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CLSI EP23 - LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT; APPROVED GUIDELINE - VOL 31; NO 18 Organization: CLSI
Date: 2011-10-01
Description: This document describes good laboratory practice for developing and maintaining a quality control plan (QCP) for medical laboratory testing using internationally recognized risk management principles. An individual QCP should be established, maintained, and modified as needed for each measuring system.
ASTM - STP1209 - QUALITY AND STATISTICS: TOTAL QUALITY MANAGEMENT Organization: ASTM
Date: 1994-01-01
Description: The latest information on Total Quality Management in standardization, with emphasis on the need to plan, control, and prepare documentation systems.
CLSI GP38APKGE - GP38-A: QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES; APPROVED GUIDELINE AND GP38-A EXECUTIVE SUMMARY: QUALITY MANAGEMENT SYSTEM: LEADERSHIP AND MANAGEMENT ROLES AND RESPONSIBILITIES Organization: CLSI
Date: 2012-01-01
Description: Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system.
IEC TR 62010 - ANALYSER SYSTEMS – MAINTENANCE MANAGEMENT - EDITION 2.0 Organization: IEC
Date: 2016-12-01
Description: Due to the complexity of modern analysers, support can be required from laboratory or product quality specialists, for example for chemometric models, who can work for other parts of the organisation.
ASTM E1029 - STANDARD GUIDE FOR DOCUMENTATION OF CLINICAL LABORATORY COMPUTER SYSTEMS Organization: ASTM
Date: 2001-11-10
Description: They typically include some or all of the following features: sample tracking, data gathering, report generation, record keeping, quality assurance, management aids, and hospital communications.
CLSI - GP06-A - INVENTORY CONTROL SYSTEMS FOR LABORATORY SUPPLIES; APPROVED GUIDELINE - FIRST EDITION; VOL. 14 NO. 3 Organization: CLSI
Date: 1994-02-01
Description: Most often, communication with the vendor is required, especially concerning product improvements, method changes, and similar information that affects the test procedure or quality control. The clinical laboratory must accept the responsibility for these functions and provide accurate records to allow traceability for overall audit purposes.
CRC - HANDBOOK OF THE ASSISTED - HANDBOOK OF THE ASSISTED REPRODUCTION LABORATORY Organization: CRC
Date: 2000-05-15
Description: In general, the current Handbook will (1) review male and female reproductive systems and processes, (2) discuss the clinical diagnosis and management of male and female infertility, (3) provide new information on the state-of-the-art techniques of egg and embryo culture, micromanipulation, and biopsy, and (4) present various aspects of quality control, quality assurance, and clinical laboratory management. It is intended that this Handbook will be used by laboratory directors as a management tool, by technologists and bench personnel (especially new hires) as a training guide, and by students as a resource for study.
ISO/IEC 25024 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - MEASUREMENT OF DATA QUALITY - FIRST EDITION Organization: ISO
Date: 2015-10-15
Description: It can be applied in many types of information systems, for example, such as follows: — legacy information system; — data warehouse; — distributed information system; — cooperative information system; — world wide web.
CLSI POCT07 - QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE; APPROVED GUIDELINE - VOL 30; NO 20 Organization: CLSI
Date: 2010-10-01
Description: Error indicators for each analytical phase are suggested for incorporation into a quality management program. This guideline serves as a complementary tool to laboratory quality management procedures.
NASA NPR 8570.1 REV A - NASA ENERGY MANAGEMENT PROGRAM Organization: NASA
Date: 2013-07-12
Description: (5) Promotes mitigation of energy-related climate change risks and impacts, availability of cleaner energy sources, and improved air quality. b. NPD 8500.1, NASA Environmental Management, establishes NASA policy to reduce energy risk to mission, maintain compliance with applicable external requirements, and promote energy conservation.
ASTM E1381 - STANDARD SPECIFICATION FOR LOW-LEVEL PROTOCOL TO TRANSFER MESSAGES BETWEEN CLINICAL LABORATORY INSTRUMENTS AND COMPUTER SYSTEMS Organization: ASTM
Date: 2002-08-10
Description: Typically, the computer system will be a Clinical Laboratory Information Management System (CLIMS). The terminology of the Organization for International Standards (ISO) Reference Model for Open Systems Interconnection (OSI) is generally followed in describing the communications protocol and services.
DS/ISO/IEC 25051 - SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - REQUIREMENTS FOR QUALITY OF READY TO USE SOFTWARE PRODUCT (RUSP) AND INSTRUCTIONS FOR TESTING Organization: DS
Date: 2014-02-14
Description: The intended users of this International Standard include: a) suppliers when: 1) specifying requirements for a COTS software product; 2) assessing their own software products against the claimed performance; 3) issuing declarations of conformity (ISO/IEC 17050); 4) applying for certificates or marks of conformity (ISO/IEC Guide 23); b) certification bodies that may wish to establish a third-party certification scheme (international, regional or national) (ISO/IEC Guide 28); c) testing laboratories which will have to follow the instructions for testing when testing for a certificate or a mark of conformity (ISO/IEC 17025); d) accreditation bodies for accrediting registration or certification bodies and testing laboratories; e) potential acquirers who may: 1) compare the requirements for the intended work task with the information in product descriptions of existing software products; 2) look for certified COTS software product; 3) check if the requirements are otherwise met; f) end users who may profit from better software products; g) organizations: 1) establishing management and engineering environments based on the quality requirements and methods of this international standard; and 2) managing and improving their quality processes and personnel. h) regulatory authorities who may require or recommend the requirements of this International Standard for COTS software products used in safety or business-critical applications.
