2022 Internal Audit Checklist 9001-2015

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

• Yes

  No

  N/A

Part 1 (Section 4.0)

• Audit Checklist Part 1

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 4.0 Context of the Organization

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has your organization determined external and internal issues relevant to its purpose and its strategic direction that affect its ability to achieve the intended result(s) of its QMS?

  Yes

  No

  N/A

• Does your organization monitor and review information about these external and internal issues?

  Yes

  No

  N/A

• Does the organization determine the interested parties that are relevant to the QMS?

  Yes

  No

  N/A

• Does the organization determine the requirements of these interested parties that are relevant to the QMS?

  Yes

  No

  N/A

• Does your organization monitor and review information about these interested parties and their relevant requirements?

  Yes

  No

  N/A

• Has your organization determined the scope of its QMS?

  Yes

  No

  N/A

• Has your organization considered external and internal issues as part of determining the scope?

  Yes

  No

  N/A

• Has your organization considered the requirements of relevant interested parties as part of determining the scope?

  Yes

  No

  N/A

• Has your organization considered its products and services as part of determining the scope?

  Yes

  No

  N/A

• Has the organization applied all applicable requirements of the International Standard within the determined scope of its QMS?

  Yes

  No

  N/A

• Is the scope of the organization's QMS available and maintained as documented information?

  Yes

  No

  N/A

• Do any requirements determined as not being applicable affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?

  Yes

  No

  N/A

• Has the organization established, implemented, maintained and continually improved a QMS in accordance with the International Standard?

  Yes

  No

  N/A

• Has your organization determined the processes needed for its QMS and their application throughout the organization?

  Yes

  No

  N/A

• Has your organization determined the inputs required and outputs expected from processes needed for its QMS?

  Yes

  No

  N/A

• Has your organization determined the sequence and interaction of the processes needed for its QMS?

  Yes

  No

  N/A

• Has your organization determined and applied the criteria and methods needed to ensure the effective operation and control of the processes needed for its QMS?

  Yes

  No

  N/A

• Has your organization determined the resources needed for processes required by its QMS?

  Yes

  No

  N/A

• Has your organization assigned the responsibilities and authorities for the processes needed for its QMS?

  Yes

  No

  N/A

• Has your organization addressed the risks and opportunities determined in accordance with the requirements of section 6.1?

  Yes

  No

  N/A

• Has your organization evaluated the processes needed for its QMS and ensured that these processes achieve their intended results?

  Yes

  No

  N/A

• Has your organization improved its QMS processes and its QMS?

  Yes

  No

  N/A

• Has the organization maintained documented information to support the operation of its processes?

  Yes

  No

  N/A

• Has the organization retained documented information to have confidence that the processes are being carried out as planned?

  Yes

  No

  N/A

Part 2 (Section 5.0)

• Audit Checklist Part 2

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 5.0 Leadership

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has top management demonstrated leadership and commitment with respect to the QMS?

  Yes

  No

  N/A

• Does top management take accountability for the effectiveness of the QMS?

  Yes

  No

  N/A

• Does top management ensure that the quality policy and quality objectives are established for the QMS and are compatible with the context and strategic direction of the organization?

  Yes

  No

  N/A

• Does top management ensure the integration of the QMS requirements into the organization's business processes?

  Yes

  No

  N/A

• Does top management promote the use of the process approach and riskbased thinking?

  Yes

  No

  N/A

• Does top management ensure that the resources needed for the QMS are available?

  Yes

  No

  N/A

• Does top management communicate the importance of effective quality management and of conforming to the QMS requirements?

  Yes

  No

  N/A

• Does top management ensure that the QMS achieves its intended results?

  Yes

  No

  N/A

• Is top management engaging, directing and supporting persons to contribute to the effectiveness of the QMS?

  Yes

  No

  N/A

• Does top management promote improvement?

  Yes

  No

  N/A

• Does top management support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?

  Yes

  No

  N/A

• Does top management demonstrate leadership and commitment with respect to customer focus by ensuring that customer and applicable statutory and regulatory requirements are determined, understood and consistently met?

  Yes

  No

  N/A

• Does top management demonstrate leadership and commitment with respect to customer focus by ensuring that the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?

  Yes

  No

  N/A

• Does top management demonstrate leadership and commitment with respect to customer focus by ensuring that the focus on enhancing customer satisfaction is maintained?

