Title Page
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Site conducted
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Conducted on
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Auditor
4.0 Context of the Organization
4.1 Understanding the organization and its context
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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 IMS?
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Does your organization monitor and review information about these external and internal issues?
4.2 Understanding the needs and expectations of interested parties
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Does the organisation determine the interested parties that are relevant to the IMS?
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Does the organisation determine the relevant needs, expectations and requirements of these interested parties that are relevant to the IMS?
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Does your organization monitor and review information about these interested parties, compliance obligations and their relevant requirements?
4.3 Determining the scope of the Quality and Environmental management system
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Does your organization determine the boundaries and applicability of the IMS to establish its scope?
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When determining this scope, has your organization considered the external and internal issues referred to in 4.1?
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When determining this scope, has your organization considered the compliance obligations of relevant interested parties referred to in 4.2?
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When determining this scope, has your organization considered its organizational units, functions and physical boundaries?
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When determining this scope, has your organization considered the activities, products and services of your organization?
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When determining this scope, has your organization considered its authority and ability to exercise control and influence?
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Has your organization applied all the requirements of this International Standard if they are applicable within the determined scope of its IMS?
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Is the scope of your organization’s IMS available and maintained as documented information? (See 7.5.1a)
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Does the scope state the types of products and services covered, and provide justification for any requirement of this International Standard that your organization determines is not applicable to the scope of its IMS?
4.4 Quality and Environmental management system and its processes
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Has your organization established, implemented, maintained and continually improved an IMS, including the processes needed and their interactions, in accordance with the requirements of this International Standard?
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Has your organization considered the knowledge gained in 4.1 and 4.2 when establishing and maintaining the IMS?
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Has your organization determined the processes needed for the IMS and their application throughout your organization?
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Has your organization determined the inputs required and the outputs expected from these processes (See 4.4)?
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Has your organization determined the sequence and interaction of these processes; (See 4.4)?
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Has your organization determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; (See 9.0)?
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Has your organization determined the resources needed for these processes and ensure their availability; (See 7.1)?
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Has your organization assigned responsibilities and authorities for these processes; (See 5.3)?
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Has your organization addressed the risks and opportunities as determined in accordance with the requirements of 6.1?
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Has your organization evaluated these processes and implement any changes needed to ensure that these processes achieve their intended results?
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Does your organization improve the processes and the IMS as per the requirements of 10?
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To the extent necessary, does your organization maintain documented information to support the operation of its processes? (See 7.5.1b)
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To the extent necessary, does your organization retain documented information to have confidence that the processes are being carried out as planned? (See 7.5.1b)
5.0 Leadership
5.1 Leadership and commitment
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Does Top management demonstrate leadership and commitment with respect to the IMS by taking accountability for the effectiveness of the IMS?
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Does Top management demonstrate leadership and commitment with respect to the IMS by ensuring that the policy and objectives are established for the IMS and are compatible with the context and strategic direction of your organization?
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Does Top management demonstrate leadership and commitment with respect to the IMS by ensuring the integration of the IMS requirements into your organization’s business processes?
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Does Top management demonstrate leadership and commitment with respect to the IMS by ensuring that the resources needed for the IMS are available?
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Does Top management demonstrate leadership and commitment with respect to the IMS by communicating the importance of effective quality and environmental management and of conforming to the IMS requirements?
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Does Top management demonstrate leadership and commitment with respect to the IMS by ensuring that the IMS achieves its intended results?
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Does Top management demonstrate leadership and commitment with respect to the IMS by engaging, directing and supporting persons to contribute to the effectiveness of the IMS?
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Does Top management demonstrate leadership and commitment with respect to the IMS by promoting continual improvement?
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Does Top management demonstrate leadership and commitment with respect to the IMS by supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?
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Does Top management demonstrate leadership and commitment with respect to the IMS by promoting the use of the process approach and risk-based thinking?
5.2 Quality and Environmental Policy
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Does Top management establish, implement and maintain a policy that is appropriate to the purpose and context of your organization and supports its strategic direction?
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Does Top management establish, implement and maintain a policy that provides a framework for setting quality and environmental objectives?
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Does Top management establish, implement and maintain a policy that commits to the protection of the environment, including prevention of pollution and other specific commitment(s) relevant to the organization?
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Does Top management establish, implement and maintain a policy that commits to fulfil its compliance obligations?
