Title Page
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Conducted on (Select Date and Time)
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Prepared by (Name of Auditor)
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Location (Select Location subject to Audit)
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Serial Number of ISO Audit (From audit schedule - Item ID)
Audit Scope and Criteria
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ISO 9001 - Audit Scope
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ISO 9001 - Audit Criteria
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Audited Person Name and Appointment (If Process or Document - Write the name of the document and file location or upload copy of document concerned)
Management
4.1: Understanding the organization and its context
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Has your company determined the external and internal issues that are relevant to your purpose and strategic direction?
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Have you considered the relevant issues that affect your ability to achieve the intended results of the Quality Management System (QMS)?
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How do you monitor and review the information related to the external and internal issues?
4.2: Understanding the needs and Expectations of interested parties
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With consideration given to their impact or potential impact on your company’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, have you determined the interested parties that are relevant to the QMS?
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Have you determined the requirements of these interested parties that are relevant to the QMS?
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How do you monitor and review the information about the interested parties and their relevant requirements?
4.3: Determining the scope of the quality management system
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To establish the scope of the QMS, has your company determined the boundaries and applicability of the QMS?
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When determining the scope of the QMS, have you considered the external and internal issues (per 4.1)?
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When determining the scope of the QMS, have you considered the requirements of relevant interested parties (per 4.2)?
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When determining the scope of the QMS, have you considered the products and services of your company?
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When a requirement of ISO 9001:2015 can be applied, has your company applied the requirement?
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When requirements cannot be applied, and in order to claim conformity to ISO 9001:2015, how do you determine if your ability or responsibility to ensure conformity of products and services are not affected?
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Is the scope of the QMS available and maintained as documented information?
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In the scope of the QMS, have you stated the products and services covered by the QMS?
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Has your company provided justification for any instance where a requirement of the standard cannot be applied?
4.4: Quality management system and its processes
4.4.1
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Has your company obtained the current version of the ISO 9001:2015 international standard?
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As required by the standard, have you established, documented, implemented, maintained and continually improved the QMS?
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Have you determined the processes needed for the QMS, their interactions and applications throughout your company?
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For the QMS processes have you determined the inputs required and the outputs expected from the processes?<br>
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For the QMS processes have you determined the sequence and interaction of the processes?
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For the QMS processes have you determined the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of the processes?
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For the QMS processes have you determined the resources needed and ensure their availability?
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For the QMS processes have you determined the assignment of the responsibilities and authorities for these processes?
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For the QMS processes have you determined the risks and opportunities (per 6.1), and plans to implement the appropriate actions to address them?
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For the QMS processes have you determined the methods for monitoring, measuring, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results?
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For the QMS processes have you determined the opportunities for improvement of the processes and the QMS?
4.4.2
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Have you maintained the necessary documented information to support the operation of processes?
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Has your company retained the necessary documented information to provide the confidence that the processes are being carried out as planned?
5.1: Leadership and commitment
5.1.1 General
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Has top management demonstrated leadership and commitment with respect to the QMS by taking accountability of the effectiveness of the QMS?
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Has top management demonstrated leadership and commitment with respect to the QMS by ensuring that the quality policy and quality objectives are established for the QMS and are compatible with the strategic direction and the context of the organization?
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Has top management demonstrated leadership and commitment with respect to the QMS by ensuring that the quality policy is communicated, understood and applied within the company?
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Has top management demonstrated leadership and commitment with respect to the QMS by ensuring the integration of the QMS requirements into the company’s business processes?
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Has top management demonstrated leadership and commitment with respect to the QMS by promoting awareness of the process approach?
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Has top management demonstrated leadership and commitment with respect to the QMS by ensuring that the resources needed for the QMS are available?
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Has top management demonstrated leadership and commitment with respect to the QMS by communicating the importance of effective quality management and of conforming to the QMS requirements?
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Has top management demonstrated leadership and commitment with respect to the QMS by engaging, directing and supporting persons to contribute to the effectiveness of the QMS?
