IECQ OPERATIONAL DOCUMENT

Transcription

1 IECQ OD 3405 Edition IECQ OPERATIONAL DOCUMENT IEC Quality Assessment System for Electronic Components (IECQ System) Procedures for the issuing of IECQ Certificates of Conformity for Aerospace, Defence, and High Performance electronics Control Plans IECQ OD 3405: (en)

2 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2017 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, without permission in writing from either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office Tel.: , rue de Varembé Fax: CH-1211 Geneva 20 Switzerland About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards, Technical Specifications, Technical Reports and other documents. Available for PC, Mac OS, Android Tablets and ipad. IEC publications search - The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee, ). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also once a month by . Electropedia - The world's leading online dictionary of electronic and electrical terms containing terms and definitions in English and French, with equivalent terms in 16 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/glossary electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch.

3 IECQ OD 3405 Edition IECQ OPERATIONAL DOCUMENT IEC Quality Assessment System for Electronic Components (IECQ System) Procedures for the issuing of IECQ Certificates of Conformity for Aerospace, Defence, and High Performance electronics Control Plans INTERNATIONAL ELECTROTECHNICAL COMMISSION

4 2 IECQ OD 3405:2017 IEC 2017 CONTENTS FOREWORD... 3 INTRODUCTION Scope and application... 5 SECTION 1 PROCEDURES FOR THE ISSUING OF AN IECQ ADHP CERTIFICATE OF CONFORMITY... 6 SECTION 2 SURVEILLANCE AUDITS PROCEDURES FOR MAINTAINING VALIDITY OF AN IECQ ADHP CERTIFICATE OF CONFORMITY SECTION 3 PROCEDURES FOR THE PROCESSING OF CHANGES TO ISSUED IECQ ADHP CERTIFICATES OF CONFORMITY Bibliography Figure 1 IECQ ADHP Certificate of Conformity application process... 7 Figure 2 Process for maintaining an IECQ ADHP Certificate of Conformity Figure 3 Summary of process for dealing with IECQ ADHP Certificate of Conformity changes... 21

5 IECQ OD 3405:2017 IEC INTERNATIONAL ELECTROTECHNICAL COMMISSION IECQ Operational Document 3405 Procedures for the issuing of IECQ Certificates of Conformity for Aerospace, Defence, and High Performance electronics Control Plans FOREWORD This Operational Document OD 3405 sets out the procedures for the processing of applications for IECQ ADHP Certificates of Conformity, for ADHP Control Plan(s) in accordance with the Rules and Procedures IECQ Document History Date Summary Initial edition Address: IECQ Secretariat c/o IEC Sydney Office The Executive Centre Australia Square, Level George Street Sydney NSW 2000 Australia Contact details: Tel: Fx: info@iecq.org

6 4 IECQ OD 3405:2017 IEC 2017 INTRODUCTION This document is supplementary to the operational manuals and procedures operated by IECQ Certification Bodies (IECQ CBs) for the purpose of ensuring a thorough and consistent assessment of applications for IECQ Certificates of Conformity of the following Aerospace, Defence, and High Performance (ADHP) electronics Control Plans: Electronic Component Management Plan (ECMP) Counterfeit Parts Control Plan (CPCP) Lead-free Control Plan (LFCP) Obsolescence Management Plan (OMP) COTS Assembly Management Plan (CAMP) This IECQ Operational Document comprises 3 sections: Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity Section 2 Surveillance audits Procedures for maintaining validity of an IECQ ADHP Certificate of Conformity Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity The procedures are set out in table form identifying: step number showing the link between flowcharts and table description of the activity related documents responsible person or party additional comments and remarks where appropriate This Operational Document also captures previous decisions of the IECQ Management Committee concerning the expansion of the IECQ ECMP Scheme to include plans other than ECMP now known as the IECQ ADHP Scheme. The preparation of this document has been done with the aim of alignment with various ISO/IEC International Standards and Guides.