  Yes

  No

  N/A

• Has top management established, implemented and maintained a quality policy?

  Yes

  No

  N/A

• Is the quality policy appropriate to the purpose and context of the organization, and does the policy support the organization's strategic direction?

  Yes

  No

  N/A

• Does the quality policy provide a framework for setting quality objectives?

  Yes

  No

  N/A

• Does the quality policy include a commitment to satisfy applicable requirements?

  Yes

  No

  N/A

• Does the quality policy include a commitment to continual improvement of the QMS?

  Yes

  No

  N/A

• Is the quality policy available and maintained as documented information?

  Yes

  No

  N/A

• Is the quality policy communicated, understood and applied within the organization?

  Yes

  No

  N/A

• Is the quality policy available to relevant interested parties as appropriate?

  Yes

  No

  N/A

• Has top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?

  Yes

  No

  N/A

• Has top management assigned the responsibility and authority for ensuring that the QMS conforms to the requirements of the International Standard?

  Yes

  No

  N/A

• Has top management assigned the responsibility and authority for ensuring that the processes are delivering their intended outputs?

  Yes

  No

  N/A

• Has top management assigned the responsibility and authority for reporting on the performance of the QMS and on opportunities for improvement, in particular to top management?

  Yes

  No

  N/A

• Has top management assigned the responsibility and authority for ensuring the promotion of customer focus throughout the organization?

  Yes

  No

  N/A

• Has top management assigned the responsibility and authority for ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?

  Yes

  No

  N/A

Part 3 (Section 6.0)

• Audit Checklist Part 3

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 6.0 Planning

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has the organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 when planning for the QMS?

  Yes

  No

  N/A

• Has the organization determined the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended result(s)?

  Yes

  No

  N/A

• Has the organization determined the risks and opportunities that need to be addressed to enhance desirable effects?

  Yes

  No

  N/A

• Has the organization determined the risks and opportunities that need to be addressed to prevent or reduce undesired effects?

  Yes

  No

  N/A

• Has the organization determined the risks and opportunities that need to be addressed to achieve improvement?

  Yes

  No

  N/A

• Has your organization planned actions to address risks and opportunities?

  Yes

  No

  N/A

• Has your organization planned how to integrate and implement the actions into its quality management system processes?

  Yes

  No

  N/A

• Has your organization planned how to evaluate the effectiveness of actions to address risks and opportunities?

  Yes

  No

  N/A

• Has your organization established quality objectives at relevant functions, levels and processes needed for the QMS?

  Yes

  No

  N/A

• Are the quality objectives consistent with the quality policy?

  Yes

  No

  N/A

• Are the quality objectives measurable?

  Yes

  No

  N/A

• Do the quality objectives take into account applicable requirements?

  Yes

  No

  N/A

• Are the quality objectives relevant to conformity of products and services and to enhancement of customer satisfaction?

  Yes

  No

  N/A

• Are the quality objectives monitored?

  Yes

  No

  N/A

• Are the quality objectives communicated?

  Yes

  No

  N/A

• Are the quality objectives updated as appropriate, and is documented information maintained on them?

  Yes

  No

  N/A

• Has your organization determined what will be done when planning how to achieve its quality objectives?

  Yes

  No

  N/A

• Has your organization determined what resources will be required when planning how to achieve its quality objectives?

  Yes

  No

  N/A

• Has your organization determined who will be responsible when planning how to achieve its quality objectives?

  Yes

  No

  N/A

• Has your organization determined when the objectives will be completed when planning how to achieve its quality objectives?

  Yes

  No

  N/A

• Has your organization determined how the results will be evaluated when planning how to achieve its quality objectives?

  Yes

  No

  N/A

• Does the organization carry out changes to its QMS in a planned manner when it determines changes are needed?

  Yes

  No

  N/A

• Does the organization consider the purpose of the changes and their potential consequences?

  Yes

  No

  N/A

• Does the organization consider the integrity of the QMS when it determines changes are needed?

  Yes

  No

  N/A

• Does the organization consider the availability of resources when it determines changes to its QMS are needed?

  Yes

  No

  N/A

• Does the organization consider the allocation or reallocation of responsibilities and authorities when it determines changes to its QMS are needed?

