Is a quality plan prepared for a specific project/contract detailing the processes and documents?
Are appropriate records maintained?
Does the organisation determine and review requirements related to the product (including maintenance) prior to tendering?
Are records and actions from the review maintained?
Are documents amended and relevant personnel notified when changes are made to the product?
Are there affective arrangements for dealing with customer complaints?
Does the organisation plan and control the development of a product?
Are design and development inputs determined and records maintained for the functional and performance requirements?
Are design and development inputs determined and records maintained for applicable statutory and regulatory requirements?
Are design and development outputs approved and do they meet the input requirements?
Are design and development outputs approved and do they contain or reference acceptance criteria?
Are systematic review of design and development performed to evaluate the ability of the results to meet requirements?
Are systematic review of design and development performed to identify any problems and propose necessary actions?
Are planned verification and/or validation requirements performed and are outcomes and necessary actions recorded?
Are design and development changes identified, reviewed verified, validated as appropriate and approved?
Are records maintained of the changes, review of the changes and necessary actions?
Does the organisation ensure that a purchased product confirms to specified requirements?
Is the type and extent of control of the supplier dependant on the effect of the purchased product on the final product?
Does the organisation evaluate and select suppliers on their ability to meet the organisation's selection criteria?
Are results and actions of evaluations recorded?
Does the purchase information define the specified requirements?
Does the organisation establish and implement the inspection of other activities to ensure product verification?
Has the organisation controlled processes for planning and production of the specifications of the product?
Has the organisation controlled processes for planning and production of the availability of work instructions, as necessary?
Has the organisation controlled processes for planning and production of the use of suitable equipment?
Has the organisation controlled processes for planning and production of the availability and use of monitoring and measuring devices?
Has the organisation controlled processes for planning and production of the implementation of monitoring and measuring and the release of hold points?
Are processes validated where the resulting output cannot be verified by subsequent monitoring or measurement?
Is the product identified where appropriate?
Is the product status identifiable with respect to monitoring and measuring requirements?
Where necessary, is measurement equipment identifiable and calibrated to appropriate standards and at nominated intervals and are calibration records maintained?