ISO 9001:2015 Mock Audit 

Checklist 
 
This inspection gives a complete analysis of your organization's alignment with 
ISO 9001 standards. This portion covers understanding, quality management 
and leadership. 
 
 

By:  

Date: 

Time:  

Understanding the organization and its context 

 
1. Verify how the organization has  Yes  No  N/A  Comments 
determined external and internal issues 
relevant to its purpose and strategic 
direction. 

2. Verify how these issues affect the  Yes  No  N/A  Comments 
ability to achieve the intended result of 
the QMS. 

3. Verify how the organization monitors  Yes  No  N/A  Comments 

and reviews information about these 
internal and external issues. 

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 Understanding the needs and expectations of interested parties 
 
4. Verify how organization determined  Yes  No  N/A  Comments 
relevant interested parties to QMS. 

5. Verify how the organization has  Yes  No  N/A  Comments 

determined the relevant needs and 
expectations of interested parties. 

6. Verify how the organization has  Yes  No  N/A  Comments 

determined the impact or potential 
impact of the interested parties. 

7. Verify how the organization monitors  Yes  No  N/A  Comments 

and reviews information about 
interested parties and their relevant 
requirements 

Determining the scope of the quality management system  

 
8. Verify the QMS scope considers the  Yes  No  N/A  Comments 
following: 

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 9. External and internal issues.  Yes  No  N/A  Comments 

10. The requirements of relevant interested  Yes  No  N/A  Comments 

parties. 

11. The products and services of the  Yes  No  N/A  Comments 
organization. 

12. Verify how the organization has  Yes  No  N/A  Comments 
determined how the ISO 9001:2015 
standard is applied within the 
organization. 

13. If the organization has determined any  Yes  No  N/A  Comments 
of the requirements of the ISO 
9001:2015 standard not to be 
applicable, show me how conformity of 
products and services are not affected 
by this. 
14. Verify QMS scope is documented.  Yes  No  N/A  Comments 

15. Verify scope states what products and  Yes  No  N/A  Comments 
services are covered by the QMS and 
how it justifies instances where 
requirements cannot be applied. 

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Quality management system and its processes 
 
16. Show how the processes have been  Yes  No  N/A  Comments 
determined and how they interact. 

17. Verify how the processes for the QMS  Yes  No  N/A  Comments 
were determined. Verify the inputs and 
outputs to the processes. 

18. Verify the sequence and interaction of  Yes  No  N/A  Comments 
the processes. 

19. Verify the criteria, methods,  Yes  No  N/A  Comments 

measurement and related performance 
indicators needed to operate and 
control the processes. 

20. Verify how resources are determined  Yes  No  N/A  Comments 
and allocated. 

21. Verify how responsibilities and  Yes  No  N/A  Comments 

authorities are determined. 

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22. Verify how risks and opportunities are  Yes  No  N/A  Comments 
considered and what actions are taken 
to address them. 

23. Verify what methods are used to  Yes  No  N/A  Comments 
monitor, measure and evaluate 
processes. Verify changes, if needed, 
are implemented to achieve intended 
results. 

24. Verify how opportunities for  Yes  No  N/A  Comments 

improvement for the QMS and its 
processes are determined. 

25. Reviewed documented information  Yes  No  N/A  Comments 

created to support the operation of its 
processes. 

Leadership and commitment 

 
26. Top management is identified.  Yes  No  N/A  Comments 

27. Verify top management demonstrates  Yes  No  N/A  Comments 

leadership and commitment by. 

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28. Taking accountability for QMS  Yes  No  N/A  Comments 
effectiveness. 

29. Ensuring the QMS policy and objectives  Yes  No  N/A  Comments 
are established and are compatible 
with strategic direction and context of 
organization. 

30. Ensuring the QMS is integrated into  Yes  No  N/A  Comments 
organization's business processes. 

31. Promoting the use of the process  Yes  No  N/A  Comments 
approach and risk-based thinking. 

32. Ensuring resources are available.  Yes  No  N/A  Comments 

33. Communicating the importance of  Yes  No  N/A  Comments 

effective QMS and of conforming to its 
requirements. 

34. Ensuring intended outcomes.  Yes  No  N/A  Comments 

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35. Engaging, directing and supporting  Yes  No  N/A  Comments 
persons to contribute to the 
effectiveness of the QMS. 

