ISO 9001:2015 Master Internal Audit Checklist

The internal audit checklist will ensure your audits concisely appraise your management system and processes against the requirements of ISO Enter 'x' into Column E, F or G. Capture Provide a reference to the
9001:2015. Answer questions 1 to 305 to determine conformance. The audit results are summarized in the 'Audit Results' worksheet. OFIs in Column H. Note any process or practice that seems
Describe the possible cause of the minor or documentation, records, observations, Audit Risk
weak, cumbersome, redundant or
Audit Finding major nonconformance. questioning, etc. supporting the answer Score
Each audit question phrases each ISO 9001:2015 'shall' requirement as a question, in order to elicit either a 'yes' or 'no' response, that can be complex.
each audit finding.
represented as an 'x'. The scoring formula assumes each requirement conforms, until an 'x' is entered into Column F or G.
Conform Minor NC Major NC OFI
Clause No
Clause Title Q-No Audit Question Possible Root-cause Audit Evidence & Notes Opportunities to Improve Status %
Has your organization determined external and internal issues relevant to its purpose and its strategic
4.1 Organizational Context 1 x 100
direction that affect its ability to achieve the intended result(s) of its quality management system?

4.1 Organizational Context 2 Does your organization monitor and review information about these external and internal issues? x 100

Does your organization determine the interested parties that are relevant to the quality management
4.2 Relevant Interested Parties 3 x 100
system?
Does your organization determine the requirements of these interested parties that are relevant to the
4.2 Relevant Interested Parties 4 x 100
quality management system?
Does your organization monitor and review information about these interested parties and their
4.2 Relevant Interested Parties 5 x 100
relevant requirements?
Does your organization determine the boundaries and applicability of the quality management system
4.3 Management System Scope 6 x 100
to establish its scope?
When determining this scope, has your organization considered the external and internal issues
4.3 Management System Scope 7 x 100
referred to in 4.1?
When determining this scope, has your organization considered the requirements of relevant
4.3 Management System Scope 8 x 100
interested parties referred to in 4.2?
When determining this scope, has your organization considered all relevant products, services and
4.3 Management System Scope 9 x 100
work-related activities, functions and physical boundaries to the quality management system?
Has your organization applied all the requirements of ISO 9001:2015 if they are applicable within the
4.3 Management System Scope 10 x 100
determined scope of the quality management system?
Does the scope state the types of products and services covered, and provide justification for any
4.3 Management System Scope 11 requirement of ISO 9001:2015 that your organization determines is not applicable to the scope of its x 100
quality management system?
Is the scope of your organization’s quality management system available and maintained as
4.3 Management System Scope 12 x 100
documented information and available to interested parties and workers? (See 7.5.1a)
Has your organization established, implemented, maintained and continually improved its quality
4.4 Management System Processes 13 management system, including the processes needed and their interactions, in accordance with the x 100
requirements of ISO 9001:2015?
Has your organization determined the process required for the quality management system, including
4.4 Management System Processes 14 x x 100
their interactions, in accordance with requirements and their application throughout the organization?
Has your organization determined the inputs required and the outputs expected from these
4.4 Management System Processes 15 x 100
processes?

4.4 Management System Processes 16 Has your organization determined the sequence and interaction of these processes? x 75

Has your organization determined and applied the criteria and methods (including monitoring,
4.4 Management System Processes 17 measurements and related performance indicators) needed to ensure the effective operation and x x 100
control of these processes?
Has your organization determined the resources needed for these processes and ensure their
4.4 Management System Processes 18 x 25
availability?

4.4 Management System Processes 19 Has your organization assigned responsibilities and authorities for these processes? x 100
Has your organization addressed the risks and opportunities as determined in accordance with the
4.4 Management System Processes 20 x 100
requirements of 6.1?
Has your organization evaluated these processes and implement any changes needed to ensure that Human - Understands, but did not follow
4.4 Management System Processes 21 x x 100
these processes achieve their intended results? procedure(s)

4.4 Management System Processes 22 Does your organization improve the processes and the quality management system? x Materials - Not appropriate for the task 100

To the extent necessary, does your organization maintain documented information to support the
4.4 Management System Processes 23 x Human - Inadequate management involvement 75
operation of its processes?
To the extent necessary, does your organization retain documented information to have confidence
4.4 Management System Processes 24 x Human - Stress demands 100
that the processes are being carried out as planned?
Has Top Management demonstrated leadership and commitment to the quality management system
5.1.1 General 25 x Materials - Not appropriate for the task 100
by taking accountability for the effectiveness of your organization’s quality management system?
Has Top Management demonstrated leadership and commitment to the quality management system
Human - Knowledge or training not adequate for
5.1.1 General 26 by ensuring that your organization’s environmental policies and objectives are established and x 100
the task
documented, and are compatible your organization’s goals (See 6.2) and its context (See 4.0)?
Has Top Management demonstrated leadership and commitment to the quality management system
5.1.1 General 27 x Environment - Disorderly workplace 25
by ensuring that quality requirements are integrated into your organization’s business processes?
Does Top management demonstrate leadership and commitment with respect to the quality
5.1.1 General 28 x Materials - Lack of raw material 100
management system by promoting the use of the process approach and risk-based thinking?
Has Top Management demonstrated leadership and commitment to the quality management system
5.1.1 General 29 x x Machinery - Improper equipment installation 100
by ensuring that your organization has the required resources to implement it?