DSF/ISO/IEC DIS 25051 - SOFTWARE ENGINEERING - SOFTWARE PRODUCT QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - REQUIREMENTS FOR QUALITY OF COMMERCIAL OFF-THE-SHELF (COTS) SOFTWARE PRODUCT AND INSTRUCTIONS FOR TESTING Organization: DS
Description: The intended users of this International Standard include: a) suppliers when: 1) specifying requirements for a COTS software product; 2) assessing their own software products against the claimed performance; 3) issuing declarations of conformity (ISO/IEC 17050); 4) applying for certificates or marks of conformity (ISO/IEC Guide 23); b) certification bodies that may wish to establish a third-party certification scheme (international, regional or national) (ISO/IEC Guide 28); c) testing laboratories which will have to follow the instructions for testing when testing for a certificate or a mark of conformity (ISO/IEC 17025); ISO/IEC 25051: REVISION (E) © ISO/IEC 20** - All rights reserved 2 d) accreditation bodies for accrediting registration or certification bodies and testing laboratories; e) potential acquirers who may: 1) compare the requirements for the intended work task with the information in product descriptions of existing software products; 2) look for certified COTS software product; 3) check if the requirements are otherwise met; f) end users who may profit from better software products; g) organizations: 1) establishing management and engineering environments based on the quality requirements and methods of this international standard; and 2) managing and improving their quality processes and personnel. h) regulatory authorities who may require or recommend the requirements of this International Standard for COTS software products used in safety or business-critical applications.
API RP 555 - PROCESS ANALYZERS - THIRD EDITION Organization: API
Date: 2013-06-01
Description: Chapter 2 describes the requirement for analyzer system data management. Chapter 3 provides information on analyzer calibration and validation.
ASTM D8006 - STANDARD GUIDE FOR SAMPLING AND ANALYSIS OF RESIDENTIAL AND COMMERCIAL WATER SUPPLY WELLS IN AREAS OF EXPLORATION AND PRODUCTION (E&P) OPERATIONS Organization: ASTM
Date: 2016-03-01
Description: This guide provides information on typical residential and commercial water supply well systems and guidance on developing and implementing a sampling program, including determining sampling locations, suggested purging techniques, selection of potential analyses and laboratory certifications, data management, and integrity. It also includes guidance on personal safety.
NASA NPR 1800.1 REV C W/CHG 2 - NASA OCCUPATIONAL HEALTH PROGRAM PROCEDURES W/CHANGE 2 (05/17/2013) Organization: NASA
Date: 2009-10-06
Description: (1) NPR 1441.1, NASA Records Retention Schedules; (2) 5 U.S.C. 552a, the Privacy Act of 1974, as amended; and (3) The Health Information Management System (HIMS) in NASA's "Privacy Act; Annual Notice and Amendment to Systems of Records," published in the Federal Register.
SAE AS6171 - TEST METHODS STANDARD; GENERAL REQUIREMENTS, SUSPECT/COUNTERFEIT, ELECTRICAL, ELECTRONIC, AND ELECTROMECHANICAL PARTS Organization: SAE
Date: 2016-10-01
Description: The requirements of this document supplement the requirements of a higher level quality standard (e.g., AS9100, AS9003, AS9120, ISO 9001) and other quality management system documents.
ASTM D5851 - STANDARD GUIDE FOR PLANNING AND IMPLEMENTING A WATER MONITORING PROGRAM Organization: ASTM
Date: 1995-10-10
Description: Detecting Existing and Emerging Problems— Determining if, how, or where a substance may move through an aquatic system, or if water quantities are changing. Developing and Implementing Management and Regulatory Programs—Includes baseline and reconnaissance monitoring to characterize existing conditions such as to identify critical areas or hot spots; implementation monitoring to assess whether activities were carried out as planned; and compliance monitoring to determine if specific water quality or water use criteria were met.
NASA-STD-8739.9 - SOFTWARE FORMAL INSPECTIONS STANDARD Organization: NASA
Date: 2013-06-17
Description: This Standard may also apply to the Jet Propulsion Laboratory or to other contractors, grant recipients, or parties to agreements only to the extent specified or referenced in their contracts, grants, or agreements.
CRC - JOINT REPLACEMENT AND BON - JOINT REPLACEMENT AND BONE RESORPTION: PATHOLOGY, BIOMATERIALS AND CLINICAL PRACTICE Organization: CRC
Date: 2005-11-09
Description: Preface Over the last four decades, investigators around the globe have toiled in clinics, in laboratories, and in operating rooms trying to understand the causes of bone resorption around joint replacements.

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