36. Promoting continuous improvement  Yes  No  N/A  Comments 

37. Supporting other relevant management  Yes  No  N/A  Comments 

roles to demonstrate their leadership as 
it applies to their areas of 
responsibility. 

38. Verify how top management  Yes  No  N/A  Comments 

demonstrates leadership and 
commitment with respect to customer 
focus by ensuring that. 

39. Customer and applicable statutory and  Yes  No  N/A  Comments 
regulatory requirements are 
determined, understood and 
consistently met. 

40. The risks and opportunities that affect  Yes  No  N/A  Comments 
product and service conformity and the 
ability to enhance customer 
satisfaction are determined and 
addressed. 

41. The focus of enhancing customer  Yes  No  N/A  Comments 

satisfaction is maintained. 

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Policy 
 
42. Verify the quality policy ... is  Yes  No  N/A  Comments 
appropriate to the purpose and context 
of the organization and supports its 
strategic direction. 

43. Verify the quality policy ... provides a  Yes  No  N/A  Comments 
framework for setting quality 
objectives. 

44. Verify the quality policy ... includes a  Yes  No  N/A  Comments 
commitment to satisfy applicable 
requirements. 

45. Verify the quality policy ... includes a  Yes  No  N/A  Comments 
commitment to continual improvement 
of the QMS. 

46. Verify QMS Policy is maintained as  Yes  No  N/A  Comments 
documented information. 

47. Verify QMS Policy is communicated,  Yes  No  N/A  Comments 

understood and applied within the 
organization. 

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48. Verify QMS Policy is available to  Yes  No  N/A  Comments 
relevant interested parties. 

Organizational roles, responsibilities and authorities 

 
49. Verify responsibilities and authorities  Yes  No  N/A  Comments 
for relevant roles are assigned and 
communicated within the organization. 

50. Verify top management assigns  Yes  No  N/A  Comments 

responsibility and authority for.. 

51. Ensuring the QMS conforms to the ISO  Yes  No  N/A  Comments 
9001:2015 standard. 

52. Ensuring that processes are delivering  Yes  No  N/A  Comments 
their intended outputs. 

53. Reporting on the performance of the  Yes  No  N/A  Comments 

QMS and on opportunities for 
improvement, in particular to top 
management. 

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54. Ensuring the promotion of customer  Yes  No  N/A  Comments 
focus throughout the organization. 

55. Ensuring the integrity of the QMS is  Yes  No  N/A  Comments 
maintained when changes to the QMS 
are planned and implemented. 

Actions to address risks and opportunities 

 
56. Verify how the internal and external  Yes  No  N/A  Comments 
issues and interested parties are 
considered when planning for the QMS? 

57. Verify how risks and opportunities are  Yes  No  N/A  Comments 
determined and addressed so the QMS 
can achieve its intended results, 
prevent and reduce undesired effects 
and achieve continual improvement. 

58. Verify how actions are planned to  Yes  No  N/A  Comments 
address risks and opportunities. 

59. Verify how actions are integrated and  Yes  No  N/A  Comments 
implemented into the QMS processes. 

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60. Verify how the organization evaluates  Yes  No  N/A  Comments 
the effectiveness of the actions. 

61. Verify how actions are taken to address  Yes  No  N/A  Comments 
risks and opportunities determined as 
being appropriate to the potential 
impact on the conformity of products 
and services. 

Quality objectives and planning to achieve them 

 
62. Verify quality objectives are established  Yes  No  N/A  Comments 
at relevant functions, levels and 
processes. 

63. Verify the quality objectives are..  Yes  No  N/A  Comments 

64. Consistent with the quality policy.  Yes  No  N/A  Comments 

65. Measurable.  Yes  No  N/A  Comments 

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66. Taking into account applicable  Yes  No  N/A  Comments 
requirements. 

67. Relevant to the conformity of products  Yes  No  N/A  Comments 

and services and to the enhancement 
of customer satisfaction. 

68. Monitored.  Yes  No  N/A  Comments 

69. Communicated.  Yes  No  N/A  Comments 

70. Updated as appropriate.  Yes  No  N/A  Comments 

71. Verify objectives are documented.  Yes  No  N/A  Comments 

72. Verify how the organization determines  Yes  No  N/A  Comments 
what will be done, with what resources, 
when completed and how the results 
will be evaluated for quality objectives. 

