品质管理系统所要求的文件应予以管制。品质记录是一种特殊型态的文件，应依据4.2.4项条文要求加以管制。
Documents required by the quality management system shall be controlled. Records are special type of document and shall be controlled according to the requirements give in 4.2.4.
品质管理系统文件有包括品质手册吗?。
Does the quality management system documentation include a quality manual?
本技术规范，伴随适用的顾客特定要求，界定了采用 本文件之业者的基本品质管理系统要求。
This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.
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