Title Page

  • ISO 9001:2015 Audit designed to cover clauses in relation to Leadership within the QMS

  • Conducted on

  • Prepared by

  • Location
  • Clauses Audited:
    5.1.2 Customer focus
    8.4 Control of externally provided products and services
    8.4.2 Type and extent of control of external provision
    8.5 Production and service provision
    8.5.1 Control of production and service provision
    8.5.2 Identification and traceability
    8.5.3 Property belonging to customers or external providers
    8.5.4 Preservation
    8.5.6 Control of changes
    8.6 Release of products and services
    9.1.2 Customer satisfaction

  • Additional Clauses Audited :

5.1.2 Customer Focus

  • Show me how top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and applicable statutory and<br>regulatory requirements are determined and met.

  • How are risks and opportunities that can affect conformity of products and services determined?

  • How is the ability to enhance customer satisfaction determined and addressed?

  • How is customer satisfaction maintained?

  • How is the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements maintained?

8.4 Control of externally provided products and services

  • How do you ensure externally provided processes, products and services conform to specified requirements?

  • Show me how you apply specified requirements for the control of externally provided products and services when:<br>Products and services are provided by external providers for incorporation into your own products and services; <br>You provide products and services directly to customers by external providers on your behalf;<br>A process or part-process is provided by an external provider as a result of a decision to outsource a process or function.

  • Show me how you establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers. <br>How do you assess their ability to provide processes or products and services in accordance with specified requirements?

  • What documented information do you have of the results of evaluations, monitoring of performance and revaluations of external providers?

8.4.2 Type and extent of control of external provision

  • How do you determine the controls applied to the external provision of processes, products and services and take into consideration:<br>a) The potential impact of the externally provided processes, products and services on the ability to consistently meet customer and applicable statutory and regulatory requirements?<br>b) The perceived effectiveness of the controls applied by the external provider?

  • What verification or other activities do you have to ensure externally provided processes, products and services do not adversely affect your ability to consistently deliver conforming products and services to your customers?

  • When processes or functions have been outsourced to external providers, how do you consider a) and b) in 8.4.1 and how do you define the controls intended to be applied to the external provider and to the resulting process output?

8.5 Production and service provision

8.5.1 Control of production and service provision

  • What controlled conditions do you have for production and service provision, including delivery and post-delivery activities?

8.5.2 Identification and traceability

  • What means do you use to identify process outputs to ensure conformity of products and services?

  • How do you identify the status of process outputs?

  • How do you control the unique identification of process outputs, where applicable? <br>What documented information do you retain?

  • NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products, services, intermediate parts, components, etc.

8.5.3 Property belonging to customers or external providers

  • What care do you provide for customer or external provider’s property while under your control?<br>How do you identify, verify, protect and safeguard that property which is provided for use or incorporation into your products or services?

  • What means do you use to report to the customer or external provider if their property is incorrectly used, lost, damaged or found to be unsuitable for use?

  • NOTE Customer property can include material, components, tools and equipment, customer premises, intellectual property and personal data.

8.5.4 Preservation

  • How do you ensure preservation of process outputs during production and service provision to maintain conformity to product requirements?

  • NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.

8.5.6 Control of changes

  • How do you review and control unplanned changes to ensure continuing conformity with specified requirements?

  • What documented information can you show me which describes the results of reviews of changes, the personnel authorizing change and any necessary actions?

8.6 Release of products and services

  • Show me how planned arrangement have been implemented at appropriate stages to verify product and service requirements have been met. Show me what evidence you retain.

  • Show me how the release of products and services is held until planned arrangements for verification of conformity have been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable. Show me documented information which shows traceability to the person authorizing release of products and services.

9.1.2 Customer satisfaction

  • How do you monitor customer perception of the degree to which requirements have been met?

  • How do you obtain information relating to customer views and opinions of your products and services?

  • What methods for obtaining and using this information do you have?

  • NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market-share analysis, compliments, warranty claims and dealer reports.

Audit Findings And Non Conformance's

  • Executive Summary / Overall Conclusions

  • Non Conformity / findings raised

  • Auditor Signature

  • End of Report

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