.) Ltd.

Keys To Test

Question # Answer
01 b
02 d
03 e
04 c
05 c
06 a
07 d
08 a
09 c
10 d
11 a
12 b
13 d
14 d
15 b
16 a, d, b, c, e
17 b, c, a, d
18 2, 1, 3, 2
19 Plan, Do, Check, Act/Action
20 Resource Management,
ProductRealization,
Measurement, Analysis & Improvement ,
Management Responsibility

QMS Knowledge Review 3

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