Quality Requirements for Suppliers
The QRS-01 (Quality Requirements for Suppliers) and associated modules QRS-XXX is the Quality Manual applicable to all Suppliers when referred to within a Purchase Order or Agreement, and shall be flowed-down to all Sub-tier Suppliers. The QRS-XXX Modules shall be applied at their latest revision as published below.
All Suppliers must be approved to supply articles. The Aerospace companies are expected to be certified to the EN/AS/JISQ9100 series, as applicable, and the QRS-01 contains specific Leonardo Helicopters requirements that are in addition to these standards.
The use of IAQG documents and guidelines, such as SCMH (Supply Chain Management Handbook), are recommended to supplement the application of QRS-01.
The revised QRS-01 Issue 6 and associated modules areeffective immediately for new approved Suppliers andapplicable from October 1st, 2020 to all current Suppliers.
Safety Requirements for Suppliers
The SRS-01 (Safety Requirements for Suppliers) and associated modules SRS-XXX is the Safety Manual applicable to all Suppliers when referred to within a Purchase Order or Agreement, and shall be flowed-down to all Sub-tier Suppliers. The SRS-XXX Modules shall be applied at their latest revision as published below.
All Suppliers must be approved to supply articles. The SRS-01 contains specific Leonardo Helicopters requirements consistent with ICAO Annex 19 framework and European Regulations time schedule.
The use of documents and guidelines, such as SM-0001 SMS International Industry Standard, are recommended to supplement the application of SRS-01.
TheSRS-01 Issue 0 and associated modules are effective immediately for new approved Suppliers andapplicable from December 2nd 2022 for Part 145 certified Suppliers and from March 7th, 2023 for Part 21 certified Suppliers. A transition period of 2 years will be allowed to complete the implementation, at the end of which the Findings have to be closed.
The certified Suppliers will need to comply with the revised Leonardo supplier qualification process that will include also Safety Requirements.
Regarding non certified Suppliers, Leonardo Helicopters proposes a voluntary implementation of safety requirements (reference SRS-101/102) through a two phase approach (Basic and Advanced) with a suggested two years implementation period in line with the requirements of the certified suppliers. The Suppliers willing to pursue this approach will need to notify their interest to the LH Procurement that will re-launch the qualification process for their company.
Furthermore, in the coming months, Leonardo Helicopters will engage Key Suppliers to improve the current contractual agreements based on supplier characteristics and performance on airworthiness and safety issues.
E-learning Platform
Here you will find the link to new Supplier e-learning Platform, to be trained on QRS-01 and SRS-01 to facilitate the understanding and implementation of quality and safety requirements.
This is a platform where LH approved suppliers and suppliers under approval can take free training on QRS-01 and SRS-01, with final test and certificate for each QRS-XXX and SRS-XXX modules.
Registration link:
https://qrs01supplier.leonardocompany.com/moodle/local/selfregistration/index.php
Access link for already registered users:
https://QRS01supplier.leonardocompany.com
The registration and link are valid for both courses. The user must select the course first and then the relevant modules within the course. All LH suppliers are encouraged to register and attend the training. Check the FAQ section for additional information (purpose, how it works, who can apply and how)
QRS-01 Issue 6 and associated modules
QRS-01 Quality Requirements for Suppliers Issue 6 – Main Document
Please do NOT delete or modify
Document
Title
QRS-01
Quality Requirements for Suppliers Issue 6– Main Document
New Issue
QRS-01
Appendix 1 – Record Retention Table (Issue 03)
New Issue
QRS-01
Appendix 2 – Program Additional Requirements (Issue 09)
New Issue