  Yes

  No

  N/A

Part 4 (Section 7.0)

• Audit Checklist Part 4

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 7.0 Support

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has your organization determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS?

  Yes

  No

  N/A

• Has the organization considered the capabilities of and restraints on existing internal resources?

  Yes

  No

  N/A

• Has the organization considered what needs to be obtained from external providers?

  Yes

  No

  N/A

• Has the organization determined and provided the persons necessary for the effective implementation of its QMS and for the operation and control of its processes?

  Yes

  No

  N/A

• Has the organization determined, provided and maintained the infrastructure necessary for the operation of its processes and to achieve conformity of products and services?

  Yes

  No

  N/A

• Has the organization determined, provided and maintained the environment necessary for the operation of its processes and to achieve conformity of products and services?

  Yes

  No

  N/A

• Has the organization determined and provided the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements?

  Yes

  No

  N/A

• Has the organization ensured that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken?

  Yes

  No

  N/A

• Has the organization ensured that the resources provided are maintained to ensure their continuing fitness for their purpose?

  Yes

  No

  N/A

• Has measuring equipment been calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards?

  Yes

  No

  N/A

• Has measuring equipment been identified in order to determine the status of the equipment?

  Yes

  No

  N/A

• Has measuring equipment been safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results?

  Yes

  No

  N/A

• Has your organization determined the knowledge necessary for the operation of its processes and to achieve conformity of products and services?

  Yes

  No

  N/A

• Is this knowledge maintained and made available to the extent necessary?

  Yes

  No

  N/A

• Has the organization considered its current knowledge and determined how to acquire or access any necessary additional knowledge and required updates when addressing changing needs and trends?

  Yes

  No

  N/A

• Has the organization determined the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the QMS?

  Yes

  No

  N/A

• Has the organization ensured that these persons are competent on the basis of appropriate education, training, or experience?

  Yes

  No

  N/A

• Has the organization taken actions, where applicable, to acquire the necessary competence and evaluate the effectiveness of the actions taken?

  Yes

  No

  N/A

• Has the organization retained documented information as evidence of competence?

  Yes

  No

  N/A

• Has the organization ensured that persons doing work under the organization's control are aware of the quality policy?

  Yes

  No

  N/A

• Has the organization ensured that persons doing work under the organization's control are aware of relevant policy objectives?

  Yes

  No

  N/A

• Has the organization ensured that persons doing work under the organization's control are aware of their contribution to the effectiveness of the QMS, including the benefits of improved performance?

  Yes

  No

  N/A

• Has the organization ensured that persons doing work under the organization's control are aware of the implications of not conforming with the QMS requirements?

  Yes

  No

  N/A

• Has the organization determined on what it will communicate internally and externally relevant to the QMS?

  Yes

  No

  N/A

• Has the organization determined when it will communicate internally and externally relevant to the QMS?

  Yes

  No

  N/A

• Has the organization determined with whom it will communicate internally and externally relevant to the QMS?

  Yes

  No

  N/A

• Has the organization determined how it will communicate internally and externally relevant to the QMS?

  Yes

  No

  N/A

• Has the organization determined who will communicate internally and externally relevant to the QMS?

  Yes

  No

  N/A

• Does the organization's QMS include documented information required by the International Standard?

  Yes

  No

  N/A

• Does the organization's QMS include documented information determined by the organization as being necessary for the effectiveness of the QMS?

  Yes

  No

  N/A

• Does the organization ensure appropriate identification and description when creating and updating documented information?

  Yes

  No

  N/A

• Does the organization ensure appropriate format when creating and updating documented information?

  Yes

  No

  N/A

• Does the organization ensure appropriate review and approval when creating and updating documented information?

  Yes

  No

  N/A

• Is documented information required by the QMS and the International Standard controlled to ensure it is available and suitable for use, where and when it is needed?

  Yes

  No

  N/A

• Is documented information required by the QMS and the International Standard adequately protected?

  Yes

  No

  N/A

• Are distribution, access, retrieval and use of documented information controlled?

  Yes

  No

  N/A

• Are storage and preservation of documented information, including preservation of legibility, controlled?

  Yes

  No

  N/A

• Are changes to documented information controlled?

  Yes

  No

  N/A

• Are retention and disposition of documented information controlled?

  Yes

  No

  N/A

• Is documented information of external origin determined by the organization to be necessary for the planning and operation of the QMS identified and controlled?