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Planning of changes 
 
73. Verify how QMS changes are planned  Yes  No  N/A  Comments 
systematically. 

74. Verify how the organization  Yes  No  N/A  Comments 

demonstrates the purpose and 
potential consequences of changes. 

75. Verify how the organization considers  Yes  No  N/A  Comments 
the integrity of the QMS. 

76. Verify how resources are made  Yes  No  N/A  Comments 
available. 

77. Verify how responsibility and authority  Yes  No  N/A  Comments 
is allocated and reallocated. 

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Resources 
 
78. Verify how resources are determined  Yes  No  N/A  Comments 
for the organization. 

79. Show me how the capabilities and  Yes  No  N/A  Comments 
constraints on internal resources are 
considered. 

80. Show me how needs from external  Yes  No  N/A  Comments 
providers are considered. 

81. Verify how the organization provides  Yes  No  N/A  Comments 
persons necessary to consistently meet 
customer, applicable statutory and 
regulatory requirements for the QMS 
including the necessary processes. 

82. Verify how the organization determines,  Yes  No  N/A  Comments 
provides and maintains the 
infrastructure for the operation of 
processes to achieve products and 
services conformity. 

83. Verify how the organization determines,  Yes  No  N/A  Comments 
provides and maintains the 
environment for the operation of 
processes to achieve products and 
service conformity. 

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84. Verify how resources are determined to  Yes  No  N/A  Comments 
ensure valid and reliable monitoring 
and measuring results. 

85. Verify how the organization ensures  Yes  No  N/A  Comments 
that the resources provided are suitable 
for the speci 

Competence 
 
86. Show me how you determine the  Yes  No  N/A  Comments 
necessary competence of people doing 
work under your control that affects 
quality performance. 

87. Show me how you determine  Yes  No  N/A  Comments 

competence on the basis of 
appropriate education, training or 
experience. 

88. Show me how you take actions to  Yes  No  N/A  Comments 
acquire necessary competence where 
applicable and how do you evaluate the 
effectiveness of those actions. 

89. Verify documented information as  Yes  No  N/A  Comments 

evidence of competence where 
appropriate. 

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Awareness 
 
90. Verify people doing work under the  Yes  No  N/A  Comments 
organization's control are aware of the 
quality policy. 

91. Verify people doing work under the  Yes  No  N/A  Comments 
organization's control are aware of the 
relevant quality objectives. 

92. Verify people doing work under the  Yes  No  N/A  Comments 
organization's control are aware of their 
contribution to the effectiveness of the 
QMS, including the benefits of 
improved performance. 

93. Verify people doing work under the  Yes  No  N/A  Comments 
organization's control are aware of the 
implications of not conforming with the 
QMS requirements. 

Communication 
 
94. Verify internal and external  Yes  No  N/A  Comments 
communication process (what, when, 
with whom and how to communicate). 

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Documented information 
 
95. Verify documented information  Yes  No  N/A  Comments 
required by the ISO 9001:2015 
standard. 

96. Verify documented information that  Yes  No  N/A  Comments 

shows the effectiveness of the QMS. 

97. Show me that your documented  Yes  No  N/A  Comments 

information contains appropriate 
identification, format (language, 
software version, graphics, ...) and 
media (paper, electronic, ...). 

98. Show me how the documented  Yes  No  N/A  Comments 

information is reviewed and approved 
for suitability and adequacy. 

99. Show me how you control documented  Yes  No  N/A  Comments 
information and make it available and 
suitable for use. Tell me how you 
protect your documented information. 

100.Verify how the organization controls  Yes  No  N/A  Comments 

the distribution, access, retrieval, use, 
storage, preservation, legibility, control 
of changes, retention and disposition 
of documented information. 

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101.Verify documented information of  Yes  No  N/A  Comments 
external origin is identified, as 
appropriate, and controlled. 

Operational planning and control 

 
102.Verify how the organization has  Yes  No  N/A  Comments 
planned, implemented and controlled 
processes needed to meet the 
requirements of products and 
services. 

103.Verify how requirements for products  Yes  No  N/A  Comments 

and services are determined. 

104.Verify how criteria for processes and  Yes  No  N/A  Comments 
acceptance for products and services 
are determined. 

105.Verify how resources are determined.  Yes  No  N/A  Comments 

106.Verify how process control is  Yes  No  N/A  Comments 

implemented. 