7 IECQ OD 3405:2017 IEC Procedures for the issuing of IECQ Certificates of Conformity for Aerospace, Defence and High Performance electronics Control Plans 1 Scope and application IECQ ADHP Certificate of Conformity (CoC) A Certificate of Conformity may be issued when a given plan has been assessed and found to be compliant to the applicable industry standard(s), and that the plan owner s procedures and processes have been assessed and found to be implemented and comply as detailed in that plan(s), as described in Section 1. It is essential for this type of certification that the plan owner is confident that its plan(s) is (are) compliant with the applicable industry standard(s), and if applicable that its customer has reviewed and accepted its plan(s), before engaging with an IECQ CB. This certification type Certificate of Conformity covers: the compliance evaluation of the plan(s) to the applicable industry standard(s) 1 the compliance evaluation that the plan owner has documented procedures and processes implemented per the plan(s) (usually referred to as first level documentation) the compliance evaluation of the procedures and processes per the plan(s) technical appropriateness the compliance evaluation of the plan owner organization resources are technically competent to use the implemented procedures and processes per the plan(s) the compliance evaluation of the implementation and use of the documented procedures and processes within the organization per the plan(s) the on-going compliance surveillance of the plan owners plan(s) and the implementation, technical appropriateness, technical competency and use of the documented procedures and processes per the plan(s) and to the applicable industry standard(s) An IECQ ADHP Compliance Certification may include all relevant plan(s) and referenced industry standard(s) as applicable on the one Certificate of Conformity (Master Site Certificate). Alternatively, separate IECQ ADHP Certificates of Conformity may be issued per plan. An IECQ ADHP Compliance Certification shall only cover one legal entity: the issued Certificate of Conformity (Master Site Certificate) shall clearly detail the one legal entity and one physical address separate Additional Site Certificates of Conformity associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations of a multi-site application 1 For the industry standards relevant to the listed plan types, see Bibliography.

8 6 IECQ OD 3405:2017 IEC 2017 SECTION 1 PROCEDURES FOR THE ISSUING OF AN IECQ ADHP CERTIFICATE OF CONFORMITY This section is to be applied by IECQ CBs when processing new applications for an IECQ ADHP Certificate of Conformity to any or any combination of the industry standards listed in Bibliography. These steps are in line with the requirements of ISO/IEC as relevant. Figure 1 describes the Certification Body process for the initial and on-going realization of an IECQ ADHP Certificate of Conformity.

9 IECQ OD 3405:2017 IEC Figure 1 IECQ ADHP Certificate of Conformity application process

10 Figure 1 Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) 1 Application received in accordance with IECQ 03-4 and the IECQ CB s internal procedures 2 Contract review to be conducted by the IECQ CB receiving the application, in accordance with the IECQ CB's own quality system and as required by ISO/IEC Contract review shall include: a review to ensure that the application is within the scope of acceptance of the IECQ CB whether the applicant has an established quality management system, evidence of the registration of a documented quality management system shall be obtained and reviewed. Does the scope still cover business being conducted etc. whether a surcharge applies for applicants from non-member countries (refer to OD 011, IECQ Scheme fees) estimation of costs and time to complete project development and agreement of the audit programme, including multi-site as applicable determination of company location(s) determination of any special requirements, for example travel for site audit etc. agreement on method and system of payment by applicant, in accordance with IECQ CB s own policy and quality system details of plan(s) advised and within scope of CB capabilities and resources 3 IECQ CB shall proceed only after the contract review has been successfully completed 3a Where unsuccessful, IECQ CB shall communicate in writing to the applicant with the applicant is permitted to amend their application or select another IECQ CB, when the IECQ CB s scope of IECQ acceptance does not cover the application 4 The IECQ CB shall conduct an assessment of the plan and establish its compliance with the stated standards/specifications. This shall be done by a fully qualified IECQ ADHP TE (SME) 5 IECQ CB shall proceed only after the plan(s) review has been successfully completed IECQ 03-4 IECQ CB procedures IECQ CB s own certification procedures as included in their quality system as required by ISO/IEC IECQ 03-4 and any relevant IECQ technical notices Standards and specifications as stated in the plan(s) IECQ CB IECQ CB and applicant IECQ CB IECQ CB IECQ CB LA/TE or IECQ CB LA & TE IECQ CB IECQ 03-4 covers the 3 rd party assessment of conformity of ADHP Plans The results of the contract review shall be documented and the applicant advised 8 IECQ OD 3405:2017 IEC 2017

11 Figure 1 5a Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) Where unsuccessful, IECQ CB shall communicate in writing to the applicant with the applicant is permitted to amend their plan(s) to fulfil the requirements of the stated standards/specifications IECQ CB 6 IECQ CB to record the plan(s) revision control and retain on file IECQ CB 7 Preparation for the plan conformity assessment on-site audit The relevant established audit checklists for the referenced standards shall be utilized IECQ OD 3401 IECQ 03-4 using relevant checklists in accordance with OD 3402 and applicable IECQ technical notices IECQ CB LA/TE Where the applicant already maintains an IECQ ADHP CoC to one of more of the relevant referenced standards or their equivalent, the CB may utilize the audit report as evidence of compliance together with an assessment of any differences. For example, a conformity assessment to IEC TS may be utilized to demonstrate compliance with the equivalent clauses of SAE EIASTD4899 ensuring that any differences or extra requirements are assessed IECQ OD 3405:2017 IEC Stage 1 Independent review by IECQ CB staff to establish the applicants written procedures and processes comply with the plan(s) IECQ CB LA/TE

