Information
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Site conducted
IMS Audit Checklist
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Audit Title
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Location
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Conducted on
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Prepared by
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Prepared by
4 Context of the organization
Introduction
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Please complete all sections starting immediately below. This internal self-assessment will evaluate the compliance of your Integrated Management System with ISO 9001:2016, 14001:2016 & 45001:2018. Remember to attach evidence to items where required, and to sign off and complete this assessment in the final section.
4.1 Understanding the organization and its context
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Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.
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Verify how these issues affect the ability to achieve the intended result of the IMS.
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Verify how the organization monitors and reviews information about these internal and external issues.
4.2 Understanding the needs and expectations of interested parties
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Verify how organization determined relevant interested parties to IMS.
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Verify how the organization has determined the relevant needs and expectations of interested parties.
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Verify how the organization has determined the impact or potential impact of the interested parties.
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Verify how the organization monitors and reviews information about interested parties and their relevant requirements.
4.3 Determining the scope of the quality management system
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Verify the IMS scope considers the following:
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External and internal issues.
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The requirements of relevant interested parties.
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The products and services of the organization.
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Verify how the organization has determined how the ISO 9001:2015, 14001:2015 & 45001:2018 standards are applied within the organization.
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If the organization has determined any of the requirements of the ISO 9001:2015, 14001:2015 & 45001:2018 standards not to be applicable, show me how conformity of products and services are not affected by this.
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Verify IMS scope is documented.
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Verify scope states what products and services are covered by the IMS and how it justifies instances where requirements cannot be applied.
4.4 Quality management system and its processes
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Show me how the processes have been determined and how they interact.
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Verify how the processes for the IMS were determine. Verify the inputs and outputs to the processes.
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Verify the sequence and interaction of of the processes.
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Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.
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Verify how resources are determined and allocated.
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Verify how responsibilities and authorities are determined.
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Verify how risks and opportunities are considered and what actions are taken to address them.
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Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.
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Verify how opportunities for improvement for the IMS and its processes are determined.
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Reviewed documented information created to support the operation of its processes.
5 Leadership
5.1 Leadership and commitment
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Top management is identified
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Verify top management demonstrates leadership and commitment by
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Taking accountability for IMS effectiveness
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Ensuring the IMS policy and objectives are established and are compatible with strategic direction and context of organization
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Ensuring the IMS is integrated into organization's business processes
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Promoting the use of the process approach and risk-based thinking
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Ensuring resources are available
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Communicating the importance of effective IMS and of conforming to its requirements
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Ensuring intended outcomes
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Engaging, directing and supporting persons to contribute to the effectiveness of the IMS
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Promoting continuous improvement
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Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility
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Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that
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customer and applicable statutory and regulatory requirements are determined, understood and consistently met.
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the risks and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.
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the focus of enhancing customer satisfaction is maintained.
5.2 Policies
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Verify the Quality, WHS & Environmental policies ...
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are appropriate to the purpose and context of the organization and supports its strategic direction.
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provides a framework for setting objectives.
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includes a commitment to satisfy; applicable requirements (Quality), compliance obligations (Environmental), legal obligations and other requirements (WHS)
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Environmental Policy includes a commitment to the protection of the environment, including the prevention of pollution
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WHS Policy includes a commitment to provide safe and healthy working conditions for the prevention of work-related injury and ill health
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WHS Policy includes a commitment to eliminate hazards and reduce OH&S risk
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WHS Policy includes a commitment to consultation and participation of workers, and, where they exist, worker' representatives
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includes a commitment to continual improvement of the IMS.
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Verify Quality / WHS / Environmental Policy is maintained as documented information.
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Verify Quality / WHS / Environmental Policy is communicated, understood and applied within the organization.
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Verify Quality / WHS / Environmental Policy is available to relevant interested parties.
5.3 Organizational roles, responsibilities and authorities
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Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization
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Verify top management assigns responsibility and authority for..
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ensuring the IMS conforms to the ISO 9001:2015, 14001:2015 & 45001:2018 standards.
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ensuring that processes are delivering their intended outputs.
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reporting on the performance of the IMS and on opportunities for improvement, in particular to top management.
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ensuring the promotion of customer focus throughout the organization.
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ensuring the integrity of the IMS is maintained when changes to the IMS are planned and implemented.