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Has top management demonstrated leadership and commitment with respect to the QMS by promoting continual improvement?
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Has top management demonstrated leadership and commitment with respect to the QMS by supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?
5.1.2 Customer Focus
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Has the top management demonstrated leadership and commitment with respect to customer focus by ensuring that the customer requirements and applicable statutory and regulatory requirements are determined and met?
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Has the top management demonstrated leadership and commitment with respect to customer focus by ensuring that the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?
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Has the top management demonstrated leadership and commitment with respect to customer focus by ensuring that the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements are maintained?
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Has the top management demonstrated leadership and commitment with respect to customer focus by ensuring that the focus on enhancing customer satisfaction is maintained?
5.2: Policy
5.2.1 Developing the quality policy
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Has your top management established, implemented and maintained a quality policy that is appropriate to the purpose and context of the organization?
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Has your top management established, implemented and maintained a quality policy that provides a framework for setting and reviewing quality objectives?
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Has your top management established, implemented and maintained a quality policy that includes a commitment to satisfy applicable requirements?
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Has your top management established, implemented and maintained a quality policy that includes a commitment to continual improvement of the QMS?
5.2.2 Communicating the quality Policy
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How do you ensure that your quality policy is communicated, understood and applied within your company?
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How do you ensure that your quality policy is available as documented information?
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How do you ensure that your quality policy is available to relevant interested parties?
5.3: Organizational roles, responsibilities and authorities
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Has top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the company?
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Has the top management assigned the responsibility and authority for ensuring that the QMS conforms to the requirements of ISO 9001:2015 standard?
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Has the top management assigned the responsibility and authority for ensuring that the processes are delivering their intended outputs?
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Has the top management assigned the responsibility and authority for reporting on the performance of the QMS on opportunities for improvement and for reporting to top management?
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Has the top management assigned the responsibility and authority for ensuring the promotion of customer focus throughout your company?
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Has the top management assigned the responsibility and authority for ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?
6.1: Actions to address risks and opportunities
6.1.1
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When planning for the QMS, has your company considered the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed?
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Have you performed this to give assurance that the QMS can achieve its intended results?
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Have you performed this to enhance desirable effects?
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Have you performed this to prevent, or reduce undesired effects?
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Have you performed this to achieve improvement?
6.1.2
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Has your company planned actions to address these risks and opportunities?
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Has your company planned how to integrate, implement the actions into the QMS processes and evaluate the effectiveness of these actions.
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Have you taken actions to address risks and opportunities that are proportionate to the potential impact on the conformity of products and services?
6.2: Quality objectives and planning to achieve them
6.2.1
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Has your company established quality objectives at relevant functions, levels and processes?
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Have you considered that the quality objectives consistent with the quality policy?
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Have you considered that the objectives measurable?
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Have you considered if they are relevant to conformity of products and services and the enhancement of customer satisfaction?
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Have you considered if they take into account applicable requirements?
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Have you considered if they are monitored; communicated, and updated as required?
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Have you retained documented information for the quality objectives?
6.2.2
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When planning how to achieve the quality objectives, has your company determined what will be done?
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When planning how to achieve the quality objectives, has your company determined what resources will be required?
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When planning how to achieve the quality objectives, has your company determined who will be responsible?
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When planning how to achieve the quality objectives, has your company determined when it will be completed?
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When planning how to achieve the quality objectives, has your company determined how the results will be evaluated?
6.3: Planning of changes
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When your company determined that changes are needed to the QMS, have you carried out the changes in a planned and systematic manner?
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Have you considered the purpose of the change and any of its potential consequences?
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Have you considered the integrity of the QMS?
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Have you considered the availability of resources?
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Have you considered the allocation or reallocation of responsibilities and authorities?
7.1: Resources
7.1.1 General
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Has your company determined and provided the resources needed to establish, implement, maintain and continually improve the QMS?
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Have you considered the capabilities of, and constraints on, existing internal resources?