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Does Top management establish, implement and maintain a policy that includes a commitment to continual improvement of the IMS?
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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?
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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?
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Does Top management demonstrate leadership and commitment with respect to customer focus by ensuring that the focus on enhancing customer satisfaction is maintained?
5.2.2 Communicating the policy
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Is the policy available and being maintained as documented information? (See 7.5.1a)
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Is the policy communicated, understood and applied within the organization?
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Is the policy available to relevant interested parties, as appropriate?
5.3 Organizational roles, responsibilities and authorities
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Does Top management ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within your organization?
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Has Top management assigned the responsibility and authority for ensuring that the IMS conforms to the requirements of this International Standard?
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Has Top management assigned the responsibility and authority for reporting on the performance of the IMS and on opportunities for improvement (see 10.1), in particular to top management?
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Has Top management assigned the responsibility and authority for ensuring that the processes are delivering their intended outputs?
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Has Top management assigned the responsibility and authority for ensuring that the integrity of the IMS is maintained when changes to the IMS are planned and implemented?
6.0 Planning
6.1.1 Actions to address risks and opportunities (General)
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Has your organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to give assurance that the IMS can achieve its intended results?
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Has your organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to give assurance that the IMS can enhance desirable effects or outcomes?
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Has your organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to give assurance that the IMS can prevent, or reduce, undesired effects including the potential for external environmental conditions to affect the organization?
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Has your organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to give assurance that the IMS can achieve improvement?
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Does your organization plan the actions to address these risks and opportunities i.e. potential emergency situations, including those that can have an environmental impact?
6.1.2 How the organisation plan to address risks and opportunities
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Does your organization determine the environmental aspects of its activities, products and services that it can control and/or influence and their associated environmental impacts?
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Does your organization, when determining environmental aspects, change, including planned or new developments, and new or modified activities, products and services?
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Does your organization when determining environmental aspects take into account abnormal conditions and reasonably foreseeable emergency situations?
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Does the organization determine those aspects that have or can have a significant environmental impact by using established criteria?
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Does your organization communicate its significant environmental aspects among the various levels and functions of the organization, as appropriate?
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Does your organization maintain documented information for its environmental aspects and associated environmental impacts?
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Does your organization maintain documented information for criteria used to determine its significant environmental aspects?
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Does your organization maintain documented information for significant environmental aspects?
6.1.3 Compliance obligations
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Does your organization determine and have access to the compliance obligations related to its quality and environmental aspects?
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Does your organization determine how these compliance obligations apply to the organization?
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Does your organization take compliance obligations into account when establishing, implementing. maintaining and continually improving its IMS?
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Does your organization retain and maintain documented information of its compliance obligations?
6.1.4 Planning action
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Does your organization plan how to integrate and implement the actions into its IMS processes (see 4.4)?
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Does your organization plan how to evaluate the effectiveness of these actions?
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Are actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?
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Does your organization plan how to take action to address its significant quality and environmental aspects?
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Does your organization plan how to take action to address its compliance obligations?
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Does your organization plan how to take action to address its risks and opportunities as identified in 6.1.1?
6.2.1 Quality and Environmental objectives
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Has your organization established objectives at relevant functions, levels and processes needed for the IMS taking into account significant quality and environmental aspects and associated compliance obligations and considering its risk and opportunities?
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Are the quality and environmental objectives consistent with the policy?
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Are the quality and environmental objectives measurable?
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Are the quality and environmental objectives monitored?
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Are the quality and environmental objectives communicated?
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Are the quality and environmental objectives updated as appropriate?
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Does your organization maintain documented information on the quality and environmental objectives? (See 7.5.1a)
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Do the quality objectives take into account applicable requirements?
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Are the quality objectives relevant to conformity of products and services and to enhancement of customer satisfaction?
6.2.2 Quality and Environmental objectives and planning actions to achieve them
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When planning how to achieve its quality and environmental objectives, does your organization determine what will be done?
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When planning how to achieve its quality and environmental objectives, does your organization determine what resources will be required?
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When planning how to achieve its quality and environmental objectives, does your organization determine who will be responsible?
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When planning how to achieve its quality and environmental objectives, does your organization determine when it will be completed?
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When planning how to achieve its quality and environmental objectives, does your organization determine how the results will be evaluated, including indicators for monitoring progress towards achievement of its measurable objective (see 9.1.1)?
