ISO 9001:2015 provides a number of examples of improvement.

Which of the following is NOT

listed as an example of improvement*
Preventive action

Breakthrough change, innovation and re-organization

Correction

Corrective action
The scope of the quality management system needs to be available and be maintained as
documented information*
True

False
The organisation needs to retain documented information to have the confidence that the
processes are being carried out as planned*
True

False
"Action to eliminate the cause of a nonconformity and to prevent recurrence" is called a*
Nonconformity

Preventive action

Corrective action

Correction
What must be considered when determining the scope of the management system, according to
ISO 9001:2015*
Requirements of the relevant interested parties

Internal and external issues

Products and services of the organisation

All of the above

None of the above

The needs and expectations of interested parties need to be maintained as documented
information*
True

False
 "Combination of internal and external issues that can have an effect on an organizations
approach to developing and achieving its objectives" is called*

o Environment of the organisation

o Context of the organisation

o External provider

o Quality management systems realization

The Annex SL Framework is designed to*

make it harder for organisations to understand ISO management systems

make things more complex so that Quality Managers have higher salaries

make it easier for everyone to understand management systems and implement multiple ISO
standards

all of the above

none of the above

Context of the organization need to be maintained as documented information*
True

False
ISO 9001:2015 terms and definitions are located in*
Wikipedia

ISO 9000:2015

ISO 9004:2004

All of the above

None of the above

1.1"The degree to which a set of inherent characteristics of an object fulfils requirements" is known
as:

A. Conformity
B. Quality
C. Grade
D. Capability
E. None of the above
1.2In accordance with ISO 9001:2015, which of the following requires documented information to be
retained by the organization?

A. Evidence of competence
B. Internal audit results
C. Management review results
D. All of the above
E. None of the above

1.3ISO 9001:2015 requires that the quality policy:

A. Must be reviewed for continuing suitability

B. Must be communicated and understood within the organization
C. Must provide a framework for establishing and reviewing quality objectives
D. All of the above
E. None of the above

1.4Which of the following is not one of the seven Quality Management Principles?

A. System Approach to Management

B. Engagement of people
C. Leadership
D. Customer focus
E. None of the above

1.5According to ISO 9001:2015, organizational knowledge shall be

A. Documented and such documented information shall be maintained

B. Available to everybody
C. Determined to achieve conformity in products and services
D. All of the above
E. None of the above
F. Why should your QMS be regularly monitored and evaluated?
G.
2. What does interrelated processes mean?
H.
3. Name three activities you must do under the Act part of your PDCA
cycle?
I.
4. How is risk-based thinking integrated into the ISO 9001 standard?
J.
5. How does an organization provide assurance of conformity to
requirements?
K.
6. What factors should be considered in designing and implementing your
QMS?
L.
7. What is meant by an organizations strategic direction?
M.
8. How do you determine if a contextual factor is relevant to your
organization?
N.
9. When does an interested party become relevant to your QMS?
O.
10. Name some factors in determining the applicability of the requirements
of the ISO 9001 standard to your QMS?
P.
11. What should the documented statement of QMS scope include?
Q.
12. What are performance indicators?
R.
13. How does the organizations context affect its quality policy and
objectives?
S.
14. What is meant by integrating the QMS requirements into the
organizations business activities?
T.
15. How does top management provide support to personnel to contribute
to QMS effectiveness?
U.
16. Name some measures to gauge the effectiveness of customer focus?
V.
17. What does it mean for the quality policy to support the organizations
strategic direction?
W.
18. In this standard, who performs the management representatives
responsibilities that existed in the previous version of the ISO 9001
standard?
X.
19. What is risk and how is it related to uncertainty?
Y.
20. Explain what desirable effects mean?
Z.
21. What should quality objectives focus on?
AA.
22. How are quality objectives related to risk management?
BB.
23. List some activities required for effective planning of change control?
CC.
24. Provide some examples of risks or constraints related to use of
resources in your organization?
DD.
25. What factors should be considered in determining infrastructure
resources?
EE.
26. What is ergonomics and provide examples of factors to be considered?
FF.
27. How are monitoring and measurement resources used for reference
purposes controlled?
GG.
28. What is the difference between calibrating and verifying a
measurement and monitoring resource?
HH.
29. Name some risks related to organizational knowledge?
II.
30. What is the difference between education and skills?
JJ.
31. What are risks related to communication?
KK.
32. What factors determine the extent of documented information?
LL.
33. Name some controls required for maintaining documented
information?
MM.
34. What are contingency actions and why should your customers be
notified?
NN.
35. What are contingency actions and why should your customers be
notified?
OO.
36. Why is it important to review customer requirements before committing
to accept their orders?
PP.
37. When should you include Design and development (DD) in your QMS
scope?
QQ.
38. Why should customers and users be involved in the DD process and
how should it take place?
RR.
39. Why is information from previous DD useful?
SS.
40. Why do design verification and validation need to done more than
once?
TT.
41. What type of DD output information should be provided to other
processes or departments?
UU.
42. What processes and documents do DD changes impact?
VV.
43. What should be considered in defining the controls over externally
provided products and services?
WW.
44. What is the difference between general verification and QA verification
of purchased product?
XX.
45. What should a review of purchasing information include and how should
it be evidenced?
YY.
46. What documented information should be maintained and retained on
process validation?
ZZ.
47. What is product status, why is it needed and how is it different from
product identification?
AAA.
48. What risks is customer property exposed to?
BBB.
49. Can services be exposed to preservation risks?
CCC.
50. Name some controls over post-delivery activities?
DDD.
51. What should your plan for monitoring and measurement activities
include?
EEE.
52. What three ways can an n/c arise?
FFF.
53. What is measurement and how is it different from monitoring?
GGG.
54. What should the scope of customer feedback information include?
HHH.
III.
55. In planning your internal audit program, what input information should
you consider?
JJJ.
56. What is breakthrough improvement?
KKK.
57. What is the difference between n/c, correction and corrective action?
LLL.
58. What factors should be considered in determining whether a corrective
action is needed for a n/c?
MMM.
59. What is meant by suitability of the QMS?
NNN. 1. How will the introduction of the Annex SL framework for ISO management
system standards affect Quality professionals? (Select One)
OOO. a) It will make it harder for quality professionals to manage multiple ISO management system
standards.
PPP. b) It will increase variation in the structure of ISO management system standards.
QQQ. c) It will make it easier for quality professionals to manage multiple ISO management system
standards
RRR. d) It will prescribe a non-holistic approach to an organisation's quality management system.
SSS. 2. In clause 4 of FDIS (Final Draft International Standard) ISO 9001, 'Context of
the Organisation', quality professionals will need to determine which of the
following: (Select Three)
TTT. a) The scope of the quality management system
UUU. b) The organisation's policies and objectives
VVV. c) The organisation's risks and opportunities
WWW. d) Which of the organisaton's policies and objectives will be listed publicly
XXX. 3. Under ISO 9001:2015, organisations WILL NOT be required to have
documentation in the form of: (Select Two)
YYY. a) a policy
ZZZ. b) a quality manual
AAAA. c) quality procedures
BBBB. d) documented information
CCCC. 4. Under ISO 9001:2015, organisations will have to: (Select One)
DDDD. a) identify risks
EEEE. b) identify opportunities
FFFF. c) take action to address the identified risks
GGGG. d) all of the above
HHHH. 5. Will auditors be required to audit top management under ISO 9001:2015?
(Select One)
IIII. a) Yes
JJJJ. b) No