qc080000改版(參考版)
2025-02-14 17:01本頁面
【正文】 b) process equipment and testing equipments (both hardware and software), and c) supporting services (such as testing, data puting, munication or information systems). none added as follows: Work environment The anization shall determine, provide and maintain the work environment needed to achieve HSF products. v2023和 v2023的差異 a paragraph on change management added as follows: The anization shall establish and maintain procedure for changes that will potentially lead to the change of HSF characteristic of products. The anization shall plan and implement verification, validation and approval for such changes, and evaluate the results of changes. Changes that have potential impact on HSF characteristic of products can not be implemented without approval of customers where necessary. Records shall be maintained for changes implemented. Note: changes include those within the anization and those within the supply chain that the anization can influence. v2023和 v2023的差異 a paragraph added as follows: The anization shall determine the responsibility and channel for the collection, delivery and summarization of these requirements, and determine how these requirements apply to its products. divided into and , C) is moved to a), and read as: Customer munication The anization shall determine and implement effective arrangements for munication with customers in format and channel specified by legal or customer requirements in relation to a) any use of, contamination by or mixing with product or processes that contain hazardous substances, b) any information, records, documents or evidences requested by customer, and c) changes that may have impact on the HSF characteristic of product. v2023和 v2023的差異 The suitable stage and method shall be determined for the review, verification and validation of the HSF characteristic of product during design and development. added. Inputs shall include legal and customer requirements on hazardous substance control and be in line with the internal HSF acceptance criteria for HSF product (see ). added. Where appropriate, the HSF outputs shall provide appropriate information for customer munication, purchasing, production, pr
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