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When planning how to achieve its quality and environmental objectives, does your organization consider how its actions to achieve its quality and environmental objectives can be integrated into its business processes?
6.3 Planning of changes
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When your organization determines the need for changes to the IMS, are the changes carried out in a planned manner (see 4.4).
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Does your organization consider the purpose of the changes and their potential consequences?
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Does your organization consider the integrity of the IMS?
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Does your organization consider the availability of resources?
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Does your organization consider the allocation or reallocation of responsibilities and authorities?
7.0 Support
7.1.1 Resources general
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Does your organization determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the IMS?
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Does your organization consider the capabilities of, and constraints on, existing internal resources?
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Does your organization consider what needs to be obtained from external providers?
7.1.2 Resources people
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Does your organization determine and provide the staff necessary for the effective implementation of its IMS and for the operation and control of its processes?
7.1.3 Resources infrastructure
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Does your organization determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services?
7.1.4 Environment for the operation of processes
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Does organization determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services?
7.1.5.1 Monitoring and measuring resources general
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Does your organization determine and provide 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?
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Does your organization ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken?
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Does your organization ensure that the resources are maintained to ensure their continuing fitness for their purpose?
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Does your organization retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources?
7.1.5.2 Measurement traceability
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When measurement traceability is a requirement, or is considered by your organization to be an essential part of providing confidence in the validity of measurement results, is measuring equipment calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, is the basis used for calibration or verification retained as documented information?
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When measurement traceability is a requirement, or is considered by your organization to be an essential part of providing confidence in the validity of measurement results is measuring equipment identified in order to determine their status?
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When measurement traceability is a requirement, or is considered by your organization to be an essential part of providing confidence in the validity of measurement results safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results?
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Does your organization determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose?
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Does your organization determine previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, does your organization take appropriate action as necessary?
7.1.6 Organizational knowledge
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Does your organization determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services?
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Is organizational knowledge maintained and made available to the extent necessary?
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When addressing changing needs and trends, does your organization consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates?
7.2 Competence
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Does your organization determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the IMS while fulfilling its compliance obligations?
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Does your organization ensure that these persons are competent on the basis of appropriate education, training, or experience?
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Does your organization ensure training needs associated with its environmental aspects and its IMS are met?
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Does your organization, where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken?
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Does your organization retain appropriate documented information as evidence of competence? (See 7.5.1b)
7.3 Awareness
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Does your organization ensure that persons doing work under your organization’s control are aware of the quality and environmental policy?
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Does your organization ensure that persons doing work under your organization’s control are aware of the relevant quality and environmental objectives?
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Does your organization ensure that persons doing work under your organization’s control are aware of the significant quality and environmental aspects and related or potential quality and environmental impacts associated with their work?
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Does your organization ensure that persons doing work under your organization’s control are aware of their contribution to the effectiveness of the IMS, including the benefits of improved performance?
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Does your organization ensure that persons doing work under your organization’s control are aware of the implications of not conforming to the IMS requirements?
7.4.1 Communication
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Does your organization establish, implement and maintain process(es) need for internal and external communications relevant to the IMS?
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Does your organization determine the internal and external communications relevant to the IMS, including what it will communicate?
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Does your organization determine the internal and external communications relevant to the IMS, including when to communicate?
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Does your organization determine the internal and external communications relevant to the IMS, including with whom to communicate?
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Does your organization determine the internal and external communications relevant to the IMS, including how to communicate?
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Does your organization determine the internal and external communications relevant to the IMS, including who communicates?
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Does your organization when determining the internal and external communications, take into account its compliance obligations?
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Does your organization determine the internal and external communications to ensure that quality and environmental information communicated is consistent with information generated within the IMS and is reliable?
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How does your organization respond to relevant communications on its IMS?
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Does your organization retain documented information as evidence of its communications as appropriate?
7.4.2 Internal communication
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How does your organization determine the internal communications information is relevant to the IMS among the various levels and functions of the organization including changes to the IMS as appropriate?
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How does your organization determine the internal communications process(es) enable persons doing work under the organization’s control to contribute to continual improvement?
7.4.3 External communication
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How does your organization determine how the external information relevant to the IMS as established by the organizations communication process(es) as required by its compliance obligations is communicated?