12 Figure 1 Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) 9 Documentation assessment: Assessment of the applicant s quality management system procedures that relate to the plan(s) to be covered by the IECQ ADHP CoC 9a Generally this will relate to determining that the applicant has documented processed and practices implemented per the plan(s) Where serious deficiencies in the applicant s implemented documented processes and procedures, these shall be raised by the IECQ CB as major non-conformances and the applicant required to take action to correct this situation (usually by the introduction or amendment of processes/practises), prior to proceeding with the certification process Where the documentation assessment is satisfactory and/or only minor noncompliance with various plan(s) requirements are raised by the IECQ CB, the process of on-site auditing may continue Where major issues are raised that require a major revision of the documented procedures and practices or plan(s), then the on-site audit should await the finalization of the documentation revision Where major issues were found during 12 the applicant is to revise their documentation and re-submit to the IECQ CB for further review 10 Stage 2 Preparation for the plan(s) implementation on-site audit 11 The IECQ CB conducts on-site audit of all sites This on-site audit shall seek to verify that relevant procedures and work instructions are in place and that there are records and evidence to demonstrate that the requirements of the plan(s) and IECQ 03-4 are being met by the applicant Applicant s plan(s) IECQ 03-4 IECQ OD 3405 Applicant s plan(s) and IECQ 03-4 using relevant checklists in accordance with OD 3402 IECQ CB to which the application was made IECQ CB LA/TE or IECQ CB LA & TE The IECQ CB may use contract audit staff and TE s but shall at all times remain the IECQ CB responsible for the planning and conduct of the audit Where the plan(s) are used in multi sites, especially different countries each location shall be audited, prior to the issuing of the IECQ ADHP CoC 10 IECQ OD 3405:2017 IEC 2017

13 Figure 1 11a Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) Where the on-site audit of the applicant s location reveals non-conformances the IECQ CB shall determine whether such minor non-conformances pose a risk to noncomplying product being released to the market. If there is any risk that this may be the case, then the non-conformances shall be treated as major non-conformances and certification shall not proceed until the issue is rectified and the nonconformances closed Where non-conformances of a minor nature, i.e. that do not impact on the compliance of the component product, with the specification(s), certification may proceed on the basis that the non- conformances will be addressed with the view to being closed at the next surveillance audit at the latest However corrective action response shall be provided to the IECQ CB in timely manner, normally within 1 month The raising of any non-conformance may give rise to the need for the IECQ CB to review some of the quality system documentation of the manufacturer 12 A report of the assessment/audit of the applicant s documented systems and implementation of, including site audit, shall be compiled by the IECQ CB 13 An independent review of the report shall be conducted within the IECQ CB to whom the original application was made The independent review shall be conducted by a staff member of the IECQ CB that is not responsible for the audit In accordance with the IECQ CB s own quality management system Applicant IECQ CB conducting the audit/assessment IECQ CB to whom the original application for an IECQ ADHP CoC was made Generally this will be the IECQ CB to whom the application has been made, but may be compiled by another IECQ CB requested to conduct the audit by the original IECQ CB This independent review is to ensure that a complete assessment and audit has taken place and that the recommendations are in line with the audit findings and any NCRs and related corrective actions Further guidance is found in ISO/IEC IECQ OD 3405:2017 IEC

14 Figure 1 Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) 14 The IECQ CB to which the application for an IECQ ADHP CoC has been made shall determine that the audit report is complete and complies with the following: IECQ Rules and Procedures IECQ CB s own quality management system all NCRs provide a clear description of their nature clear detailed report including full list of: plan(s) and their control documented procedures relating to the plan(s) and their control an IECQ ADHP Compliance Certification may include all relevant plan(s) and referenced industry standard(s) as applicable on the one CoC (Master Site Certificate). Alternatively, separate IECQ ADHP CoCs may be issued per plan an IECQ ADHP Compliance Certification shall only cover one legal entity: the issued CoC (Master Site Certificate) shall clearly detail the one legal entity and one physical address separate Additional Site CoCs associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations of a multi-site application The applicant and or IECQ Secretary may need to be informed where errors or discrepancies are of a major nature, for example incorrect audit personnel conducting the audit or insufficient audit depth revealed 15 The final report shall be issued by the IECQ CB to whom the original application was made, to the applicant and a copy retained on the IECQ CB file At least the following details shall be communicated by the IECQ CB issuing the audit report to the manufacturer: unique audit report reference number or identifier name and address of manufacturer(s) covered by site audit(s) and scope of the audit date of audit completion any test report references covered during the audit findings of the audit, for example No. of major or minor non-conformances and IECQ CB s recommendation whether or not certification is being recommended IECQ 03-4 IECQ OD 3401 IECQ CB s own quality management system IECQ audit report template Final decision being taken by the IECQ CB to which the original application has been made IECQ CB to whom the original application was made IECQ CB that issues the audit report The review should also ensure that the principles and guidelines of ISO/IEC are followed 12 IECQ OD 3405:2017 IEC 2017

