Title Page
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Audit date :
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Audit reference :
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Auditor :
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Auditee :
Mandatory Audit Questions
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Are procedures being audited meeting the requirements of the where applicable e.g., ISO 9001:2015 and customer-specific codes of practise?
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Are documents accessible and readily available on the master register?
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Are documents in use the correct revisions?
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Have the relevant staff been trained on these documents?
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Are training records up-to-date with the current documents?
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Previous Audit Reviewed?
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Any NC Raised in Previous Audit Closed?
Audit Specific Questions
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Are the quality policy and objectives in place consistent with the organization’s strategy?
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Evidence
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How are policies and objectives communicated within the organization
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Evidence
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Can you demonstrate how policies are understood and applied
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Evidence
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Is the QMS used to help manage the business?
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Evidence
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Are the resources available for the functioning of the QMS?
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Evidence
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Has everybody been told how important the QMS is and why it’s critical to conform to its requirements?
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Evidence
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Does the QMS produce the expected outcomes?
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Evidence
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How is the importance of an effective QMS management communicated?
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Evidence
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Has leadership been shown in getting employees involved in the QMS?
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Evidence
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Have other managers been assisted in showing QMS leadership?
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Evidence
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Have improvement activities been encouraged?
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Evidence
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Have the responsibilities and authorities for customer service and sales been clearly defined?
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Evidence
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Have the customer requirements been reviewed for accuracy and completeness?
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Evidence
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Have people been trained in customer communications?
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Evidence
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Is top management providing leadership in respect of setting quality objectives, promoting the process approach to risk-based thinking and supporting relevant management roles?
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Evidence
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Customer Focus – Has the organization addressed the risks and opportunities that can affect conformity of products and services.
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Evidence
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How is customer satisfaction adequately determined
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Evidence
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Determine how this process is planned, implemented and improved
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Evidence
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Are appropriate corrective actions undertaken when things go wrong
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Evidence
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How does Top Management ensure that the focus on enhancing customer satisfaction is maintained
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Evidence
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Has Top management ensured that customer and applicable statutory and regulatory requirements are identified and consistently met
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Evidence
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Is there evidence that top management are attending management review meetings
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Evidence
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Is there evidence that the QMS, Quality Manager & Continuous Improvement initiative are supported by top management
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Evidence
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Has the organisation ensured that responsibilities and authorities for relevant roles are assigned and understood and communicated
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Evidence
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Have top management established and implemented a Quality Policy that is appropriate to the purpose and context of the organization?
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Evidence
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Does the policy fit the organization’s purpose, environment and strategy?
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Evidence
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Does the policy give direction for determining quality objectives?
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Evidence
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Has the policy been shared openly, comprehended by employees, and utilized within the organization?
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Evidence
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Does it commit to meeting applicable requirements?
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Evidence
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Does it commit to continually improving the QMS?
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Evidence
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Is the quality policy documented?
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Evidence
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Is it accessible to interested parties?
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Evidence
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Is the Quality Policy authorised by the person with overall responsibility for the site
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Evidence
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Does the company have an organisational chart demonstrating the management structure of the company
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Evidence
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Does the org chart clearly indicate the reporting lines for all managers on the site and where applicable the relationship with company head office roles
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Evidence
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Has top management assigned the responsibility and authority for ensuring that the quality management system conforms to the requirements of ISO9001
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Evidence
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Has top management assigned the responsibility and authority for ensuring that the processes are delivering their intended outputs
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Evidence
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Is there sufficient engineering, production, customer service, and quality support to meet customer needs
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Evidence
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The organisational chart includes position & named person occupying the role or where job titles are used only, is the evidence via documentation indicting the person occupying each role [example job spec]
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Evidence
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Does the chart clearly indicate the persons responsible for the management of the QMS
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Evidence
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Have responsibilities been defined for key aspects of the QMS including for example, decisions on corrective actions, non-conforming products, process deviations, doc control, customer complaints, product release, change management etc
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Evidence
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Is there evidence that the quality assurance/quality control department have the freedom and authority to stop production if an action non-compliant with the quality assurance system is taken?
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Evidence
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Does the chart clearly document who is expected to deputise in the absence of a manager, this may be in the form of an additional table if not contain on the chart
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Evidence
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Does the deputy have the knowledge & ability to adequately cover the absent manager
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Evidence
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How does the site senior management ensure that employees are aware of their responsibilities
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Evidence
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Do employees understand their responsibilities within the context of the overall purpose of the management system
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Evidence
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Where documented work instructions exist for activities undertaken the relevant employee has access to these
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Evidence
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Can the employee [including temporary or agency staff] demonstrate that work is carried out in accordance with the work instructions - confirm
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Evidence
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Processes and procedures to fulfil requirements are adequately resourced – confirm how are resources determined [including in management meetings, annual review etc]
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Evidence
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Has top management communicated the business’s organization chart
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Evidence
Opportunity For Improvement
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Number of OFI raised :
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Details
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Have the OFI details been added to HubSpot
Non-conformance
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Number of Non-conformances raised :
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Details
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Have the Non-conformance details been added to HubSpot