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IEC Quality Assessment System for Electronic Components (IECQ System)

IECQ OD 3406 Edition 1.0 2017-08

IECQ OPERATIONAL DOCUMENT

Procedures for the issuing of IECQ Certificates of Implementation for Aerospace, Defence, and High Performance electronics Control Plans

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IECQ OD 3406 Edition 1.0 2017-08

IECQ OPERATIONAL DOCUMENT


INTERNATIONAL ELECTROTECHNICAL COMMISSION

IEC Quality Assessment System for Electronic Components (IECQ System)

– 2 – IECQ OD 3406:2017 © IEC 2017

CONTENTS

FOREWORD ........................................................................................................................... 3 INTRODUCTION ..................................................................................................................... 4 1 Scope and application ..................................................................................................... 5 SECTION 1 – PROCEDURES FOR THE ISSUING OF AN IECQ ADHP CERTIFICATE OF IMPLEMENTATION ........................................................................................................... 6 SECTION 2 – SURVEILLANCE AUDITS – PROCEDURES FOR MAINTAINING VALIDITY OF AN IECQ ADHP CERTIFICATE OF IMPLEMENTATION .................................. 17 SECTION 3 – PROCEDURES FOR THE PROCESSING OF CHANGES TO ISSUED IECQ ADHP CERTIFICATES OF IMPLEMENTATION ........................................................... 23 Bibliography .......................................................................................................................... 34 Figure 1 – IECQ ADHP Certificate of Implementation application process ............................... 7 Figure 2 – Process for maintaining an IECQ ADHP Certificate of Implementation ................. 18 Figure 3 – Summary of process for dealing with IECQ ADHP Certificate of Implementation changes ....................................................................................................... 24

IECQ OD 3406:2017 © IEC 2017 – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________

IECQ Operational Document 3406 –


FOREWORD

This Operational Document OD 3406 sets out the procedures for the processing of applications for IECQ ADHP Certificates of Implementation, for ADHP Control Plan(s) in accordance with the Rules and Procedures IECQ 03-4.

Document History

Date Summary

2017-05-22 Initial edition

Address: IECQ Secretariat c/o IEC Sydney Office The Executive Centre Australia Square, Level 33 264 George Street Sydney NSW 2000 Australia Contact details: Tel: +61 2 4628 4690 Fx: +61 2 4627 5285 [email protected] www.iecq.org


http://www.iecq.org/

http://www.iecq.org/

– 4 – IECQ OD 3406:2017 © 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 Implementation of the following Aerospace, Defence, and High Performance (ADHP) electronics Control Plans1:

– 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 IECQ ADHP Certificate of Implementation – Section 2 – Surveillance audits – Procedures for maintaining validity of an IECQ ADHP

Certificate of Implementation – Section 3 – Procedures for the processing of changes to issued IECQ ADHP Certificates

of Implementation

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.

1 For the industry standards relevant to the listed plan types, see Bibliography.

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1 Scope and application

IECQ ADHP Certificate of Implementation (CoI)

It is essential for this type of certification that the plan owner is confident that their customer has reviewed and accepted their plan(s), before engaging with an IECQ CB.

A Certificate of Implementation may be issued when the plan owner’s processes for given plan(s) are assessed and found to be implemented as documented in those plan(s), as described in this publication.

This certification type “Certificate of Implementation” covers:

– the evaluation that the plan owner has plan(s) that have been reviewed and accepted by their customer with a clear unambiguous approval status, detailing revision and date

– the evaluation that the plan owner has documented procedures and processes implemented per the plan(s) within their organization (usually referred to as first level documentation)

– the evaluation of the implementation and use of the documented procedures and processes within the organization per the plan(s) by the IECQ CB

– the on-going annual surveillance that the plan owner’s plan(s) have been reviewed and accepted by their customer on a 3 year basis as a minimum requirement

– the on-going surveillance of the implementation and use of the documented procedures and processes per the plan(s) by the IECQ CB

This certification type “Certificate of Implementation” does not cover:

– verification of the plan(s) compliance to any referenced industry standard(s)2 – verification of the procedures and processes per the plan(s) technical appropriateness, – verification of the technical competency of the plan owner’s organization resources to

use the implemented procedures and processes per the plan(s)

An IECQ ADHP Implementation Certification may include all relevant plan(s) ONLY on the one Certificate of Implementation (Master Site Certificate). Alternatively, separate IECQ ADHP Certificates of Implementation maybe issued per plan.

