ASQ-E4-2004.pdf

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1、ANSI/ASQ E4-2004 AMERICAN NATIONAL STANDARD Quality systems for environmental data and technology programs - Requirements with guidance for use AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE, WI 53201-3005 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=I

2、HS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI/ASQ E4-2004 AMERICAN NATIONAL STANDARD Quality systems for environmental data and technology programs - Requirements with guidance for use App

3、roved as an American National Standard by: ASC Z 1 on Quality, Environment, Dependability and Statistics, Subcommittee on Quality Management Secretariat, American Society for Quality An American National Standard Approved on February 4,2004 American National Standards: An American National Standard

4、implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he o

5、r she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National

6、Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive curre

7、nt information on all standards by calling or writing the American National Standards Institute. Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking per

8、mitted without license from IHS -,-,- 02004 by ASQ Copyright Protection Notice for the ANSI/ASQ E4-2004 Standard. This publication is subject to copyright claims of ASQ. Not for resale. No part of this publication may be reproduced in electronic form, including an electronic retrieval system, withou

9、t the prior written permission of ASQ. All requests pertaining to the ANSUASQ E4-2004 Standard should be submitted to ASQ. ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standa

10、rds Administrator at the address below. ASQ Mission: The American Society for Quality advances individual and organizational performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange. Published bv: ii Copyright American Society for Quality

11、Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD ANSIIASQ E4-2004 Contents . Foreword V O Introduction 0.1 . General 0.2

12、 . Compatibility with Other Management Systems 1 Scope 2 General Principles and Applications 2.1 General Principles 2.2 Applications 3 Normative References 4 . Terms and Definitions 4.1 . Environmental Data 4.2 Environmental Data Operations 4.3 Environmental Processes 4.4 . Environmental Programs 4.

13、6 Environmental Technology 5 Management Systems 5.1 . General 5.2 . Management and Organization 5.3 Quality System and Description 5.4 Personnel Qualification and Training 5.5 Procurement of Items and Services 5.6 . Documents and Records 5.7 . Computer Hardware and Software 5.8 . Planning 5.9 Implem

14、entation of Work Processes 5.10 . Assessment and Response 5.1 1 Quality Improvement 6 . Collection and Evaluation of Environmental Data 6.1 . General 6.2 Planning and Scoping 6.3 . Design of Data Collection Operations 6.4 Implementation of Planned Operations 6.5 . Assessment and Response 6.6 . Asses

15、sment and Verification of Data Usability 7 Design. Construction and Operation of Environmental Technology 7.1 . General 7.2 . Planning 7.3 . Design of Systems 7.4 . Construction/Fabrication of Systems and Components 7.5 Operation of Environmental Technology vi vi vi 1 1 1 3 3 5 5 5 6 7 8 8 9 10 10 1

16、1 12 12 12 13 14 16 17 17 17 17 18 19 20 22 iii Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NA

17、TIONAL STANDARD ANSIIASQ E4-2004 7.6 . Assessment and Response 7.7 Verification and Acceptance of Systems 23 23 Annex A . Terms and Definitions (Normative) 24 Annex B . Guidelines on the Use of ANSVASQ E4 (Informative) 31 Annex C . Crosswalk between ANSVASQ E4 and IS0 9001 40 iv Copyright American S

18、ociety for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD ANSIIASQ E4-2004 Foreword The American National Stan

19、dards Institute (ANSI) is the national standards-setting body for the United States of America and is the U.S. member body to the International Organization for Standardization (ISO). In carrying out the development of American National Standards, ANSI often delegates the preparation of standards to

20、 accredited technical organizations. The American Society for Quality (ASQ) is recognized by ANSI for the preparation of quality-related standards. The ASQ Mission is to facilitate continuous improvement and increase customer satisfaction by identifying, communicating, and promoting the use of quali

21、ty principles, concepts, and technologies; and thereby be recognized throughout the world as the leading authority on, and champion for, quality. ANSVASQ E4 was prepared by the Energy and Environmental Division of ASQ under the auspices of the ANSI ASC Z1 Committee. The Energy and Environmental Divi

22、sion wishes to thank the following members of the Work Group: Gary L. Johnson, Convenor Larry D. Becker Stanley M. Blacker John R. Gelzer, Jr. Myrna Goss RoseMary Gustin Terrell E. Horne Donald C. Johnson Paul C. Mills Charles H. Moseley, Jr. Michael F. Nicol Steve Stubbs Martin Stutz Dean W. Wolfe

23、Jeffrey C. Worthington U.S. Environmental Protection Agency U.S. Army Corps of Engineers MAC Technical Services Consultant Florida International University CDM Federal Corporation Consultant U.S. Environmental Protection Agency DynCorp BWXT Y12 Duke Engineering Services Texas Commission on Environme