7.5.1 Documented information general
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Does your organization’s IMS include documented information required by this International Standard?
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Does your organization’s IMS include documented information determined by your organization as being necessary for the effectiveness of the IMS?
7.5.2 Creating and updating
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When creating and updating documented information, does your organization ensure appropriate identification and description (e.g. a title, date, author, or reference number)?
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When creating and updating documented information, does your organization ensure appropriate format (e.g. language, software version, graphics) and media (e.g. paper, electronic)?
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When creating and updating documented information, does your organization ensure appropriate review and approval for suitability and adequacy?
7.5.3.1 Control of documented information
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Is documented information (required by the IMS and ISO 9001) controlled to ensure it is available and suitable for use, where and when it is needed?
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Is documented information (required by the IMS and ISO 9001) controlled to ensure it is adequately protected from loss of confidentiality, improper use, or loss of integrity?
7.5.3.2 Control of documented information
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For the control of documented information, does your organization address the distribution, access, retrieval and use?
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For the control of documented information, does your organization address storage and preservation, including preservation of legibility?
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For the control of documented information, does your organization address control of changes (e.g. version control)?
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For the control of documented information, does your organization address retention and disposition?
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Is documented information of external origin determined by your organization to be necessary for the planning and operation of the IMS identified as appropriate, and being controlled?
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Is documented information retained as evidence of conformity protected from unintended alterations?
8.0 Operations
8.1 Operational planning and control
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by determining the requirements/establishing criteria for the process(es)?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by establishing criteria for and implementing control of the processes in accordance with the operating criteria?
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Does your organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?
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Does your organization ensure that outsourced processes are controlled or influenced (see 8.4)?
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Does your organization ensure the type and extent of control or influence to be applied to the process(es) shall be defined within the IMS?
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Does your organization establish controls to ensure that its environmental requirement(s) is addressed in the design and development process for the product or service, considering each life cycle stage?
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Does your organization determine its environmental requirements for the procurement of products and services, as appropriate?
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Does your organization communicate its relevant environmental requirements to external providers including contractors?
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Does your organization consider the need to provide information about potential significant environmental impacts associated with the transportation or delivery, use, end-of-life treatment and final disposal of its products and services?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by determining, maintaining and retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by establishing criteria for the acceptance of products and services?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by determining the resources needed to achieve conformity to product and service requirements?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by implementing control of the processes in accordance with the criteria?
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Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1 and 6.2 by determining, maintaining and retaining documented information to the extent necessary to demonstrate the conformity of products and services to their requirements?
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Are the outputs of the planning process suitable for your organization’s operations?
8.2 Emergency preparedness and response
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Does your organization establish, implement and maintain the processes needed to prepare for and respond to potential emergency situations as identified in 6.1.1?
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Does your organization prepare to respond by planning actions to prevent or mitigate adverse environmental impacts from emergency situations?
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Does your organization respond to actual emergency situations?
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Does your organization take action to prevent or mitigate the consequences of emergency situations, appropriate to the magnitude of the emergency and the potential environmental impact?
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Does your organization periodically test the planned response actions, where practicable?
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Does your organization periodically review and revise the processes and planned response actions in particular after the occurrence of emergency situations or tests?
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Does your organization provide relevant information and training related to emergency preparedness and response as appropriate, to relevant interested parties, including persons working under its control?
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Does your organization maintain documented information to the extent necessary to have confidence that the processes are carried out as planned?
8.2.1 Requirements for products and services - Customer communication
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Does communication with customers include providing information relating to products and services?
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Does communication with customers include handling enquiries, contracts or orders, including changes?
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Does communication with customers include obtaining customer feedback relating to products and services, including customer complaints?
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Does communication with customers include handling or controlling customer property?
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Does communication with customers include establishing specific requirements for contingency actions, when relevant?
8.2.2 Requirements for products and services - Determining the requirements for products and services
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When determining the requirements for the products and services to be offered to customers, does your organization ensure that the requirements for the products and services are defined, including any applicable statutory and regulatory requirements?
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When determining the requirements for the products and services to be offered to customers, does your organization ensure that the requirements for the products and services are defined, including those considered necessary by your organization?
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When determining the requirements for the products and services to be offered to customers, does your organization ensure that your organization can meet the claims for the products and services it offers?
8.2.3.1 Review of the requirements for products and services
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Does your organization ensure that it has the ability to meet the requirements for products and services to be offered to customers?
