IECQ OD 3802-2015 IEC Quality Assessment System for Electronic Components (IECQ System) - Quality system requirements for manufacturers seeking IECQ LED Compone.pdf

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1、 IEC Quality Assessment System for Electronic Components (IECQ System) IECQ OD 3802 Edition 1.0 2015-07 IECQ OPERATIONAL DOCUMENT Quality system requirements for manufacturers seeking IECQ LED Component Product Certificates of Conformity for Component Product(s) associated with LED lighting IECQ OD

2、3802:2015-07(en) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2015 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, wit

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11、D 3802 Edition 1.0 2015-07 IECQ OPERATIONAL DOCUMENT Quality system requirements for manufacturers seeking IECQ LED Component Product Certificates of Conformity for Component Product(s) associated with LED lighting INTERNATIONAL ELECTROTECHNICAL COMMISSION IEC Quality Assessment System for Electroni

12、c Components (IECQ System) 2 IECQ OD 3802:2015 IEC 2015 CONTENTS FOREWORD . 3 INTRODUCTION . 4 1 Scope 5 1.1 General . 5 1.2 Permissible exclusions 5 2 Normative references 5 3 Terms and definitions 5 4 Quality management system requirements 6 4.1 General requirements . 6 Annex A (normative) Quality

13、 planning requirements for manufacturers of component parts for use or related to LED lighting 13 A.1 General . 13 A.2 Application 13 A.3 Requirements for the content of manufacturers product quality plans (process manual) 13 A.4 Ensuring conformity 14 A.4.1 General . 14 A.4.2 Documented procedures

14、14 A.5 Specifications . 14 Annex B (informative) Guidance for manufacturers . 15 B.1 Guidance for procedure in the event of failure in a periodic test 15 B.2 Changes (modifications) . 16 B.3 Outsourcing of critical processes 16 B.4 Release for delivery and validity of release . 18 B.4.1 General . 18

15、 B.4.2 Validity of release 18 B.5 Quality conformance inspection 18 B.5.1 General . 18 B.5.2 Lot-by-lot tests. 18 B.5.3 Periodic tests . 18 B.5.4 Destructive tests 19 B.5.5 Use of in-process testing . 19 B.5.6 Test severity 19 B.5.7 Alternative test methods 19 B.5.8 Measurement uncertainty 19 B.5.9

16、Non-conforming components in lot-by-lot tests 19 B.5.10 Non-conformances in periodic tests . 19 B.5.11 Release or rejection of lots 19 B.5.12 Identification of released lots . 19 B.6 Customer returns and appropriate corrective action 20 B.7 Inspection lots 20 B.7.1 Formation of inspection lots . 20

17、Bibliography 21 IECQ OD 3802:2015 IEC 2015 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ IECQ Operational Document 3802 Quality system requirements for manufacturers seeking IECQ LED Component Product Certificates of Conformity for Component Product(s) associated with LED lighting FOREWORD This Oper

18、ational Document, OD 3802 sets out the quality system requirements for manufacturers seeking IECQ LED Component Product Certificates of Conformity (CoC), for Component Product(s) associated with LED lighting in accordance with the Rules and Procedures, IECQ 03-8. This publication has been prepared b

19、y the Management Committee (MC) of the IECQ. Document History Date Summary 2015-03-28 Working Group Final Draft issued as MC/325/CD 2015-05-09 Updated Draft Following 1 May 2015 Singapore MC meeting issued as MC/325A/CA Address: IECQ Secretariat c/o IEC Sydney Office The Executive Centre Australia S

20、quare, Level 33 264 George Street Sydney NSW 2000 Australia Contact details: Tel: +61 2 4628 4690 Fx: +61 2 4627 5285 infoiecq.org www.iecq.org 4 IECQ OD 3802:2015 IEC 2015 INTRODUCTION This operational document, OD 3802 sets out the IECQ System requirements for manufacturers quality system, relatin

21、g to the production of Component Product for use in or in association with LED lighting. This document shall be read in conjunction with ISO 9001:2008. The purpose of this document is to embrace the “good manufacturing practices”. The requirements contained in this document are in addition to the ba

22、sic quality management system requirements of ISO 9001:2008. To assist in both the implementation of these requirements, they have been set out using the same structure and clause numbering of ISO 9001:2008 in order that manufacturers can simply add these requirements to their existing ISO 9001 qual

23、ity management system. IECQ OD 3802:2015 IEC 2015 5 Quality system requirements for manufacturers seeking IECQ LED Component Product Certificates of Conformity for Component Product(s) associated with LED lighting 1 Scope 1.1 General This document specifies particular requirements and guidance on th

24、e establishment and maintenance of a quality system to meet the requirements of the IECQ Scheme for LED Lighting. While based on the objectives of ISO 9001, it does not preclude the use of other quality systems that are compatible with the objectives of ISO 9001:2008, subject to the acceptance of th

25、e IECQ CB to which an application for IECQ LED Lighting Certification is made. Therefore, when IECQ CBs assess the quality systems of manufacturers, this document shall be the basis of the initial assessment and subsequent surveillance visits. The intention of this document is that quality managemen

26、t system requirements of the IECQ Scheme for LED Lighting are to be congruent with the elements of ISO 9001:2008. 1.2 Permissible exclusions Permissible exclusions relating to Clause 7 of ISO 9001, as provided in ISO 9001, are not accepted within the IECQ Scheme for LED Lighting. 2 Normative referen

27、ces The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9001, Quality management systems Requirem

