BS EN 9104-002:2016

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Aerospace series. Quality management systems – Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs

Published By	Publication Date	Number of Pages
BSI	2016	98

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Categories: 03.100.70 - Management systems, BSI

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Description

The requirements established in this document are applicable to the IAQG and associated sectors for managing oversight to established requirements contained in EN 9104-series standards (i.e., EN 9104‑001 , EN 9104‑002 , EN 9104‑003 ). The requirements are applicable to IAQG working groups for oversight.

NOTE

All required forms are depicted in Appendix A. These form exhibits are provided for reference only; the current versions of these forms are available on the IAQG website.

1.1 Purpose

The purpose of this standard is to document the ICOP oversight process and define a robust shared oversight process which provides objective evidence of conformance to established aerospace industry EN 9100-series standards (i.e., EN 9100 , EN 9110 , EN 9120 ) requirements and associated accreditation/certification.

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PDF Pages	PDF Title
4	Contents Page Appendices Page Tables Page
5	European foreword
8	1 Scope 1.1 Purpose 2 Normative references
9	3 Terms and definitions
11	4 General
12	5 Requirements for oversight and assessment personnel 5.1 General 5.1.1 OP assessors are responsible for ensuring they have the training, experience, and competence, as required by this standard, and they have been authorized by their employing company. They shall complete Form A, “Other Party (OP) Assessor Industry… 5.1.2 OP assessors shall be approved in accordance with this standard by their respective employers or SMS Oversight Chair. They shall verify continued support and provide objective evidence every three years, via submission of a completed declaration… 5.1.3 AB assessors shall be competent and qualified, as required by the EN 9104-001 standard. ABs shall ensure that AB assessors receive training as it relates to their roles and responsibilities described in this standard. 5.2 Other party assessor 5.2.1 OP assessor conducting oversight assessments shall have knowledge of the ICOP scheme [i.e., knowledge of all parts of the EN 9104-series standards requirements, knowledge of the relevant AQMS and ISO standards, applicable International Accredita… 5.2.2 OP assessors shall initially and in each three year period fulfil auditing, training, and work experience requirements as follows: 5.2.3 OP assessor training shall include knowledge of the standards and documents referenced within this standard, including the following documentation:
13	5.3 Confidentiality and conflicts of interest 5.3.1 All IAQG OPMT, SMS, CBMC members, and OP assessors shall complete the appropriate declaration form (see Forms A and B) for confidentiality and conflicts of interest, prior to membership or assignment. The SMS shall retain copies of all completed… 5.3.2 These forms shall be provided to any assessed organization (e.g., AB, CB, AAB, TPAB, certified organization), upon request. 5.3.3 Auditors, that have an employment relationship with a CB, can be neither OP assessors nor voting members of any IAQG OPMT, SMS, or CBMC committees. 5.3.4 Certain data in the form of audit reports, nonconformities, checklists, or other company specific information, generated by the application of this standard, shall be handled as confidential (commonly referred to as proprietary or sensitive) bet… 5.3.5 OP assessors shall not disclose the assessed organization’s performance data with the assessed organization’s clients without written permission (e.g., AB performance to CB or CB performance to certified organization). 5.3.6 Conflicts of interest that shall prevent participation as an OP assessor in an oversight assessment activity shall include:
14	5.3.7 OP assessors shall declare any perceived potential or actual conflicts of interest, prior to acceptance of an oversight assignment. Potential conflicts of interest shall be recorded on the “Other Party (OP) Assessor Industry Controlled Other Par… 6 Responsibilities 6.1 General 6.1.1 The IAQG OPMT, each SMS or CBMC, and participating organizations shall ensure that all participants in oversight are aware of their roles and responsibilities. 6.1.2 All participants shall ensure that they have an agreed arrangement with their employing organization, prior to participation in oversight of the ICOP scheme. Such an arrangement shall provide participants with the appropriate authority and resou… 6.1.3 Oversight assessment team members shall declare any conflicts of interest that may exist for a particular assessment assignment (e.g., OP assessor contracted by AB). Any such conflicts shall be reviewed and resolved between all affected parties,… 6.2 Oversight assessment team leader 6.2.1 For joint team assessments (AB and OP assessor), a participating AB assessor shall be the oversight assessment team leader. For non-joint team assessments (assessment without an AB assessor), a participating OP assessor shall be the oversight as… 6.2.2 Prior to the conduct of an oversight assessment, the oversight assessment team leader shall be identified and their role communicated to all affected parties. 6.2.3 The oversight assessment team leader shall ensure the oversight activity is accomplished in accordance with the requirements of this standard by:
15	6.2.4 Additional responsibilities of the oversight assessment team leader include the following: 6.3 Other party assessor 6.3.1 OP assessors are responsible to ensure they have been authorised and approved by their respective IAQG member company or SMS Oversight Chair, and shall submit an “Other Party (OP) Assessor Industry Controlled Other Party (ICOP) Declaration Form”… 6.3.2 The OP assessor and their employing organization shall maintain records to support the qualification of OP assessors, in accordance with the requirements of this standard. Records supporting qualification and approval shall be made available to … 6.3.3 OP assessors shall declare any potential or actual conflicts of interest (see 5.3), prior to acceptance of each oversight assignment. 6.3.4 Additional OP assessor responsibilities include the following: 6.4 International aerospace quality group other party management team 6.4.1 The responsibility of the IAQG OPMT is to manage the EN 9104-series standards application on a global level, including monitoring that each SMS has implemented their sector schemes and is in conformance with EN 9104-series standards requirements… 6.4.2 The IAQG OPMT Oversight Chair manages the IAQG OPMT oversight activities; these activities include the following:
16	6.4.3 The IAQG OPMT shall assign a lead OP assessor that is responsible to assemble a team and schedule/conduct oversight assessments of the SMS or OASIS database, per the established frequencies defined in Section 7. 6.4.4 The IAQG OPMT shall establish a process to manage complaints (see Section 9). 6.4.5 The IAQG OPMT shall establish oversight metrics and communicate reporting expectations to each SMS. 6.4.6 The IAQG OPMT shall establish a Certification Structure Oversight Committee (CSOC) that will include, from each SMS, two IAQG member company representatives and one AB representative. 6.5 Sector management structure or certification body management committee 6.5.1 An SMS may be supported by a CBMC. A CBMC shall meet the requirements defined by the SMS and the applicable SMS requirements of this standard. 6.5.2 The SMS is responsible for managing EN 9104-series standards application in their respective global sector (i.e., Asia Pacific, Americas, and Europe). These responsibilities include the following:
17	6.5.3 Each SMS shall report oversight metrics as established by the IAQG OPMT. 6.5.4 The SMS and each CBMC shall appoint an Oversight Chair. 6.6 Sector management structure or certification body management committee oversight chair 6.6.1 The SMS or CBMC Oversight Chair shall declare any potential conflicts of interest, prior to acceptance of the assignment. 6.6.2 The SMS or CBMC Oversight Chair manages the oversight activities in their respective sector; these activities include the following:
18	6.6.3 When OP assessors are linked to trade association membership (e.g., NAIA member), the Oversight Chair shall review, accept, and document approval of OP assessors on the “Other Party (OP) Assessor Industry Controlled Other Party (ICOP) Declaratio… 6.7 International aerospace quality group member company 6.7.1 Any IAQG member company wishing to recognize AQMS certification shall provide resources needed to support the ICOP scheme and conduct shared oversight. 6.7.2 IAQG member companies shall ensure that assigned representatives, who support IAQG ICOP scheme activities, have the necessary tools (e.g., published standards, computer, equipment) and resources to accomplish committed tasks. 