15 Figure 1 Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) 16 The IECQ CB to whom the application for an IECQ ADHP CoC was made shall conduct a certification review, in accordance with their quality management system, ensuring among others that: related test reports and audit reports relate to the same product(s) any major non-conformances have been successfully closed all stages of the certification process have been documented and followed, including those contained in this manual the IECQ CB have a signed commitment by the applicant to abide by the rules of the IECQ ADHP Scheme and IECQ CB s certification conditions, for example agreement to have the IECQ CB undertake or arrange for surveillance audits the applicant is aware of his/her obligations under the Scheme, including ensuring that any promotional material does not contain misleading information that may infer products NOT covered by IECQ ADHP certification Where the certification process has not been completed within a 12-month period, a new application shall be submitted IECQ 03-4 IECQ CB s own quality management system The person authorized to conduct such review within the IECQ CB to whom the original application was made IECQ OD 3405:2017 IEC a Where the review undertaken in step 16 is not successful, the IECQ CB management shall refer the matter to the IECQ CB staff responsible for the testing of products and assessment of the quality system or applicant personnel as appropriate Management of the IECQ CB to whom the original application was made 18 A draft IECQ ADHP CoC shall be compiled using the IECQ online certificate system via the level 1 password access An IECQ ADHP Compliance Certification may include all relevant plan(s) and referenced industry standard(s) as applicable on the one CoC (Master Site Certificate). Alternatively, separate IECQ ADHP CoCs may be issued per plan Refer to IECQ website IECQ OD 015 The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made An IECQ ADHP Compliance Certification shall only cover one legal entity: the issued CoC (Master Site Certificate) shall clearly detail the one legal entity and one physical address separate Additional Site CoCs associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations of a multi-site application NOTE It is highly recommended that a separate Certificate be issued under the IECQ Counterfeit Avoidance Programme so as to mitigate legal liability

16 Figure 1 Section 1 Procedures for the issuing of an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 1) 19+19a A draft of the IECQ ADHP CoC is to be reviewed for errors. It may be beneficial to pass a draft copy to the applicant for them to assist in the final review prior to issuing the CoC Every attempt shall be made to correct errors prior to issuing the CoC 20 CoC is issued via the IECQ online certificate system under the level 2 password access, with the applicant being informed in writing by the IECQ CB, via letter, fax or 21 Certification maintenance begins, refer to Section 2 of this document The IECQ CB issuing the IECQ ADHP CoC is responsible for the on-going maintenance of the CoC which shall include: conducting or arranging for surveillance assessments/audits and on-going product compliance responding to public inquiries regarding the CoC taking necessary action when aware of possible breaches by the applicant, for example claims that product not the subject of IECQ ADHP CoC are being claimed as IECQ certified Original application form submitted by the applicant IECQ 01 IECQ 03-4 IECQ CB s own quality management system Product specifications The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made Management of the IECQ CB that issued the IECQ CoC 14 IECQ OD 3405:2017 IEC 2017

17 IECQ OD 3405:2017 IEC SECTION 2 SURVEILLANCE AUDITS PROCEDURES FOR MAINTAINING VALIDITY OF AN IECQ ADHP CERTIFICATE OF CONFORMITY This section is to be applied by IECQ CBs to ensure that IECQ ADHP Certificates of Conformity issued under the IECQ ADHP Scheme remain valid through surveillance audits according to IECQ These steps are in line with the requirements of ISO/IEC 17021, in addition to the requirements as laid down in the IECQ Scheme rules IECQ Once an IECQ CB has issued an IECQ ADHP Certificate of Conformity, they are responsible to ensure that surveillance assessment visits to the manufacturing location(s) are conducted in accordance with IECQ While this section provides guidance to IECQ CBs when arranging for surveillance audits of OEMs, there may be times where possible non-compliance with the plan(s) and/or processes covered by an IECQ ADHP Certificate are suspected. IECQ CBs have the responsibility to act when this is likelihood or where IECQ ADHP Certificates of Conformity, issued by them, are being misused or misrepresented. Such action may include conducting unscheduled visits of the OEMs, or noting such instances on the IECQ CBs files for raising at the next surveillance audit. At any time during the maintenance of an IECQ ADHP Certification, the IECQ Secretariat and Executive available to provide assistance with the understanding of the process and expectation of outcomes of such surveillance activity. Figure 2 describes the certification body process for the surveillance of an IECQ ADHP Certificate of Conformity.

