IECQ-QC-001002-3-2005.pdf
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1、 INTERNATIONAL ELECTROTECHNICAL COMMISSION QC 001002-3 Fourth edition 2005-06 IEC Quality Assessment System for Electronic Components (IECQ) Rules of Procedure Part 3: Approval procedures Reference number QC 001002-3:2005(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION QC 001002-3 Fourth edition 2005-0
2、6 IEC Quality Assessment System for Electronic Components (IECQ) Rules of Procedure Part 3: Approval procedures IEC 2005 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfi
3、lm, without permission in writing from the publisher. International Electrotechnical Commission, 3, rue de Varemb, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmailiec.ch Web: www.iec.ch Commission Electrotechnique Internationale Internat
4、ional Electrotechnical Commission -2- QC 001002-3 IEC: 2005 Contents FOREWORD 4 0. An introduction to the types of approval available under the IECQ. 5 0.1Introduction 5 0.2Approval of manufacturers and other organizations 5 0.3Approvals available to manufacturers 5 0.4Approvals available to special
5、ist contractors. 6 1. Approval and accreditation of a Supervising Inspectorate(SI) 9 1.1Description and general requirements. 9 1.2Statement of Surveillance Arrangements 10 1.3Application procedure 12 1.4Appointment of the Assessment Team 13 1.5Assessment procedure 13 1.6Reporting and decision 14 1.
6、7Changes in the Annex to the NSSA. 16 1.8Maintenance, suspension and withdrawal of accreditation of an SI 17 Annex A to clause 1 (normative) Flowchart. 19 2. Requirements for the approval of an organization 20 2.1Introduction 20 2.2Non-discriminatory access to the System 20 2.3Organization approval
7、of a manufacturer, distributor or specialist contractor 20 2.4Organization approval of an independent testing laboratory . 26 2.5Extension of organization approval 27 2.6 Maintenance of organization approval. 28 2.7Withdrawal or suspension of organization approval 29 2.8Reference to ISO 9001 and ISO
8、/IEC 17025 in the On-Line Certificate Database. 29 Annex A to clause 2 (normative) Requirements for Designated Management Representative (DMR)30 Annex B to clause 2 (normative) Subcontracting in the IECQ. 32 Annex C to clause 2 (normative) IECQ policy on uncertainty of measurement and inset limits 3
9、5 3. Qualification Approval of electronic components 38 3.0Introduction 38 3.1Procedure for Qualification Approval (QA). 38 3.2Release for delivery and validity of release . 44 3.3Inspection lots 48 3.4Specifications. 48 3.5Frequency of surveillance by the SI. 48 Annex A to clause 3 (normative) Flow
10、-chart for the application of Qualification Approval. 50 Annex B to clause 3 (normative) Qualification Approval Report 51 -,-,- QC 001002-3 IEC: 2005 -3- 4. Capability Approval of an electronic component manufacturing activity . 53 4.0Introduction 53 4.1Definitions 53 4.2Procedure for Capability App
11、roval (CA). 53 4.3Release for delivery. 61 4.4Specifications. 62 4.5Register of detail specifications . 63 4.6The On-Line Certificate Database . 63 4.7Rework and repair 64 4.8Frequency of surveillance by the SI. 64 Annex A to clause 4 (normative) Requirements for the form and content of a Capability
12、 Manual. 65 Annex B to clause 4 (informative) Further guidance concerning the content of A.7: Design rules 72 Annex C to clause 4 (informative) Example of a matrix showing capability limits and the CQCs used to prove them 73 Annex D to clause 4 (normative) Capability Approval Report 76 5. Approval o
13、f specialist contractors processes and/or products within the electronic components industry 78 5.0Introduction 78 5.1Definitions 78 5.2Procedure for Process Approval (PA) 81 5.3Provision of processes or technical services. 87 5.4Specifications. 88 5.5Register of Customer Detail Specifications 89 5.
14、6The On-Line Certificate Database . 89 5.7Rework and repair 90 5.8Frequency of surveillance by the SI. 90 Annex A to clause 5 (informative) Documents for use in association with clause 5 91 6. Technology Approval of electronic component manufacturers . 92 6.0Introduction 92 6.1Definitions 92 6.2Gene
15、ral procedures. 93 6.3Management responsibility 93 6.4TA requirements 94 6.5Verification. 96 6.6Product documentation 97 6.7Procedure for TA 98 6.8Frequency of Surveillance by the SI 102 Annex A to clause 6 (informative) Application for Technology Approval 103 Annex B to clause 6 (informative) IECQ
16、Audit Statement of Readiness Company Declaration. 104 Annex C to clause 6 (normative) Form and content of a Technology Approval Declaration Document (TADD) 105 -,-,- -4- QC 001002-3 IEC: 2005 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ IEC Quality Assessment System for Electronic Components (IECQ) R
17、ules of Procedure Part 3: Approval procedures FOREWORD This publication has been prepared by the Management Committee (MC) of the IECQ. Clause 0 is unchanged from the previous edition. Clause 1 comprises the former Amendment 1 2002 to QC 001002-3 1998, without change. Clause 2 comprises the former A
18、mendment 2 2004 to QC 001002-3 1998, without change. Clauses 3, 4, 5 and 6 cancel and replace the corresponding clauses of QC 001002-3 Third edition 1998. They contain editorial up-dating and include requirements from the former ECQAC Permanent Documents. The text of this publication is based on the
19、 following documents: DocumentReport on voting IECQ-CECC MC/53/CD IECQ-CECC MC/54/CD IECQ-CECC MC/55/CD IECQ-CECC MC/56/CD IECQ-CECC MC/69/RM, as corrected by IECQ MC/69A/RM, item 7.2.1 Full information on the voting for the approval of this publication can be found in the report on voting indicated
20、 in the above table. _ -,-,- QC 001002-3 IEC: 2005 -5- IEC Quality Assessment System for Electronic Components (IECQ) Rules of Procedure Part 3: Approval procedures 0. An introduction to the types of approval available under the IECQ 0.1 Introduction This clause describes briefly the types of approv
21、al available under the IECQ as detailed in the requirements given in clause 2 and the following clauses. These approvals are summarized below with further information given in Figure 1 and Table 1. 0.2 Approval of manufacturers and other organizations This level of approval is a prerequisite to seek
22、ing any other type of approval listed in clause 2 and the following clauses and is applicable to manufacturers, distributors, independent testing laboratories and specialist contractors wishing to become approved under the IECQ. The requirements of this type of approval are described in clause 2, Re
23、quirements for the approval of an organization. It should be noted that, when carrying out the appraisal, the Supervising Inspectorate (SI) is required to take into account any relevant certificate to ISO 9001 and ISO/IEC 17025 issued by an organization declared competent to do so by the appropriate
24、 national authority. 0.3 Approvals available to manufacturers 0.3.1 Choice A manufacturer has the approvals detailed in 0.3.2 to 0.3.4 available to him. A particular manufacturer s choice of approval will depend on existence of current approvals, product range, available applicable specifications, a
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