6.7.3 IAQG member companies shall ensure that only qualified individuals are assigned as OP assessors to conduct oversight assessments or participate in joint team assessments supporting the ICOP scheme oversight process (see 5.2 for OP assessor quali… 7 Requirements for oversight assessments 7.1 Oversight frequency 7.1.1 The IAQG OPMT shall conduct an oversight assessment of each SMS at least once every two years. 7.1.2 The IAQG OPMT shall conduct oversight of the administration and functionality of the OASIS database at least once every two years. 7.1.3 An SMS may choose to conduct oversight of an approved TP training class at the frequency they deem necessary to mitigate risk. 7.1.4 The IAQG OPMT shall ensure that the required oversight assessments are conducted and completed by each SMS, as depicted in Table 1. 7.1.5 ABs shall conduct oversight assessments of their accredited CBs, based on the minimum frequencies established in the EN 9104-001 standard.
19	7.2 Sector management structure risk-based oversight 7.2.1 An SMS or CBMC may choose to utilize a risk-based approach to shared oversight. This approach can be used to effectively utilize OP assessor resources, and determine the assessments to be conducted and the frequency of shared oversight. 7.2.2 This approach applies to SMS or CBMC shared oversight activities only; ABs may utilize this process to increase shared oversight levels. 7.2.3 If a risk-based approach is implemented by an SMS or CBMC, it may be applied to any entity subject to shared oversight. When an SMS or CBMC chooses to apply risk-based shared oversight, it shall be applied equally (e.g., all CBs in the sector). 7.2.4 If the SMS or CBMC decides to utilize a risk-based approach for shared oversight, the SMS shall develop and maintain a documented procedure, which defines the risk-based shared oversight process. The risk-based shared oversight process shall inc…
20	7.2.5 A documented procedure must be developed and clearly define the methodology for risk level identification, including the requirement to document the risk analysis and decisions made. This methodology shall include influence and performance as th… 7.2.6 The risk-based shared oversight procedure shall be approved by the IAQG OPMT, prior to implementation. 7.3 Shared oversight program management 7.3.1 Each SMS and CBMC shall establish a shared oversight sub-team that is required to meet annually to review and develop a schedule for oversight activities identified in this standard. 7.3.2 The Oversight Chair shall establish and maintain the oversight schedule and ensure that only approved OP assessors are assigned to support oversight assessments. 7.3.3 Scheduling for shared oversight and assessment activities shall be based on the following: 7.3.4 The Oversight Chair has the responsibility to obtain translator support and request funding, when deemed necessary. Request for funding of translator services shall be submitted to the IAQG OPMT for approval, in advance of the assessment. 7.4 Shared oversight scheduling 7.4.1 All shared oversight assessments shall be scheduled with all affected parties, prior to conduct. Once the schedule has been established, any schedule changes shall be coordinated with all affected parties.
21	7.4.2 During scheduling any potential language issues shall be identified and addressed. For shared oversight activity (e.g., oversight of an SMS, AB, or CB), members of the oversight team shall be fluent in the language of the entity being assessed. … 7.5 Shared oversight assessment planning 7.5.1 The assessment team leader shall coordinate with all members of the assessment team and assessed organization to ensure logistics, roles, and responsibilities are defined. 7.5.2 The assessment team leader has the responsibility to communicate an effective assessment plan to the team members and the assessed organization. 7.5.3 All security clearance issues [e.g., International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR)], confidentiality, and potential conflicts of interest shall be addressed and resolved as part of the planning process. 7.5.4 Oversight team members shall review OASIS database information, prior to an oversight assessment, to gather data to assist in planning the oversight assessment. 7.5.5 The oversight assessment team leader shall request the certificated organization (CB client) to grant access to the tier two audit results (data) within the OASIS database to the assessment team leader, prior to the shared oversight event (refer… 7.6 Oversight of the online aerospace supplier information system database 7.6.1 The objective of an OASIS database oversight assessment is to verify: 7.6.2 The OASIS database oversight assessment shall be accomplished and reported utilizing Form C, “Online Aerospace Supplier Information System (OASIS) Database Management Assessment Check Sheet”, as described in Section 10. All nonconformities ident… 7.6.3 Oversight of the OASIS database will be conducted by the IAQG OPMT assigned OP assessor and supported by the IAQG OPMT OASIS database administrator. 7.7 Oversight of sector management structures and certification body management committees 7.7.1 The objective of a SMS or CBMC oversight assessment is to verify:
22	7.7.2 In preparation for an SMS or CBMC oversight assessment, the SMS or CBMC being assessed shall conduct a self-assessment using Form E, “Sector Management Structure (SMS) Assessment Check Sheet”, or Form F, “Certification Body Management Committee … 7.7.3 The SMS or CBMC oversight assessment shall be accomplished and reported utilizing the appropriate check sheet (see Form E or F), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight Nonconformity”. 7.7.4 Oversight of the SMS or CBMC will be respectively conducted by an IAQG OPMT assigned lead OP assessor or the SMS appointed lead OP assessor and supported by the SMS or CBMC Oversight Chair. 7.8 Oversight of auditor authentication bodies 7.8.1 The objective of an AAB oversight assessment is to verify: 7.8.2 The AAB assessment shall be accomplished and reported utilizing the “Auditor Authentication Body (AAB) Office Assessment Check Sheet” (see Form G), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversigh… 7.8.3 The AAB oversight assessment shall be conducted by an SMS or CBMC designated lead OP assessor and supported by the AAB management team. 7.9 Oversight of training provider approval bodies 7.9.1 The objective of a TPAB assessment is to verify:
23	7.9.2 The TPAB assessment shall be accomplished and reported utilizing the “Training Provider Approval Body (TPAB) Assessment Check Sheet” (see Form H), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight… 7.9.3 The TPAB oversight assessment shall be conducted by an SMS or CBMC designated lead OP assessor and supported by the TPAB management team. 7.10 Oversight of a training class 7.10.1 The objective of a training class oversight assessment is to verify: 7.10.2 The OP assessor shall not influence the training course; the role, when witnessing, is one of observation only. Feedback to the trainer(s) shall occur after the class has adjourned. The OP assessor and TPAB evaluator must ensure that confidenti… 7.10.3 The TP course evaluation shall be accomplished and recorded utilizing the “Training Class Witness Assessment Check Sheet” (see Form I), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight Nonconfor… 7.10.4 The training class oversight assessment shall be conducted by an SMS or CBMC designated lead OP assessor, and supported by a TPAB course evaluator and TP management team. 7.10.5 Oversight of a training class shall not be conducted, unless it is witnessed by the respective TPAB’s course evaluator. 7.11 Oversight of accreditation bodies 7.11.1 The objective of an AB oversight assessment (office or witness) is to verify:
24	7.11.2 The AB office assessment shall be accomplished and reported utilizing the “Accreditation Body (AB) Office Assessment Check Sheet” (see Form J), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight N… 7.11.3 The AB witness assessment shall be accomplished and reported utilizing the “Accreditation Body (AB) Witness Assessment Check Sheet” (see Form K), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight… 7.11.4 The OP assessor shall not influence the AB or joint assessment team; the role, when witnessing, is one of observation only. Feedback to the AB lead assessor shall occur after the assessment has concluded. The OP assessor must ensure that confid… 7.11.5 During AB witness assessments, the lead OP assessor shall witness the assessment from the opening meeting to closing meeting. 7.11.6 The AB witness assessment shall be performed while the AB is conducting an office assessment of an accredited CB. 7.11.7 The AB office or witness assessment shall be conducted by an SMS or CBMC designated lead OP assessor and supported by the AB. The same lead OP assessor shall not support a joint team assessment at the same time as an AB witness assessment. 