ISO 9001:2015 Process Audit

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

• Conducted on

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• Prepared by

• Location
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• Clauses Audited:
  4.4 Quality management system and its processes
  6 Planning for the quality management system
  6.1 Actions to address risks and opportunities
  6.2 Quality objectives and planning to achieve them
  6.3 Planning of changes
  7.1.4 Environment for the operation of processes
  8.1 Operational planning and control
  8.2 Determination of requirements for products and services
  8.2.1 Customer communication
  8.2.2 Determination of requirements related to products and services
  8.2.3 Review of requirements related to products and services
  8.3 Design and development of products and services
  8.3.2 Design and development planning
  8.3.3 Design and development inputs
  8.3.4 Design and development controls
  8.3.5 Design and development outputs
  8.4.3 Information for external providers

• Additional Clauses Audited :

4.4 Quality management system and its processes

• How has the QMS been established, implemented, maintained and continually improved? <br>How have the processes been determined and how do they interact?

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• What documented information exists to support the operation of processes?<br>How is this documented information retained? How is confidence that the processes are being carried out as planned determined?

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• How have the processes been determined for the QMS?<br>What are the inputs and outputs for those processes?<br>What is the sequence and interaction of the processes?<br>What are the criteria, methods, measurement and related performance indicators needed to operate and control those processes?<br>What resources are needed and how are these made available?<br>How are responsibilities and authorities assigned for those processes?<br>How are risks and opportunities considered and what plans are made to implement actions to address them?<br>What methods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended results?<br>How are opportunities to improve the processes and the QMS determined?

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6 Planning for the quality management system

6.1 Actions to address risks and opportunities

• How are the internal and external issues and interested parties considered when planning for the QMS?<br>How are risks and opportunities determined and addressed so that the QMS can::<br>a) achieve its intended results;<br>b) Prevent or reduce undesired effects;<br>c) Achieve continual improvement?

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• How are actions planned to address risks<br>and opportunities?<br>How are actions integrated and implemented into the QMS processes?<br>How do you evaluate the effectiveness of the actions?

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• How are actions taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services?

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6.2 Quality objectives and planning to achieve them

• How does the organization determine what will be done, with what resources, when completed and how will results be evaluated for quality objectives?

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• Where are the quality objectives and are these at all relevant functions, levels and processes?<br>Are they consistent with the quality policy?<br>Are they measureable?<br>Do they consider applicable requirements?<br>Are they relevant to the conformity of products and services and do they<br>enhance customer satisfaction?<br>Are they monitored? How? How often?<br>How are they communicated?<br>How are they updated?<br>Where is the documented information on the quality objectives?

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6.3 Planning of changes

• How are changes to the QMS planned systematically?<br>Demonstrate the purpose and potential consequences of changes;<br>Demonstrate the integrity of the QMS;<br>Demonstrate how resources are made available?<br>Demonstrate how responsibility and authority is allocated or reallocated.

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7.1.4 Environment for the operation of processes

• How do you determine, provide and maintain the environment for the operation of processes to achieve products and service conformity?

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• NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).

8.1 Operational planning and control

• How are processes needed to meet requirements for provision of products and services planned, implemented and controlled?<br>How are requirements for products and services determined?<br>How is criteria for processes and acceptance for products and services determined?<br>How are resources determined?<br>How is process control implemented?<br>Show me the documented information that shows confidence in that the processes have been carried out as planned and can demonstrate conformity of products and services.

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• How do you control planned changes? <br>How do you review the consequences of unintended changes? What action is taken to mitigate any adverse effects?

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• How have you determined that the output from the planning process is suitable for your operations?

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• How do you control outsourced processes?

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8.2 Determination of requirements for products and services

8.2.1 Customer communication

• What are your processes for communicating with customers? <br>How do you communicate information relating to:<br>Products;<br>Services;<br>Enquiries;<br>Contracts; <br>Order handling;<br>Customer views, perceptions and complaints;<br>Handling or treatment of customer property;<br>Specific requirements for contingency actions?

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8.2.2 Determination of requirements related to products and services

• What is your process to determine the requirements for products and services to be offered to potential customers? <br>How do you establish, implement and maintain this process?

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• How do you define product and service requirements including statutory and regulatory requirements?<br>How do you ensure that you have the ability to meet the defined requirements and substantiate any claims for your products and services?

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8.2.3 Review of requirements related to products and services

• How do you review:<br>Customer requirements for delivery and post-delivery?<br>Requirements necessary for customers’ specified or intended use, where known;<br>Additional statutory and regulatory requirements applicable to products and services;<br>Any other contract or order requirements.

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• Show me that the review is conducted prior to your commitment to supply products and services to your customers. <br>How do you resolve contract or order requirements which differ from those previously defined?

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• NOTE Requirements can also include those arising from relevant interested parties.

• Show me where you retain documented information which describes results of the review including any new or changed requirements.

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• How do you confirm customer requirements where the customer does not provide a documented statement?

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• Show me the documented information containing changes to products and services. <br>How do you ensure that relevant personnel are made aware of those changes?

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8.3 Design and development of products and services

• How do you establish, implement and maintain a design and development process (where detailed requirements of your products and services are not already established or defined by the customer or other parties).

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• NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision.

• NOTE 2 For services, design and development planning can address the whole service delivery process. The organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
  

8.3.2 Design and development planning

• When determining the stages and control for design and development, show me how you consider:<br>The nature, duration and complexity of the activities;<br>Requirements that specify particular process stages including applicable reviews;<br>Required verification and validation;<br>Responsibilities and authorities;<br>How interfaces are controlled between individuals and parties;<br>The need for involvement of customer and user groups.<br>Show me documented information that confirms design and development requirements have been met.

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8.3.3 Design and development inputs

• Can you show me how you determine:<br>Requirements essential for the type of products and services being designed and developed, including as applicable:<br>Functional & performance requirements;<br>Statutory and regulatory requirements;<br>Standards or codes of practice where there is a commitment to implement;<br>Internal and external resources needed for the design and development of products and services;<br>Potential consequences of failure;<br>Level of control expected of the design and development process by customers and other relevant parties.

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• How do you determine that inputs are adequate, complete and unambiguous for design and development? How do you resolve conflicts among inputs?

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8.3.4 Design and development controls

• How do controls that are applied to the design and development process ensure:<br>Results achieved by design and development activities are clearly defined?<br>Design and development reviews are conducted as planned?<br>Outputs meet the input requirements by verification/<br>Validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known)?

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8.3.5 Design and development outputs

• How do you ensure that design and development outputs:<br>Meet the input requirements for design and development?<br>Are adequate for the subsequent processes for the provision of products and services? <br>Include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?<br>Ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use?

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• Show me the documented information which results from the design and development process.

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8.4.3 Information for external providers

• Show me how you communicate to external providers, applicable requirements for:<br>Products and services to be provided or the processes to be performed on behalf of the organization;<br>Approval or release of products and services, methods, processes or equipment;<br>Competence of personnel, including necessary qualification;<br>Their interactions with the organization's quality management system;<br>The control and monitoring of the external provider’s performance to be applied by the organization;<br>Verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

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• Before you communicate with external providers, how do you ensure the adequacy of specified requirements?

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• Executive Summary / Overall Conclusions

• Non Conformity / findings raised

• Auditor Signature

  Sign

• End of Report