QRS-01
Appendix 3 – Requirements for Articles to deliver to LH Customer Support and Service (Issue 00)
New
QRS-01
Appendix 4 – Counterfeit Electrical, Electronic and Electromechanical (EEE) Parts (Issue 00)
New
QRS-01
F01 – NCR Non Conformity Report Form (Issue 01)
QRS-01
F02 - REACh Declaration Form (Issue 01)
QRS-01
F03 - MIR Form (Issue 01)
QRS-01
F04 - Log Card form (Issue 00)
QRS-01
F05 - RFVA Form (Issue 01)
Please do NOT delete or modify
QRS- 100 Digital Manufacturing – DMFG
Please do NOT delete or modify
Document
Title
QRS-100
Digital Manufacturing – DMFG (Issue 05)
Please do NOT delete or modify
QRS-101 First Article Inspection
Please do NOT delete or modify
Document
Title
QRS-101
First Article Inspection (Issue 04)
New Issue
QRS-101
F01 - PN Accountability (Issue 04)
QRS-101
F02 - Article Accountability (Issue 03)
QRS-101
F03 - Characteristic Accountability (Issue 03)
Please do NOT delete or modify
QRS-103 Quality Req. for Subcontractors, GSE, Stockists of Raw Material, Distributors
Please do NOT delete or modify
Document
Title
QRS-103
Subcontractors GSE Stockists Parts-Distributors (Issue 03)
New Issue
Please do NOT delete or modify
QRS-104 Special Processes
Please do NOT delete or modify
Document
Title
QRS-104
Special Processes (Issue 03)
New Issue
QRS-104
Annex 1 - List of LH Special Process Specifications
New Issue
Please do NOT delete or modify
QRS-105 Management of LH Equipmentand Tools
Please do NOT delete or modify
Document
Title
QRS-105
Management of LH equipmentand tools (Issue 01)
Please do NOT delete or modify
QRS-107 Management of Non-Conforming Articles
Please do NOT delete or modify
Document
Title
QRS-107
Management of Non-Conforming Articles (Issue 03)
New Issue
QRS-107
F01 - Concession form and instructions (Issue 03)
QRS-107
F02 - Deviation Permit form and instructions (Issue 02)
QRS-107
F03 - Quality Alert form (Issue 03)
QRS-107
F04- Inspection Report (Issue 00)
Please do NOT delete or modify
QRS-108 Supplier Quality Plans
Please do NOT delete or modify
Document
Title
QRS-108
Supplier Quality Plans (Issue 03)
New Issue
Please do NOT delete or modify
QRS-110 DO-PO Arrangement
Please do NOT delete or modify
Document
Title
QRS-110
DO-PO Arrangement (Issue 02)
New Issue
QRS-110
F01 - DO-PO Form (Issue 01)
QRS-110
F02 - IPO-PO Form (Issue 01)
QRS-110
F03 - SADD Form (Issue 01)
Please do NOT delete or modify
QRS-115 Requirements for Design & Development Suppliers of Airborne Equipment
Please do NOT delete or modify
Document
Title
QRS-115
Requirements for Design & Development Suppliers of Airborne Equipment (Issue 05)
New Issue
QRS-115
F01 - TAF (Issue 04)
QRS-115
F02 - COMO (Issue 01)
QRS-115
F03 - DDP 04(Issue 04)
QRS-115
F04 SCP (Issue 06)
New Issue
QRS-115
F05 - DDS (Issue 04)
New Issue
QRS-115
F06 – CMP Template (Issue 00)
Please do NOT delete or modify
QRS-116 Software Development, Quality Requirements for Suppliers
Please do NOT delete or modify
Document
Title
QRS-116
Software Development - Quality Requirements (Issue 04)
Please do NOT delete or modify
QRS-117 Complex Electronic Hardware, Quality Requirements for Suppliers
Please do NOT delete or modify
Document
Title
QRS-117
Complex Electronic HW - Quality Requirements (Issue 04)
Please do NOT delete or modify
QRS-118 Requirements for Laboratories and Manufacturers of Non-Airborne Equipment for LH Engineering
Please do NOT delete or modify
Document
Title
QRS-118
Requirements for Laboratories and
Manufacturers of Non-Airborne Equipment for LH Engineering(Issue 00)
Please do NOT delete or modify
QRS-122 Supplier Component Maintenance / Operating Manuals management
Please do NOT delete or modify
Document
Title
QRS-122
Supplier Components Maintenance-Operative Manuals (Issue 01)
Please do NOT delete or modify
Please do NOT delete or modify
QRS-130 Flow-down of LH Requirements to Sub-Tier Suppliers
Please do NOT delete or modify
Document
Title
QRS-130
Flow-down of LH Requirements to Sub-Tier Suppliers (Issue 00)
New
Please do NOT delete or modify
QRS-01 Temporary Revisions
Please do NOT delete or modify
