ISO 9001:2015 AUDIT CHECKLIST
4 CONTEXT OF THE ORGANIZATION
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT
1. Have you determined the external and internal issues that are relevant to your
2. Do you monitor and review information on these issues?
4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM
4. Have you determined and documented the boundaries and applicability of your QMS by
considering external and internal issues, requirements of interested parties and your products
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES
5. Have you established, implemented, maintained and continually improved a QMS
including all processes needed; including interactions and sequences of processes and
6. Do you maintain necessary documented information to support the processes and have
confidence they are being carried out to plan?
5.1 LEADERSHIP AND COMMITMENT
7. Does top management demonstrate leadership of the QMS by accounting for the efficiency
of the QMS, promoting QMS principles, promoting improvement and ensuring resources are
8. Does top management show leadership with respect to customer focus, customer and
statutory requirements, risks and opportunities and enhancing customer satisfaction?
9. Is a quality policy established that is appropriate for the organization, provides a
framework for quality objectives and shows commitment to satisfying requirements and
10. Is the quality policy available, maintained, communicated and understood by relevant
5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES
11. Has top management assigned responsibilities and relevant roles for the QMS
development, reporting and maintenance so that it meets the intended goals?
6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES
12. Has planning for the QMS considered issues and requirements that determine the risks
and opportunities to be addressed?
13. Has planning taken place to address the risks and opportunities identified and integrate
these into the QMS?
6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM
14. Have you established quality objectives for the QMS that are measurable, monitored,
communicated, updated and documented?
6.3 PLANNING OF CHANGES
15. When QMS changes are needed are they carried out in a planned manner?
7 SUPPORT7.1 RESOURCES
16. Have you determined the resources needed for the QMS including internal and external
resources, people, infrastructure and the environment necessary for the QMS?
17. Have you identified the resources needed for valid monitoring and measurement results
for product and service conformity including measurement traceability, safeguards for
measurement and organizational knowledge necessary for operations?
18. Have you determined the necessary competence required of persons who will perform
functions within the QMS processes?
19. Have you taken actions to ensure persons doing work within the QMS know the quality
policy, quality objectives and how they contribute to the QMS including the implications of
20. Have you determined the what, when, with whom, how and who communicates for both
internal and external communications relevant to the QMS?
7.5 DOCUMENTED INFORMATION
21. Have you set up a process to control documented information of the QMS including
creating and updating, control of use, adequate protection, control of distribution and
8 OPERATION8.1 OPERATIONAL PLANNING AND CONTROL
22. Do you plan and control processes needed for your product or service including criteria
for acceptance, resources needed, control necessary and what documented information is
needed, including control of planned changes?
8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES
23. Have you implemented processes for customer communication, determining requirements
for products and services, reviewing requirements of products and services and updating
documents when changes occur?
8.3 DESIGN AND DEVELOPMENT
24. Have you established, implemented and maintained a design and development process for
your products and services that addresses design and development planning, inputs, controls,
outputs and changes?
8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND
25. Have you taken steps to ensure externally provided processes meet requirements by
determining the type and extent of control needed and the information needed for external
8.5 PRODUCTION AND SERVICE PROVISION
26. Have you implemented the controlled conditions necessary for your production and
service provision including; necessary documented information, monitoring and
measurement, identification and traceability (if necessary), property belonging to customers
or external parties, preservation of product or service, control of changes and post delivery
activities associated with your product and service?
8.6 RELEASE OF PRODUCTS AND SERVICES
27. Have you implemented planned arrangements to verify that requirements have been met
before release of products and services?
8.7 CONTROL OF NONCONFORMING OUTPUTS
28. Have you implemented a process to identify and control nonconforming outputs of your
processes so that they are not unintentionally used until a disposition has been made? Is
documented information maintained for this process?
9 PERFORMANCE EVALUATION9.1 MONITORING, MEASUREMENT, ANALYSIS
29. Have you determined the monitoring and measurement needs, how it will be done and
when it shall be performed for the processes of the QMS and customer satisfaction? Is
analysis and evaluation done on the data and information arising from monitoring and
9.2 INTERNAL AUDIT
30. Are there audit procedures to evaluate the QMS against the planned arrangements
(including effectiveness, proper implementation and maintenance) at planned intervals? Are
results reported to management?
9.3 MANAGEMENT REVIEW
31. Does top management review the data from the QMS to assess the need for change in the
QMS, resource adequacy and the effectiveness of the QMS?
10 IMPROVEMENT10.1 GENERAL
32. Do you identify opportunities for improvement and implement action to meet
requirements and enhance customer satisfaction?
10.2 NONCONFORMITY AND CORRECTIVE ACTION
33. When a nonconformity occurs do you take action to deal with the nonconformity and deal
with the consequences, evaluate the need to eliminate the root cause of the nonconformity
and review the effectiveness of the corrective action taken?
34. After action is taken do you update any risks and opportunities found during the
corrective action and update the QMS if necessary?
10.3 CONTINUAL IMPROVEMENT
35. Do you continually improve the suitability, adequacy and effectiveness of the QMS?