An IECQ ADHP Implementation Certification shall only cover one legal entity:

– the issued Certificate of Implementation (Master Site Certificate) shall clearly detail the one legal entity and one physical address

– separate “Additional Site” Certificates of Implementation associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations of a multi-site application

2 For the industry standards relevant to the listed plan types, see Bibliography.

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SECTION 1 – PROCEDURES FOR THE ISSUING OF AN IECQ ADHP CERTIFICATE OF IMPLEMENTATION

This section is to be applied by IECQ CBs when processing new applications for an IECQ ADHP Certificate of Implementation.

These steps are in line with the requirements of ISO/IEC 17021 as relevant.

Figure 1 describes the certification body process for the initial and on-going realization of an IECQ ADHP Certificate of Implementation.

IECQ OD 3406:2017 © IEC 2017 – 7 –

Figure 1 – IECQ ADHP Certificate of Implementation application process

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Figure 1

Step

Section 1 – Procedures for the issuing of an IECQ ADHP Certificate of Implementation covering one or more plans as defined in IECQ 03-4 –

Description of activity

(see Figure 1)

Related documents By whom Notes/Comments

1 Application received in accordance with IECQ 03-4 and the IECQ CB’s internal procedures

NOTE This certificate type “Certificate of Implementation” only covers the implementation and on-going implementation of a OEM’s plan(s) within their organization; it does not cover assessment for compliance to industry standards

IECQ 03-4

IECQ CB procedures

IECQ CB IECQ 03-4 covers the 3rd party assessment of conformity and implementation of ADHP Plans

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 17021. 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 and whether this system is registered or not

– 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

IECQ CB’s own Certification procedures as included in their quality system as required by ISO/IEC 17021

IECQ 03-4 and any relevant IECQ technical notices

IECQ CB and applicant The results of the contract review shall be documented and the applicant advised

3 IECQ CB shall proceed only after the contract review has been successfully completed

IECQ CB

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 CB

4 Establish that the plan(s) compliance status has been established by the customer to the referenced external standards

IECQ CB in conjunction with the applicant

5 Has the applicant’s plan(s) been assessed for compliance and accepted by their customer?


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5a Where unsuccessful, IECQ CB shall communicate in writing to the applicant, with the applicant permitted to seek the compliance and acceptance from their customer(s)

Applicant

6 Where the applicant’s plan(s) have been assessed for compliance to the stated standards/specification and accepted by their customer evidence shall be provided of this to the IECQ CB for their records

IECQ CB

7 IECQ CB to record the plan(s) revision control and retain on file IECQ CB

8 Preparation for the plan implementation on-site audit

The relevant established audit checklists for the referenced standards shall be utilized, where the relevant industry standards are clearly contained in the plans

Where the relevant industry standards are not clearly contained in the plans, the CB shall create a specific audit checklist for the plans

Where customization or specially agreed requirements between the customer and the client are in place, these shall be added to the relevant checklists in a non-ambiguous and clear way

IECQ OD 3401

Applicant’s plan(s) and IECQ 03-4 using relevant checklists in accordance with OD3402 or a specifically developed checklist relevant for the specific plan and applicable IECQ technical notices

IECQ CB LA/TE 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 CoI

Where the applicant already maintains an IECQ ADHP CoI 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 62239-1 may be utilized to demonstrate compliance with the equivalent clauses of SAE EIASTD4899 during an implementation audit ensuring that any differences or extra requirements are assessed

9 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

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10 Documentation assessment: Assessment of the applicant’s quality management system procedures that relate to the plan(s) to be covered by the IECQ ADHP CoIs

Generally this will relate to determining that the applicant has documented procedures and processes implemented per the plan(s). Where these internal documented procedures and processes have been reviewed and accepted by the customer, evidence of this acceptance may be provided to the IECQ CB, wherein the IECQ CB would confirm and document the revisions for all relevant documentation involved

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 non compliance 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 processes or plan(s), then the on-site audit should await the finalization of the documentation revision

Applicant’s plan(s)

IECQ CB to which the application was made

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

10a Where major issues were found during Step 10 the applicant is to revise their documentation and re-submit to the IECQ CB for further review

11 Stage 2 – Preparation for the plan(s) implementation on-site audit

IECQ 03-4

IECQ OD 3401

IECQ CB LA/TE or IECQ CB LA & TE

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12 The IECQ CB conducts on-site audit of all sites in accordance with the agreed audit programme and checklists