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Have you considered what needs to be obtained from external providers?
7.1.2 People
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To ensure that your company can consistently meet customer and applicable statutory and regulatory requirements, have you determined and provided the persons necessary for the effective operation of the QMS, including the processes needed?
7.1.6 Organizational knowledge
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Has your company determined the knowledge necessary for the operation of the processes and to achieve conformity of products and services?
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As required, have you maintained and made available this knowledge?
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When addressing changing needs and trends, has your company considered its current knowledge and determined how to acquire or access the necessary additional knowledge?
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For organizational knowledge have you considered information such as intellectual property and lessons learned?
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To obtain needed knowledge, have you considered internal sources, such as learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the company and intellectual property?
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To obtain needed knowledge, have you considered external sources, such as standards, academia, conferences, gathering knowledge with customers or providers?
7.2: Competence
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Has your company determined the necessary competence of the personnel doing work that affects quality performance?
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How do you ensure that these persons are competent on the basis of appropriate education, training, or experience?
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Has your company taken actions to acquire the necessary competence?
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Have you considered, for example, the provision of training to, the mentoring of, or the re assignment of employees, or the hiring or contracting of competent persons, as relevant actions?
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How do you evaluate the effectiveness of the actions taken?
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Has your company retained documented information as evidence of competence?
7.3: Awareness
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Has your company ensured that personnel performing work under your control are aware of the quality policy?
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Has your company ensured that personnel performing work under your control are aware of the relevant quality objectives?
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Has your company ensured that personnel performing work under your control are aware of their contribution to the effectiveness of the QMS, including the benefits of improved quality performance?
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Has your company ensured that personnel performing work under your control are aware of the implications of not conforming to the QMS requirements
7.4: Communication
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Has your company determined the internal and external communications relevant to the QMS that include on what it will communicate?
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Has your company determined the internal and external communications relevant to the QMS that include when to communicate?
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Has your company determined the internal and external communications relevant to the QMS that include with whom to communicate?
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Has your company determined the internal and external communications relevant to the QMS that include how to communicate?
9.1: Monitoring, Measurement, Analysis and evaluation
9.1.1 General
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Has your company determined what needs to be monitored and measured?
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Has your company determined the methods for monitoring, measurement, analysis and evaluation to ensure valid results?
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Has your company determined when the monitoring and measuring are to be performed?
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Has your company determined when the results from monitoring and measurement are analyzed and evaluated?
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How do you ensure that monitoring and measurement activities are implemented to meet the determined requirements?
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Has your company evaluated the quality performance and the effectiveness of the QMS?
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Have you retained appropriate documented information as evidence of the results?
9.1.2 Customer Satisfaction
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Has your company monitored customer satisfaction to determine the perception of the degree to which their needs and expectations have been fulfilled?
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Have you obtained information relating to customer views and opinions of your company and your products and services?
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Have you determined the methods for obtaining and using this information?
9.1.3 Analysis and evaluation
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Has your company analyzed and evaluated the data and information resulting from monitoring, measurement?
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Have you used the results of analysis to evaluate conformity of products and services to requirements?
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Have you used the results of analysis to evaluate degree of customer satisfaction?
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Have you used the results of analysis to evaluate performance and effectiveness of the QMS?
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Have you used the results of analysis to evaluate planning has been effectively implemented?
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Have you used the results of analysis to evaluate effectiveness of actions taken to address risks and opportunities?
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Have you used the results of analysis to evaluate performance of external providers?
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Have you used the results of analysis to evaluate need for improvements to the QMS?
9.3: Management Review
9.3.1 General
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Has your top management reviewed the QMS at planned intervals, to ensure that it continues to be suitable, adequate and effective and aligned with the strategic direction of the company?
9.3.2 Management review inputs
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As inputs for the planning and conducting management reviews, have you considered the following the status of actions from previous management reviews?
