ASME STP-NU-062-1-2015 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS.pdf
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1、Comprehensive Comparison of InternationalQualityStandardsSTP-NU-062-1STP-NU-062-1 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS Prepared by: William K. Sowder, PH.D. Quality Management Services Co., LLC Date of Issuance: June 30, 2015 This report was prepared as an account of work spon
2、sored by ASME Nuclear Codes and Standards and the ASME Standards Technology, LLC (ASME ST-LLC). Neither ASME, ASME ST-LLC, the author, nor others involved in the preparation or review of this report, nor any of their respective employees, members or persons acting on their behalf, makes any warranty
3、, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness or usefulness of any information, apparatus, product or process disclosed, or represents that its use would not infringe upon privately owned rights. Reference herein to any specific commercial prod
4、uct, process or service by trade name, trademark, manufacturer or otherwise does not necessarily constitute or imply its endorsement, recommendation or favoring by ASME ST-LLC or others involved in the preparation or review of this report, or any agency thereof. The views and opinions of the authors
5、, contributors and reviewers of the report expressed herein do not necessarily reflect those of ASME ST-LLC or others involved in the preparation or review of this report, or any agency thereof. ASME ST-LLC does not take any position with respect to the validity of any patent rights asserted in conn
6、ection with any items mentioned in this document, and does not undertake to insure anyone utilizing a publication against liability for infringement of any applicable Letters Patent, nor assumes any such liability. Users of a publication are expressly advised that determination of the validity of an
7、y such patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Participation by federal agency representative(s) or person(s) affiliated with industry is not to be interpreted as government or industry endorsement of this publication. ASME is the registered
8、trademark of the American Society of Mechanical Engineers. No part of this document may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. ASME Standards Technology, LLC Two Park Avenue, New York, NY 10016-5990 ISBN No. 9
9、78-0-7918-6914-7 Copyright 2015 by ASME Standards Technology, LLC All Rights Reserved Summary of Changes June 2015 STP-NU-062-1 COMPREHENSIVE COMPARISON OF INTERNATIONAL QUALITY STANDARDS The following changes have been made to the first revision of STP-NU-062. Page Location Change All - Document nu
10、mber on all pages changed from “STP-NU-062” to STP-NU-062-1 All - General change to all pages, NQA-1 title from NQA-2008 to NQA-2012 All - General change to all 18 NQA sections lead pages, from “100 Basic “ to “100 General” ii 2nd Page Date changed to June 2015 vi Foreword ASME NQA-1 “Quality Assura
11、nce Requirements for Nuclear Facility Application-Edition 2008”, changed to ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2012”, 2 Section 2 ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2008” changed to ASME NQA-1 “Quality
12、Assurance Requirements for Nuclear Facility Application-Edition 2012” 17 Appendix A, Requirement 1 Requirement 1, 201 General, add (c) quality achievement is verified by those not directly responsible for performing the work 19-35 Appendix A, Requirement 2 Requirement 2, 100 General, deletion of “Th
13、e program shall identify the activities and items to which it applies.” 45 Appendix A, Requirement 3 Requirement 3, revise first paragraph “The design shall be defined, controlled, and verified.” 52-53 Appendix A, Requirement 3 Requirement 3, 500 Design Verification, revise and add to (a) paragraph
14、“This verification may be performed by the originators supervisor, provided (1) the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design; or (2) the supervisor is the only individual in the organiza
15、tion competent to perform the verification. Cursory supervisory reviews do not satisfy the intent of this Standard.” 109 Appendix A, Requirement 12 Requirement 12, 303 Control, delete paragraph “Methods and frequency of checking accuracy shall be defined in procedures.” 123 Appendix A, Requirement 1
16、7 Requirement 17, Sub-Section 100 General delete 4th paragraph “The term records, used throughout this section, is to be interpreted as quality assurance records.” 6 References Updated NQA titles as shown here: ASME NQA-1 Part IV, SUBPART 4.1.1 Guidance to Modification of an ISO 9001:2008, Quality M
17、anagement Systems Standard for Compliance With NQA-12008, Part I With the NQA-1a2009 Addenda ASME NQA-1 Part IV, SUBPART 4.1.4 Guidance to Modification of an IAEA GS-R-3 Quality Program to Meet NQA-1a2009 Requirements and Modification of an NQA-1a2009 Quality Program to Meet IAEA GS-R-3 Requirements
18、 STP-NU-062-1: Comprehensive Comparison of International Quality Standards v TABLE OF CONTENTS Foreword vi Abbreviations and Acronyms vii 1 PURPOSE AND SCOPE . 1 2 SELECTION OF STANDARDS . 2 3 DIFFERENCES BETWEEN STANDARDS DEVELOPMENT 3 4 IMPORTANT DIFFERENCE IN FOCUS OF REVIEWED DOCUMENTS . 4 5 SUM
19、MARY OF EVALUATION RESULTS 5 References . 6 Appendix AInternational Quality Standards Comparison 7 REQUIREMENT 1 Organization . 8 REQUIREMENT 2 Quality Assurance Program . 20 REQUIREMENT 3 Design Control . 46 REQUIREMENT 4 Procurement Document Control 69 REQUIREMENT 5 Instructions, Procedures, and D
20、rawings . 74 REQUIREMENT 6 Document Control 75 REQUIREMENT 7 Control of Purchased Items and Services 78 REQUIREMENT 8 Identification and Control of Items 89 REQUIREMENT 9 Control of Special Processes 91 REQUIREMENT 10 Inspection . 99 REQUIREMENT 11 Test Control . 102 REQUIREMENT 12 Control of Measur
21、ing and Test Equipment 109 REQUIREMENT 13 Handling, Storage, and Shipping . 115 REQUIREMENT 14 Inspection, Test, and Operating Status 118 REQUIREMENT 15 Control of Nonconforming Items . 119 REQUIREMENT 16 Corrective Action . 123 REQUIREMENT 17 Quality Assurance Records 125 REQUIREMENT 18 Audits . 13
22、4 STP-NU-062-1: Comprehensive Comparison of International Quality Standards vi FOREWORD This technical report was developed to comprehensively evaluate the following international quality standards: ASME NQA-1 “Quality Assurance Requirements for Nuclear Facility Application-Edition 2012” 1, NQSA NSQ
23、-100 “Nuclear Safety and Quality Management System Requirements” 2, IAEA GS-R-3: 2006 “The Management System for Facilities and Activities” 3, and ISO 9001:2008 “Quality Management Systems Requirements” 4. The report discusses the competitive strengths and weaknesses of these documents. Established
24、in 1880, the American Society of Mechanical Engineers (ASME) is a professional not-for-profit organization with more than 135,000 members and volunteers promoting the art, science and practice of mechanical and multidisciplinary engineering and allied sciences. ASME develops codes and standards that
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