概述:定义开发和维护用于校准的质量系统所需的要求，以确保在规定的精度范围内校准和维护适用的测量和测试设备。旨在确保用于确定材料、产品、测试或工艺可接受性的测试和测量设备的适用性，以及样品生产、测试或储存环境的适用性。涵盖产品开发、生产、环境控制和测试中使用的自动、机械和电子设备的校准和跟踪。 适用于但不限于研发、制造、设施、产品工程和QA/QC。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:校准标签示例、新仪器校准申请表、停止使用的校准标签示例关于本文件:这不是一个通用模板，这是一个19页的程序，实际上是在FDA的设施和设备操作中创建和使用的- 监管机构。公司特定信息（名称、地址、一些图像、专有产品信息等）已经过编辑，但内容和格式在很大程度上得到了保留。购买理由:将其作为您自己文档项目的起点将您文档的质量与您所在行业的同行进行比较了解您所在行业的其他公司实际在做什么谁将从中受益:制造人员设备经理实验室人员

Summary:Defines the requirements necessary to develop and maintain a quality system used for calibration to assure that applicable measuring and test equipment is calibrated and maintained within specified accuracy limits. Intended to assure the suitability for use of test and measurement equipment used to determine the acceptability of a material, product, test or process and the suitability of the environment in which samples are produced, tested or stored. Covers the calibration and tracking of automatic, mechanical and electronic equipment used in development, production, environmental control, and testing of products. Applicable to, but not limited to, R&D, Manufacturing, Facilities, Product Engineering, and QA/QC.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Examples of Calibration Labels, New Instrument Calibration Request Form, Examples of Discontinued Calibration LabelsAbout This Document:This is not a generic template, it's a 19-page procedure that was actually created and used in the Facilities & Equipment operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Manufacturing PersonnelFacilities ManagersLaboratory Personnel