  Yes

  No

  N/A

• Is documented information retained as evidence of conformity protected from unintended alterations?

  Yes

  No

  N/A

Part 5 (Section 8.0)

• Audit Checklist Part 5

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 8.0 Operation

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has your organization planned, implemented and controlled the processes needed to meet the requirements for the provision of products and services, and implemented the actions determined in Clause 6 (Planning)?

  Yes

  No

  N/A

• Has the organization determined the requirements for the products and services it provides?

  Yes

  No

  N/A

• Has the organization established the criteria for the processes?

  Yes

  No

  N/A

• Has the organization established the criteria for the acceptance of products and services?

  Yes

  No

  N/A

• Has the organization determined the resources needed to achieve conformity to the product and service requirements?

  Yes

  No

  N/A

• Has the organization implemented control of the processes in accordance with the criteria?

  Yes

  No

  N/A

• Has the organization determined, maintained and retained documented information to the extent necessary to have confidence that the processes have been carried out as planned?

  Yes

  No

  N/A

• Has the organization determined, maintained and retained documented information to the extent necessary to demonstrate the conformity of products and services to their requirements?

  Yes

  No

  N/A

• Is the output of this planning suitable for the organization's operations?

  Yes

  No

  N/A

• Has the organization controlled planned changes and reviewed the consequences of unintended changes, taking action to mitigate any adverse effects?

  Yes

  No

  N/A

• Has the organization ensured that outsourced processes are controlled?

  Yes

  No

  N/A

• Does communication with customers include providing information relating to products and services?

  Yes

  No

  N/A

• Does communication with customers include handling enquiries, contracts or orders, including changes?

  Yes

  No

  N/A

• Does communication with customers include obtaining customer feedback relating to products and services, including customer complaints?

  Yes

  No

  N/A

• Does communication with customers include handling or controlling customer property?

  Yes

  No

  N/A

• Does communication with customers include establishing specific requirements for contingency actions when relevant?

  Yes

  No

  N/A

• Has the organization ensured that the requirements for the products and services are defined, including any applicable statutory and regulatory requirements?

  Yes

  No

  N/A

• Has the organization ensured that the requirements for the products and services are defined, including those considered necessary by the organization?

  Yes

  No

  N/A

• Has the organization ensured that it can meet the claims for the products and services it offers?

  Yes

  No

  N/A

• Has the organization ensured that it has the ability to meet the requirements for products and services to be offered to customers, and has the organization conducted a review before committing to supply products and services to a customer?

  Yes

  No

  N/A

• Does the review include requirements specified by the customer, including the requirements for delivery and postdelivery activities?

  Yes

  No

  N/A

• Does the review include requirements not stated by the customer, but necessary for the specified or intended use?

  Yes

  No

  N/A

• Does the review include requirements specified by the organization?

  Yes

  No

  N/A

• Does the review include statutory and regulatory requirements applicable to the products and services?

  Yes

  No

  N/A

• Does the review include contract or order requirements differing from those previously expressed?

  Yes

  No

  N/A

• Has the organization ensured that contract or order requirements differing from those previously defined are resolved?

  Yes

  No

  N/A

• When the customer does not provide a documented statement of their requirements, has the organization confirmed the customer's requirements before acceptance?

• Has the organization retained documented information on the results of the review?

  Yes

  No

  N/A

• Has the organization retained documented information on any new requirements for the products and services?

  Yes

  No

  N/A

• Has the organization ensured that relevant documented information is amended and that relevant persons are made aware of the changed requirements when the requirements for products and services are changed?

  Yes

  No

  N/A

• Has the organization ensured that externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers?

  Yes

  No

  N/A

• Has the organization determined the controls to be applied to externally provided processes, products and services when products and services from external providers are intended for incorporation into the organization's own products and services?

  Yes

  No

  N/A

• Has the organization determined the controls to be applied to externally provided processes, products and services when products and services are provided directly to the customer(s) by external providers on behalf of the organization?

  Yes

  No

  N/A

• Has the organization determined the controls to be applied to externally provided processes, products and services when a process, or part of a process, is provided by an external provider as a result of a decision by the organization?

  Yes

  No

  N/A

• Has the organization determined and applied criteria for the evaluation, selection, monitoring of performance, and reevaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements?