24、ntal Quality U.S. Army Environmental Center Consultant U.S. Environmental Protection Agency The Energy and Environmental Division also wishes to thank the members of the ANSI Z1 Committee on Quality, Environment, Dependability, and Statistics, Subcommittee on Quality Management, for their contributi

25、ons to the consensus process by which this standard was approved. Annex B and Annex C of this American National Standard are for information only. This standard replaces ANSVASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology

26、 Programs, in its entirety. Suggestions for improvement of this standard are welcome. They should be sent to the Standards Administrator, ASQ, P.O. Box 3005, Milwaukee, WI 53201 -3005. V Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001,

27、User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD (This page intentionally left blank) ANSIIASQ E4-2004 vi Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=I

28、HS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD ANSIIASQ E4-2004 O INTRODUCTION 0.1 General This American National Standard presents requirements for a quality manageme

29、nt system for environmental programs. A national consensus standard for quality systems for environmental programs involving environmental data and technology has been shown to be a valuable instrument to verify and help to improve the suitability and effectiveness of quality control and quality ass

30、urance practices applied to environmental programs. The environmental community has been forced in the past to use several different standards and frequently has required duplicate quality assurance (QA) functions and documentation on the same project or task to satisfy different customers requireme

31、nts. This American National Standard is intended to provide a minimum set of requirements to enable organizations to plan, implement, and assess the suitability and effectiveness of a quality system to support environmental programs involving environmental data and technology. It provides definition

32、s of relevant terms and general principles necessary for any quality management system. Recognizing the diversity of scope of environmental programs and the breadth of the field of application, this standard also provides non-mandatory guidelines in an annex to enable users of the standard to extend

33、 quality beyond the minimum requirements. 0.2 Compatibility with Other Management Systems This Standard incorporates relevant criteria from other management systems standards and guidelines, including the IS0 9000 series, and presents them from an environmental data and technology perspective. There

34、 is some deliberate duplication in the Standard in order to preserve the logical flow of the requirements and to provide a self-contained document that would not require references to other standards. This Standard is intended to be used to create appropriate and effective quality systems to support

35、 an organizations mission relative to environmental programs. This Standard uses the principle of graded approach to foster the development of quality systems. Graded approach provides for a level of applied practices and their comprehensiveness that reflect the importance of the work being performe

36、d and that will produce the type and quality of results needed and expected. This Standard defines and describes quality control and quality assurance activities for environmental programs involving environmental data generation and use, and environmental technology design, development, and operatio

37、n. This Standard does not provide specifications or guidelines on environmental management systems, rather it may be used to support the quality aspects of environmental management systems and applications. Environmental management is outside the scope and intent of this standard and is addressed in

38、 IS0 14001:1996, Environmental Management Systems - Specification with Guidance for Use. This Standard may be used by organizations implementing an environmental management system to provide quality control and quality assurance support to the activities supporting the environmental management syste

39、m. Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD (This page intentionally left

40、 blank) ANSIIASQ E4-2004 viii Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 04:02:13 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD AN

41、SIIASQ E4-2004 Quality Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use 1 SCOPE This American National Standard specifies requirements for a quality system to enable an organization to formulate policies and procedures to plan and implement sufficient and a

42、dequate quality management practices for environmental programs. This Standard is applicable to any organization that wishes to a) implement, maintain, and improve a quality system for environmental programs; b) specify quality requirements when contracting for work; c) assure itself of its conformi

43、ty with its stated quality policy; and d) demonstrate such conformity to others. All the requirements in this Standard are intended to be incorporated into quality systems supporting environmental programs involving environmental data and environmental technology. The extent of the application will

44、depend on the environmental policy of the organization, the nature of its environmental programs, and the conditions under which it operates. 2 GENERAL PRINCIPLES AND APPLICATIONS 2.1 General Principles A quality system is the means by which an organization implements quality management in a systema

45、tic, organized manner. It is a management system in much the same manner as an organization manages its financial operations or health and safety programs. A Quality System encompasses a variety of technical and administrative elements, including policies and objectives, organizational authority, re

46、sponsibilities, accountability, and procedures and practices. The quality system is the “blueprint” or framework by which an organization applies sufficient quality control (QC) and quality assurance (QA) practices to ensure that the results of its environmental programs meet or exceed expectations.

47、 The quality system encompasses both management and technical activities pertaining to the planning, implementation, and assessment of environmental programs within the organizations mission and scope. The business plan model used for implementing a quality system based on this standard encompasses

48、three stages: planning, implementation, and assessment. This model is based on the concept of first planning the work, doing what was planned, and assessing the results against performance criteria, and acting on what was found by such a cornparicon. The level of detail and comprehensiveness of the quality system should be based on the principle of graded approach. The principle of graded approach recognizes that a “one size fits all” approach to quality requirements will not generally work in

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