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Does your organization conduct a review before committing to supply products and services to a customer, including requirements specified by the customer, including the requirements for delivery and post-delivery activities?
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Does your organization conduct a review before committing to supply products and services to a customer, including requirements not stated by the customer, but necessary for the specified or intended use, when known?
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Does your organization conduct a review before committing to supply products and services to a customer, including requirements specified by your organization?
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Does your organization conduct a review before committing to supply products and services to a customer, including statutory and regulatory requirements applicable to the products and services?
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Does your organization conduct a review before committing to supply products and services to a customer, including contract or order requirements differing from those previously expressed?
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Does your organization ensure that contract or order requirements differing from those previously defined are resolved?
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Are customer’s requirements confirmed by your organization before acceptance, when the customer does not provide a documented statement of their requirements?
8.2.3.2 Review of the requirements for products and services
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Does your organization retain documented information, as applicable on the results of the review? (See 7.5.1b)
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Does your organization retain documented information, as applicable on any new requirements for the products and services? (See 7.5.1b)
8.2.4 Changes to requirements for products and services
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Does your organization ensure 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? (See 7.5.2)
8.3.1 Design and development of products and services general
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Does your organization establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services?
8.4.1 Control of externally provided processes, products and services general
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Does your organization ensure that externally provided processes, products and services conform to requirements?
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Does your organization determine the controls to be applied to externally provided processes, products and services when products and services from external providers are intended for incorporation into your organization’s own products and services?
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Does your organization determine 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 your organization?
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Does your organization determine 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 your organization?
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Does your organization determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements?
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Does your organization retain documented information of these activities and any necessary actions arising from the evaluations? (See 7.5.1b)
8.4.2 Type and extent of control
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Does your organization ensure that externally provided processes, products and services do not adversely affect your organization’s ability to consistently deliver conforming products and services to its customers?
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Does your organization ensure that externally provided processes remain within the control of its IMS?
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Does your organization define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output?
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Does your organization take into consideration the potential impact of the externally provided processes, products and services on your organization’s ability to consistently meet customer and applicable statutory and regulatory requirements?
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Does your organization take into consideration the effectiveness of the controls applied by the external provider?
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Does your organization determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.3 Information for external providers
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Does your organization ensure the adequacy of requirements prior to their communication to the external provider?
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Does your organization communicate to external providers its requirements for the processes, products and services to be provided?
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Does your organization communicate to external providers its requirements for the approval of products and services?
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Does your organization communicate to external providers its requirements for the approval of methods, processes and equipment?
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Does your organization communicate to external providers its requirements for the approval of the release of products and services?
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Does your organization communicate to external providers its requirements for competence, including any required qualification of persons?
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Does your organization communicate to external providers its requirements for the external providers’ interactions with your organization?
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Does your organization communicate to external providers its requirements for the control and monitoring of the external providers’ performance to be applied by your organization?
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Does your organization communicate to external providers its requirements for the verification or validation activities that your organization, or its customer, intends to perform at the external providers’ premises?
8.5.1 Control of production and service provision
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Does your organization implement production and service provision under controlled conditions?
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Has your organization implemented controlled conditions that include 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?
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Has your organization implemented controlled conditions that include the availability of documented information that defines the results to be achieved?
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Has your organization implemented controlled conditions that include the availability and use of suitable monitoring and measuring resources?
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Has your organization implemented controlled conditions that include the implementation of monitoring and measurement 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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Has your organization implemented controlled conditions that include the use of suitable infrastructure and environment for the operation of processes?
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Has your organization implemented controlled conditions that include appointment of competent persons, including any required qualification?
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Has your organization implemented controlled conditions that include 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?
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Has your organization implemented controlled conditions that include the implementation of actions to prevent human error?
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Has your organization implemented controlled conditions that include the implementation of release, delivery and post-delivery activities?
8.5.2 Identification and traceability
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Does your organization use suitable means to identify outputs when it is necessary to ensure the conformity of products and services?
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Does your organization identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision?
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Does your organization control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability? (See 7.5.1b)
8.5.3 Property belonging to customers or external providers
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Does your organization exercise care with property belonging to customers or external providers while it is under your organization’s control or being used by your organization?
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Does your organization identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services?
