Professional Documents
Culture Documents
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:
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Understanding the needs and expectations of interested parties
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10. The requirements of relevant interested YesNo N/A Comments
parties.
15. Verify scope states what products and YesNo N/A Comments
services are covered by the QMS and
how it justifies instances where
requirements cannot be applied.
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16. Show how the processes have been YesNo N/A Comments
determined and how they interact.
17. Verify how the processes for the QMS YesNo N/A Comments
were determined. Verify the inputs and
outputs to the processes.
22. Verify how risks and opportunities are YesNo N/A Comments
considered and what actions are taken
to address them.
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23. Verify what methods are used to YesNo N/A Comments
monitor, measure and evaluate
processes. Verify changes, if needed,
are implemented to achieve intended
results.
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29. Ensuring the QMS policy and objectives YesNo N/A Comments
are established and are compatible with
strategic direction and context of
organization.
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36. Promoting continuous improvement YesNo N/A Comments
40. The risks and opportunities that affect YesNo N/A Comments
product and service conformity and the
ability to enhance customer
satisfaction are determined and
addressed.
Policy
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42. Verify the quality policy ... is appropriate YesNo N/A Comments
to the purpose and context of the
organization and supports its strategic
direction.
43. Verify the quality policy ... provides a YesNo N/A Comments
framework for setting quality
objectives.
44. Verify the quality policy ... includes a YesNo N/A Comments
commitment to satisfy applicable
requirements.
45. Verify the quality policy ... includes a YesNo N/A Comments
commitment to continual improvement
of the QMS.
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Organizational roles, responsibilities and authorities
51. Ensuring the QMS conforms to the ISO YesNo N/A Comments
9001:2015 standard.
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55. Ensuring the integrity of the QMS is YesNo N/A Comments
maintained when changes to the QMS
are planned and implemented.
56. Verify how the internal and external YesNo N/A Comments
issues and interested parties are
considered when planning for the QMS?
57. Verify how risks and opportunities are YesNo N/A Comments
determined and addressed so the QMS
can achieve its intended results,
prevent and reduce undesired effects
and achieve continual improvement.
59. Verify how actions are integrated and YesNo N/A Comments
implemented into the QMS processes.
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61. Verify how actions are taken to address YesNo N/A Comments
risks and opportunities determined as
being appropriate to the potential
impact on the conformity of products
and services.
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67. Relevant to the conformity of products YesNo N/A Comments
and services and to the enhancement
of customer satisfaction.
Planning of changes
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73. Verify how QMS changes are planned YesNo N/A Comments
systematically.
Resources
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78. Verify how resources are determined YesNo N/A Comments
for the organization.
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85. Verify how the organization ensures YesNo N/A Comments
that the resources provided are suitable
for the speci
Competence
Awareness
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90. Verify people doing work under the YesNo N/A Comments
organization's control are aware of the
quality policy.
91. Verify people doing work under the YesNo N/A Comments
organization's control are aware of the
relevant quality objectives.
92. Verify people doing work under the YesNo 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 YesNo N/A Comments
organization's control are aware of the
implications of not conforming with the
QMS requirements.
Communication
Documented information
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95. Verify documented information YesNo N/A Comments
required by the ISO 9001:2015
standard.
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Operational planning and control
104. Verify how criteria for processes and YesNo N/A Comments
acceptance for products and services
are determined.
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108. Determine how output from the YesNo N/A Comments
planning process is suitable for
operations.
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113. Customer requirements for delivery YesNo N/A Comments
and post-delivery.
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products and services: Verify how the
organization confirms customer
requirements where the customer
doesn't provide a documented
statement.
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125. The nature, duration and complexity of YesNo N/A Comments
the activities.
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Design and development inputs
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138. Verify that the inputs are complete and YesNo N/A Comments
unambiguous.
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143. Verification activities are conducted to YesNo N/A Comments
ensure that the resulting products and
services meet the requirements for the
specified application or intended use.
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149. Are adequate for the subsequent YesNo N/A Comments
processes for the provision of
products and services.
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impacts are retained.
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160. Verify how the organization YesNo 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
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166. Competence, including any required YesNo N/A Comments
qualification of persons.
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172. Verify the implementation of YesNo 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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Identification and traceability
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183. Verify retained documented YesNo N/A Comments
information for property that is
damaged or otherwise found to be
unsuitable for use.
Preservation
Post-delivery activities
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188. The nature, use and intended lifetime YesNo N/A Comments
of its products and services
Control of changes
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193. Verify at appropriate stages product YesNo N/A Comments
and service requirements have been
met.
194. Verify products and services are not YesNo 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.
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199. Segregation, containment, return or YesNo N/A Comments
suspension of provision of products
and services.
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205. Verify the organization evaluates the YesNo N/A Comments
performance and effectiveness of its
QMS.
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212. If planning has been implemented YesNo N/A Comments
effectively.
Internal audit
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218. Verify the importance of the process, YesNo N/A Comments
changes affecting the organization
and the results of previous audits are
considered.
219. Verify audit criteria and scope are YesNo N/A Comments
created for each audit.
Management review
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224. Verify management reviews QMS at YesNo N/A Comments
planned intervals.
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231. Nonconformities and corrective YesNo N/A Comments
actions.
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238. Verify outputs to management YesNo N/A Comments
review includes:
240. Any need for changes to the QMS. YesNo N/A Comments
General
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Nonconformity and corrective action
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