Document
Title
QRS Temporary Revisions
QRS-01 Temporary Revisions Log
New Issue
QRS Temporary Revisions
TR QRS-115-5
New Issue
QRS Temporary Revisions
TR QRS-101-4
New Issue
Please do NOT delete or modify
QRS-01 Configuration Log
Please do NOT delete or modify
Document
Title
QRS Configuration Log
QRS-01 Configuration Log
New Issue
Please do NOT delete or modify
Please do NOT delete or modify
SRS-01 Issue 00 and associated modules
SRS-01 Safety Requirements for Suppliers Issue 00 – Main Document
Document
Title
SRS-01
Safety Requirements for Suppliers Issue 00 – Main Document
New
SRS-100 Safety Requirements for Suppliers with SMS
Document
Title
SRS-100
Safety Requirements for Suppliers with SMS (Issue 00)
New
SRS-101 Safety Requirements for Suppliers with no SMS
Document
Title
SRS-101
Safety Requirements for Suppliers with no SMS (Issue 00)
New
SRS-102 Safety Requirements for Suppliers providing services at LH premises
Document
Title
SRS-102
Safety Requirements for Suppliers providing services at LH premises (Issue 00)
New
SRS-01 Frequently Asked Questions (FAQ)
Document
Title
SRS-01
Frequently Asked Questions (FAQ)Issue 00
New
Additional Data
Program Additional Requirements
Here below the Program Additional Requirements:
NH90 Contractual Quality Assurance Requirements supplier flowdown document
AW609 Conformity Requirements for Suppliers (Issue E)
QAS100 Issue 5
AWHERO PROGRAM QUALITY PROCEDURE
QA-PZL-141 Additional Customer requirements for PZL Suppliers_ Rev 02
QRSK-01 - Quality requirements for AW09 suppliers (11028268/ Rev B)
NGCTR (Next Generation Civil Tilt Rotor) Program Procedure
Content 2
SRS-101&102 supporting documentation
Here below the LH supporting documentation for SRS-101&102 implementation:
- Issue 0
2 Safety Culture Principles- Issue 0
3 Safety Management System (SMS) Manual Principles-Issue 0
4 Safety Manual Template-Issue 0
-Issue 0
-Issue 0
Technical Documentation
List of Approved Process
Supplier Quality restricted area for certificated supplier users only
The content is visible only to authenticated Leonardo Helicopter DivisionApproved Supplier.
List of Approved Processing (Special Processes/NDT) Companies
If you are anLeonardo Helicopter DivisionApproved Supplier:
Sign in or register for access.
If you already have a logon but cannot see any content, go to Change your profile and select the “Apply for role” tab and request "Role Supp Quality Area". The request will be reviewed by theLeonardo Helicopter DivisionQuality website owner and, if approved, will be allocated to you.
Supplier of raw material
The content is visible only to authenticatedLeonardo Helicopter DivisionApproved Supplier.
List of Approved Raw Material Suppliers
If you are anLeonardo Helicopter DivisionApproved Supplier:
- Sign in or register for access.
- If you already have a logon but cannot see any content, go to Change your profile and select the “Apply for role” tab and request "Role Supp Quality Area". The request will be reviewed by the Leonardo Helicopter DivisionQuality website owner and, if approved, will be allocated to you.
Supplier Quality restricted area
Supplier Quality restricted area for certificated supplier users only
The content is visible only to authenticated Leonardo Helicopter DivisionApproved Supplier.
If you are an Leonardo Helicopter DivisionApproved Supplier:
- Sign in or register for access.
- If you already have a logon but cannot see any content, go to Change your profile and select the “Apply for role” tab and request "Role Supp Quality Area". The request will be reviewed by the Leonardo Helicopter DivisionQuality website owner and, if approved, will be allocated to you.
NDT Responsible Level 3
As required by the §8.2.1 – sub-paragraph ‘Personnel performing NDT’, QRS-01 Issue 06:
‘The Supplier’s Responsible NDT Level 3 shall be identified and notified to the LH Corporate NDT Responsible Level 3. Similarly, the Sub-Tier’s Responsible NDT Level 3 shall be identified and notified to the LH Corporate NDT Responsible Level 3 by the Supplier.’
