Information
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Audit Title
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Document No.
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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
7.3.1 Design and Development Planning
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Does the organization plan and control the design and development of product?<br>
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During the design and development planning, does the organization determine the design and development stages?<br>
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the review, verification and validation that are appropriate to each design and development stage?<br>
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the responsibilities and authorities for design and development?<br>
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Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility?<br>
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Is planning output updated, as appropriate, as the design and development progresses?<br>
7.3.2 Design & Development Inputs
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Are inputs relating to product requirements determined and records maintained (see 4.2.4)? <br>
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Do these inputs include functional and performance requirements?<br>
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applicable statutory and regulatory requirements?<br>
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where applicable, information derived from previous similar designs?<br>
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other requirements essential for design and development?<br>
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Are these inputs reviewed for adequacy?<br>
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Are requirements complete, unambiguous and not in conflict with each other?<br>
7.3.3 Design & Development Outputs
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Are the outputs of design and development provided in a form suitable for verification against the design and development input?<br>
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Are the outputs of design and development approved prior to release?<br>
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Do design and development outputs meet the input requirements for design and development?<br>
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provide appropriate information for purchasing, production and for service provision?<br>
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contain or reference product acceptance criteria?<br>
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specify the characteristics of the product that are essential for its safe and proper use?<br>
7.3.4 Design & Development Review
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At suitable stages, are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.1)?<br>
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to evaluate the ability of the results of design and development to meet requirements?<br>
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to identify any problems and propose necessary actions?
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Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed?<br>
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Are records of the results of the reviews and any necessary actions maintained (see 4.2.4)?<br>
7.3.5 Design & Development Verification
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Is verification performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements?<br>
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Are records of the results of the verification and any necessary actions maintained (see 4.2.4)?<br>
7.3.6 Design & Development Validation
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Is design and development validation performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?<br>
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Wherever practicable, is validation completed prior to the delivery or implementation of the product?<br>
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Are records of the results of validation and any necessary actions maintained (see 4.2.4)?<br>
7.3.7 Design & Development Changes
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Are design and development changes identified and records maintained?<br>
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Are the changes reviewed, verified and validated, as appropriate, and approved before implementation?<br>
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Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered?
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Are records of the results of the review of changes and any necessary actions maintained (see 4.2.4)?<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>
Signature
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Auditors Signature
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Date