  Yes

  No

  N/A

• Has the organization retained documented information of these activities and any necessary actions arising from the evaluations?

  Yes

  No

  N/A

• Has the organization ensured that externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers?

  Yes

  No

  N/A

• Has the organization ensured that externally provided processes remain within the control of its quality management system?

  Yes

  No

  N/A

• Has the organization defined both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output?

  Yes

  No

  N/A

• Has the organization taken into consideration the potential impact of the externally provided processes, products and services on the organization's ability to consistently meet customer and applicable statutory and regulatory requirements?

  Yes

  No

  N/A

• Has the organization taken into consideration the effectiveness of the controls applied by the external provider?

  Yes

  No

  N/A

• Has the organization determined the verification or other activities necessary to ensure that the externally provided processes, products and services meet requirements?

  Yes

  No

  N/A

• Has the organization ensured the adequacy of requirements prior to their communication to the external provider?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for the processes, products and services to be provided?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for the approval of products and services?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for the approval of methods, processes and equipment?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for the approval of the release of products and services?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for competence, including any required qualification of persons?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for the external providers' interactions with the organization?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for control and monitoring of the external providers' performance to be applied by the organization?

  Yes

  No

  N/A

• Has the organization communicated to external providers its requirements for verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises?

  Yes

  No

  N/A

• Has the organization implemented production and service provision under controlled conditions?

  Yes

  No

  N/A

• Has the organization controlled the availability of documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed?

  Yes

  No

  N/A

• Has the organization controlled the availability of documented information that defines the results to be achieved?

  Yes

  No

  N/A

• Has the organization controlled the availability and use of suitable monitoring and measuring resources?

  Yes

  No

  N/A

• Has the organization controlled the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for products and services have been met?

  Yes

  No

  N/A

• Has the organization controlled the use of suitable infrastructure and environment for the operation of processes?

  Yes

  No

  N/A

• Has the organization controlled the appointment of competent persons, including any required qualification?

  Yes

  No

  N/A

• Has the organization controlled the validation and periodic 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?

  Yes

  No

  N/A

• Has the organization controlled the implementation of actions to prevent human error?

  Yes

  No

  N/A

• Has the organization controlled the implementation of release, delivery and postdelivery activities?

  Yes

  No

  N/A

• Has the organization used suitable means to identify outputs when it is necessary to ensure the conformity of products and services?

  Yes

  No

  N/A

• Has the organization identified the status of outputs with respect to monitoring and measurement requirements throughout production and service provision?

  Yes

  No

  N/A

• Has the organization controlled the unique identification of the outputs when traceability is a requirement, and has the organization retained the documented information necessary to enable traceability?

  Yes

  No

  N/A

• Has the organization exercised care with property belonging to customers or external providers while it is under the organization's control or being used by the organization?

  Yes

  No

  N/A

• Has the organization identified, verified, protected and safeguarded customers' or external providers' property provided for use or incorporation into the products and services?

  Yes

  No

  N/A

• When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, has the organization reported this to the customer or external provider and retained documented information on what has occurred?

• Has the organization preserved the outputs during production and service provision to the extent necessary to ensure conformity to requirements?

  Yes

  No

  N/A

• Has the organization met requirements for postdelivery activities associated with the products and services?

  Yes

  No

  N/A

• Has the organization considered statutory and regulatory requirements in determining the extent of postdelivery activities that are required?

  Yes

  No

  N/A

• Has the organization considered the potential undesired consequences associated with its products and services in determining the extent of postdelivery activities that are required?

  Yes

  No

  N/A

• Has the organization considered the nature, use and intended lifetime of its products and services in determining the extent of postdelivery activities that are required?

  Yes

  No

  N/A

• Has the organization considered customer requirements in determining the extent of postdelivery activities that are required?

  Yes

  No

  N/A

• Has the organization considered customer feedback in determining the extent of postdelivery activities that are required?

  Yes

  No

  N/A

• Has the organization reviewed and controlled changes for production and service provision to the extent necessary to ensure continuing conformity with requirements?

  Yes

  No

  N/A

• Has the organization retained documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?

  Yes

  No

  N/A

• Has the organization implemented planned arrangements at appropriate stages to verify that the product and service requirements have been met?

  Yes

  No

  N/A

• Has the organization prevented the release of products and services to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer?