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As inputs for the planning and conducting management reviews, have you considered the following changes in external and internal issues that are relevant to the QMS?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in customer satisfaction and feedback from relevant interested parties?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in the extent to which quality objectives have been met?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in process performance and conformity of products and services?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in nonconformities and corrective actions?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in monitoring and measurement results?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in audit results?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in the performance of external suppliers?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in the adequacy of resources?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in the effectiveness of actions taken to address risks and opportunities?
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Have you also considered information on the quality performance and effectiveness of the QMS, including trends in opportunities for improvement?
9.3.3 Management review outputs
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As outputs of your management reviews, have you included the decisions and actions related to continual improvement opportunities?
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As outputs of your management reviews, have you included the decisions and actions related to any need for changes to the QMS?
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As outputs of your management reviews, have you included the decisions and actions related to needs for resources?
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Has your company retained documented information as evidence of the results of management reviews?
10.1: General
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Has your company determined and selected opportunities for improvement and implemented actions needed to meet customer requirements and enhance customer satisfaction?
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Have you included actions for improving products and services to meet requirements as well as to address future needs and expectations?
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Have you included actions for correcting, preventing or reducing undesired effects?
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Have you included actions for improving the performance and effectiveness of the QMS?
10.3: Continual Improvement
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Has your company continually improved the suitability, adequacy, and effectiveness of the QMS?
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Have you considered the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities to be addressed as part of continual improvement?
Sales
8.1: Operational planning and control
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Has your company planned, implemented and controlled the processes needed to meet requirements for the provision of products and services and to implement the actions to address risks and opportunities by determining requirements for the product and services?
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Has your company planned, implemented and controlled the processes needed to meet requirements for the provision of products and services and to implement the actions to address risks and opportunities by establishing criteria for the processes and for the acceptance of products and services?
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Has your company planned, implemented and controlled the processes needed to meet requirements for the provision of products and services and to implement the actions to address risks and opportunities by determining the resources needed to achieve conformity to product and service requirements?
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Has your company planned, implemented and controlled the processes needed to meet requirements for the provision of products and services and to implement the actions to address risks and opportunities by implementing control of the processes in accordance with the criteria?
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Has your company planned, implemented and controlled the processes needed to meet requirements for the provision of products and services and to implement the actions to address risks and opportunities by retaining documented information to provide the confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements?
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Have you provided the output of the planning in a format that is suitable to your operations?
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How does your company control planned changes and review the consequences of unintended changes?
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When required, have you taken action to mitigate any adverse effects?
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How does your company ensure that outsourced processes are controlled (per 8.4)?
8.2: Requirements for products and services
8.2.1 Customer Satisfaction
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Has your company established the processes for communicating with customers in relation to information relating to products and services?
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Has your company established the processes for communicating with customers in relation to enquiries, contracts or order handling, including changes?
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Has your company established the processes for communicating with customers in relation to obtaining customer feedback, including customer complaints?
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Has your company established the processes for communicating with customers in relation to the handling or treatment of customer property, when applicable?
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Has your company established the processes for communicating with customers in relation to specific requirements for contingency actions, when relevant?
8.2.2 Determining the requirements related to products and services
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Has your company established, implemented and maintained a process to determine the requirements for the products and services to be offered to customers?
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How do you ensure that product and service requirements (including those considered necessary by your company), and applicable statutory and regulatory requirements, are defined?
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Have you ensured that your company has the ability to meet the defined requirements and substantiate the claims for the products and services offered?
8.2.3 Review of requirements related to products and services
8.2.3.1
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To ensure that you have the ability to meet requirements, has your company reviewed requirements specified by the customer, including the requirements for delivery and post-delivery activities?
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To ensure that you have the ability to meet requirements, has your company reviewed requirements not stated by the customer, but necessary for the customers' specified or intended use, when known?
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To ensure that you have the ability to meet requirements, has your company reviewed requirements specified by your company?
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To ensure that you have the ability to meet requirements, has your company reviewed additional statutory and regulatory requirements applicable to the products and services?