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 applicant is meeting the requirements of the plan(s) and IECQ 03-4

Utilization of IECQ technical notices shall be recorded in the site assessment report

Applicant’s plan(s), IECQ 03-4, relevant checklists and applicable IECQ technical notices

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 CoI


12a 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 non-complying 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 non-conformances closed

Where non-conformance 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-conformances may give rise to the need for the IECQ CB to review some of the quality system documentation of the manufacturer

Applicant

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13 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

IECQ CB conducting the audit/assessment

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

14 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

IECQ CB to whom the original application for an IECQ ADHP CoI was made

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 17021

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15 The IECQ CB to which the application for an IECQ ADHP CoI has been made shall determine that the audit report is complete and complies with the following, not limited to: – 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 CoI may include all relevant plan(s) as applicable on the one certification (Master Site Certificate)

– an IECQ ADHP CoI may only have one legal entity and physical address per Certificate. Separate “Additional Site” Certificates associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations

– an IECQ ADHP Implementation Certification shall only cover one legal entity:

– the issued CoI (Master Site Certificate) shall clearly detail the one legal entity and one physical address

– separate “Additional Site” CoIs 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

IECQ 03-4

IECQ OD 3406

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 17021-1 are followed

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16 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

– all plan(s) and their control, used to audit against

– 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

Contact the IECQ Secretariat for any questions or concerns

17 The IECQ CB to whom the application for an IECQ ADHP CoI 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


The person authorized to conduct such review within the IECQ CB to whom the original application was made


18+18a Where the review undertaken in Step 17 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


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19 A draft IECQ ADHP CoI shall be compiled using the IECQ online certificate system via the level 1 password access

An IECQ ADHP Implementation Certification may include all relevant plan(s) ONLY on the one CoI (Master Site Certificate). Alternatively, separate IECQ ADHP CoIs may be issued per plan

An IECQ ADHP Implementation Certification shall only cover one legal entity: – the issued CoI (Master Site Certificate) shall clearly detail the one legal entity

and one physical address


All plan(s) shall be uniquely identifiable by title and revision

All internal procedures directly related to the implementation of the plan(s) shall be uniquely identifiable by title and revision

An IECQ ADHP CoI shall not include any referenced industry standards. For example like those listed in Bibliography.

Refer to IECQ website

IECQ OD 015

The person authorized to issue IECQ ADHP CoIs within the IECQ CB to whom the original application was made


20+20a A draft of the IECQ ADHP CoI 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 CoI

Every attempt shall be made to correct errors prior to issuing the CoI

Original application form submitted by the applicant



21 CoI 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 email



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22 Certification maintenance begins, refer to Section 2 of this manual

The IECQ CB issuing the IECQ ADHP CoI is responsible for the on-going maintenance of the CoI which shall include: – conducting or arranging for surveillance assessments/audits and ongoing

product compliance

– responding to public inquiries regarding the CoI

– taking necessary action when aware of possible breaches by the applicant, for example claims that product not the subject of IECQ ADHP CoIs are being claimed as “IECQ Certified”

IECQ 01

IECQ 03-4


Product specifications

Management of the IECQ CB that issued the IECQ CoI


IECQ OD 3406:2017 © IEC 2017 – 17 –

SECTION 2 – SURVEILLANCE AUDITS – PROCEDURES FOR MAINTAINING VALIDITY OF

AN IECQ ADHP CERTIFICATE OF IMPLEMENTATION

This section is to be applied by IECQ CBs to ensure that IECQ ADHP Certificates of Implementation, issued under the IECQ ADHP Scheme remain valid, through surveillance audits according to IECQ 03-4.

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 03-4.

Once an IECQ CB has issued an IECQ ADHP Certificate of Implementation they are responsible to ensure that surveillance assessment visits to the manufacturing location(s) are conducted in accordance with IECQ 03-4.

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 Implementation 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 Implementation.