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107.Show me documented information  Yes  No  N/A  Comments 
that demonstrates processes have 
been carried out as planned and can 
demonstrate conformity of products 
and services. 

108.Determine how output from the  Yes  No  N/A  Comments 

planning process is suitable for 
operations. 

109.Verify how planned changes are  Yes  No  N/A  Comments 

controlled. Verify how unintended 
changes are reviewed and what 
actions are taken to mitigate any 
adverse effects, as necessary. 

110.Verify how outsourced processes are  Yes  No  N/A  Comments 

controlled. 

Determination of requirements for products and services 

 
111.Verify processes created for  Yes  No  N/A  Comments 
communicating with customers on 
information relating to products, 
services, enquiries, contracts, order 
handling, customer views, perceptions 
and complaints, handling or treatment 
of customer property and specific 
requirements for contingency actions. 
112. Verify process to determine the  Yes  No  N/A  Comments 
requirements for products and 
services to be offered to potential 
customers and how the process is 
established, implemented and 
maintained. 

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113.Customer requirements for delivery  Yes  No  N/A  Comments 
and post-delivery. 

114.Verify how the organization reviews..  Yes  No  N/A  Comments 

115.Requirements necessary for  Yes  No  N/A  Comments 

customer's specified or intended use, 
where known. 

116.Statutory and regulatory requirements  Yes  No  N/A  Comments 

applicable to the products and 
services 

117.Other contract or order requirements.  Yes  No  N/A  Comments 

118.Show me that the review is conducted  Yes  No  N/A  Comments 

prior to the organization's 
commitment to supply products and 
services to the customer. 

119.Verify how the organization resolves  Yes  No  N/A  Comments 

differences in the contract or order 
requirements from those previously 
defined. 

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120.Determination of requirements for  Yes  No  N/A  Comments 
products and services: Verify how the 
organization confirms customer 
requirements where the customer 
doesn't provide a documented 
statement. 
121.Determination of requirements for  Yes  No  N/A  Comments 
products and services: Verify 
documented information of reviews 
describing new or changed 
requirements to products and 
services. 
122.Determination of requirements for  Yes  No  N/A  Comments 
products and services: Verify 
documented information of amended 
reviews and how relevant personnel 
are made aware of those changes. 

Design and development of products and services 

 
123. Verify how the design and  Yes  No  N/A  Comments 
development process is established, 
implemented and maintained. 

Design and development planning 

 
124. In determining the stages and  Yes  No  N/A  Comments 
control for design and development, 
verify the organization considers.. 

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125.The nature, duration and complexity of  Yes  No  N/A  Comments 
the activities. 

126.The requirements that specify  Yes  No  N/A  Comments 

particular process stages including 
applicable reviews. 

127.Required verification and validation  Yes  No  N/A  Comments 

128.Responsibilities and authorities.  Yes  No  N/A  Comments 

129.How interfaces are controlled between  Yes  No  N/A  Comments 

individuals and parties 

130.The need for involvement of customer  Yes  No  N/A  Comments 

and user groups. 

131.Verify documented information that  Yes  No  N/A  Comments 

confirms design and development 
requirements have been met. 

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Design and development inputs 
 
132. In determining requirements  Yes  No  N/A  Comments 
essential for the type of products 
and services being designed and 
developed, the organization shall 
consider.. 

133.Functional and performance  Yes  No  N/A  Comments 

requirements. 

134.Information derived from previous  Yes  No  N/A  Comments 

similar design and development 
activities. 

135.Statutory and regulatory requirements.  Yes  No  N/A  Comments 

136.Standard or codes of practice that the  Yes  No  N/A  Comments 

organization has committed to 
implement. 

137.Potential consequences of failure due  Yes  No  N/A  Comments 

to the nature of the products and 
services. 

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138.Verify that the inputs are complete and  Yes  No  N/A  Comments 
unambiguous. 

139.Verify documented information on  Yes  No  N/A  Comments 

design and development inputs are 
retained. 

Design and development controls 

 
140. Verify the organization applies  Yes  No  N/A  Comments 
controls to the design and 
development process to ensure that.. 

Design and development inputs 

 
141. The results to be achieved are  Yes  No  N/A  Comments 
defined. 

142.Reviews are conducted to evaluate the  Yes  No  N/A  Comments 

ability of the results of design and 
development to meet requirements. 