  Yes

  No

  N/A

• Has the organization retained documented information on the release of products and services that includes evidence of conformity with the acceptance criteria?

  Yes

  No

  N/A

• Has the organization retained documented information on the release of products and services that includes traceability to the person(s) authorizing the release?

  Yes

  No

  N/A

• Has the organization ensured that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?

  Yes

  No

  N/A

• Does the organization deal with nonconforming outputs by either correction; segregation, containment, return or suspension of provision of products and services; informing the customer; or obtaining authorization for acceptance under concession?

  Yes

  No

  N/A

• Has the organization retained documented information that describes the nonconformity?

  Yes

  No

  N/A

• Has the organization retained documented information that describes the actions taken?

  Yes

  No

  N/A

• Has the organization retained documented information that describes any concessions obtained?

  Yes

  No

  N/A

• Has the organization retained documented information that identifies the authority deciding the action in respect of the nonconformity?

  Yes

  No

  N/A

Part 6 (Section 9.0)

• Audit Checklist Part 6

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 9.0 Performance Evaluation

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has your organization determined what needs to be monitored and measured?

  Yes

  No

  N/A

• Has your organization determined the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?

  Yes

  No

  N/A

• Has your organization determined when the monitoring and measuring shall be performed?

  Yes

  No

  N/A

• Has your organization determined when the results from monitoring and measurement shall be analyzed and evaluated?

  Yes

  No

  N/A

• Has your organization evaluated the performance and the effectiveness of the QMS?

  Yes

  No

  N/A

• Has your organization retained appropriate documented information as evidence of the results?

  Yes

  No

  N/A

• Has your organization monitored customers' perceptions of the degree to which their needs and expectations have been fulfilled?

  Yes

  No

  N/A

• Has your organization determined the methods for obtaining, monitoring and reviewing this information?

  Yes

  No

  N/A

• Has your organization analyzed and evaluated appropriate data and information arising from monitoring and measurement?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate conformity of products and services?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate the degree of customer satisfaction?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate the performance and effectiveness of the QMS?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate if planning has been implemented effectively?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate the effectiveness of actions taken to address risks and opportunities?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate the performance of external providers?

  Yes

  No

  N/A

• Has your organization used the results of its analysis to evaluate the need for improvements to the QMS?

  Yes

  No

  N/A

• Has your organization conducted internal audits at planned intervals?

  Yes

  No

  N/A

• Do the internal audits provide information on whether the QMS conforms to the organization's own requirements for its QMS?

  Yes

  No

  N/A

• Do the internal audits provide information on whether the QMS conforms to the requirements of the International Standard?

  Yes

  No

  N/A

• Do the internal audits provide information on whether the QMS is effectively implemented and maintained?

  Yes

  No

  N/A

• Has your organization planned, established, implemented and maintained an audit program including the frequency, methods, responsibilities, planning requirements and reporting, which take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits?

  Yes

  No

  N/A

• Has your organization defined the audit criteria and scope for each audit?

  Yes

  No

  N/A

• Does your organization select auditors and conduct audits to ensure objectivity and the impartiality of the audit process?

  Yes

  No

  N/A

• Does your organization ensure that the results of the audits are reported to relevant management?

  Yes

  No

  N/A

• Does your organization take appropriate correction and corrective actions without undue delay?

  Yes

  No

  N/A

• Does your organization retain documented information as evidence of the implementation of the audit program and the audit results?

  Yes

  No

  N/A

• Does top management review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration the status of actions from previous management reviews?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration changes in external and internal issues that are relevant to the QMS?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in customer satisfaction and feedback from relevant interested parties?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in the extent to which quality objectives have been met?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in process performance and conformity of products and services?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in nonconformities and corrective actions?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in monitoring and measurement results?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in audit results?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration information on the performance and effectiveness of the QMS, including trends in the performance of external providers?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration the adequacy of resources?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration the effectiveness of actions taken to address risks and opportunities?

  Yes

  No

  N/A

• Is the management review planned and carried out taking into consideration opportunities for improvement?

  Yes

  No

  N/A

• Do the outputs of the management review include decisions and actions related to opportunities for improvement?

  Yes

  No

  N/A

• Do the outputs of the management review include decisions and actions related to any need for changes to the QMS?

  Yes

  No

  N/A

• Do the outputs of the management review include decisions and actions related to resource needs?