18 16 IECQ OD 3405:2017 IEC 2017 Figure 2 Process for maintaining an IECQ ADHP Certificate of Conformity

19 Figure 2 Section 2 Surveillance audits Procedures for maintaining an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 2) 1 IECQ ADHP CoC verified as valid by the IECQ CB that issued the IECQ ADHP CoC and confirms details on IECQ online certificate system website are current and correct, for example location(s), plan(s) covered etc. Refer to Section 3 regarding processes for dealing with changes in IECQ ADHP Certification 2 IECQ CB that issued the IECQ ADHP Certification shall arrange to conduct the surveillance audit Where the IECQ CB that issued the IECQ ADHP Certification is no longer capable they shall assist the client to transfer to another IECQ CB in accordance with IECQ 03-1, Clause Wherein owing to the technical nature of the IECQ ADHP Certification the incoming IECQ CB shall treat the application as an initial application in accordance with Section 1 of this publication, incl. but not limited to: plan(s) review if required stage 1 document review all sites to be assessed IECQ 03-4 IECQ CB s own quality system IECQ CB that issued the IECQ ADHP CoC Surveillance audits are to be scheduled on a minimum of 12 month basis IECQ OD 3405:2017 IEC Review of the revision control of the plan(s) covered by the IECQ ADHP Certification; determine any changes that have taken place since the last audit This review of plan(s) may take place either prior to the site visit or as part of the on-site visit and audit of the manufacturer s premises Determine category of change: minor major IECQ CB conducting the audit In most cases it is more productive to conduct this document review at the clients premises as part of the on-site audit 4 Have the plan(s) changed revision? IECQ CB 5 Where the review in step 5 reveals changes to the plan(s) IECQ CB shall process these changes in accordance with Section 3 regarding processes for dealing with changes in IECQ ADHP Certification IECQ OD 3405 Section 3 IECQ CB ISO provides guidance on the effective auditing of management systems 6 The IECQ CB conducts on-site and remote audits of sites as appropriate and agreed between the client and the CB and IECQ 03-4 These audits shall seek to verify that relevant procedures and work instructions are in place and that there are records and evidence to demonstrate that the requirements of the plan(s) and IECQ 03-4 are being met by the client IECQ 03-4 and client s plan(s) using relevant checklists IECQ CB conducting the audit

20 Figure 2 Section 2 Surveillance audits Procedures for maintaining an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 2) 7 A report of the assessment/audit of the applicant s documented systems and implementation of, including site audit, shall be compiled by the IECQ CB 8 An independent review of the report shall be conducted within the IECQ CB to whom the original application was made The independent review shall be conducted by a staff member of the IECQ CB that is not responsible for the audit 9+9a The IECQ CB shall determine that the audit report is complete and complies with the following: IECQ Rules and Procedures IECQ CB s own quality management system all NCRs provide a clear description of their nature The applicant and or IECQ Secretary may need to be informed where errors or discrepancies are of a major nature, for example incorrect audit personnel conducting the audit or insufficient audit depth revealed 10 The final report shall be issued by the IECQ CB to the client and a copy retained on the IECQ CB files At least the following details shall be communicated by the IECQ CB issuing the audit report to the manufacturer: unique audit report reference number or identifier name and address of manufacturer(s) covered by site audit(s) and scope date of audit completion any test report references covered during the audit findings of the audit, for example No. of major or minor non-conformances and IECQ CB s recommendation whether or not certification is being recommended IECQ 03-4 In accordance with the IECQ CB s own quality management system IECQ 03-4 IECQ OD 3401 IECQ CB s own quality management system IECQ audit report template IECQ CB that issued the IECQ CoC IECQ CB to whom the original application for an IECQ ADHP CoC was made Final decision being taken by the IECQ CB to which the original application has been made IECQ CB to whom the original application was made IECQ CB that issues the audit report This independent review is to ensure that a complete assessment and audit has taken place and that the recommendations are in line with the audit findings and any NCRs and related corrective actions Further guidance is found in ISO/IEC The review should also ensure that the principles and guidelines of ISO/IEC are followed 18 IECQ OD 3405:2017 IEC 2017

