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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 and the relevant needs, expectations and requirements of those identified?
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Does your organization monitor and review information about these interested parties 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 and the compliance obligations of relevant interested parties referred to in 4.1 and 4.2?
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When determining this scope, has your organization considered its organizational units, functions and physical boundaries as well as the activities, products and services of your organization and 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) and 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 and in consideration to the knowledge gained in 4.1 and 4.2?
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Has your organization determined the processes needed for the IMS and their application throughout your organization, inputs required and the outputs expected from these processes and 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) and 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 and retain documented information to support the operation of its processes and have confidence that the processes are being carried out as planned? (See 7.5.1b)
5.0 Leadership
5.1.1 Leadership and commitment general
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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 ensuring that the quality policy and quality objectives are established for the IMS, are compatible with the context and strategic direction of your organization and the integration of the IMS requirements into your organization’s business processes and 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 and achieves its intended results 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 and 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 ensuring the integration of the IMS requirements into your organization’s business processes and promoting the use of the process approach and risk-based thinking, resources needed are available?
5.2 Quality & Environmental Policy
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Does Top management establish, implement and maintain a quality and environmental policy is appropriate to the purpose and context of your organization and supports its strategic direction and provides a framework for setting quality and environmental objectives and achieves its intended results and by engaging, directing and supporting persons to contribute to the effectiveness of the IMS? Does the policy commit to the protection of the environment, including prevention of pollution and other specific commitment(s) relevant to the organization as well as fulfilling its compliance obligations and committing 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 and 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 and ensuring that the focus on enhancing customer satisfaction is maintained?
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 at each level and that the IMS conforms to the requirements of this International Standard?
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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 reporting on the performance of the IMS and on opportunities for improvement (see 10.1), in particular to top management and 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
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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 and enhance desirable effects or outcomes and reduce undesired effects, can achieve improvement and can prevent, or reduce, undesired effects including the potential for external environmental conditions to affect the organization?
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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? Does your organization maintain documented information on risks and opportunities?
6.1.2 How the organisation plan to address risks and opportunities
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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 and 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 establish, implement and maintain a process(es) for hazard identification that is ongoing and proactive?
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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 and those aspects that have or can have a significant environmental impact by using established criteria?
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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 and take into account abnormal conditions and reasonably foreseeable emergency situations?
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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 plan how to evaluate the effectiveness of these actions and 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 maintain documented information for its environmental aspects and associated environmental impacts and for criteria used to determine its significant environmental aspects?
6.1.3 Compliance obligations
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Does your organization establish, implement, maintain and continually improve the process and IMS to determine and have access to up-to-date compliance obligations and other requirements that are applicable to its quality and environmental aspects and how these legal requirements and other requirements apply to the organization and what needs to be communicated?
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Does your organization maintain and retain documented information on its compliance obligations and other requirements and ensure that it is updated to reflect any changes?
6.1.4 Planning action
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Does your organization plan action on how to integrate and implement the actions into its IMS processes or other business processes (See 4.4) and evaluate the effectiveness of these actions?
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Does your organization plan how to take action to address the risks and opportunities (see 6.1.1), compliance obligations and significant quality and environmental aspects and compliance obligations and other requirements (see 6.1.3).
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Are actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?
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 continual improvement of the IMS and performance 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 objectives consistent with the quality policy while also being measurable, monitored, communicated, updated as appropriate and take into account applicable requirements, relevant to conformity of products and services and used to enhance customer satisfaction?
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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 and are the objectives relevant to conformity of products and services and to enhancement of customer satisfaction?
6.2.2 Quality and environmental objectives and planning 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, resources required, who is responsible, when it will be completed and how the results will be evaluated, including indicators for monitoring progress towards achievement of its measurable objective (see 9.1.1) as well as how actions to achieve objectives will be integrated into the organization’s 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, integrity of the IMS, availability of resources and 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 and 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 and 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 and 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 and this knowledge is 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 and that 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 whilst retaining 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 and objectives?
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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 and also the implications of not conforming to the IMS requirements?
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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?
7.4 Communication
7.4.1 Communication General
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Does your organization determine the internal and external communications relevant to the IMS, including what, when, with whom, how and who it will communicate, taking 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? 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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Does your organization externally communicate information relevant to the IMS as established by the organizations’ communication process(es) and taking into account its compliance obligations and other requirements?
7.5.1 Documented information general
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Does your organization’s IMS include documented information required by this International Standard 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), format (e.g. language, software version, graphics) and media (e.g. paper, electronic) and 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, ISO 9001 and ISO 14001) controlled to ensure it is available and suitable for use, where and when it is needed and 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 while addressing the 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), 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 be controlled?
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Is documented information retained as evidence of conformity protected from unintended alterations? (e.g. documented control register).
