1.
Documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;
对生产、安装及服务的方式,若缺少作业程序会对质量有所不利时,应制定该等书面程序;
2.
The manufacturer shall establish and maintain documented procedures for contract review and for the co-ordination of these activities.
制造业者应建立并维持合约审查及协调各项审查活动之书面程序。
3.
The manufacturer shall establish and maintain documented procedures to ensure that purchased product conform to specified requirements.
制造业者应建立并维持书面程序,以确保所购产品符合规定要求。
4.
Inspect and test the product as required by the quality plan and/or documented procedures;
按照质量计划或书面程序要求,对产品加以检验与测试。
5.
Verification of conformance to the specified requirements shall be in accordance with the quality plan and/or documented procedures.
规定要求之查证应依照质量计划或书面程序进行。
6.
The manufacturer shall establish and maintain procedures for implementing corrective and preventive action.
制造业者应建立并维持各项书面程序,以执行矫正与预防措施。
7.
The supplier shall prepare documented procedures consistent with the requirements of this Practice and the manufacturer's stated quality policy.
制造业者应遵照本规范要求及既定之质量政策,明定各项书面程序。
8.
Repaired and/or reworked product shall be re-inspected in accordance with the quality plan and/or documented procedures.
经修理或重加工之产品应依质量计划或书面程序,重新予以检验。
9.
Does the foundry perform salvage and repair operations? Are there written procedures?
工厂是否执行修补/修理操作？是否有相关的书面程序？
10.
abbreviated written audit program
简略书面审计程序表
11.
detailed written audit program
详细书面审计程序表
12.
hearings and written proceeding
开庭和书面审理程序
13.
no detailed written audit program
无详细书面审计程序表
14.
block-oriented compiler
面向程序块的编译程序
15.
The manufacturer shall establish, document and maintain procedures for the issue of advisory notices for medical devices. These procedures shall be capable of being implemented at any time.
制造业者应建立、书面化与维持发布医疗器材说明事项之程序,此程序应可随时执行。
16.
Implementation of International Instruments and Procedures Branch
国际文书和程序执行处
17.
electronic library search
电子式图书查找程序
18.
Company Operation Procedures Listing
公司运作程序书目录