21 Figure 2 Section 2 Surveillance audits Procedures for maintaining an IECQ ADHP Certificate of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 2) 11,12+13 The IECQ CB shall review proposed corrective actions relating to Non-Conformance Reports (NCRs) in terms of: 13a+13b the time to implement such action is appropriate whether a follow up audit is necessary or can verification be handled at the next scheduled surveillance audit NOTE Where Major NCRs are raised consideration must be given to the likelihood of non-complying product being released to the market The IECQ CB will need to determine whether the IECQ ADHP CoC needs to be suspended or cancelled. Given the seriousness of the situation, prompt action by the IECQ CB is required. This includes notifying the applicant listed on the IECQ ADHP CoC in writing and the IECQ Secretariat requesting that the IECQ ADHP CoC be suspended or withdrawn 14 Where the IECQ CB is satisfied that a full and complete surveillance assessment/audit has been completed demonstrating compliance with continued implementation of the plan(s) and IECQ 03-4, the IECQ CB that issued the IECQ ADHP CoC shall confirm that the details of the IECQ ADHP CoC as recorded on the IECQ online certificate system website are accurate and up to date The IECQ CB shall then schedule the next surveillance audit visit, in accordance with IECQ 03-4 IECQ 03-4 IECQ 03-4 IECQ CB IECQ CB that issued the IECQ ADHP CoC IECQ CB that issued the IECQ ADHP CoC IECQ OD 3405:2017 IEC

22 20 IECQ OD 3405:2017 IEC 2017 SECTION 3 PROCEDURES FOR THE PROCESSING OF CHANGES TO ISSUED IECQ ADHP CERTIFICATES OF CONFORMITY This section is to be applied by IECQ CBs when processing applications for changes to IECQ ADHP Certification. These steps are in line with the requirements of ISO/IEC 17021, in addition to the requirements as laid down in the IECQ ADHP Scheme rules IECQ Figure 3 describes the certification body procedures for the processing of changes to an IECQ ADHP Certificate of Conformity.

23 IECQ OD 3405:2017 IEC Figure 3 Summary of process for dealing with IECQ ADHP Certificate of Conformity changes

24 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 1 Application received in accordance with IECQ 03-4 and the IECQ CB s internal procedures 2 Contract review to be conducted by the IECQ CB receiving the application, in accordance with the IECQ CB's own quality system and as required by ISO/IEC Contract review shall include: a review to ensure that the application is within the scope of acceptance of the IECQ CB whether the applicant has an established quality management system, evidence of the registration of a documented quality management system shall be obtained and reviewed. Does the scope still cover business being conducted etc. whether a surcharge applies for applicants from non-member countries (refer to OD 011, IECQ Scheme fees) estimation of costs and time to complete project agreement on method and system of payment by applicant, in accordance with IECQ CB s own policy and quality system confirmation and agreement of the audit programme, including multi-site as applicable confirmation of company location(s) determination of any special requirements, for example travel for site audit etc. details of plan(s) advised and within scope of CB capabilities and resources confirmation of company ownership confirm any changes in management and its impact on the certification compliance 3 IECQ CB shall only proceed where the contract review has been successfully completed 3a Where unsuccessful, IECQ CB shall communicate in writing to the applicant with the applicant is permitted to amend their application or select another IECQ CB, when the IECQ CB s scope of IECQ acceptance does not cover the application IECQ 03-4 IECQ CB procedures IECQ CB s own Certification procedures as included in their quality system as required by ISO/IEC IECQ 03-4 and any relevant IECQ technical notices IECQ CB IECQ CB and applicant IECQ CB IECQ CB IECQ 03-4 covers the 3 rd party assessment and implementation of ADHP Plans The results of the contract review shall be documented and the applicant advised 22 IECQ OD 3405:2017 IEC 2017

25 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 4 Review of the revision control of the plan(s) covered by the IECQ ADHP Certification; determine the changes that have taken place since the last audit This review of plan(s) may take place either prior to the site visit or as part of the on-site visit and audit of the manufacturer s premises Determine category of change: minor major 5 The IECQ CB shall conduct an assessment of the changes to the plan(s) and establish corrective actions to establish compliance with the stated standards/ specifications This shall be done by a fully qualified IECQ ADHP TE (SME) 6 IECQ CB shall proceed only after the plan(s) review has been successfully completed 6a Where unsuccessful, IECQ CB shall communicate in writing to the applicant with the applicant is permitted to amend their plan(s) to fulfil the requirements of the stated standards/specifications Standards and specifications as stated in the plan(s) IECQ CB in conjunction with the applicant IECQ CB LA/TE or IECQ CB LA & TE IECQ CB IECQ CB IECQ OD 3405:2017 IEC IECQ CB to record the revised plan(s) revision control and retain on file IECQ CB 8 Preparation for the plan conformity assessment on-site audit Determine the extent of the changes and prepare suitable checklist based on relevant established audit checklists for the referenced standards IECQ OD 3401 IECQ 03-4 using relevant checklists in accordance with OD 3402 and applicable IECQ technical notices IECQ CB IECQ CB LA/TE Where the applicant already maintains an IECQ ADHP CoC to one of more of the relevant referenced standards or their equivalent, the CB may utilize the audit report as evidence of compliance together with an assessment of any differences. For example, a conformity assessment to IEC TS may be utilized to demonstrate compliance with the equivalent clauses of SAE EIASTD4899 ensuring that any differences or extra requirements are assessed

