【正文】
oduct, prior to release for use during production, installation or servicing, and are rechecked at prescribed intervals.The suppliers shall establish the extent and frequency of such checks and maintains records as evidence of control.Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data is be made available, when required by the customer or customer’s representative, for verification that the inspection, measuring and test equipment is functionally adequate. Control procedureThe supplier shall:a) determine the measurements to be made and the accuracy required, and selected the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision。e) maintain calibration records。I) safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting. Inspection and test statusThe inspection and test status of product is identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed.The identification of inspection and test status is maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see )] is dispatched, used or installed.The inspection and test status of product is in accordance with the procedure. Control of nonconforming product GeneralThe supplier shall establish and maintained documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation.This control provides for identification, documentation, evaluation, segregation (when practical), disposition, and for notification to the functions concerned. Review and disposition of nonconforming productThe responsibility for review and authority for the disposition of nonconforming product is defined.Nonconforming product is reviewed in accordance with documented procedures. It may be:a) reworked to meet the specified requirements。c) determination of the corrective action needed to eliminate the cause of nonconformities。d) ensuring that relevant information on actions taken is submitted for management review (see ).Preventive actions have been pleted in accordance with the procedures. Handling, storage, packaging, preservation and delivery GeneralThe supplier shall establish and maintained documented procedures for handling, storage, packaging, preservation and delivery of product. HandlingThe supplier shall provide methods of handling product that prevent damage or deterioration. StorageThe supplier uses designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery.Appropriate methods for authorizing receipt to and dispatch from such areas are stipulated.In order to detect deterioration, the condition of product in stock is assessed at appropriate intervals. PackagingThe supplier controls packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements. PreservationThe supplier applies appropriate methods for preservation and segregation of product when the product is under the supplier’s control. DeliveryThe supplier arranges for the protection of the quality of product after final inspection and test.Where contractually specified, this protection is extended to include delivery to destination. Control of quality recordsThe supplier shall establish and maintained documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.Pertinent quality records from the subcontractor are an element of the data.All quality records are legible and stored/retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.Retention times of quality records are established and recorded.Where agreed contractually, quality records are made available for evaluation by the customer or the customer’s representative for an agreed period.Records are stored in accordance with the procedures. Internal quality auditsThe supplier shall establish and maintained documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results ply with planned arrangements and to determine the effectiveness of the quality system.Internal quality audits are scheduled on the basis of the status and importance of the activity to be audited.Internal audits are carried out by personnel independent of those having direct responsibility for the activity being audited.The results of the audits are recorded and brought to the attention of the personnel having responsibility in the area audited.The management personnel responsible for the area take timely corrective action on deficiencies found during the audit.Followup activities verify and record the implementation and effectiveness of the corrective action taken. TrainingThe supplier shall establish and maintained documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality.Personnel performing specific assigned tasks are qualified on the basis of appropriate education, training and/or experience, as required.Appropriate records of training are maintained. ServicingWhere servicing is a specifie