5.4 Participation, consultation and representation - ISO 45001:2018
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Process has been established to ensure effective participation and consultation by workers at all levels and functions of the organization
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With the mechanisms, time and resources to participate in, at at minimum, the processes of the OH&S MS
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With timely access to clear, understandable and relevant information about the OH&S management system
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Identifying and removing obstacles or barriers to participation and minimizing those that cannot be removed
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Encouraging timely reporting and response to work-related hazards, OH&S risks, OH&S opportunities, incidents and nonconformities
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Ensure that relevant external interested parties are consulted, when appropriate, about matters pertinent to the OH&S management system
6 Planning
6.1 Actions to address risks and opportunities
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Verify how the internal and external issues and interested parties are considered when planning for the IMS?
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Verify how risks and opportunities are determined and addressed so the IMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement
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Verify how actions are planned to address risks and opportunities.
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Verify how actions are integrated and implemented into the IMS processes.
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Verify how the organization evaluates the effectiveness of the actions.
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Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services.
6.1.2O Hazard identification and assessment of OH&S risks - ISO 45001:2018
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Verify process to determine and assess hazards and opportunities in the workplace and to workers that takes into account
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Routine and non-routine activities and situations
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Emergency situations
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People (workers, contractors and visitors) who have access to or are in the vicinity of the workplace and their activities and for workers who perform work-related activities at a location not under direct control of the organization
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Organization's operations and activities including the design of work areas, processes, etc., changes in knowledge of hazards, situations occurring in the vicinity of the workplace or not controlled by the organization
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Actual or proposed changes in the organization, its operations, processes, activities and OH&S management system
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Past incidents, internal or external to the organization, including emergencies, and their causes
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Applicable legal and other requirements
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Effectiveness of existing controls
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Consideration of the hierarchy of controls
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Opportunities to eliminate or reduce OH&S risks and to adapt work to workers
6.1.2E Environmental aspects - ISO14001:2015
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Determine environmental aspects
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Determine significant environmental aspects (threats or opportunities) using established criteria that have or can have significant environmental impact
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Significant environmental aspects have been communicated among various organizational levels and functions, as appropriate
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Verify documented information:
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Environmental aspects and associated environmental impacts
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Criteria used to determine its significant environment aspects
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Significant environmental aspects
6.1.3O Determination of legal and other requirements - ISO45001:2018
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Verify process to identify and have access to up-to-date legal and other requirements that are applicable to its OH&S risks and management system
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Determine how to apply and meet these requirements
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Verify maintained and retained documented information
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Applicable legal and other requirements, ensuring this documented information is updated to reflect changes
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To show how compliance with its applicable legal and other requirements is achieved
6.1.3 Compliance obligations
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Determine and have access to the compliance obligations to the organization related to its environmental aspects
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Determine how these compliance obligations apply to the organization
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Take into account compliance obligations when establishing, implementing, maintaining and continually improving the IMS
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Verify documented information
6.1.4O Planning to take action - ISO 45001:2018
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Organization shall plan actions to address its OHS risks and opportunities
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Organization shall plan actions to address applicable legal and other requirements
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Organization shall plan actions to prepare for, and respond to, emergency situations, how to integrate and implement the relevant actions, including the determination and application of controls, into the OH&S management system
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Organization shall plan how to evaluate the effectiveness of these actions and respond accordingly
6.1.4E Planning action - ISO 14001:2016
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Organization shall plan to take action to address its significant environmental aspects, compliance obligations and identified risks and opportunities
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Organization shall plan how to integrate and implement the actions into its EMS processes and evaluate the effectiveness of these actions
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Were the organizations technological, financial, operational and financial options/requirements considered
6.2 Quality objectives and planning to achieve them
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Verify quality objectives are established at relevant functions, levels and processes.
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Verify the quality objectives are..
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consistent with the quality policy.
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measurable.
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taking into account applicable requirements.
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relevant to the conformity of products and services and to the enhancement of customer satisfaction.
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moinitored.
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communicated.
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updated as appropriate.
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Verify objectives are documented.
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Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.
6.3 Planning of changes
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Verify how IMS changes are planned systematically.
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Verify how the organization demonstrates the purpose and potential consequences of changes.
