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 previous EA findings
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Review corrective actions for any customer complaints
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Review corrective actions for any customer audit findings
7.1 Planning of Product Realization
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Has the organization planned and developed the processes needed for product realization?<br>
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Is planning of product realization consistent with the requirements of the other processes of the quality management system (see 4.1)?<br>
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In planning product realization, has the organization determined the following, as appropriate: quality objectives and requirements for the product?<br>
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the need to establish processes, documents, and provide resources specific to the product?<br>
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required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance?<br>
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records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)?<br>
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Is the output of this planning in a form suitable for the organization's method of operations?<br>
7.2.1 Determination of Requirements Related to the Product
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Has the organization determined requirements specified by the customer, including the requirements for delivery and post-delivery activities?<br>
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requirements not stated by the customer but necessary for specified or intended use, where known?<br>
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statutory and regulatory requirements related to the product?<br>
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any additional requirements considered necessary by the organization?<br>
7.2.2 Review of Requirements Related to the Product
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Does the organization review the requirements related to the product?<br>
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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)?<br>
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Does this review ensure that product requirements are defined?<br>
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contract or order requirements differing from those previously expressed are resolved?<br>
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the organization has the ability to meet the defined requirements?<br>
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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?<br>
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?<br>
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enquiries, contracts or order handling, including amendments?<br>
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customer feedback, including customer complaints?<br>
7.4.1 Purchasing Process
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Does the organization ensure that purchased product conforms to specified purchase requirements?<br>
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Is the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product?<br>
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Does the organization evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements?<br>
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Have criteria for selection, evaluation and re-evaluation been established?<br>
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Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4)?<br>
7.4.2 Purchasing Information
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Does purchasing information describe the product to be purchased, including where appropriate requirements for approval of product, procedures, processes and equipment?<br>
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requirements for qualification of personnel?<br>
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quality management system requirements?<br>
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Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?<br><br><br><br>
7.4.3 Verification of Purchased Product
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Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?<br>
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Where the organization or its customer intends to perform verification at the supplier's premises, has the organization stated the intended verification arrangements and method of product release in the purchasing information?<br>
7.5.4 Customer property
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Does the organization exercise care with customer property while it is under the organization's control or being used by the organization?<br>
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Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product?<br>
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If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer by the organization?<br>
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If any customer property is lost, damaged or otherwise found to be unsuitable for use, are records maintained (see 4.2.4)?<br>
7.5.5 Preservation of product
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Does the organization preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements?<br>
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As applicable, does this preservation include identification, handling, packaging, storage and protection?<br>
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Does preservation also apply to the constituent parts of a product?<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?<br>
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Have the methods for obtaining and using this information been determined?<br>
Signatures
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Auditor
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Name
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Auditee
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Name