28、ents IECQ 03-8, Rules of Procedure Part 8: IECQ Scheme for LED Lighting IECQ 03-1, Rules of Procedure Part 1: General requirements for all IECQ Schemes 3 Terms and definitions The definitions of IECQ 03-8, IECQ 01 and ISO 9001 apply, as do the following definitions: 3.1 contract requirements forming

29、 an agreement between a manufacturer and a customer and transmitted by any appropriate means 3.2 customer complaint any reported written or verbal allegation made by a customer which concerns the identity, quality, durability, safety, security, conformity or performance of Component Products covered

30、 by an IECQ LED Lighting Certificate. 3.3 schedule drawing drawing listed in the IECQ CBs internal files 6 IECQ OD 3802:2015 IEC 2015 3.4 Component Product(s) an electronic device or module, range of electronic devices or modules, related materials, assemblies that are the subject of IECQ LED Lighti

31、ng Certification. Component Product also includes items and devices that are not electronic but are used in conjunction with electronic devices to ensure their functionality, e.g. spacers, housings, mounting devices, sealing components, etc. 3.5 related drawing drawing not listed in the IECQ Test Re

32、port, but used, for example for detailed manufacture of component parts 3.6 technical documentation documentation that enables the conformity of the product with the requirements of the standard(s) to be assessed. It shall, to the extent necessary for such assessment, cover the design, manufacture a

33、nd operation of the product and shall to that extent contain: a general type-description; design and manufacturing drawings and layouts of components, sub-assemblies, circuits diagrams, etc.; descriptions and explanations necessary for the understanding of said drawings and layouts and the operation

34、 of the product; a list of the standards and specifications referred to in the IECQ Test Report, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the standards; thermal and electrical ratings; optical ratings; results of design calculations made, exam

35、inations carried out, etc.; test reports. 3.7 manufacturers documents those documents required by a manufacturer when making an application for an IECQ Certificate (IECQ LED Component Product Certificate). For example, instructions, related drawings, data sheets and sales literature 4 Quality manage

36、ment system requirements 4.1 General requirements This document specifies particular requirements and guidance on the establishment and maintenance of a quality system to meet the requirements of the IECQ System. It does not preclude the use of other quality systems that are compatible with the obje

37、ctives of ISO 9001, subject to the acceptance of an IECQ CB. Therefore, IECQ CB assesses the quality systems of organizations with respect to this document. This document shall be the basis of the initial assessment and subsequent surveillance visits. ISO 9001:2008, Clause 4.2.3 Control of documents

38、 In addition to the requirements of ISO 9001:2008 documented procedures shall also define the controls of the following: IECQ OD 3802:2015 IEC 2015 7 a) Manufacturers documents shall be controlled b) Documented procedures shall ensure that information contained within manufacturers documents is comp

39、atible with equipment documents. The manufacturer shall not initially approve or subsequently amend related drawings and specifications unless they are in compliance with the schedule drawings and specifications without the approval of the IECQ CB c) The quality system shall ensure that no factor (t

40、ype, characteristic, position etc.) defined covered by IECQ and technical documentation (e.g. schedule drawings) is modified d) There shall be a documented system that refers all related drawings to the relevant schedule drawings e) Where there are common schedule drawings associated with more than

41、one component part there shall be a documented system to ensure simultaneous supplementary action in the event of an amendment to such drawings NOTE Some manufacturers use common components with common drawing numbers on more than one product. Some of these products may have different persons respon

42、sible for them. Therefore, if one product with a common component and drawing number is revised to meet a need and the necessary supplementary certificate obtained, there needs to be a system for ensuring that any other certificates that call up such components are also subject to supplementary cert

43、ification in order to avoid those products not being in compliance with their equipment documents. f) The manufacturer shall document which IECQ CB is responsible for each IECQ Certified Component Product g) Where equipment documents or manufacturers documents are passed to a third party, they shall

44、 be provided in a way that is not misleading ISO 9001:2008, Clause 4.2.4 Control of records The requirements of ISO 9001:2008 apply along with the following: The manufacturer shall retain adequate quality records to demonstrate conformity of the component product. As a minimum, the list of documents

45、 requiring control and retention, as far as applicable, shall be: inspection and test data (per batch); calibration data; supplier evaluation. ISO 9001:2008, Clause 5 Management responsibility ISO 9001:2008, Clause 5.1 Management commitment The requirements of ISO 9001:2008 apply. ISO 9001:2008, Cla

46、use 5.2 Customer focus The requirements of ISO 9001:2008 apply. ISO 9001:2008, Clause 5.3 Quality policy The requirements of ISO 9001:2008 apply. ISO 9001:2008, Clause 5.4 Planning ISO 9001:2008, Clause 5.4.1 Quality objectives The requirements of ISO 9001:2008 apply. 8 IECQ OD 3802:2015 IEC 2015 IS

47、O 9001:2008, Clause 5.4.2 Quality management system planning The requirements of ISO 9001:2008 apply along with the following: All the elements, requirements and provisions adopted by the manufacturer in order to ensure compliance of the component product with the specifications as listed on the IEC

48、Q Certificate and technical documentation shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of quality programs, plans, manuals and records. ISO 9001:2008, Cla

49、use 5.5 Responsibility, authority and communication ISO 9001:2008, Clause 5.5.1 Responsibility and authority The requirements of ISO 9001:2008 apply along with the following: Responsibilities and authority for the following shall be defined: the effective coordination of activities with respect to the design, manufacture and release of component parts covered by IECQ Certification intended for use in LED lighting systems; the authorization of initial approval and changes to related drawings