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Verify how the organization considers the integrity of the IMS.
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Verify how resources are made available.
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Verify how responsibility and authority is allocated and reallocated.
7 Support
7.1 Resources
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Verify how resources are determined for the organization.
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Show me how the capabilities and constraints on internal resources are considered.
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Show me how needs from external providers are considered.
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Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the IMS including the necessary processes.
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Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.
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Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity.
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Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
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Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.
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Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.
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Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards. If no standards, show me documented information which is used as the basis for calibration or verification.
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Show me how measurement instruments are identified.
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Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.
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Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration. Verify any actions taken.
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Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.
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Verify how knowledge is maintained and made available to the extent necessary.
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Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.
7.2 Competence
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Show me how you determine the necessary competence of people doing work under your control that affects quality, OH&S, and environmental performance.
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Show me how you determine competence on the basis of appropriate education, training or experience.
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Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.
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Verify documented information as evidence of competence where appropriate.
7.3 Awareness
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Verify people doing work under the organization's control are aware of
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the Quality, WHS, and Environmental policies.
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the relevant quality, OH&S, and environmental objectives.
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their contribution to the effectiveness of the IMS, including the benefits of improved performance.
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the implications of not conforming with the IMS requirements.
7.4 Communication
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Verify internal and external communication process (what, when, with whom and how to communicate).
7.5 Documented information
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Verify documented information required by the ISO 9001:2015, 14001:2015 & 45001:2018 standard.
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Verify documented information that shows the effectiveness of the IMS.
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Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
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Show me how the documented information is reviewed and approved for suitability and adequacy.
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Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
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Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
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Verify documented information of external origin is identified, as appropriate, and controlled.
8 Operation
8.1 Operational planning and control
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Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.
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Verify how requirements for products and services are determined.
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Verify how criteria for processes and acceptance for products and services are determined.
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Verify how resources are determined.
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Verify how process control is implemented.
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Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.
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Determine how output from the planning process is suitable for operations.
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Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
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Verify how outsourced processes are controlled.
8.1.2 Eliminating hazards and reducing OH&S risks
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Verify that the organization has established, implemented and maintained processes using the hierarchy of controls to eliminate and reduce OH&S risks
8.1.3 Management of change
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Verify that the organization has established processes for the implementation and control of planned temporary and permanent changes that impact OH&S performance. These include:
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new and existing products, services and processes, including changes (including workplace locations, work organization, working conditions, equipment, work force)
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changes to legal or other requirements
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changes in knowledge or information about hazards and OH&S risks
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developments in knowledge and technology
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Verify that the organization reviews the consequences of unintended changes and takes action to mitigate and adverse effect, if necessary
8.1.4.1 Procurement
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Verify controls for procurement, i.e. products, hazardous materials or substances, raw materials, equipment or services, conform to its OH&S management system
8.1.4.2 Contractors
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Verify the organization's process to identify and communicate on the hazards, and to evaluate and control the OH&S risks, arising from the:
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Verify process where the requirements of the OH&S management system, or at least the equivalent, are met by the contractors and their workers (including criteria for selection of contractors)
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Verify process for coordinating relevant portions of the OH&S management system with other organizations for multi-employer workplaces
8.1.4.3 Outsourcing
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Verify outsourced processes affecting its OH&S management system are controlled
8.2 Determination of requirements for products and services
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Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.
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Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.
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Verify how product and service requirements including statutory and regulatory requirements are defined. Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services.
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Verify how the organization reviews..
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customer requirements for delivery and post-delivery.
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requirements necessary for customer's specified or intended use, where known.
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statutory and regulatory requirements applicable to the products and services.
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other contract or order requirements.
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Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer.
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Verify how the organization resolves differences in the contract or order requirements from those previously defined.
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Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.
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Verify documented information of reviews describing new or changed requirements to products and services.
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Verify documented information of amended reviews and how relevant personnel are made aware of those changes.
