Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Audit Preparation
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Review corrective actions for previous IA findings
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Review corrective actions for any customer complaints
4.1 General Requirements
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Has the organization established, documented, implemented and maintained a quality management system?<br>
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Do those in the department now where it is kept?<br>
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Has the organization determined the process under the quality management system and the application required for Tenders, Enquiries and quotations (see 1.2)?
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Has the organization determined criteria and methods needed to ensure that both the operation and control of these process is effective?<br>
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Has the organization ensured the availability of resources and information necessary to support the operation and monitoring of these processes?<br>
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Has the organization monitored, measured where applicable, and analysed this process?<br>
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Has the organization implemented actions necessary to achieve planned results and continual improvement of these process?
4.2.1 Documentation Requirements - General
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Has the organization documented procedures and records required by this International Standard?<br>
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Has the organization a system for Control of documents?
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Has the organization a system for Control of quality records?
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Has the organization a system for Control of non-conformity?
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Has the organization a system for Corrective action?
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Are records controlled according to the requirements given in 4.2.4?
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Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?
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Has the organization a system to review and update as necessary and re-approve documents?
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Has the organization a system to ensure that changes and the current revision status of documents are identified?
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Has the organization a system to ensure that relevant versions of applicable documents are available at points of use?
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Has the organization a system to ensure that documents remain legible and readily identifiable?
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Has the organization a system to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the process are identified and their distribution controlled?
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Has the organization a system to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?<br>
4.2.4 Control of Records
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Have records been established to provide evidence of conformity to requirements and of the effective operation of the process?<br>
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Are they controlled?
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Has a documented procedure been established to define the controls needed for the identification of records?
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Has a documented procedure been established to define the controls needed for the Storage of records?<br>
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Has a documented procedure been established to define the controls needed for the Protection of records?
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Has a documented procedure been established to define the controls needed for the Retrieval of records?<br>
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Has a documented procedure been established to define the controls needed for the retention time of records?
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Has a documented procedure been established to define the controls needed for the destruction of records?<br>
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Are records readily retrievable?<br>
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Are records legible?
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Are records readily identifiable?<br>
5.2 Customer Focus
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Does top management ensure that customer requirements are determined?<br>
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Does top management ensure that customer requirements are met?<br>
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Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?
5.3 Quality Policy
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Does top management ensure that the quality policy is communicated and understood within the organization?<br>
5.4.1 Quality Objectives
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Does top management ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization.
5.5.1 Responsibility and Authority
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Does top management ensure that responsibilities and authorities are defined and communicated within the organization?
5.5.3 Internal Communication
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Has top management ensured that appropriate communication processes are established within the organization?
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Has top management ensured that communication takes place regarding the effectiveness of the process within the quality management system?
6.1 Provision of Resources
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Has the organization determined and provided the resources needed to implement and maintain the quality management system process and continually improve its effectiveness?<br>
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Has the organization determined and provided the resources needed to enhance customer satisfaction by meeting customer requirements?
6.2.1 Human Resources - General
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Are personnel performing work affecting conformity to product requirements competent on the basis of appropriate education, training, skills and experience?<br>
6.2.2 Competence, Awareness & Training
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Has the organization determined the necessary competence for personnel performing work affecting conformity to product requirements?
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Has the organization determined the necessary competence where applicable, provided training or taken other actions to achieve the necessary competence?
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Has the organization evaluated the effectiveness of the actions taken?
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Has the organization ensured that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?
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Has the organization maintained appropriate records of education, training, skills and experience (see 4.2.4)?<br>
6.3 Infrastructure
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Has the organization determined, provided and maintained the infrastructure needed to achieve conformity to product requirements?<br>
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Does this infrastructure include, as applicable buildings, workspace and associated utilities?
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Does this infrastructure include process equipment (both hardware and software)?<br>
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Does this infrastructure include supporting services (such as transport, communication or information systems)?
6.4 Work Environment
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Has the organization determined and managed the work environment needed to achieve conformity to product requirements?
7.2.1 Determination of Requirements Related to the Product/process
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Has the organization determined requirements specified by the customer, including the requirements for delivery and post-delivery activities?
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Has the organization determined requirements not stated by the customer but necessary for specified or intended use, where known?
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Has the organization determined statutory and regulatory requirements related to the product?
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Has the organization determined any additional requirements considered necessary by the organization?<br>
7.2.2 Review of Requirements Related to the Product/process
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Does the organization review the requirements related to the process?
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Is this review conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)?
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Does this review ensure that product requirements are defined?<br>
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Does this review ensure that contract or order requirements differing from those previously expressed are resolved?<br>
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Does this review ensure that the organization has the ability to meet the defined requirements?
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Have records of the results of the review and actions arising from the review been maintained (see 4.2.4)?<br>
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Where the customer provides no documented statement of requirement, have the customer requirements been confirmed by the organization before acceptance?<br>
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Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
7.2.3 Customer Communication
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Does the organization determine and implement effective arrangements for communicating with customers in relation to product information?
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Does the organization determine and implement effective arrangements for communicating with customers in relation to enquiries, contracts or order handling, including amendments?
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Does the organization determine and implement effective arrangements for communicating with customers in relation to customer feedback, including customer complaints?
7.5.3 Identification and traceability
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Where appropriate, does the organization identify the product by suitable means throughout product realization?
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Does the organization identify the product status with respect to monitoring and measurement requirements throughout product realization?<br>
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Where traceability is a requirement, does the organization control and record the unique identification of the product and maintain records (see 4.2.4)?<br>
8.2.1 Customer satisfaction
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As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements?
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Have the methods for obtaining and using this information been determined?
8.2.3 Monitoring and measurement of processes
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Does the organization apply suitable methods for monitoring and, where applicable, measurement of the quality management system process<br>
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Do these methods demonstrate the ability of the process to achieve planned results?
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When planned results are not achieved, is correction and corrective action taken, as appropriate?
8.2.4 Monitoring and measurement of product
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Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1)?
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Has evidence of conformity with the acceptance criteria been maintained?<br>
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Do records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)?
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Does the organization ensure that the release of product and delivery of service shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer?
8.5.2 Corrective action
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Does the organization take action to eliminate the causes of nonconformities in order to prevent recurrence?<br>
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Are corrective actions appropriate to the effects of the nonconformities encountered?<br>
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Has a documented procedure been established to define requirements for reviewing nonconformities (including customer complaints)?<br>
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Has a documented procedure been established to define requirements for determining the causes of nonconformities?<br>
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Has a documented procedure been established to define requirements for evaluating the need for action to ensure that nonconformities do not recur?
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Has a documented procedure been established to define requirements for determining and implementing action needed?
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Has a documented procedure been established to define requirements for records of the results of action taken (see 4.2.4)?
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Has a documented procedure been established to define requirements for reviewing the effectiveness of the corrective action taken?
8.5.3 Preventive action
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Has the organization determined action to eliminate the causes of potential nonconformities in order to prevent their occurrence?
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Are preventive actions appropriate to the effects of the potential problems?
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Has a documented procedure been established to define requirements for determining potential nonconformities and their causes?
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Has a documented procedure been established to define requirements for evaluating the need for action to prevent occurrence of nonconformities?
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Has a documented procedure been established to define requirements for determining and implementing action needed?
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Has a documented procedure been established to define requirements for records of results of action taken (see 4.2.4)?
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Has a documented procedure been established to define requirements for reviewing the effectiveness of the preventive action taken?
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Assessor
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Process Owner
