Title Page

  • Audit date :

  • Audit reference :

  • Auditor :

  • Auditee :

Mandatory Audit Questions

  • Are procedures being audited meeting the requirements of the where applicable e.g., ISO 9001:2015 and customer-specific codes of practise?

  • Are documents accessible and readily available on the master register?

  • Are documents in use the correct revisions?

  • Have the relevant staff been trained on these documents?

  • Are training records up-to-date with the current documents?

  • Previous Audit Reviewed?

  • Any NC Raised in Previous Audit Closed?

Audit Specific Questions

  • Are the quality policy and objectives in place consistent with the organization’s strategy?

  • Evidence

  • How are policies and objectives communicated within the organization

  • Evidence

  • Can you demonstrate how policies are understood and applied

  • Evidence

  • Is the QMS used to help manage the business?

  • Evidence

  • Are the resources available for the functioning of the QMS?

  • Evidence

  • Has everybody been told how important the QMS is and why it’s critical to conform to its requirements?

  • Evidence

  • Does the QMS produce the expected outcomes?

  • Evidence

  • How is the importance of an effective QMS management communicated?

  • Evidence

  • Has leadership been shown in getting employees involved in the QMS?

  • Evidence

  • Have other managers been assisted in showing QMS leadership?

  • Evidence

  • Have improvement activities been encouraged?

  • Evidence

  • Have the responsibilities and authorities for customer service and sales been clearly defined?

  • Evidence

  • Have the customer requirements been reviewed for accuracy and completeness?

  • Evidence

  • Have people been trained in customer communications?

  • Evidence

  • Is top management providing leadership in respect of setting quality objectives, promoting the process approach to risk-based thinking and supporting relevant management roles?

  • Evidence

  • Customer Focus – Has the organization addressed the risks and opportunities that can affect conformity of products and services.

  • Evidence

  • How is customer satisfaction adequately determined

  • Evidence

  • Determine how this process is planned, implemented and improved

  • Evidence

  • Are appropriate corrective actions undertaken when things go wrong

  • Evidence

  • How does Top Management ensure that the focus on enhancing customer satisfaction is maintained

  • Evidence

  • Has Top management ensured that customer and applicable statutory and regulatory requirements are identified and consistently met

  • Evidence

  • Is there evidence that top management are attending management review meetings

  • Evidence

  • Is there evidence that the QMS, Quality Manager & Continuous Improvement initiative are supported by top management

  • Evidence

  • Has the organisation ensured that responsibilities and authorities for relevant roles are assigned and understood and communicated

  • Evidence

  • Have top management established and implemented a Quality Policy that is appropriate to the purpose and context of the organization?

  • Evidence

  • Does the policy fit the organization’s purpose, environment and strategy?

  • Evidence

  • Does the policy give direction for determining quality objectives?

  • Evidence

  • Has the policy been shared openly, comprehended by employees, and utilized within the organization?

  • Evidence

  • Does it commit to meeting applicable requirements?

  • Evidence

  • Does it commit to continually improving the QMS?

  • Evidence

  • Is the quality policy documented?

  • Evidence

  • Is it accessible to interested parties?

  • Evidence

  • Is the Quality Policy authorised by the person with overall responsibility for the site

  • Evidence

  • Does the company have an organisational chart demonstrating the management structure of the company

  • Evidence

  • 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

  • Evidence

  • Has top management assigned the responsibility and authority for ensuring that the quality management system conforms to the requirements of ISO9001

  • Evidence

  • Has top management assigned the responsibility and authority for ensuring that the processes are delivering their intended outputs

  • Evidence

  • Is there sufficient engineering, production, customer service, and quality support to meet customer needs

  • Evidence

  • 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]

  • Evidence

  • Does the chart clearly indicate the persons responsible for the management of the QMS

  • Evidence

  • 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

  • Evidence

  • 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?

  • Evidence

  • 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

  • Evidence

  • Does the deputy have the knowledge & ability to adequately cover the absent manager

  • Evidence

  • How does the site senior management ensure that employees are aware of their responsibilities

  • Evidence

  • Do employees understand their responsibilities within the context of the overall purpose of the management system

  • Evidence

  • Where documented work instructions exist for activities undertaken the relevant employee has access to these

  • Evidence

  • Can the employee [including temporary or agency staff] demonstrate that work is carried out in accordance with the work instructions - confirm

  • Evidence

  • Processes and procedures to fulfil requirements are adequately resourced – confirm how are resources determined [including in management meetings, annual review etc]

  • Evidence

  • Has top management communicated the business’s organization chart

  • Evidence

Opportunity For Improvement

  • Number of OFI raised :

  • Details

  • Have the OFI details been added to HubSpot

Non-conformance

  • Number of Non-conformances raised :

  • Details

  • Have the Non-conformance details been added to HubSpot

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.