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To ensure that you have the ability to meet requirements, has your company reviewed contract or order requirements differing from those previously expressed?
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Has the company conducted the review prior to your commitment to supply products and services to the customer?
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How does the review ensure that contract or order requirements differing from those previously defined are resolved?
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When the customer does not provide a documented statement of their requirements, how do you confirm the customer requirements before accepting an order?
8.2.3.2
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Has your company retained documented information describing the results of the review, including any new or changed requirements for the products and services?
8.2.4 Changes to requirements for products and services
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When requirements for products and services are changed, how does your company ensure that relevant documented information is amended?
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How do you make the relevant personnel aware of the changed requirements?
Purchasing
8.4: Control of externally supplied processes, products and services
8.4.1 General
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Has your company ensured that externally provided processes, products, and services conform to specified requirements?
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Have you applied the specified requirements for the control of externally provided products and services when products and services are provided by external providers for incorporation into your own products and services?
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Have you applied the specified requirements for the control of externally provided products and services when products and services are provided directly to the customer(s) by external providers on behalf of your company?
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Have you applied the specified requirements for the control of externally provided products and services when a process or part of a process is provided by an external provider as a result of your decision to outsource a process or function?
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Have you established and applied 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 specified requirements?
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Has your company retained appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the external providers?
8.4.2 Type and extent of control
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When determining the type and extent of controls to be applied to the external provision of processes, products and services, has your company considered the potential impact of the externally provided processes, products and services on your company’s ability to consistently meet customer and applicable statutory and regulatory requirements?
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When determining the type and extent of controls to be applied to the external provision of processes, products and services, has your company considered the perceived effectiveness of the controls applied by the external supplier?
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Has your company established and implemented verification or other activities necessary to ensure the externally provided processes, products and services do not adversely affect your ability to consistently deliver conforming products and services to customers?
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Have the processes or functions that have been outsourced to an external provider remained within the scope of your QMS?
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Accordingly, within that scope, has your company considered the above potential impact and perceived effectiveness and define both the controls it intends to apply to the external provider and those it intends to apply to the resulting process output?
8.4.3 Information for external suppliers
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Has your company communicated to external suppliers the products and services to be provided or the processes to be performed?
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Has your company communicated to external suppliers the approval or release of products and services, methods, processes or equipment?
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Has your company communicated to external suppliers the competence of personnel, including necessary qualification; their interactions with your QMS?
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Has your company communicated to external suppliers the control and monitoring of the external supplier’s performance to be applied by your company?
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Has your company communicated to external suppliers the verification activities that your company or your customer intends to perform at the external provider’s premises?
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How does your company ensure the adequacy of specified requirements prior to their communication to the external provider?
Manufacturing
7.1: Resources
7.1.3 Infrastructure
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To achieve conformity of products and services, has your company determined, provided and maintained the infrastructure for the operation of the processes?
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Have you considered buildings and associated utilities as infrastructure?
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Have you considered equipment including hardware and software as infrastructure?
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Have you considered transportation as infrastructure?
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Have you considered information and communication technology as infrastructure?
7.1.4 Environment for the operation of processes
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Has your company determined, provided and maintained the environment necessary for the operation of the processes and to achieve conformity of products and services?
8.5: Production and service provision
8.5.1 Control of production and service provision
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Has your company implemented the controlled conditions for production and service provision?
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In the controlled conditions have you included the availability of documented information that defines the characteristics of the products to be produced, the services to be provided, and the activities to be performed?
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In the controlled conditions have you included the availability of documented information that defines the results to be achieved?
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In the controlled conditions have you included the availability and use of monitoring and measuring resources?
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In the controlled conditions have you included the monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met?
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In the controlled conditions have you included the use and control of suitable infrastructure and process environment?
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In the controlled conditions have you included the appointment of competent personnel, including any required qualifications?
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In the controlled conditions have you included the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?
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In the controlled conditions have you included the implementation of actions to prevent human error?