8.2O Emergency Preparedness & Response - ISO 45001:2018
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Verify the organization has established, implemented and maintained a process(es) for potential emergency situations
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Organization shall take into account at all stages of the process the needs and capabilities of relevant interested parties and ensure their involvement
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Verify documented information
8.2E Emergency Preparedness & Response - ISO 14001:2015
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Verify the organization has established, implemented and maintained a process(es) for potential emergency situations
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Verify the organization
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prepares to respond to prevent or mitigate adverse environmental impacts from emergency situations
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responds to actual emergency situations
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takes action to prevent or mitigate the consequences of emergency situations
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periodically tests the planned response actions, where practicable
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periodically reviews and revises the process(es) and planned response actions, in particular after the occurrence of an emergency situation or test
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provided relevant information and training to relevant interested parties, including persons working under its control
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Verify documented information
8.3 Design and development of products and services
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Verify how the design and development process is established, implemented and maintained.
8.3.2 Design and development planning
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In determining the stages and control for design and development, verify the organization considers..
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the nature, duration and complexity of the activities.
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the requirements that specify particular process stages including applicable reviews.
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required verification and validation.
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responsibilities and authorities.
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how interfaces are controlled between individuals and parties.
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the need for involvement of customer and user groups.
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Verify documented information that confirms design and development requirements have been met.
8.3.3 Design and development inputs
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In determining requirements essential for the type of products and services being designed and developed, the organization shall consider..
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functional and performance requirements.
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information derived from previous similar design and development activities.
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statutory and regulatory requirements.
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standard or codes of practice that the organization has committed to implement.
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potential consequences of failure due to the nature of the products and services.
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Verify that the inputs are complete and unambiguous.
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Verify documented information on design and development inputs are retained.
8.3.4 Design and development controls
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Verify the organization applies controls to the design and development process to ensure that..
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the results to be achieved are defined.
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reviews are conducted to evaluate the ability of the results of design and development to meet requirements.
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verification activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.
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validation activities are conducted to ensure that the resulting products and services meet the requirements of the specified application or intended use.
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any necessary actions are taken on problems determined during the reviews, or verification and validation activities.
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Verify documented information of these activities are retained.
8.3.5 Design and development outputs
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Verify the organization ensures the design and development outputs..
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meet the input requirements.
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are adequate for the subsequent processes for the provision of products and services.
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include or reference monitoring and measuring requirements, as appropriate , and acceptance criteria.
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specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
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Verify documented information on design and development outputs are retained.
8.3.6 Design and development changes
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Verify the organization identifies, reviews and controls changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
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Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.
8.4 Control of externally provided processes, products and services
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Verify how the organization ensures externally provided processes, products and services conform to specified requirements.
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Verify controls applied to externally provided processes, products and services when products and services are intended for incorporation into the organization's own products and services, products and services are provided directly to the customer or a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
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Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.
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Verify documented information of activities and actions arising from the evaluations.
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Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output.
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Verify how the organization considers the potential impact of the external provided processes, products and services on its ability to meet customer and applicable statutory and regulatory requirements.
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Verify the effectiveness of the controls applied by the external provider.
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Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.
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Verify the organization communicates to external providers its requirements for..
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the processes, products and services to be provided.
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the approval of product and services; methods, processes and equipment; and the release of products and services.
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competence, including any required qualification of persons.
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the external providers' interactions with the organization.
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control and monitoring of the external providers' performance to be applied by the organization.
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verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises.
8.5 Production and service provision
8.5.1 Control of production and service provision
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Verify the organization has documented information that defines the characteristics of the products to be produced, the services to be provided or the activities to be performed and the results to be achieved.
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Verify the availability and use of suitable monitoring and measuring resources.
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Verify the implementation of monitoring and measuring 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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Verify the use of suitable infrastructure and environment for the operation of processes.
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Verify the appointment of competent persons, including any required qualification.
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Verify the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.
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Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)
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Verify the implementation of release, delivery and post-delivery activities.
8.5.2 Identification and traceability
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Verify how organization identifies outputs from the process to ensure conformity.
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How does the organization identify the status of process outputs.
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Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.
8.5.3 Property belonging to customers or external providers
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What care is provided to customers' or external providers' property?
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Verify how the organization identifies, verifies, protects and safeguards customers' or external providers' property which is provided for use or incorporation into the organization's products or services.
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Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.
8.5.4 Preservation
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Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.
8.5.5 Post-delivery activities
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Verify the organization considers the following to meet post-delivery activities.
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statutory and regulatory requirements
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potential undesired consequences associated with its products and services
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the nature, use and intended lifetime of its products and services
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customer requirements
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customer feedback
8.5.6 Control of changes
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Verify how the organization reviews and controls changes for production or service provision.
