C00 标准化、质量管理 标准查询与下载

DB61/T 491-2010 城镇企业职工基本养老保险基金征缴

本标准适用于在各级养老保险经办机构（以下简称经办机构）参保的缴费单位及其职工、个体工商户和灵活就业人员养老保险基金征缴业务。

Collection and payment of basic pension insurance funds for urban enterprise employees

DB61/T 492-2010 城镇企业职工基本养老保险待遇社会化发放

本标准适用于在各级养老保险经办机构（以下简称经办机构）参保缴费并按规定办理了离休、退休（职）手续人员的养老保险待遇社会化发放管理业务。

Socialized distribution of basic endowment insurance benefits for urban enterprise employees

ANSI/NFPA 1250-2010 火灾应急服务机构风险管理的推荐实施规程

This recommended practice establishes minimum criteria to develop, implement, or evaluate an emergency service organization risk management program for effective risk identification, control, and financing.

Recommended Practice in Fire and Emergency Service Organization Risk Management

ISO 13485:2003/Cor 1:2009 医疗器械.质量管理体系.管理用途的要求.技术勘误表1

Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1

ANSI/NCPDP BUSV 3.0-2009 国家药物处方委员会出具发票单位标准实施指南.版本3.0

NCPDP Billing Unit Standard Implementation Guide Version 3.0

GOST R 53079.4-2008 医学化验室技术.检验科试验的质量保证.第4部分:预分析阶段的指导规则

Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 4. Rules for conducting of preanalytical stage

ASTM E2537-08 药品和生物药品生产中持续质量验证的标准指南

Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA initiative Pharmaceutical cGMPs for the 21st Century. This guide supports, and is consistent with, elements from ICH Q8 and ICH Q9. According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the knowledge that the risk-based monitoring and control strategy will enable control of the CQAs, should provide the confidence needed to show validation with each batch. This is as opposed to a conventional discrete process validation approach.1.1 This guide describes Continuous Quality Verification (CQV) as an approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. CQV is similarly described as Continuous Quality Assurance (U.S. FDA) and Continuous Process Verification (ICH Q8). 1.2 Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety, and efficacy. Process validation is a way in which companies provide that assurance. 1.3 With the knowledge obtained during the product lifecycle, a framework for continuous quality improvement will be established where the following may be possible: (1) risk mitigated, (2) process variability reduced, (3) process capability enhanced, (4) process design space defined or enhanced, and ultimately (5) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement). 1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for Purified Water and Water for Injection systems, and so forth). 1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement and/or redesign of an existing process. 1.6 Continuous quality verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space. 1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.

Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

GOST R 52960-2008 法医科学实验室认可.GOST R ISO/IEC 17025的应用指南

Forensic science laboratories accreditation. Guidance on the application of GOST R ISO/IEC 17025

GOST R 53092-2008 质量管理体系.保健服务机构的过程改进指南

Quality management systems. Guidelines for process improvements in health service organizations

BS PD CEN/TR 15592:2007 医疗卫生服务.质量管理体系.性能改善用医疗卫生服务中EN ISO 9004-2000标准的使用指南

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization. This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties. This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001. This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies. Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness. To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation. An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 individual “should” performance improvement guideline statements of the standard. These statements can be used to create a check list for evaluators (see A.3). Using the EN ISO 9004:2000 criteria, organisations can assess the maturity of their quality management system (see A.2) and identify opportunities for improvement. This Technical Report ensures that those health system activities that are necessary for continuous improvement, risk management and reduction of variation and organisational waste are carried out consistently and in a controlled manner. This Technical Report addresses any health system or health care organisation involved in the provision of health services to the population including prevention, care and rehabilitation, regardless of the type and size of the system/organisation and the product or service provided.

Health services — Quality management systems — Guide for the use of EN ISO 9004:2000 in health services for performance improvement

SANS 16001:2007 HIV和AIDS管理体系．一般要求

This standard specifies general requirements for HIV and AIDS management systems. It is applicable to any organization that wishes to establish, implement, maintain and improve an HIV and AIDS management system.

