ISO 9001:2015 Master Internal Audit Checklist

Quick Links: Guidance Result Charts Process Report Action Report Question Guidance

Before you begin auditing, review and edit the process name list in Cell B313. This will populate the drop-down menus in Column E and various axes within the audit result charts. Use the drop-down menu in Column F to select one of four audit findings defined by the audit criteria. Column G will automatically display a recommendation based on the audit finding. The response is then
automatically represented as an 'x' in either Column H, I, J, or K. These columns are hidden. The indicator in Column L will update according to the perceived level of risk, e.g., minor or major. (Ref. Clause 6.4.8, ISO 19011:2018). Use the drop-down menus in Col M to select an appropriate root-cause. You can change this list by editing the root-cause list in Cell M313. Describe how to
correct a nonconformance or adopt an opportunity in Col N. Record audit evidence, such as document numbers and revisions in Col O.

Audit Findings & Actions

Ref No. Clause Title Q-No Requirements/Questions Process Name Audit Result Recommendations Score Possible Root-cause Action Plan Audit Evidence & Notes

Has your organization determined external and internal issues (Incl. whether climate change is a relevant
4.1 Organizational Context 1 issue) are applicable to its purpose and its strategic direction that affect its ability to achieve the intended Business Planning Minor NC Identify and discuss the root-cause within 4 weeks and correct. 75 Human - Poor employee involvement Reinforce training
result(s) of its quality management system?
Contain the problem imediately. Identify the root-cause within one week and Process - Procedures or work-instructions were
4.1 Organizational Context 2 Does your organization monitor and review information about these external and internal issues? Business Planning Major NC 25 Review and rewrite WI
correct. inadequate/non-existent
Relevant Interested Does your organization determine the interested parties that are relevant to the quality management
4.2 3 Business Planning Minor NC Identify and discuss the root-cause within 4 weeks and correct. 75 Human - Lack of skill, training or experience Reinforce training
Parties system?
Relevant Interested Does your organization determine the requirements (Incl. those relating to climate change) of the interested
4.2 4 Design & Development Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Parties parties that are relevant to the quality management system?
Relevant Interested Does your organization monitor and review information about these interested parties and their relevant Contain the problem imediately. Identify the root-cause within one week and
4.2 5 Business Review Major NC 25 Process - Procedure was contradictory or confusing Review and rewrite procedure
Parties requirements? correct.
Management System Does your organization determine the boundaries and applicability of the quality management system to Contain the problem imediately. Identify the root-cause within one week and
4.3 6 Management System Major NC 25 Human - Inadequate management involvement Reinforce training
Scope establish its scope? correct.
Management System When determining this scope, has your organization considered the external and internal issues referred to in
4.3 7 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Scope 4.1?
Management System When determining this scope, has your organization considered the requirements of relevant interested
4.3 8 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Scope parties referred to in 4.2?
Management System When determining this scope, has your organization considered all relevant products, services and work-
4.3 9 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Scope related activities, functions and physical boundaries to the quality management system?
Management System Has your organization applied all the requirements of ISO 9001:2015 if they are applicable within the
4.3 10 Management System Minor NC Identify and discuss the root-cause within 4 weeks and correct. 75 Human - Poor employee involvement Review training procedure
Scope determined scope of the quality management system?
Does the scope state the types of products and services covered, and provide justification for any
Management System Review and implement actions to deploy the opportunity to improve the
4.3 11 requirement of ISO 9001:2015 that your organization determines is not applicable to the scope of its quality Management System Opportunity 100 Opportunity for improvement Review scope
Scope process(s).
management system?
Management System Is the scope of your organization’s quality management system available and maintained as documented Contain the problem imediately. Identify the root-cause within one week and
4.3 12 Management System Major NC 25 Human - Human error Reinforce training
Scope information and available to interested parties and workers? (See 7.5.1a) correct.
Has your organization established, implemented, maintained and continually improved its quality
Management System
4.4 13 management system, including the processes needed and their interactions, in accordance with the Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
requirements of ISO 9001:2015?
Management System Has your organization determined the process required for the quality management system, including their
4.4 14 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes interactions, in accordance with requirements and their application throughout the organization?
Management System
4.4 15 Has your organization determined the inputs required and the outputs expected from these processes? Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
Management System
4.4 16 Has your organization determined the sequence and interaction of these processes? Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
Has your organization determined and applied the criteria and methods (including monitoring,
Management System
4.4 17 measurements and related performance indicators) needed to ensure the effective operation and control of Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
these processes?
Management System
4.4 18 Has your organization determined the resources needed for these processes and ensure their availability? Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
Management System
4.4 19 Has your organization assigned responsibilities and authorities for these processes? Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes
Management System Has your organization addressed the risks and opportunities as determined in accordance with the
4.4 20 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes requirements of 6.1?
Management System Has your organization evaluated these processes and implement any changes needed to ensure that these
4.4 21 Management System Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Processes processes achieve their intended results?
Management System Contain the problem imediately. Identify the root-cause within one week and
4.4 22 Does your organization improve the processes and the quality management system? Management System Major NC 25 Human - Did not follow procedures, a one-time lapse Review training procedure
Processes correct.
Management System To the extent necessary, does your organization maintain documented information to support the operation Contain the problem imediately. Identify the root-cause within one week and
4.4 23 Management System Major NC 25 Human - Physically unable perform the task Reassign duties
Processes of its processes? correct.
Management System To the extent necessary, does your organization retain documented information to have confidence that the Review and implement actions to deploy the opportunity to improve the
4.4 24 Management System Opportunity 100 Opportunity for improvement Review previous management review minutes
Processes processes are being carried out as planned? process(s).
Leadership & Has Top Management demonstrated leadership and commitment to the quality management system by
5.1.1 25 Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General taking accountability for the effectiveness of your organization’s quality management system?
Has Top Management demonstrated leadership and commitment to the quality management system by
Leadership &
5.1.1 26 ensuring that your organization’s quality policy and objectives are established, are documented; and are Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General
compatible your organization’s goals (See 6.2) and its context (See 4.0)?
Leadership & Has Top Management demonstrated leadership and commitment to the quality management system by
5.1.1 27 Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General ensuring that quality requirements are integrated into your organization’s business processes?
Leadership & Does Top management demonstrate leadership and commitment with respect to the quality management
5.1.1 28 Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General system by promoting the use of the process approach and risk-based thinking?
Leadership & Has Top Management demonstrated leadership and commitment to the quality management system by
5.1.1 29 Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General ensuring that your organization has the required resources to implement it?
Does Top management demonstrate leadership and commitment with respect to effective quality
Leadership &
5.1.1 30 management system by communicating the importance of effective quality management and of conforming Business Planning Conforms Continue to monitor trends and indicators to determine ongoing stability. 100
Commitment - General
to quality management requirements?