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When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, does your organization report this to the customer or external provider and retain documented information on what has occurred? (See 7.5.1b)
8.5.4 Preservation
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Does your organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
8.5.5 Post-delivery activities
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Does your organization meet requirements for post-delivery activities associated with the products and services?
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In determining the extent of post-delivery activities that are required, does your organization consider statutory and regulatory requirements?
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In determining the extent of post-delivery activities that are required, does your organization consider the potential undesired consequences associated with its products and services?
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In determining the extent of post-delivery activities that are required, does your organization consider the nature, use and intended lifetime of its products and services?
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In determining the extent of post-delivery activities that are required, does your organization consider customer requirements?
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In determining the extent of post-delivery activities that are required, does your organization consider customer feedback?
8.5.6 Control of changes
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Does your organization review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?
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Does your organization retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review? (See 7.5.1b)
8.6 Release of products and services
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Does your organization implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
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Does your organization ensure that the release of products and services to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer?
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Does your organization retain documented information on the release of products and services including evidence of conformity with the acceptance criteria?
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Does your organization retain documented information on the release of products and services including traceability to the person(s) authorizing the release? (See 7.5.1b)
8.7.1 Control of nonconforming outputs
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Does your organization ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
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Does your organization take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services?
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Does your organization take appropriate action based on the nature of nonconforming products and services detected after delivery of products, during or after the provision of services?
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Does your organization deal with nonconforming outputs (in one or more of the following ways), correction; segregation, containment, return or suspension of provision of products and services; informing the customer; obtaining authorization for acceptance under concession?
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Is conformity to the requirements verified when nonconforming outputs are corrected?
8.7.2 Control of nonconforming outputs documented information
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Does your organization retain documented information that describes the nonconformity? (See 7.5.1b)
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Does your organization retain documented information that describes the actions taken?
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Does your organization retain documented information that describes any concessions obtained?
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Does your organization retain documented information that identifies the authority deciding the action in respect of the nonconformity?
9.0 Performance Evaulation
9.1.1 Monitoring, measurement, analysis and evaluation general
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Does your organization determine what needs to be monitored and measured?
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Does your organization determine the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?
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Does your organization determine the criteria against which it will evaluate its environmental performance and appropriate indicators?
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Does your organization determine when the monitoring and measuring shall be performed?
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Does your organization determine when the results from monitoring and measurement shall be analysed and evaluated?
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Does your organization evaluate the performance and the effectiveness of the IMS?
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Does your organization communicate relevant environmental performance information both internally and externally as identified in its communication process(es) as required by its compliance obligations?
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Does your organization retain appropriate documented information as evidence of the results? (See 7.5.1b)
9.1.2 Customer satisfaction
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Does your organization monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled?
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Does your organization determine the methods for obtaining, monitoring and reviewing this information?
9.1.3 Analysis and evaluation of compliance
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Does your organization establish, implement and maintain process(es) needed to evaluate fulfilment of its compliance obligations?
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Does your organization determine the frequency that compliance will be evaluated which is needed to evaluate fulfilment its compliance obligations?
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Does your organization determine how to evaluate compliance and take action if needed to evaluate fulfilment of its compliance obligations?
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Does your organization maintain knowledge and understanding of its compliance status needed to evaluate fulfilment of its compliance obligations?
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Does your organization retain documented information as evidence of the compliance evaluation result needed to evaluate fulfilment of its compliance obligations?
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Does your organization analyse and evaluate appropriate data and information arising from monitoring and measurement?
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Does your organization ensure that the results of analysis are used to evaluate conformity of products and services?
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Does your organization ensure that the results of analysis are used to evaluate the degree of customer satisfaction?
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Does your organization ensure that the results of analysis are used to evaluate the performance and effectiveness of the IMS?
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Does your organization ensure that the results of analysis are used to evaluate if planning has been implemented effectively?
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Does your organization ensure that the results of analysis are used to evaluate the effectiveness of actions taken to address risks and opportunities?
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Does your organization ensure that the results of analysis are used to evaluate the performance of external providers?
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Does your organization ensure that the results of analysis are used to evaluate the need for improvements to the IMS?
9.2.1 Internal audit general
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Does your organization conduct internal audits at planned intervals to provide information on whether the IMS conforms to your organization’s own requirements for its IMS?
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Does your organization conduct internal audits at planned intervals to provide information on whether the IMS conforms to the requirements of ISO 9001 and 14001?