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In the controlled conditions have you included the implementation of products and services release, delivery and post-delivery activities?
8.5.2 Identification and Traceability
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When required to ensure conformity of products and services, has your company used suitable means to identify process outputs?
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Have you identified the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision?
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When traceability is required, how do you control the unique identification of process outputs?
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Have you retained the documented information needed to maintain traceability?
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Have you considered process outputs as the results of any activities which are ready for delivery to the customer or to an internal customer, such as a receiver of the inputs to the next process?
8.5.3 Property belonging to customers and external suppliers
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Has your company exercised care with property belonging to the customer or external providers while it is under your control?
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Have you identified, verified, protected and safeguarded the external property provided for use or incorporation into the products and services?
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When external property is incorrectly used, lost, damaged or otherwise found to be unsuitable for use, have you reported this to the customer or external provider?
8.5.4 Preservation
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Has your company ensured preservation of process outputs during production and service provision, as needed to maintain conformity to requirements?
8.5.5 Post-delivery activities
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Has your company met the requirements for post-delivery activities associated with the products and services?
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When determining your post-delivery activities, have you considered the risks associated with the products and services?
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When determining your post-delivery activities, have you considered the nature, use and intended lifetime of the products and services?
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When determining your post-delivery activities, have you considered the customer feedback?
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When determining your post-delivery activities, have you considered the statutory and regulatory requirements?
8.5.6 Control of changes
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Has your company reviewed and controlled unplanned changes essential for production or service provision in order to ensure continuing conformity with specified requirements?
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Have you retained documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions?
8.6: Release of products and services
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Has your company implemented the planned arrangements at appropriate stages to verify that product and service requirements have been met?
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Have you retained evidence of conformity with the acceptance criteria?
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How do you ensure that the release of products and services to the customer does not proceed until the planned verification of conformity has been satisfactorily completed?
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Have you released unverified products or services only after obtaining a relevant internal authority or as required by the customer?
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In your documented information have you provided traceability to the person(s) authorizing release of products and services for delivery to the customer?
8.7: Control of nonconforming outputs
8.7.1
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Has your company ensured outputs that do not conform to requirements are identified and controlled to prevent their unintended use or delivery?
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Have you taken corrective action based on the nature of the nonconformity and the impact on the conformity of products and services?
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Have you also applied corrective action to non-conforming products and services detected after delivery of the products or during the provision of the service?
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Has your company dealt with nonconforming outputs through correction?
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Has your company dealt with nonconforming outputs by segregation, containment, return or suspension of provision of products and services?
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Has your company dealt with nonconforming outputs by informing the customer?
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Has your company dealt with nonconforming outputs by obtaining authorization for acceptance with a concession?
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After correcting nonconforming process outputs, products and services, how do you verify that the requirements are met?
8.7.2
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Have you retained documented information that describes the nonconformity?
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Have you retained documented information that describes the actions taken on nonconforming outputs?
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Have you retained documented information that describes any concessions obtained?
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Have you retained documented information that identifies the authority that made the decision regarding dealing with the nonconformity?
Support
7.1: Resources
7.1.5 Monitoring and measuring resources
7.1.5.1 General
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When measuring or monitoring is used for evidence of conformity of products and services, has your company determined the resources needed to ensure valid and reliable monitoring and measuring results?
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Have you ensured that the resources provided are suitable for the type of monitoring and measurement activities being undertaken?
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Have you ensured that the resources provided are maintained to ensure their continued fitness for their purpose?
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Have you retained documented information as evidence of fitness for purpose of monitoring and measurement resources?
7.1.5.2 Measurement traceability
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Where measurement traceability is a requirement, such as with a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by your company to be an essential part of providing confidence in the validity of measurement results, have you verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards?
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Where measurement traceability is a requirement, such as with a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by your company to be an essential part of providing confidence in the validity of measurement results, where no such standards exist, do you retain documented information for the basis used for calibration or verification?