26 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 9 Determine of the changes to the plan(s) effect previous Stage 1 documentation review 10 Stage 1 Independent review by IECQ CB staff to establish the applicant s written procedures and processes comply with the plan(s) 11 Documentation assessment: Assessment of the client s quality management system procedures that relate to the plan(s) to be covered by the IECQ ADHP CoC 11a Generally this will relate to determining that the applicant has documented processed and practices implemented per the plan(s) Where serious deficiencies in the applicant s implemented documented processes and procedures, these shall be raised by the IECQ CB as major non-conformances and the applicant required to take action to correct this situation (usually by the introduction or amendment of processes/practises), prior to proceeding with the certification process Where the documentation assessment is satisfactory and/or only minor noncompliance with various plan(s) requirements are raised by the IECQ CB, the process of on-site auditing may continue Where major issues are raised that require a major revision of the documented procedures and practices or plan(s), then the on-site audit should await the finalization of the documentation revision Where major issues were found during 11 the applicant is to revise their documentation and re-submit to the IECQ CB for further review 12 Stage 2 Prepare and conduct facility(s) on-site audit for implementation of the plan(s) This maybe be in conjunction with planned annual surveillance or a special audit as agreed between the client and the CB 13 The IECQ CB conducts on-site audit of all sites This on-site audit shall seek to verify that relevant procedures and work instructions are in place and that there are records and evidence to demonstrate that the requirements of the plan(s) and IECQ 03-4 are being met by the applicant Client s plan(s) IECQ 03-4 IECQ OD 3401 using relevant checklists Applicant s plan(s) and IECQ 03-4 using relevant checklists in accordance with OD 3402 IECQ CB LA/TE IECQ CB LA/TE IECQ CB to which the application was made IECQ CB LA/TE or IECQ CB LA & TE The IECQ CB may use contract audit staff and TEs but shall at all times remain the IECQ CB responsible for the planning and conduct of the audit Where the plan(s) are used in multi sites, especially different countries each location shall be audited, prior to the issuing of the IECQ ADHP CoC 24 IECQ OD 3405:2017 IEC 2017

27 Figure 3 13a Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) Where the on-site audit of the client s location reveals non-conformances the IECQ CB shall determine whether such minor non-conformances pose a risk to noncomplying product being released to the market. If there is any risk that this may be the case then the non-conformances shall be treated as major non-conformances and certification shall not proceed until the issue is rectified and the nonconformances closed Where non-conformances of a minor nature, i.e. that do not impact on the compliance of the component product, with the specification(s), certification may proceed on the basis that the non-conformances will be addressed with the view to being closed at the next surveillance audit at the latest However corrective action response shall be provided to the IECQ CB in timely manner, normally within 1 month The raising of any non-conformance may give rise to the need for the IECQ CB to review some of the quality system documentation of the manufacturer 14 A report of the assessment/audit of the applicant s documented systems and implementation of, including site audit, shall be compiled by the IECQ CB 15 An independent review of the report shall be conducted within the IECQ CB to whom the original application was made The independent review shall be conducted by a staff member of the IECQ CB that is not responsible for the audit In accordance with the IECQ CB s own quality management system Applicant IECQ CB conducting the audit/assessment IECQ CB to whom the original application for an IECQ ADHP CoC was made Generally this will be the IECQ CB to whom the application has been made, but may be compiled by another IECQ CB requested to conduct the audit by the original IECQ CB This independent review is to ensure that a complete assessment and audit has taken place and that the recommendations are in line with the audit findings and any NCRs and related corrective actions Further guidance is found in ISO/IEC IECQ OD 3405:2017 IEC

28 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 16 The IECQ CB to which the application for an IECQ ADHP CoC has been made shall determine that the audit report is complete and complies with the following: IECQ Rules and Procedures IECQ CB s own quality management system all NCRs provide a clear description of their nature IECQ 03-4 IECQ OD 3401 IECQ CB s own quality management system Final decision being taken by the IECQ CB to which the original application has been made The review should also ensure that the principles and guidelines of ISO/IEC are followed The applicant and or IECQ Secretary may need to be informed where errors or discrepancies are of a major nature, for example incorrect audit personnel conducting the audit or insufficient audit depth revealed 17 The final report shall be issued by the IECQ CB to whom the original application was made, to the applicant and a copy retained on the IECQ CB file At least the following details shall be communicated by the IECQ CB issuing the audit report to the manufacturer: unique audit report reference number or identifier name and address of manufacturer(s) covered by site audit(s) and scope date of audit completion any test report references covered during the audit findings of the audit, for example No. of major or minor non-conformances and IECQ CB s recommendation whether or not certification is being recommended IECQ audit report template IECQ CB to whom the original application was made IECQ CB that issues the audit report 26 IECQ OD 3405:2017 IEC 2017