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Figure 2 – Process for maintaining an IECQ ADHP Certificate of Implementation

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Step

Section 2 – Surveillance audits – Procedures for maintaining validity of an IECQ ADHP Certificate of Implementation covering one or more plans as

defined in IECQ 03-4 – Description of activity

(see Figure 2)


1 IECQ ADHP CoI verified as valid by the IECQ CB that issued the IECQ ADHP CoI 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

IECQ 03-4 IECQ CB that issued the IECQ ADHP CoI

Surveillance audits are to be scheduled on a minimum of 12 month basis

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 their shall assist the client to transfer to another IECQ CB in accordance with IECQ 03-1, Clause 9.18. 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 CB’s own quality system

3 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 – For example: corrections to typographical errors, page numbering,

index

– Major – For example: any changes of wording, phrasing, either editorial or technical

IECQ CB conducting the audit

In most cases it is more productive to conduct this document review at the client’s premises as part of the on-site audit

4 Have the plan(s) changed revision? IECQ CB

5 Where the review in Step 4 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

NOTE it is recommended that customer review cycle falls within the IECQ CB surveillance/audit cycle to avoid any lapses in Certification

IECQ OD 3406 Section 3

IECQ CB ISO 19011 provides guidance on the effective auditing of management systems

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6 The IECQ CB conducts on-site and remote audits of sites as appropriate and agreed between the client and the CB in accordance with 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

Where customisation or specially agreed requirements between the customer and the client are in place, these shall be added to the relevant checklists in a non-ambiguous and clear way

IECQ 03-4 and client’s plan(s) using relevant checklists

IECQ CB conducting the audit


IECQ 03-4 IECQ CB that issued the IECQ CoI







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9+9a The IECQ CB shall determine that the audit report is complete and complies with the following, not limited to: – IECQ Rules and Procedures




− plan(s) and their control

− documented procedures relating to the plan(s) and their control


– an IECQ ADHP CoI may only have one legal entity and physical address per CoI. Separate “Additional Site” CoIs associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations


IECQ 03-4

IECQ OD 3401




10 The final report shall be issued by the IECQ CB to the client and a copy retained on the IECQ CB files


– name and address of manufacturer(s) covered by site audit(s) and scope





IECQ audit report template




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11,12+13 The IECQ CB shall review proposed corrective actions relating to Non Conformance Reports (NCRs) in terms of: – the time to implement such action is appropriate, including where applicable

consideration for the time the customer may need to review and accept the proposed amendments

– 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

IECQ CB Contact the IECQ Secretariat for any questions or concerns

13a+13b The IECQ CB will need to determine whether the IECQ ADHP CoI 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 CoI in writing and the IECQ Secretariat requesting that the IECQ ADHP CoI be suspended or withdrawn

IECQ 03-4

IECQ CB that issued the IECQ ADHP CoI


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 CoI shall confirm that the details of the IECQ ADHP Implementation Certificate 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 CB that issued the IECQ ADHP CoI


IECQ OD 3406:2017 © IEC 2017 – 23 –

SECTION 3 – PROCEDURES FOR THE PROCESSING OF CHANGES TO

ISSUED IECQ ADHP CERTIFICATES OF IMPLEMENTATION

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 03-4.

Figure 3 describes the certification body procedures for the processing of changes to an IECQ ADHP Certificate of Implementation.

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Figure 3 – Summary of process for dealing with IECQ ADHP Certificate of

Implementation changes

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Section 3 – Procedures for the processing of changes to IECQ ADHP Certificate of Implementation 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

IECQ 03-4

IECQ CB procedures

IECQ CB IECQ 03-4 covers the 3rd party assessment and implementation of ADHP Plans

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 17021. 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) and the type of certification 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

IECQ CB’s own certification procedures as included in their quality system as required by ISO/IEC 17021

IECQ 03-4 and any relevant IECQ technical notices

IECQ CB and applicant The results of the contract review shall be documented and the applicant advised

3 IECQ CB shall only proceed where the contract review has been successfully completed

IECQ CB

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 CB

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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 – For example: corrections to typographical errors, page numbering,

index

– Major – For example: any changes of wording, phrasing, editorial or technical


5 Have the client’s revised plan(s) been assessed for compliance and accepted by their customer?


5a Where unsuccessful, IECQ CB shall communicate in writing to the applicant with the applicant is permitted to seek the compliance and acceptance from their customer(s)

Applicant

6 Where the client’s revised plan(s) have been assessed for compliance to the stated standards/specification and accepted by their customer, evidence shall be provided of this to the IECQ CB for their records

IECQ CB

7 IECQ CB to record the revised plan(s) revision control and retain on file IECQ CB

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8 Preparation for the plan implementation assessment on-site audit

Determine the extent of the changes and prepare for suitable checklist based on relevant established audit checklists for the referenced standards or where the relevant industry standards are not clearly contained in the plans, the CB shall create a specific audit checklist for the plans