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143.Verification activities are conducted to  Yes  No  N/A  Comments 
ensure that the resulting products and 
services meet the requirements for the 
specified application or intended use. 

144.Validation activities are conducted to  Yes  No  N/A  Comments 

ensure that the resulting products and 
services meet the requirements of the 
specified application or intended use. 

145.Any necessary actions are taken on  Yes  No  N/A  Comments 
problems determined during the 
reviews, or verification and validation 
activities. 

146.Verify documented information of  Yes  No  N/A  Comments 

these activities are retained 

Design and development outputs 

 
147. Verify the organization ensures the  Yes  No  N/A  Comments 
design and development outputs.. 

148.Meet the input requirements.  Yes  No  N/A  Comments 

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149.Are adequate for the subsequent  Yes  No  N/A  Comments 
processes for the provision of 
products and services. 

150.Include or reference monitoring and  Yes  No  N/A  Comments 

measuring requirements, as 
appropriate , and acceptance criteria. 

151.Specify the characteristics of the  Yes  No  N/A  Comments 

products and services that are 
essential for their intended purpose 
and their safe and proper provision. 

152.Verify documented information on  Yes  No  N/A  Comments 

design and development outputs are 
retained. 

Design and development changes 

 
153. Verify the organization identifies,  Yes  No  N/A  Comments 
reviews and controls changes made 
during, or subsequent to, the design 
and development of products and 
services, to the extent necessary to 
ensure that there is no adverse 
impact on conformity to 
requirements. 
154. Verify documented information on  Yes  No  N/A  Comments 
design and development changes, 
the result of reviews, the 
authorization of changes and the 
actions taken to prevent adverse 
impacts are retained. 

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Control of externally provided processes, products and services 
 
155. Verify how the organization ensures  Yes  No  N/A  Comments 
externally provided processes, 
products and services conform to 
specified requirements. 

156. Verify controls applied to externally  Yes  No  N/A  Comments 

provided processes, products and 
services when products and services 
are intended for incorporation into 
the organization's own products and 
services, products and services are 
provided directly to the customer or 
a process, or part of a process, is 
provided by an external provider as a 
result of a decision by the 
organization. 
157. Verify how the organization  Yes  No  N/A  Comments 
determines and applies criteria for 
the evaluation, selection, monitoring 
of performance and re-evaluation of 
external providers. 

158. Verify documented information of  Yes  No  N/A  Comments 

activities and actions arising from 
the evaluations. 

159. Verify how the organization  Yes  No  N/A  Comments 

determines controls applied to the 
external provision of processes, 
products and services and the 
resulting output. 

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160. Verify how the organization  Yes  No  N/A  Comments 
considers the potential impact of the 
external provided processes, 
products and services on its ability 
to meet customer and applicable 
statutory and regulatory 
requirements 
161. Verify the effectiveness of the  Yes  No  N/A  Comments 
controls applied by the external 
provider. 

162. Verify how the organization  Yes  No  N/A  Comments 

determines the verification, or other 
activities, necessary to ensure the 
externally provided processes, 
products and services meet 
requirements. 
163. Verify the organization  Yes  No  N/A  Comments 
communicates to external providers 
its requirements for. 

164. The processes, products and  Yes  No  N/A  Comments 

services to be provided. 

165. The approval of product and  Yes  No  N/A  Comments 

services; methods, processes and 
equipment; and the release of 
products and services. 

166. Competence, including any required  Yes  No  N/A  Comments 

qualification of persons. 

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167. The external providers' interactions  Yes  No  N/A  Comments 
with the organization. 

168. Control and monitoring of the  Yes  No  N/A  Comments 

external providers' performance to 
be applied by the organization. 

169. Verification or validation activities  Yes  No  N/A  Comments 

that the organization, or its 
customer, intends to perform at the 
external providers' premises. 

Control of production and service provision 

 
170. Verify the organization has  Yes  No  N/A  Comments 
documented information that 
defines the characteristics of the 
products to be produced, the 
services to be provided or the 
activities to be performed and the 
results to be achieved. 
171.Verify the availability and use of  Yes  No  N/A  Comments 
suitable monitoring and measuring 
resources. 

172. Verify the implementation of  Yes  No  N/A  Comments 

monitoring and measuring activities 
at appropriate stages to verify that 
criteria for control of processes or 
outputs, and acceptance criteria for 
products and services, have been 
met. 