7.12 Oversight of certification bodies 7.12.1 The objective of a CB office or witness assessment is to verify: 7.12.2 The CB office assessment shall be accomplished and reported utilizing the “Certification Body (CB) Office Assessment Check Sheet” (see Form L), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight N… 7.12.3 The CB witness assessment shall be accomplished and reported utilizing the “Certification Body (CB) Witness Assessment Check Sheet” (see Form M), as described in Section 10. All nonconformities identified shall be recorded on Form D, “Oversight… 7.12.4 The OP assessor shall not influence the CB audit team; the role, when witnessing, is one of observation only. Feedback to the CB audit team shall occur after the audit has concluded. The OP assessor must ensure that confidentiality is maintained. 7.12.5 During CB witness assessments, the OP assessor shall witness the audit from the opening meeting to closing meeting. 7.12.6 The CB witness assessment shall be performed while the CB is conducting an AQMS audit of a client. This activity shall not occur during special or short notice audits. 7.12.7 The witness assessment process shall include a review of the completed audit report utilizing the “EN 9101 Audit Report Review Assessment Check Sheet” (see Form N), as described in section 10. All nonconformities identified shall be recorded on…
25	7.12.8 The CB office or witness assessment shall be conducted by an SMS or CBMC designated OP assessor and supported by the CB. 7.13 International aerospace quality group member company supplemental oversight 7.13.1 IAQG member companies may conduct additional (supplemental) oversight, which is in addition to the minimum EN 9104-002 standard requirements and independent of the SMS shared oversight schedule. 7.13.2 Supplemental oversight conducted by IAQG member companies shall not duplicate SMS or CBMC activities. 7.13.3 IAQG member company supplemental oversight shall adhere to the following requirements: 7.14 Reporting of oversight assessments 7.14.1 The appropriate EN 9104-002 standard forms shall be completed by the assessment team, upon completion of the oversight assessment. All Nonconformity Reports (NCRs) shall be issued to the assessed organization at the conclusion of the assessment…
26	7.14.2 During joint oversight assessments, any OP assessor’s completed EN 9104-002 standard forms shall be provided to the AB lead assessor for incorporation into the AB report. This report shall be treated as part of the AB’s assessment record to be … 7.14.3 Any nonconformity identified, during the assessment, shall be recorded on Form D, “Oversight Nonconformity”. 7.14.4 When oversight assessments are conducted jointly, nonconformities shall be provided to the oversight assessment team leader to be reviewed for inclusion into the assessment report. 7.14.5 During independent shared oversight assessments (i.e., not conducted jointly with the AB), the completed EN 9104-002 standard forms shall be provided to the SMS or CBMC Oversight Chair for analysis and record retention. 7.15 Oversight assessment nonconformities 7.15.1 The oversight assessment team leader shall ensure that all nonconformities identified, during an oversight assessment, are processed in accordance with the EN 9104-001 standard and have been contained; satisfactorily corrected with root cause a… 7.15.2 Open nonconformities that exceed 90 calendar days from date of issuance shall be processed as follows: 8 Annual review of oversight assessment results 8.1 General 8.2 Sector management structure review or certification body management committee review
27	8.3 Accreditation body review 8.3.1 Each AB shall report annually to the SMS or CBMC the following information in relationship to the ICOP scheme for each CB they have accredited: 8.3.2 Each AB shall report annually to the SMS or CBMC the results of any IAF peer evaluations, IAQG member company, and regulatory authority assessments conducted for AB conformance to the EN 9104-series standards. 9 Complaint resolution process
28	10 Records
29	11 Notes
30	Appendix A EN 9104-002 FORMS
93	Appendix B ACRONYM LOG
95	Appendix C Industry Controlled Other Party (ICOP) Process Model

Additional information

Status	Under Review
Pages	98
Publication Date	2016-06-30
ISBN	978 0 580 83013 6
Standard Number	BS EN 9104-002:2016
Title	Aerospace series. Quality management systems – Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs
Identical National Standard Of	EN 9104-002:2016
Replaces	BS EN 9104-002:2008
Descriptors	Certification (approval), Documents, Air transport engineering, Management, Quality management, Certification bodies, Quality auditing, Quality assurance, Quality assurance systems, Aircraft components, Approval organizations, Records (documents)
Publisher	BSI
Committee	ACE/1
ICS Codes	03.100.70 - Management systems

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BS EN 9104-002:2016

1.1 Purpose

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