In order to comply with this requirement, the Supplier shall submit all of the documented information listed below:
- Level 3 certificate of the Supplier’s Responsible Level 3 in accordance with EN4179/NAS410,
- Formal appointment letter as Responsible Level 3 issued by the Employer (Supplier Company),
- Written Practice approved by the Supplier’s Responsible Level 3 and including Leonardo Helicopters additional requirements, when applicable,
to the following e-mail address:
ResponsibleLevel3.lhd@leonardo.com
Quality Plan Templates and Checklists
Document
Title
QRS_108
QP Template - Manufacturer
New Issue
QRS_108
QP Template - Subcontractor
New Issue
QRS_108
QP Template - DO/PO Arrangement
New Issue
QRS_108
QP Template - Repair, overhaul or modification of a part/system
New
Archive
QRS-01 Issue 5 and associated modules
QRS-01 Issue 5 and associated modules_ Archive
QRS-01 Issue 4 and associated modules
QRS-01 Issue 4 and associated modules_ Archive
Quality Approval and Provisions
Quality & approval
Leonardo Helicopters Supplier Quality Assurance (SQA) is an integrated cross geographical department that has developed and implemented supplier initial evaluation and re-evaluation processes based on perceived industry best practice.
SQA’s main responsibilities include:
- Provision of specialist Quality input to the Leonardo Helicopters Supplier Selection Process.
- Evaluation of all new suppliers of products, software and aerospace services ensuring the Supplier’s Quality Management System is compliant with Leonardo Helicopters requirements.
- Re-evaluation of suppliers of products, software and aerospace services (in conjunction with Leonardo Helicopters Supply Chain Engineering) ensuring suppliers have the capability to maintain compliance with Leonardo Helicopters requirements.
- Maintenance of the Leonardo Helicopters Approved Supplier Database.
- Provision of supporting Quality documentation to the Leonardo Helicopters global supplier base.
Quality assurance provisions
Quality Assurance requirements
for the fulfilment of the order, the supplier shall comply with Leonardo Helicopter Division suppliers' quality manual (qrs 01)* and all the procedures quoted by reference in the same. the above manual applies to all the direct material supplies. in the event the order is placed on an agent or commercial organization, the latter shall assure the supplier/manufacturer that will effectively execute the supply, shall apply the quality assurance provisions hereinafter set forth.
GENERAL PROVISIONS **
- For the duration of the Order, the Supplier shall ensure the application of the Quality Level recognized by Leonardo Helicopter Division exclusively for the scope of the qualification.
- With reference to the peculiarity of the supply in Order, Leonardo Helicopter Division reserves the right to implement a specific Quality Plan or Supply Control Plan.
- Both during and after the completion of the Order, the Supplier undertakes to promptly provide Leonardo Helicopter Division with information on continuous airworthiness concerning the materials supplied.
- In the event Leonardo Helicopter Division deems useful to execute an on-site test, the Supplier shall notify Leonardo Helicopter Division the beginning of the acceptance test with ten day notice.
- The Supplier shall assure free access to Leonardo Helicopter Division representatives and ,as applicable, to its customers and/or Military and Civil Authorities.
- The Supply must be manufactured in compliance with the configuration and quality provisions required by the Order. Any change shall be approved in writing in advance by Leonardo Helicopter Division
- Parts/assemblies shall be identified and serialised as required by applicable technical/ manufacturing documentation.
- Complete Supply traceability shall be ensured from incoming material/component to end product.
- All items delivered to Leonardo Helicopter Division must be preserved, packed and shipped according to the Order requirements or, if not specified, to the best commercial rules (ref. MIL-P-116). Item subject to shelf life must be delivered with at least ¾ of full life. Parts and/or single packages and relevant Certificates of Conformances shall indicate, as applicable: cure date, batch/lot number, assembly date, expiry date.
- Every Supply shall be always delivered with a Certificate of Conformity to the Order requirements as per "Annex B" of AQAP-2070 or equivalent document containing, at least, the same information.
- Items from a "Stockist/Distributor" must be always delivered with Certificate of Conformity and copy of the original Certificate of Manufacturer.
- * The entire quality documentation concerning the accomplishment of the Order is available on this web site
- ** The provisions of clauses 1, 3, 7, 8, 10, 11, do not apply to indirect materials.
PARTICULAR PROVISIONS (in addition to the General Provisions)
Write the two digits of the Quality Codes reported in the Purchase Order line item in order to get explanation of the appropriate meaning.