  Yes

  No

  N/A

• Has the organization retained documented information as evidence of the results of management reviews?

  Yes

  No

  N/A

Part 7 (Section 10.0)

• Audit Checklist Part 7

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Section 10.0 Improvement

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Has your organization determined and selected opportunities for improvement and implemented any necessary actions to meet customer requirements and enhance customer satisfaction?

  Yes

  No

  N/A

• Do the actions to meet customer requirements and enhance customer satisfaction include improving products and services to meet requirements as well as to address future needs and expectations?

  Yes

  No

  N/A

• Do the actions to meet customer requirements and enhance customer satisfaction include correcting, preventing or reducing undesired effects?

  Yes

  No

  N/A

• Do the actions to meet customer requirements and enhance customer satisfaction include improving the performance and effectiveness of the QMS?

  Yes

  No

  N/A

• When a nonconformity occurs, including any arising from complaints, does the organization react to the nonconformity and, as applicable, take action to control and correct it?

• When a nonconformity occurs, including any arising from complaints, does the organization react to the nonconformity and, as applicable, deal with the consequences?

• When a nonconformity occurs, including any arising from complaints, does the organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by reviewing and analyzing the nonconformity?

• When a nonconformity occurs, including any arising from complaints, does the organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by determining the causes of the nonconformity?

• When a nonconformity occurs, including any arising from complaints, does the organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by determining if similar nonconformities exist or could potentially occur?

• When a nonconformity occurs, including any arising from complaints, does the organization implement any action needed?

• When a nonconformity occurs, including any arising from complaints, does the organization review the effectiveness of any corrective action taken?

• When a nonconformity occurs, including any arising from complaints, does the organization update risks and opportunities determined during planning, if necessary?

• When a nonconformity occurs, including any arising from complaints, does the organization make changes to the QMS, if necessary?

• Does the organization retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken?

  Yes

  No

  N/A

• Does the organization retain documented information as evidence of the results of any corrective action?

  Yes

  No

  N/A

• Does the organization continually improve the suitability, adequacy and effectiveness of the QMS?

  Yes

  No

  N/A

• Does the organization consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement?

  Yes

  No

  N/A

Part 8 (Procedures)

• Audit Checklist Part 8

  Yes

  No

  N/A

• Mandatory Documents

  Yes

  No

  N/A

• NonMandatory Documents

  Yes

  No

  N/A

• Mandatory Records

  Yes

  No

  N/A

• Procedures (NonMandatory Documents)

  Yes

  No

  N/A

• Clause

  Yes

  No

  N/A

• Ref

  Yes

  No

  N/A

Audit Question

• Audit Findings

  Yes

  No

  N/A

• Audit Evidence

  Yes

  No

  N/A

• Opportunities for Improvement (OFI)

  Yes

  No

  N/A

• (Score "1" per box)

  Yes

  No

  N/A

• OFI

  Yes

  No

  N/A

• MINOR NC

  Yes

  No

  N/A

• MAJOR NC

  Yes

  No

  N/A

• Provide reference to documented information to justify the finding

  Yes

  No

  N/A

• Provide suggestions for process improvement

  Yes

  No

  N/A

• Does your organization have a procedure for determining the context of the organization and interested parties?

  Yes

  No

  N/A

• Does your organization have a procedure for addressing risks and opportunities?

  Yes

  No

  N/A

• Does your organization have a procedure for competence, training and awareness?

  Yes

  No

  N/A

• Does your organization have a procedure for equipment maintenance and measuring equipment?

  Yes

  No

  N/A

• Does your organization have a procedure for document and record control?

  Yes

  No

  N/A

• Does your organization have a procedure for sales?

  Yes

  No

  N/A

• Does your organization have a procedure for production and service provision?

  Yes

  No

  N/A

• Does your organization have a procedure for warehousing?

  Yes

  No

  N/A

• Does your organization have a procedure for management of nonconformities and corrective actions?

  Yes

  No

  N/A

• Does your organization have a procedure for monitoring customer satisfaction?

  Yes

  No

  N/A

• Does your organization have a procedure for internal audit?

  Yes

  No

  N/A

• Does your organization have a procedure for management review?

  Yes

  No

  N/A

• Totals for this section

  Yes

  No

  N/A

• Overall totals

  Yes

  No

  N/A