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

  • Has it been determined what needs to be monitored and measured from both internal and external sources? e.g. Customer satisfaction and perception, Product conformance; Process performance; Product and process characteristics; Trends in products and processes; Opportunities for preventive action; Suppliers and subcontractors

  • Evidence :

  • Have methods for monitoring, measurement, analysis, and evaluation been made?

  • Evidence :

  • What will be monitored, measured, analysed, and evaluated?

  • Evidence :

  • Where will the monitoring, measurement, analysis, and evaluation take place?

  • Evidence :

  • Are documents retained as evidence of the performance of the quality management system

  • Evidence :

  • Which meetings or processes will perform these tasks?

  • Evidence :

  • Who will be involved?

  • Evidence :

  • When will the monitoring and measurement be performed?

  • Evidence :

  • When will results be analysed and evaluated?

  • Evidence :

  • Have the performance and effectiveness of the QMS been evaluated?

  • Evidence :

  • How effective is the QMS?

  • Evidence :

  • How effective is the planning?

  • Evidence :

  • Is there a need for improvements to the QMS?

  • Evidence :

  • Is there a customer complaints procedure?

  • Evidence :

  • Does the procedure defined responsibilities for logging and tracking complaints, clearing technical issues, determining problem causes and actions to address them

  • Evidence :

  • Are records available to show your organization has implemented a consistent and systematic approach to dealing with customer feedback

  • Evidence :

  • Has the organisation developed processes for obtaining information on customer perception & are records available

  • Evidence :

  • Are records available indicting the organization has analysed and evaluated customer data

  • Evidence :

  • Is the customer data reviewed for trends and is analysis made available to relevant staff?

  • Evidence :

  • Are process (method, techniques, format, etc.) in place to identify what analysis is required?

  • Evidence :

  • Do the processes in place include quality records, monitoring and measuring results, process performance results, objectives, internal audit findings, customer surveys and feedback, 2nd or 3rd-party audit results, competitor and benchmarking information, product test results, complaints, supplier performance information etc

  • Evidence :

  • Area results recorded & analyze?

  • Evidence :

  • How does the organisation ensure analysis is valid?

  • Evidence :

  • Is there an audit schedule establish that cover all requirements of the ISO9001 standards & customer specific requirements where applicable?

  • Evidence :

  • Is the audit schedule based on risk, importance of the processes or from results of previous audits?

  • Evidence :

  • How are audits are planned?

  • Evidence :

  • Is there a procedure identifying the auditing process

  • Evidence :

  • What are the requirements of formal reporting?

  • Evidence :

  • Is auditing criteria used as a reference against which conformity is determined

  • Evidence :

  • Is it documented who maintains the audit schedule?

  • Evidence :

  • Does the schedule identify internal auditors?

  • Evidence :

  • Are internal auditors trained?

  • Evidence :

  • Do the audit results confirm conformity & non-conformity?

  • Evidence :

  • Are supporting audit materials and notes retained?

  • Evidence :

  • Does the audit check the status of any outstanding issues since the last audit

  • Evidence :

  • Does the audit identify the need for corrective or improvement measures

  • Evidence :

  • Is the audit report signed by the lead auditor and the auditee?

  • Evidence :

  • Are actions taken relating to the identified causes?

  • Evidence :

  • Have all actions been completed?

  • Evidence :

  • Is there evidence that the corrective actions are verified & the nonconformity has been removed or reduced to an acceptable level?

  • Evidence :

  • Are result of internal audit analysis & results of internal audits evaluated

  • Evidence :

  • Are results communicated to top management

  • Evidence :

  • Is the effectiveness of the audit programme reviewed as a part of management review?

  • Evidence :

  • Does the audit programme cover processes that can impact on customer satisfaction

  • Evidence :

  • Is process auditing criteria used as a reference against which conformity is determined

  • Evidence :

  • Are process audits sufficient in regards to frequency e.g., newly implemented or recently modified process audited more frequently

  • Evidence :

  • Are all processes formally audited at least once during a 2-year audit cycle?

  • Evidence :

  • Do process audit identify opportunities for improvement and possible corrective actions

  • Evidence :

  • Does the company verify that corrective actions taken in process audits are completed?

  • Evidence :

  • Is there a process audit schedule in place with audits conducted at planned intervals

  • Evidence :

  • Do process auditing drive continuous improvement

  • Evidence :

  • Has the frequency or intervals of the top management’s formal review been defined.

  • Evidence :

  • Does the management review address the possible need for changes to policy, objectives, targets, and other elements of the QMS?

  • Evidence :

  • Is the management review chaired by a member of top management

  • Evidence :

  • Are records of the management review available

  • Evidence :

  • Does management review include the following [at a minimum]?• the status of actions from previous management reviews;<br>• changes in external and internal issues that are relevant to the quality management system;<br>• customer satisfaction and feedback from relevant interested parties;<br>• the extent to which quality objectives have been met;<br>• process performance and conformity of products and services;<br>• nonconformities and corrective actions;<br>• monitoring and measurement results;<br>• audit results<br>• the performance of external providers;<br>• the adequacy of resources;<br>• Risk & opportunities <br>• opportunities for improvement<br>

  • Evidence :

  • Are management meetings occurring at the frequency defined

  • Evidence :

  • Based on the data presented, has the organisation define changes that may be required to the management system or your processes

  • Evidence :

  • Are results and action items from the management review documented, communicated to affected individuals & and tracked to completion

  • Evidence :

  • Does the site utilise performance metrics

  • Evidence :

  • Have targets for performance metrics been identified

  • Evidence :

  • Is it defined how performance metrics are monitored

  • Evidence :

  • Are performance metrics driving the expected outcome

  • Evidence :

  • Where performance metrics indicate underperformance is action take to address

  • 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.