03.120.10 质量管理和质量保证 标准查询与下载

ISO 10014:2021 质量管理.挖掘金融和经济利益导则

This document gives guidelines for realizing financial and economic benefits by applying a top-down structured approach to achieving financial and economic benefits. The structured approach uses the quality management principles and quality management system described in the ISO 9000 family of management system standards to: a) monitor and manage trends in key performance metrics; b) take improvement action based on the observed metrics. This document is directed specifically to the top management of an organization. This document is applicable to any organization, whether from the public, private or not-for-profit sector, regardless of its business model, revenue, number of employees, diversity of product and service offerings, organizational culture, complexity of processes, place or number of locations. This document complements ISO 9001:2015 and ISO 9004:2018 for performance improvements and provides examples of achievable benefits from the application of concepts in those standards. This document identifies associated practical management methods and tools to assist in realizing the benefits.

Quality management systems - Managing an organization for quality results - Guidance for realizing financial and economic benefits

KS J 0015-2021 基于现行良好生产规范的生物制药生产质量手册

Quality manual in biopharmaceutical production based on current Good Manufacturing Practice

KS J 0018-2021 基于良好生产规范的生物制药生产材料系统政策

Materials system policy in biopharmaceutical production based on Good Manufacturing Practice

KS J 0020-2021 基于良好生产规范的生物制药生产体系政策

Production system policy in biopharmaceutical production based on Good Manufacturing Practice

KS J 0017-2021 基于良好生产规范的生物制药生产质量体系政策

Quality system policy in biopharmaceutical production based on Good Manufacturing Practice

KS J 0022-2021 基于良好生产规范的生物制药生产实验室控制体系政策

Laboratory control system policy in biopharmaceutical production based on Good Manufacturing Practice

KS J 0021-2021 基于良好生产规范的生物制药生产中的包装和标签系统政策

Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice

NF L36-236*NF EN 6099:2021 航空航天系列 杆端、球面、滑动轴承、金属对金属 技术规范

Aerospace series - Rod-end, spherical, plain bearing, metal to metal - Technical specification

T/CSBME 038-2021 区域远程医学影像中心图像及诊断报告质量控制

本文件对适用于配置有PACS（图像存档和传输系统）的各级医院的医学影像科、各种规模的区域远程医学影像中心的影像诊断及指标，影像诊断质控报表、影像诊断质控的监测质控项目和诊断报告质量控制进行了规定。

Quality control of image and diagnostic report in regional remote medical imaging center

T/LZZLXH 064-2021 实验室检测仪器设备维护保养规范

7　维护操作 7.1　由获得授权的人员，按照正式发布的作业指导书实施维护操作； 7.2　如果是首次实施维护，应在有经验的人员指导下进行； 7.3　维护的任何时候遇到操作上的困难，应寻求相关帮助； 7.4　维护结束后做好相关记录； 如果作业指导书有对维护后的检测仪器及设备进行验证的要求，应按要求实施验证。

Specifications for maintenance of laboratory testing instruments and equipment

T/LZZLXH 060-2021 化学分析实验室安全标志使用规范

各区域标志要求 6.1　用于业务接洽和业务接待的区域 在用于业务接洽和业务接待的区域，应根据需要，设置禁止进入标志。必要时还应设置请勿喧哗、请勿吸烟等提示标志。 6.2　样品管理及样品存放区域 在样品管理和样品存放区域至少应设置下列标志： a)未经许可不得入内、禁止烟火、禁止吸烟等禁止标志； b)用于存放样品的货架区域应设置禁止倚靠、禁止攀爬等禁止标志； c)在整个样品存放区域应设置灭火装置标志； d)在工作区设置必须戴口罩、必须戴手套等指令标志，并设置注意通风警告标志； e)有冷冻保存的样品存放区域应设置当心低温警告标志； 存放有危险化学品的区域应设置当心中毒警告标志，同时设置按要求移取货物指令标志。

Specifications for the use of safety signs in chemical analysis laboratories

DS/ISO 10013:2021 质量管理体系 文件化信息指南

Quality management systems – Guidance for documented information

ISO 10013:2021 质量管理体系文件化信息指南

This document gives guidance for the development and maintenance of the documented information necessary to support an effective quality management system, tailored to the specific needs of the organization. This document can also be used to support other management systems, e.g. environmental or occupational health and safety management systems.

Quality management systems — Guidance for documented information

T/HPPX 001-2021 黑龙江省知名品牌建设与评价指南

       本文件规定了黑龙江省知名品牌建设与评价指南术语和定义、品牌建设目标、品牌组织建设、品牌 制度建设、品牌文化与理念建设、品牌建设实践、产品型品牌建设、制造环节品牌建设、营销环节品牌 建设、经营环节品牌建设、售后环节品牌建设、服务型企业品牌建设、品牌建设成效、评价规则。        本文件适用于对黑龙江省内注册的合法经营企业、产品的知名度开展品牌评价，及对开展品牌建设 进行指导，品牌服务机构开展咨询顾问和辅导，也适用于第三方评价。

Guidelines for Building and Evaluation of Famous Brands in Heilongjiang Province

PN-EN 9100-2018-08 P 质量管理体系 航空、航天和国防组织的要求

Quality Management Systems -- Requirements for Aviation, Space and Defence Organizations

DB43/T 1999-2021 产品质量监督抽查抽样规范

Sampling specification for product quality supervision and random inspection

DS/ISO 19443:2021 质量管理体系 核能行业供应链中提供核安全重要产品和服务的组织应用 ISO 9001:2015 的具体要求（ITNS）

Quality management systems – Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS)

OENORM EN 9114-2021 航空航天系列 质量体系 直航 航空航天公司指南

Aerospace series - Quality systems - Direct Ship - Guidance for Aerospace Companies

SN ISO 10002:2021 质量管理 顾客满意 组织投诉处理指南

Quality management - Customer satisfaction - Guidelines for complaints handling in organizations

DB12/T 630.1-2021 天津质量奖 第1部分：评价总则

Tianjin Quality Award Part 1: General Evaluation Rules