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Verify retained documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.
8.6 Release of products and services
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Verify at appropriate stages product and service requirements have been met.
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Verify products and services are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by relevant authority and, as applicable, by the customer.
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Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.
8.7 Control of nonconforming outputs
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Verify that outputs that do not conform to requirements are identified and controlled.
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Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services).
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Correction
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Segregation, containment, return or suspension of provision of products and services
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Informing the customer
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Obtaining authorization for acceptance under concession
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Verify conformity to the requirements when nonconforming outputs are corrected.
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Verify retained documented information that describes the nonconformity, describes actions taken, describes any concessions obtained and identifies the authority deciding the action in respect of the nonconformity.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
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Verify the organization has determined what needs to be monitored and measured, the methods to be used, when it will be performed, analyzed and evaluated.
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Verify the organization evaluates the performance and effectiveness of its IMS.
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Review retained appropriate documented information
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Verify the organization monitors customers' perceptions of the degree to which their needs and expectations have been fulfilled.
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Verify the organization analyzes and evaluates:
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conformity of products and services.
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the degree of customer satisfaction.
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the performance and effectiveness of the IMS.
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if planning has been implemented effectively.
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the effectiveness of actions taken to address risks and opportunities.
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the performance of external providers.
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the need for improvements the the IMS.
9.1.2O Evaluation of compliance - ISO 45001:2018
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Verify process for evaluating compliance with applicable OH&S legal requirements and other requirements to which the organization subscribes
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Verify how the organization determines frequency and method(s) by which compliance will be evaluated, evaluates compliance and takes action, if necessary, and how it maintains knowledge and understanding of its status of conforming with legal and other requirements
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View retained documented information of the compliance evaluation
9.1.2E Evaluation of compliance - ISO 14001:2015
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Verify process for evaluating compliance with applicable environmental legal requirements and other requirements to which the organization subscribes
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Verify organization has:
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determined the frequency that compliance will be evaluated
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evaluated compliance and take action if needed
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maintained knowledge and understanding of its compliance status
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View retained appropriate documented information
9.2 Internal audit
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Verify audits are conducted at planned intervals
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Verify organization has established, implemented, and maintains an internal audit program
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Verify the importance of the process, changes affecting the organization and the results of previous audits are considered
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Verify audit criteria and scope are created for each audit
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Auditors are objective and impartial
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Audit results reported to relevant management
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Verify appropriate correction and corrective actions are taken without delay
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Review retained documented information
9.3 Management review
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Verify management reviews IMS at planned intervals
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Verify inputs to management review includes:
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status of actions from previous management reviews
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changes in external and internal issues relevant to the IMS
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customer satisfaction and feedback from relevant interested parties
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the extent to which quality objectives have been met
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process performance and conformity of products and services
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nonconformities and corrective actions
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monitoring and measurement results
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audit results
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the performance of external providers
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adequacy of resources
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effectiveness of actions taken to address risks and opportunities
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opportunities for improvement
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Verify outputs to management review includes:
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opportunities for improvement
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any need for changes to the IMS
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resource needs
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Verify retained documented information
10 Improvement
10.1 General
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Verify the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or reduces undesired effects and improves the performance and effectiveness of the QMS.
10.2 Nonconformity and corrective action
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Verify how organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences.
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Verify how the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.
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Verify how organization implements necessary actions.
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Verify how organization evaluates the effectiveness of actions taken.
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Verify the organization updates risks and opportunities determined during planning, if necessary.
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Verify any changes made to the IMS, if necessary.
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Verify retained documented information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions
10.2O Incident, nonconformity and corrective action - ISO 45001:2018
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Verify participation of workers in the determination of root causes
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Verify implemented actions and their effectiveness
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Verify documented information communicated to relevant workers and relevant interested parties
10.3 Continual improvement
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Verify how the organization continually improves. Does it 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?
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Verify workers are consulted in continual improvement process
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Verify results of continual improvement is communicated to its workers
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Verify retained documented information
Sign Off
Sign Off
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I, the undersigned, have completed this audit in an accurate manner. I have attached evidence as required and declare this assessment complete.
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Full name and signature of auditor
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Full name and signature of auditor