HIV and AIDS management systems - General requirements

CSA Z20514-07-CAN/CSA-2007 健康信息,信息资料,定义,范围和内容.第1版

Canadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve co

Health informatics ?Electronic health record ?Definition, scope and context First Edition

CSA Z614-07-2007 儿童游乐场和设备.第4版

Exclusion de responsabilité Ce document est fourni sans assertion, garantie ni condition explicite ou implicite de quelque nature que ce soit, y compris, mais non de façon limitative, les garanties ou conditions implicites relatives à la qualité marchan

Children's Playspaces and Equipment Fourth Edition

CSA Z21091-07-CAN/CSA-2007 健康信息-专业人员和患者的安全,通讯和身份识别目录服务

Health informatics -Directory services for security, communications and identification of professionals and patients

Health informatics ?Directory services for security, communications and identification of professionals and patients

ANSI/ASTM E2117:2006 医疗记录质量保证计划的鉴定和确立用分类指南

This guide covers the establishment of a quality assurance program for dictation, medical transcription, and related processes. Quality assurance (QA) is necessary to ensure the accuracy of healthcare documentation. Quality documentation protects healthcare providers, facilitates reimbursement, and improves communication among healthcare providers, thus improving the overall quality of patient care. This guide establishes essential and desirable elements for quality healthcare documentation, but it is not purported to be an exhaustive list. The QA personnel for medical transcription should have an understanding of the processes and variables or alternatives involved in the creation of medicolegal documents and an understanding of quality assurance issues as they pertain to medical transcription. Qualified personnel include certified medical transcriptionists (CMTs), quality assurance professionals, or individuals who hold other appropriately related credentials or degrees. The medical transcriptionist (MT) and QA reviewer should establish a cooperative partnership so that the review outcomes are objective and educational to include corrective actions and remedies. Policies should be developed to minimize subjective review, which can lead to forceful implementation of one style at the expense of other reasonable choices. Objective review, including an appeals process, should follow organizational standards that have been agreed upon by the full team of QA personnel, MTs, and management staff.

Classifications Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription

CSA ISO 17432-06-CAN/CSA:2006 健康信息学 信息和通信 DICOM不变对象的网上存取.第1版

Informatique de sant? Messages et communication Accès au web pour les objets persistants DICOM Premiere Edition

Health informatics Messages and communication Web access to DICOM persistent objects First Edition

ASSE 6000 SERIES-2006 医用气系统专家人员职业质量标准

Professional Qualifications Standard for Medical Gas Systems Personnel - Medical Gas Systems Specialists - Medical Gas Systems Installers - Bulk Medical Gas Systems Installers - Medical Gas Systems Inspectors - Medical Gas Systems Verifiers - Medical Gas

Professional Qualifications Standard for Medical Gas Systems Personnel - Medical Gas Systems Specialists - Medical Gas Systems Installers - Bulk Medical Gas Systems Installers - Medical Gas Systems Inspectors - Medical Gas Systems Verifiers - Medical Gas

CSA PLUS 13485-2006 ISO 13485基本使用手册用于贯彻ISO 13485标准到医疗装置的制造

This Addendum specifies additional component and transmission requirements for a 50/125 μm optical fiber cable capable of supporting 10 Gb/s serial transmission up to 300 m (984 ft) using 850 nm nominal wavelength lasers. These cables are suitable for u

The ISO 13485 essentials A practical handbook for implementing the ISO 13485 Standard for manufacturers of medical devices

CSA Z107.10-06-2006 加拿大听力标准使用指南.第1版

This International Standard specifies multilink procedures where a multiplicity of parallel data links at the data link layer are used to provide a variable bandwidth data link between network layer entities. The multilink procedures (MLP) exist as a

Guide for the use of acoustical Standards in Canada First Edition

IWA 1-2005 质量管理体系.卫生服务组织的过程改进指南

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization. This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties. This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

Quality management systems - Guidelines for process improvements in health service organizations