概述:为确定用于评估产品和生产相关材料质量的适当抽样计划提供指南。适用于制造商生产的用于临床和商业用途的最终产品和组件。也适用于从外部供应商购买并用于制造过程和最终套件组件的零件。包括一般原则、取样计划确定、材料特性、验收历史、成本和规定的取样要求。包括符合ISO TR 8550和ISO 2859的规定- ISO 3534和ANSI/ASQC S2。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:无关于本文件:这不是通用模板，这是一个5页的程序，实际上是在FDA监管机构的质量保证操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）。 )已被修订，但内容和格式基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，谁会从中受益:质量保证经理制造经理质量控制人员

Summary:Provides a guideline for determining appropriate sampling plans used to assess the quality of product and production related materials. Applicable to final product and subassemblies manufactured by for clinical and commercial uses. Also applies to parts purchased from outside vendors and used in manufacturing processes and final kit assemblies. Covers general principles, sampling plan determination, material characteristics, acceptance history, cost, and regulated sampling requirements. Includes provisions for compliance with ISO TR 8550, ISO 2859-1, ISO 3534, and ANSI/ASQC S2.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout This Document:This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Assurance 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:Quality Assurance ManagersManufacturing ManagersQuality Control Personnel