29 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 18 The IECQ CB to whom the application for an IECQ ADHP CoC was made shall conduct a certification review, in accordance with their quality management system, ensuring among others that: related test reports and audit reports relate to the same product(s) any major non-conformances have been successfully closed all stages of the certification process have been documented and followed, including those contained in this manual the IECQ CB have a signed commitment by the applicant to abide by the rules of the IECQ ADHP Scheme and IECQ CB s certification conditions, for example agreement to have the IECQ CB undertake or arrange for surveillance audits the applicant is aware of his/her obligations under the Scheme, including ensuring that any promotional material does not contain misleading information that may infer products NOT covered by IECQ ADHP certification Where the certification process has not been completed within a 12-month period, a new application shall be submitted IECQ 03-4 IECQ CB s own quality management system The person authorized to conduct such review within the IECQ CB to whom the original application was made IECQ OD 3405:2017 IEC a Where the review undertaken in step 18 is not successful, the IECQ CB management shall refer the matter to the IECQ CB staff responsible for the testing of products and assessment of the quality system or applicant personnel as appropriate Management of the IECQ CB to whom the original application was made 20 A draft amended IECQ ADHP CoC shall be compiled using the IECQ online certificate system via the level 1 password access An IECQ ADHP Compliance Certification may include all relevant plan(s) and referenced industry standard(s) as applicable on the one CoC (Master Site Certificate). Alternatively, separate IECQ ADHP CoCs may be issued per plan Refer to IECQ website IECQ OD 015 The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made An IECQ ADHP Compliance Certification shall only cover one legal entity: the issued CoC (Master Site Certificate) shall clearly detail the one legal entity and one physical address separate Additional Site CoCs associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations of a multi-site application NOTE It is highly recommended that a separate Certificate be issued under the IECQ Counterfeit Avoidance Programme so as to mitigate legal liability

30 Figure 3 Section 3 Procedures for the processing of changes to issued IECQ ADHP Certificates of Conformity covering one or more plans as defined in IECQ 03-4 Description of activity (see Figure 3) 21+21a A draft of the amended IECQ ADHP CoC is to be reviewed for errors. It may be beneficial to pass a draft copy to the applicant for them to assist in the final review prior to issuing the CoC Every attempt shall be made to correct errors prior to issuing the CoC 22 CoC is issued via the IECQ online certificate system under the level 2 password access, with the applicant being informed in writing by the IECQ CB, via letter, fax or 23 Certification maintenance begins, refer to Section 2 of this manual The IECQ CB issuing the IECQ ADHP CoC is responsible for the on-going maintenance of the CoC which shall include: conducting or arranging for surveillance assessments/audits and on-going product compliance responding to public inquiries regarding the CoC taking necessary action when aware of possible breaches by the applicant, for example claims that product not the subject of IECQ ADHP CoCs are being claimed as IECQ certified Original application form submitted by the applicant IECQ 01 IECQ 03-4 IECQ CB s own quality management system The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made The person authorized to issue IECQ ADHP CoCs within the IECQ CB to whom the original application was made Management of the IECQ CB that issued the IECQ CoC 28 IECQ OD 3405:2017 IEC 2017

31 IECQ OD 3405:2017 IEC Bibliography (Use current revisions unless otherwise specified) IEC TS , Process management for avionics Management plan Part 1: Preparation and maintenance of an electronic components management plan IEC TS , Process management for avionics Management plan Part 2: Preparation and maintenance of an electronic COTS assembly management plan IEC 62402, Obsolescence management Application guide IEC TS , Process management for avionics Aerospace and defence electronic systems containing lead-free solder Part 1: Preparation for a lead-free control plan IEC TS , Process management for avionics Counterfeit prevention Part 1: Avoiding the use of counterfeit, fraudulent and recycled electronic components SAE AS5553, Counterfeit Electrical, Electronic, and Electromechanical (EEE) Parts; Avoidance, Detection, Mitigation, and Disposition SAE EIA933, Requirements for a COTS Assembly Management Plan SAE EIASTD4899, Requirements for an Electronic Components Management Plan SAE GEIASTD0005-1, Performance Standard for Aerospace and High Performance Electronic Systems Containing Lead-free Solder (Formerly TechAmerica GEIA-STD ) SAE STD0016, Standard for Preparing a DMSMS Management Plan

32

33 INTERNATIONAL ELECTROTECHNICAL COMMISSION 3, rue de Varembé PO Box 131 CH-1211 Geneva 20 Switzerland Tel: Fax: info@iec.ch