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Does your organization conduct internal audits at planned intervals to provide information on whether the IMS is effectively implemented and maintained?
9.2.2 Internal audit company input
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Does your organization plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting your organization, and the results of previous audits?
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Does your organization define the audit criteria and scope for each audit?
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Does your organization select auditors and conduct audits to ensure objectivity and the impartiality of the audit process?
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Does your organization ensure that the results of the audits are reported to relevant management?
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Does your organization take appropriate correction and corrective actions without undue delay?
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Does your organization retain documented information as evidence of the implementation of the audit programme and the audit results? (See 7.5.1b)
9.3.1 Management review general
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Does Top management review your organization’s IMS, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of your organization?
9.3.2 Management review input
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Does the management review planned and carried out take into consideration the status of actions from previous management reviews?
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Does the management review planned and carried out take into consideration changes in external and internal issues that are relevant to the IMS?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in customer satisfaction and the needs and expectations of relevant interested parties, including compliance obligations?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in the extent to which quality objectives have been met, including its significant environmental aspects?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including its risks, opportunities and trends in process performance and conformity of products and services?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in the extent to which environmental objectives have been achieved?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in nonconformities and corrective actions?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in monitoring and measurement results?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in audit results?
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Does the management review planned and carried out take into consideration the adequacy of resources?
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Does the management review planned and carried out take into consideration the relevant communication(s) from interested parties, including complaints?
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Does the management review planned and carried out take into consideration the effectiveness of actions taken to address risks and opportunities for continual improvement?
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Does the management review planned and carried out take into consideration opportunities for improvement?
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Does the management review planned and carried out take into consideration information on the performance and effectiveness of the IMS, including trends in the performance of external providers?
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Does the management review planned and carried out take into consideration the effectiveness of actions taken to address risks and opportunities (see 6.1)?
9.3.3 Management review outputs
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Do the outputs of the management review include decisions and actions related to opportunities for improvement?
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Do the outputs of the management review include decisions and actions related to any need for changes to the IMS?
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Do the outputs of the management review include decisions and actions related to resource needs?
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Does your organization retain documented information as evidence of the results of management reviews? (See 7.5.1b)
10.0 Improvement
10.1 Improvement general
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Does your organization determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction?
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Does your organization determine and select opportunities for improvement and implement any necessary actions to improving products and services to meet requirements as well as to address future needs and expectations?
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Does your organization determine and select opportunities for improvement and implement any necessary actions to correcting, preventing or reducing undesired effects?
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Does your organization determine and select opportunities for improvement (see 9.1, 9.2 and 9.3) and implement any necessary actions to improving the performance and effectiveness, to achieve the intended outcomes of the IMS?
10.2.1 Nonconformity and corrective action
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When nonconformities occur, including any arising from complaints, does your organization react to the nonconformity and take action to control and correct it?
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When nonconformities occur, including any arising from complaints, does your organization react to the nonconformity to deal with the consequences, including mitigating adverse environmental impacts?
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When nonconformities occur, including any arising from complaints, does your organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order to ensure that it does not recur or occur elsewhere by reviewing and analysing the nonconformity?
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When nonconformities occur, including any arising from complaints, does your organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order to ensure that it does not recur or occur elsewhere by determining the causes of the nonconformity?
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When nonconformities occur, including any arising from complaints, does your organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order to ensure that it does not recur or occur elsewhere by determining if similar nonconformities exist, or could potentially occur?
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When nonconformities occur, including any arising from complaints, does your organization implement any action needed?
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When nonconformities occur, including any arising from complaints, does your organization review the effectiveness of any corrective action taken?
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When nonconformities occur, including any arising from complaints, does your organization make changes to the IMS, if necessary?
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Does your organization ensure that corrective actions are appropriate to the effects of the nonconformities encountered, including the environmental impact(s)?
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When nonconformities occur, including any arising from complaints, does your organization update risks and opportunities determined during planning, if necessary?
10.2.2 Nonconformity and corrective action documented information
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Does your organization retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken? (See 7.5.1b)
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Does your organization retain documented information as evidence of the nature of the results of any corrective action? (See 7.5.1b)
10.3 Continual Improvement
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Does your organization continually improve the suitability, adequacy and effectiveness of the IMS to enhance performance?
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Does your 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?
