ASME NQA TECH REPT-1993 Comparison of ASME NQA-1 and ISO 9001《ASME NQA-1和ISO 9001标准的对比》.pdf
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1、 ASME NOA TECHNICAL REPORT Comparison of ASME NQA-1 and IS0 9001 I The American Society of Mechanical Engineers I I 345 East 47th Street, New York, N.Y. 1001 7 - Date of Issuance: September 15, 1993 ASME is the registered trademark of the American Society of Mechanical Engineers. No part of this doc
2、ument may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. Copyright 0 1993 by THE AMERICAN SOCIETY OF MECHANICAL ENGINEERS All Rights Reserved Printed in USA. FOREWORD (This Foreword is not part of the Task Group Repor
3、t.) The attached report takes each NQA-1 Basic Requirement and indicates the compa- rable paragraphs of IS0 9001. A summary of the requirments of each is provided. The Task Group has added a narrative comparison of the requirements of each and a con- clusion noting if an NQA-1 program would meet the
4、 IS0 9001 requirement and vice versa. 111 . ASME COMMITTEE ON NUCLEAR QUALITY ASSURANCE Task Group for NQA-l/ISO 9001 Comparison (The following is the roster of the Task Group at the time of the preparation of this report.) TASK GROUP PERSONNEL R. W. Boyce, Chairman T. R. Colandrea K. Ennis H. A. Ma
5、nning R. J. Vurpillat V CONTENTS Foreword . Task Group Roster NQA-1 Basic Requirement 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Organization . Quality Assurance Program . Personnel Indocrination and Training Design Control . Procurement Document Control . Instructions. Procedures. and Drawings Do
6、cument Control . Control of Purchased Items and Services . Identification and Control of Items . Control of Processes . Inspection Test Control Control of Measuring and Test Equipment . Handling. Storage. and Shipping Inspection. Test. and Operating Status . Control of Nonconforming Items Corrective
7、 Action Quality Assurance Records Audits IS0 9001 Requirements Without Specific NQA-1 Counterparts . and Control of Supplier Nonconformances . 111 V 1 1. 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 10 vii COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 1 Supplement 1s-1 Organization 4.1.2.1 Responsib
8、ility and Authority 4.1.2.3 Management Representative Requires that a quality organization be established Requires that a quality organization be established with a responsible level of management identified. with a responsible level of management identified. COMPARISON NQA-1 and IS0 9001 have equiv
9、alent require- ments. CONCLUSION A quality program that meets the requirements of either standard would meet the requirements of both standards. Basic Requirement 2 Quality Assurance Program 4.2 Quality System Requires that a quality program be developed, Requires that a quality program be developed
10、, documented, and implemented. documented, and implemented. COMPARISON NQA-1 and IS0 9001 have equivalent require- ments. CONCLUSION A quality program that meets the requirements of either standard would meet the requirements of both standards. 1 COMPARISON OF ASME NQA-1 AND IS0 9001 Supplement 2s-1
11、 through 2s-4 Personnel Indoctrination and Training 4.1.2.2 Verification Resources and Personnel 4.18 Training Requires that personnel be indoctrinated, trained, Requires that all personnel receive training in ac- and evaluated. The indoctrination, training, and eval- cordance with written procedure
12、s. uation must be documented. Specific requirements are provided for indoctrination and training of audit and NDE personnel. COMPARISON NQA-1 contains more specific requirements for the indoctrination, training, and evaluation of per- sonnel. CONCLUSION A quality program that meets the requirements
13、of NQA-1 will meet the requirements of IS0 9001. Con- versely, a quality program that meets the require- ments of IS0 9001 may not meet the requirements of NQA-1. Basic Requirement 3 Supplement 3s-1 Design Control 4.4 Design Control Requires that the design process be defined, con- Requires that the
14、 design process be defined, con- trolled, and documented. All designs must be verified trolled, and documented. All designs must be verified and all changes reviewed and approved. and all changes reviewed and approved. COMPARISON NQA-1 contains more specific requirements for the identification of in
15、dividuals and groups respon- sible for design activities (ie., review, approval, and verification). Also, NQA-1 requires more detailed design procedures. IS0 9001 does not address com- puter software. CONCLUSION A quality program that meets the requirements of NQA-1 will meet the requirements of IS0
16、 9001. Con- versely, a quality program that meets the require- ments of IS0 9001 may not meet the requirements of NQA-1. 2 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 4 Supplement 4s-1 Procurement Document Control 4.6.2 Assessment of Subcontractors 4.6.3 Purchasing Data 4.6.4 Verificatio
17、n of Purchased Product Requires that procurement documents be pre- Requires that procurement documents be pre- pared, reviewed, and approved. Provides for specific pared, reviewed, and approved. Provides for specific items to be included in the procurement documents. items to be included in the proc
18、urement documents. be reviewed and approved. Requires that changes to procurement documents COMPARISON IS0 9001 does not provided for the control of changes to procurement documents. Also, the pro- curement documents are not required to include items addressing noncomformances or spare and re- place
19、ment parts. CONCLUSION A quality program that meets the requirements of NQA-1 will meet the requirements of IS0 9001. Con- versely, a quality program that meets the require- ments of IS0 9001 may not meet the requirements of NQA-1. Basic Requirement 5 4.2(b) Quality System Instructions, Procedures,
20、and Drawings 4.4.4(b) Design Output Requires that activities be performed in accord- Requires that activities be performed in accord- ance with documented procedures, instructions, or ance with documented procedures, instructions, or drawings. These documents must include or refer- drawings. These d
21、ocuments must include or refer- ence acceptance criteria of the activity. ence acceptance criteria for the activity. COMPARISON NQA-1 and IS0 9001 have equivalent require- ments. CONCLUSION A quality program that meets the requirements of either standard would meet the requirements of both standards
22、. 3 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 6 Supplement 6s-1 Document Control 4.5 Document Control Requires that documents specifying quality re- Requires that documents specifying quality re- quirements be identified, reviewed, approved, and quirements be identified, reviewed, appr
23、oved, and controlled. controlled. COMPARISON NQA-1 and IS0 9001 have equivalent require- ments except that NQA-1 allows minor revisions to be made without the same review and approval re- quired for the original document or major revisions. IS0 9001 requires a master list, or equivalent, be establis
24、hed to identify current revision of the docu- ments and it recommends identification of the nature of the changes to the documents. CONCLUSION A quality program that meets the requirements of IS0 9001 will meet the requirements of NQA-1. Con- versely, a quality program that meets the require- ments
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