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173.Verify the use of suitable  Yes  No  N/A  Comments 
infrastructure and environment for the 
operation of processes. 

174.Verify the appointment of competent  Yes  No  N/A  Comments 

persons, including any required 
qualification. 

175. Verify the validation, and periodic  Yes  No  N/A  Comments 
revalidation, of the ability to achieve 
planned results of the processes for 
production and service provision, 
where the resulting output cannot be 
verified by subsequent monitoring or 
measurement. 
176. Verify the implementation of actions  Yes  No  N/A  Comments 
to prevent human error (i.e. poke 
yoke, visual locations, checklist, 
emergency stops, templates, 
document control, ...) 

177.Verify the implementation of release,  Yes  No  N/A  Comments 

delivery and post-delivery activities. 

Identification and traceability 

 
178. Verify how organization identifies  Yes  No  N/A  Comments 
outputs from the process to ensure 
conformity. 

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179. How does the organization identify  Yes  No  N/A  Comments 
the status of process outputs. 

180. Verify how the organization controls  Yes  No  N/A  Comments 
the unique identification of process 
outputs when traceability is required. 
Verify documented information of 
traceability, where required. 

Property belonging to customers or external providers 

 
181. What care is provided to customers'  Yes  No  N/A  Comments 
or external providers' property? 

182. Verify how the organization  Yes  No  N/A  Comments 

identifies, verifies, protects and 
safeguards customers' or external 
providers' property which is provided 
for use or incorporation into the 
organization's products or services. 
183. Verify retained documented  Yes  No  N/A  Comments 
information for property that is 
damaged or otherwise found to be 
unsuitable for use. 

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Preservation 
 
184. Verify how the organization ensures  Yes  No  N/A  Comments 
preservation of the process outputs 
to ensure conformity to 
requirements. 

Post-delivery activities 
 
185. Verify the organization considers the  Yes  No  N/A  Comments 
following to meet post-delivery 
activities. 

186. Statutory and regulatory  Yes  No  N/A  Comments 

requirements 

187. Potential undesired consequences  Yes  No  N/A  Comments 

associated with its products and 
services 

188. The nature, use and intended lifetime  Yes  No  N/A  Comments 
of its products and services 

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189. Customer requirements  Yes  No  N/A  Comments 

190. Customer feedback  Yes  No  N/A  Comments 

Control of changes 
 
191. Verify how the organization reviews  Yes  No  N/A  Comments 
and controls changes for production 
or service provision. 

192. Verify retained documented  Yes  No  N/A  Comments 

information describing the results of 
the review of changes, the person(s) 
authorizing the change and any 
necessary actions arising from the 
review. 

Release of products and services 

 
193. Verify at appropriate stages product  Yes  No  N/A  Comments 
and service requirements have been 
met. 

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194. Verify products and services are not  Yes  No  N/A  Comments 
released to the customer until the 
planned arrangements have been 
satisfactorily completed, unless 
otherwise approved by relevant 
authority and, as applicable, by the 
customer. 
195. Verify retained documented  Yes  No  N/A  Comments 
information that shows evidence of 
conformity with acceptance criteria 
and traceability to person(s) 
authorizing the release. 

Control of nonconforming outputs 

 
196. Verify that outputs that do not  Yes  No  N/A  Comments 
conform to requirements are 
identified and controlled. 

197. Verify appropriate action is taken for  Yes  No  N/A  Comments 
nonconforming products and 
services (also include after delivery 
of product or during/after the 
provision of services). 

198. Correction.  Yes  No  N/A  Comments 

199. Segregation, containment, return or  Yes  No  N/A  Comments 

suspension of provision of products 
and services. 

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200. Informing the customer.  Yes  No  N/A  Comments 

201. Obtaining authorization for  Yes  No  N/A  Comments 

acceptance under concession. 

202. Verify conformity to the  Yes  No  N/A  Comments 

requirements when nonconforming 
outputs are corrected. 

203. Verify retained documented  Yes  No  N/A  Comments 

information that describes the 
nonconformity, describes actions 
taken, describes any concessions 
obtained and identifies the authority 
deciding the action in respect of the 
nonconformity. 

Monitoring, measurement, analysis and evaluation 

 
204. Verify the organization has  Yes  No  N/A  Comments 
determined what needs to be 
monitored and measured, the 
methods to be used, when it will be 
performed, analyzed and evaluated. 

