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

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

25、of NQA-1 may not meet the requirements of IS0 9001. Basic Requirement 7 4.6.1 General Supplement 7s-1 4.6.2 Assessment of Subcontractors Control of Purchased Items and Services 4.6.4 Verification of Purchased Product 4.7 Purchaser Supplied Product Requires that the purchase of items and services Req

26、uires that the purchase of items and services is controlled. Provides for Source evaluation, evalu- is controlled. Provides for source evaluation, evalu- ation of objective evidence, source inspection, audit, ation of objective evidence, source inspection, and and examination. examination. COMPARISO

27、N NQA-1 contains additional requirements for ex- ternal audits, control of nonconformances, procur- ment planning, and commercial grade items. Commercial grade items are not applicable to IS0 9001. NQA-1 provides specific requirements for the control of purchased items and services. CONCLUSION A qua

28、lity 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. 4 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 8 Supplement 8s-1 Identification and

29、Control of Items 4.10 Inspection and Testing 4.8 Product Identification and Traceability Requires that items be identified and controlled Requires that items be identified and controlled to prevent the use of nonconforming items. to prevent the use of nonconforming items. COMPARISON NQA-1 contains a

30、dditional requirements for the control of limited life items. The other requirements for identification and control of items are equivalent. 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 requir

31、e- ments of IS0 9001 may not meet the requirements of NQA-1. Basic Requirement 9 Supplement 9s-1 Control of Processes 4.9 Process Control Requires that all processes affecting be controlled. Requires that all processes affecting be controlled. Special processes must be performed in accordance Specia

32、l processes must be performed in accordance with written procedures by qualified individuals using with written procedures by qualified individuals using qualified equipment. qualified equipment. COMPARISON NQA-1 and IS0 9001 have equivalent require- ments. CONCLUSION A quality program that meets th

33、e requirements of either standard would meet the requirements of both standards. 5 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 10 Supplement 10s-1 Inspection 4.10 Inspection and Testing Requires that inspections performed to verify con- Requires that inspections performed to verify con-

34、formance of items to specified criteria be controlled. formance of items to specified criteria be controlled. Items may not be used until after any required in- Items may not be used until after any required in- spection has been successfully accomplished. spection has been successfully accomplished

35、. COMPARISON NQA-1 contains additional requirements for the qualification of inspection personnel. NQA-1 con- tains more specific requirements for records. CONCLUSION A quality program that meets the requirements of NQA-1 will meet the requirements of IS0 9001. Con- versely, a quality program that m

36、eets the require- ments of IS0 9001 may not meet the requirements of NQA-1. Basic Requirement 11 Supplement 11s-I and 11s-2 Test Control 4.10 Inspection and Testing Requires that tests performed to verify conform- Requires that tests performed to verify conform- ance of items to specified criteria b

37、e controlled. ance of items to specified criteria be controlled. Items may not be used until after any required test Items may not be used until after any required test has been successfully accomplished. has been successfully accomplished. -. COMPARISON NQA-1 contains additional requirements for th

38、e evaluation of test results by personnal that have spe- cific authority. NQA-1 contains more specific re- quirements for records. 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 o

39、f IS0 9001 may not meet the requirements of NQA-1. 6 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 12 4.11 Inspection, Measuring and Test Equipment Supplement 12s-1 Control of Measuring and Test Equipment Requires that measuring and test equipment be Requires that measuring and test equipm

40、ent be controlled and calibrated. identified, controlled, and calibrated. Also, the mea- surements to be taken must be identified and docu- mented. COMPARISON IS0 9001 contains a more comprehensive and de- tailed definition of the requirements for the control of inspection, measuring and test equipm

41、ent. It also includes specific provisions for checking the capabil- ity of test hardware (such as jigs, fixtures, templates, patterns) and test software. While the intent of NQA-1 is the same, it does not contain similar ex- plicit requirements. CONCLUSION A quality program that meets the requiremen

42、ts of IS0 9001 will meet the requirements of NQA-1 (Basic Requirement 12 and Supplement 12s-1). Con- versely, a quality program that meets the require- ments of NQA-1 may not meet the requirements of IS0 9001. Basic Requirement 13 Supplement 13s-1 Handling, Storage, and Shipping 4.15 Handling, Stora

43、ge, Packaging and Delivery Requires that product be controlled to prevent Requires that product be controlled to prevent damage, loss, or deterioration. damage, loss, or deterioration. Also, requires specific assessment of the effectiveness of the control pro- cedures used. COMPARISON IS0 9001 requi

44、rements are more programmatic in nature, NQA-1 requirements more specific. IS0 9001 includes a requirement for detecting deterio- ration of product(s) through periodic assessment of the condition of products in storage. CONCLUSION A program meeting NQA-1 may not completely meet the requirements of I

45、S0 9001. Similarly, a pro- gram meeting IS0 9001 may not completely meet the requirements of NQA-1. 7 COMPARISON OF ASME NQA-1 AND IS0 9001 Basic Requirement 14 Inspection, Test, and Operating Status 4.12 Inspection and Test Status Requires that items be identified as to their con- Requires that ite

46、ms be identified as to their con- formance to specified requirements to prevent the formance to specified requirements to prevent the use of nonconforming items. Also, the authority to use of nonconforming items. Also, the authority to identify the status of the items must be documented. identify th

47、e status of the items must be documented. 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. One exception is that IS0 9001 specifi- cally addresses test software whi

48、le NQA-1 does not provide specific requirements. Basic Requirement 15 Supplement 15s-1 Control of Nonconforming Items and Supplement 7s-1, Section 9 Control of Supplier Nonconformances 4.13 Control of Nonconforming Product Requires that nonconforming items be identified Requires that nonconforming i

49、tems be identified and controlled until final disposition. and controlled until final disposition. COMPARISON NQA-1 and IS0 9001 have equivalent require- ments. However, NQA-1, Supplement 15s-1 contains more detailed requirements concerning identifica- tion, segregation, and dispositioning of nonconform- ing items. 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 requ