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Where measurement traceability is a requirement, such as with a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by your company to be an essential part of providing confidence in the validity of measurement results, is the measurement equipment identified in order to determine their calibration status?
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Where measurement traceability is a requirement, such as with a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by your company to be an essential part of providing confidence in the validity of measurement results, is the measurement equipment safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results?
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When an instrument is found to be out of calibration, how does your company determine if the validity of previous measurement results has been adversely affected?
7.5: Documented Information
7.5.1 General
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In your QMS have you included documented information required by the ISO 9001:2015 standard?
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In your QMS have you included documented information determined by your company as necessary for the effectiveness of the QMS?
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For the documented information of the QMS, have you considered the size of your company and the type of activities, processes, products and services?
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For the documented information of the QMS, have you considered the complexity of processes and their interactions?
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For the documented information of the QMS, have you considered the competence of personnel?
7.5.2 Creating and updating
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When creating and updating documented information how does the company ensure appropriate identification and description, such as a title, date, author, or reference number?
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When creating and updating documented information how does the company ensure appropriate format, such as language, software version, graphics and media, such as paper, electronic?
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When creating and updating documented information how does the company ensure appropriate review and approval for suitability and adequacy?
7.5.3 Control of documented information
7.5.3.1
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How do you control the documented information required by the QMS and by ISO 9001:2015 to ensure that it is available and suitable for use, where and when it is needed?
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How do you control the documented information required by the QMS and by ISO 9001:2015 to ensure that it is adequately protected, such as from loss of confidentiality, improper use, or loss of integrity?
7.5.3.2
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For the control of documented information, has your company addressed the distribution, access, retrieval and use?
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For the control of documented information, has your company addressed the storage and preservation, including preservation of legibility?
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For the control of documented information, has your company addressed control of changes (e.g. version control)?
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For the control of documented information, has your company addressed the retention and disposition?
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Has your company identified and controlled the documented information from external origin and determined by your company to be necessary for the planning and operation of the QMS?
9.2: Internal Audit
9.2.1
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Has your company conducted internal audits at planned intervals to determine whether the QMS conforms to your own QMS requirements and to the ISO 9001:2015 requirements?
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Has your company conducted internal audits at planned intervals to determine whether the QMS is effectively implemented and maintained?
9.2.2
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Has your company planned, established, implemented and maintained an audit program that includes the frequency, methods, responsibilities, planning requirements and reporting?
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Has your company considered the importance of the processes concerned, changes impacting on your company, and the results of previous audits?
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Has your company defined the audit criteria and scope for each audit?
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Has your company selected auditors and conduct audits to ensure objectivity and the impartiality of the audit process?
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Has your company ensured that the results of the audits are reported to relevant management?
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Has your company taken timely correction and corrective actions without undue delay?
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Have you retained documented information as evidence of the implementation of the audit program and the audit results?
10.2 Nonconformity and corrective action
10.2.1
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When nonconformities occur, including those resulting from complaints, how does your company react to the nonconformity and as needed taken action to control and correct it; and dealt with the consequences of the nonconformity?
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When nonconformities occur, including those resulting from complaints, how does your company evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by
- Reviewing and analyzing the nonconformity?
- Determining the cause of the nonconformity?
- Determining if similar nonconformities exist, or could potentially occur?
- None of the above
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When nonconformities occur, including those resulting from complaints, how does your company implement any action needed?
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When nonconformities occur, including those resulting from complaints, how does your company review the effectiveness of any corrective action taken?
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When nonconformities occur, including those resulting from complaints, how does your company update the risks and opportunities determined during the planning stages?
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When nonconformities occur, including those resulting from complaints, how does your company make changes to the QMS if needed?
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Has your company taken corrective actions that are appropriate to the effects of the nonconformities encountered?
10.2.2
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Has your company retained documented information as evidence of the nature of the nonconformities and any subsequent actions taken?
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Has your company retained documented information as evidence of the results of any corrective action?