IECQ OD 3401

Applicant’s plan(s) and IECQ 03-4 using relevant checklists in accordance with OD3402 or a specifically developed checklist relevant for the specific plan and applicable IECQ technical notices

IECQ CB

IECQ CB LA/TE

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 CoIs


9 Determine of the changes to the plan(s) effect previous Stage 1 documentation review

IECQ CB LA/TE

10 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

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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 CoIs

Generally this will relate to determining that the applicant has documented procedures and processes 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 non-compliance 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 processes or plan(s), then the on-site audit should await the finalization of the documentation revision

Client’s plan(s)

IECQ CB to which the application was made

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

11a Where major issues were found during Step 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

IECQ 03-4

IECQ OD 3401 using relevant checklists

IECQ CB LA/TE or IECQ CB LA & TE

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13 The IECQ CB conducts on-site audit of all sites in accordance with the agreed audit programme and checklists

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

Utilization of IECQ technical notices shall be recorded in the site assessment report

Applicant’s plan(s), IECQ 03-4, relevant checklists and applicable IECQ technical notices

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 CoIs


13a 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 non-complying product being released to the market. If there is any risk that this may be the case then the non-conformance shall be treated as major non-conformances and certification shall not proceed until the issue is rectified and the non- conformances 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-conformances may give rise to the need for the IECQ CB to review some of the quality system documentation of the manufacturer

Applicant

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IECQ CB conducting the audit/assessment

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







16 The IECQ CB to which the application for an IECQ ADHP CoI has been made shall determine that the audit report is complete and complies with the following, not limited to: – IECQ Rules and Procedures




− plan(s) and their control

− documented procedures relating to the plan(s) and their control


– an IECQ ADHP CoI may only have one legal entity and physical address per Certificate. Separate “Additional Site” CoIs associated to a Master Site (to the one legal entity) shall cover additional trading names or site locations


IECQ 03-4

IECQ OD 3401




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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


– name and address of manufacturer(s) covered by site audit(s) and scope





IECQ audit report template




18 The IECQ CB to whom the application for an IECQ ADHP CoI 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


The person authorized to conduct such review within the IECQ CB to whom the original application was made


19+19a 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


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20 A draft amended IECQ ADHP CoI shall be compiled using the IECQ online certificate system via the level 1 password access

An IECQ ADHP Implementation Certification may include all relevant plan(s) ONLY on the one CoI (Master Site Certificate). Alternatively, separate IECQ ADHP CoIs may be issued per plan

An IECQ ADHP Implementation Certification shall only cover one legal entity: – the issued CoI (Master Site Certificate) shall clearly detail the one legal entity

and one physical address


All plan(s) shall be uniquely identifiable by title and revision

All internal procedures directly related to the implementation of the plan(s) shall be uniquely identifiable by title and revision

An IECQ ADHP CoI shall not include any referenced industry standards. For example like those listed in Bibliography.

Refer to IECQ website

IECQ OD 015



21+21a A draft of the amended IECQ ADHP CoI 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 CoI

Every attempt shall be made to correct errors prior to issuing the CoI

Original application form submitted by the applicant



22 CoI 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 email



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23 Certification maintenance begins, refer to Section 2 of this manual

The IECQ CB issuing the IECQ ADHP CoI is responsible for the on-going maintenance of the CoI which shall include: − conducting or arranging for surveillance assessments/audits and ongoing

product compliance

− responding to public inquiries regarding the CoI

− taking necessary action when aware of possible breaches by the applicant, for example claims that product not the subject of IECQ ADHP CoIs are being claimed as “IECQ certified”

IECQ 01

IECQ 03-4


Management of the IECQ CB that issued the IECQ CoI


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Bibliography

(Use current revisions unless otherwise specified)

IEC TS 62239-1, Process management for avionics – Management plan – Part 1: Preparation and maintenance of an electronic components management plan

IEC TS 62239-2, 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 62647-1, Process management for avionics – Aerospace and defence electronic systems containing lead-free solder – Part 1: Preparation for a lead-free control plan

IEC TS 62668-1, 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-0005-1)

SAE STD0016, Standard for Preparing a DMSMS Management Plan

INTERNATIONAL ELECTROTECHNICAL COMMISSION 3, rue de Varembé PO Box 131 CH-1211 Geneva 20 Switzerland Tel: + 41 22 919 02 11 Fax: + 41 22 919 03 00 [email protected] www.iec.ch

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