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 by determining the requirements for the products and services, establishing criteria for processes and control, acceptance of products and services and achieving the conformity to 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 by determining, maintaining and retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and demonstrate the conformity of products and services to their requirements?
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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) and that 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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Are the outputs of the planning process suitable for your organization’s operations and have controlled planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?
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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, and 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, handling enquiries, contracts or orders, including changes, obtaining customer feedback relating to products and services, including customer complaints, handling or controlling customer property and 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, those considered necessary by your organization and 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, requirements specified by your organization and 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 statutory and regulatory requirements applicable to the products and services and 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 and 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)
8.2.1 Requirements for products and services - Customer Communication
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Does communication with customers include providing information relating to products and services, handling enquiries, contracts or orders, including changes, obtaining customer feedback relating to products and services, including customer complaints, handling or controlling customer property and 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, considered necessary by your organization and 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, post-delivery activities and those not stated by customer but are necessary?
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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, statutory and regulatory requirements, contract or order requirements differing from those previously expressed?
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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 and 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 and 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 and 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 and 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, approval of products and services, approval of methods, processes and equipment and the release of products and services and including any required competence and 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 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 to 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 and 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 and 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, potential undesired consequences associated with its products and services, nature, use and intended lifetime of its products and services, customer requirements and feedback obtained?
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 and 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 taking into consideration after delivery of products, during or after the provision of services?
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Does your organization take appropriate action based on the nature of nonconforming products and services detected and also when nonconforming outputs by correction; segregation, containment, return or suspension of provision of products and services; informing the customer; obtaining authorization for acceptance under concession?
8.7.2 Control of nonconforming outputs documented information
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Does your organization retain documented information that describes the nonconformity, actions taken, concessions obtained and the authority deciding the action in respect of the nonconformity? (See 7.5.1b)
9.0 Performance Evaulation
9.1.1 Monitoring, measurement, analysis and evaluation
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Does your organization determine what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results?
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Does your organization determine when the monitoring and measuring shall be performed, when results from monitoring and measurement shall be analysed and evaluated?
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Does your organization determine the criteria against how it will evaluate its environmental performance and appropriate indicators?
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Does your organization evaluate the performance and the effectiveness of the IMS and retain appropriate documented information as evidence of the results? (See 7.5.1b)?
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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?
9.1.2 Evaluation of compliance (ISO 45001)
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Does your organization establish, implement and maintain a process(es) for evaluating compliance with legal requirements and other requirements (see 6.1.3)?
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Does your organization determine the frequency and methods for the evaluation of compliance?
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Does your organization evaluate compliance and take action if needed (see 10.2)?
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Does your organization maintain knowledge and understanding of its compliance status with legal requirements and other requirements and is documented information retained of the compliance evaluation results?
9.1.2 Customer satisfaction (ISO 9001)
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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
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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 and maintain knowledge and understanding to evaluate fulfilment its compliance obligations and how to evaluate compliance and take action if 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 and degree of customer satisfaction and 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, the effectiveness of actions taken to address risks and opportunities, performance of external providers and need for improvement to the IMS?
9.2.1 Internal audit
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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, the requirements of ISO 9001:2015 and ISO 14001:2015 and whether the IMS is effectively implemented and maintained?
9.2.2 Internal audit programme
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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 and the results are reported to relevant management for 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 taking into consideration the status of actions from previous management reviews and 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 feedback from relevant interested parties, including compliance obligations, and the extent to which quality and environmental objectives have been met, including its significant environmental aspects and process performance and conformity of products and services?
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Does the management review planned and carried out taking into consideration information on the performance and effectiveness of the IMS, including trends in nonconformities and corrective actions, the extent to which environmental objectives have been achieved, monitoring and measurement results, audit results and performance of external providers?
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Does the management review planned and carried out taking into consideration the adequacy of resources, effectiveness of actions taken to address risks and opportunities (see 6.1) for continual improvements?
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, decisions and actions related to any changed to the IMS and resources 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 and any necessary actions to improving products and services to meet requirements as well as to address future needs and expectations which will help in correcting, preventing or reducing undesired effects?
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Does your organization determine and select opportunities for improvement 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 take action to control and correct it and 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 that it does not recur or occur elsewhere by reviewing and analysing, determining the cause and identifying trends occurring the nonconformity?
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When nonconformities occur, including any arising from complaints, does your organization implement any action needed, conduct review, update risks and opportunities as necessary?
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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)?
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 and keep a retain documented information as evidence or results of any corrective actions? (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 by enhancing performance, promoting a culture that supports an IMS, promoting the participation of workers in implementing actions for the continual improvement of the IMS, communicating the relevant results of continual improvement to workers and maintaining and retaining documented information as evidence of continual improvement?
- Compliant
- OFI
- Minor NC
- Major NC
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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?