205. Verify the organization evaluates the  Yes  No  N/A  Comments 
performance and effectiveness of its 
QMS. 

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206. Review retained appropriate  Yes  No  N/A  Comments 
documented information. 

207. Verify the organization monitors  Yes  No  N/A  Comments 

customers' perceptions of the 
degree to which their needs and 
expectations have been fulfilled. 

208. Verify the organization analyzes and  Yes  No  N/A  Comments 
evaluates: 

209. Conformity of products and services.  Yes  No  N/A  Comments 

210. The degree of customer satisfaction.  Yes  No  N/A  Comments 

211. The performance and effectiveness  Yes  No  N/A  Comments 

of the QMS. 

212. If planning has been implemented  Yes  No  N/A  Comments 

effectively. 

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213. The effectiveness of actions taken to  Yes  No  N/A  Comments 
address risks and opportunities. 

214. The performance of external  Yes  No  N/A  Comments 

providers. 

215. The need for improvements the  Yes  No  N/A  Comments 
QMS. 

Internal audit 
 
216. Verify audits are conducted at  Yes  No  N/A  Comments 
planned intervals. 

217. Verify organization has established,  Yes  No  N/A  Comments 

implemented, and maintains an 
internal audit program. 

218. Verify the importance of the process,  Yes  No  N/A  Comments 
changes affecting the organization 
and the results of previous audits are 
considered. 

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219. Verify audit criteria and scope are  Yes  No  N/A  Comments 
created for each audit. 

220. Auditors are objective and impartial.  Yes  No  N/A  Comments 

221. Audit results reported to relevant  Yes  No  N/A  Comments 

management. 

222. Verify appropriate correction and  Yes  No  N/A  Comments 

corrective actions are taken without 
delay. 

223. Review retained documented  Yes  No  N/A  Comments 

information. 

Management review 
 
224. Verify management reviews QMS at  Yes  No  N/A  Comments 
planned intervals. 

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225. Verify inputs to management review  Yes  No  N/A  Comments 
includes: 

226. Status of actions from previous  Yes  No  N/A  Comments 

management reviews. 

227. Changes in external and internal  Yes  No  N/A  Comments 

issues relevant to the QMS. 

228. Customer satisfaction and feedback  Yes  No  N/A  Comments 

from relevant interested parties. 

229. The extent to which quality  Yes  No  N/A  Comments 

objectives have been met. 

230. Process performance and  Yes  No  N/A  Comments 

conformity of products and services. 

231. Nonconformities and corrective  Yes  No  N/A  Comments 

actions. 

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232. Monitoring and measurement  Yes  No  N/A  Comments 
results. 

233. Audit results.  Yes  No  N/A  Comments 

234. The performance of external  Yes  No  N/A  Comments 

providers. 

235. Adequacy of resources.  Yes  No  N/A  Comments 

236. Effectiveness of actions taken to  Yes  No  N/A  Comments 

address risks and opportunities. 

237. Opportunities for improvement.  Yes  No  N/A  Comments 

238. Verify outputs to management  Yes  No  N/A  Comments 

review includes: 

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239. Opportunities for improvement.  Yes  No  N/A  Comments 

240. Any need for changes to the QMS.  Yes  No  N/A  Comments 

241. Resource needs.  Yes  No  N/A  Comments 

242. Verify retained documented  Yes  No  N/A  Comments 

information. 

General 
 
243. Verify the organization determines  Yes  No  N/A  Comments 
and selects opportunities for 
improvement to improve products 
and services, corrects, prevents or 
reduces undesired effects and 
improves the performance and 
effectiveness of the QMS. 

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Nonconformity and corrective action 
 
244. Verify how organization reacts to  Yes  No  N/A  Comments 
nonconformity, including complaints, 
by evaluating how its takes action to 
control and correct it and how it 
deals with the consequences. 

245. Verify how the organization  Yes  No  N/A  Comments 

evaluates the need for action to 
eliminate the cause(s) of the 
nonconformity, in order that it does 
not recur or occur elsewhere. 

246. Verify how organization implements  Yes  No  N/A  Comments 

necessary actions. 

247. Verify how organization evaluates  Yes  No  N/A  Comments 

the effectiveness of actions taken. 

248. Verify the organization updates risks  Yes  No  N/A  Comments 
and opportunities determined during 
planning, if necessary. 

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