FAQ
When does QRS-01 Issue 6 and associated Modules become applicable?
QRS-01 Issue 6 and associated Modules will become applicable from October 1st, 2020 and will be required in the Purchase Orders. Consequently, Suppliers are required to implement changes and revise their quality plans within March 31st, 2021.
For new approved Suppliers, they will be applicable immediately.
Which revision of QRS-XXX Modules shall be applied?
The QRS-XXX Modules shall always be individually applied at their latest revision Issue published in the Leonardo Helicopters web page above.
A configuration log showing the list of the current QRS-XXX revisions (including Attachments, Appendixes and Forms) is published in the QRS webpage. This log highlights the changed documents.
Which Leonardo Helicopters suppliers shall apply the QRS-01?
A: The QRS-01 and associated modules shall be applied by all aerospace Leonardo Helicopters suppliers worldwide, to confirm a unique approach on Quality.
Which are the main changes of the QRS-01 Issue 06and associated Modules?
The main changes involve the following subjects:
- Issue of a new Module (QRS-130), to facilitate and improve Flowdown of LH Requirements to Sub-Tier Suppliers. This document shall be part of contractual requirements between Suppliers and their Sub-Tiers
- New requirements for prevention of counterfeit Electrical, Electronic, Electromechanical (EEE) Parts (QRS-01 Appendix 4)
- Provisions for delivering certified Articles with EASA Form 1 (or equivalent, e.g. 8130-3) “Prototype” and “New” at every stage of technical data approval (QRS01 Main Document, QRS-110, QRS-
108) - FOD Prevention Program requirements (QRS-01 Main document).
A Gap Analysis Matrix is also available with a detailed description of all the introduced changes, in order to support you in their identification and implementation.
QRS-01 GAP ANALYISIS Issue 6, June 2020
How Suppliers can address questions for clarifications about QRS-01 and/or submit suggestions for improvement?
Please submit your requests / suggestions to your Leonardo Helicopters Supplier Quality Assurance contact or to through functional mailbox: AWSupplierQualityAssurance.AW@leonardo.com
To whom Suppliers have to send Quality Alerts/Notification of Escape/Service Bulletin?
Any Quality Alert/Notification of Escape or Service Bulletin shall be sent to LH Chief Project of reference, LH Quality Control of Reference and LH SQA (AWSupplierQualityAssurance.AW@leonardo.com). For UK only, to AWL_Product_Qualityalert.mbx.aw@leonardo.com .
Any other contact referred to in the contract shall be put in copy. Further details can be found in QRS-107.
Are previous QRS-XXX revisions still available on website?
The Supplier should download the QRS-XXX modules, and retain the superseded Issues where needed. However, only the previous issues of the QRS-01 and associated Modules (as they were published before the Issue 6), are still available in the QRS website in the “Additional Data / Archive” section.
How often the QRS-01 will be revised?
The QRS-01 and associated Modules is revised once a year, normally in June. Impellent changes are introduced through Temporary Revisions.
Can I use “Mod Strike” labels or plates?
Yes, the Supplier shall demonstrate that its design system is capable of ensuring a satisfactory configuration control. The system shall guarantee the traceability of minor changes coordinated with LH Engineering (both physical and documental), usually using the "modification status" or "amendment" or equivalent code.
It is acceptable to physically record the embodiment of minor changes through the use of `Mod Strike’ plates or by other traceable means. Ref QRS-115 para 5.3.5.1. The CofC shall include “modification status”, Ref QRS-01 para. 13.1. It is also recommended to include “modification status” on package labelling.
How does a Supplier receive a request for a Quality Plan?
A Quality Plan is typically required by LH through Statement of Work or Purchase Order. An example is the Quality Plan for Manufacturers who design and manufacture new articles.
In other situations, the Quality Plan is required by Supplier Quality Assurance or by Procurement, following specific communication received by the Supplier. An example is the Quality Plan supporting permanently or temporarily work transfer.
In all other cases, the Supplier has directly to submit the Quality Plan to LH in order to document how he intends to fulfilLH Contractual requirements, to document any deviations and align his Quality Management System to LH Requirements.
How often Quality Plans should be reviewed? Does a Supplier have to resubmit them after each revision of the QRS?
The main purposes of a QP are to identify any gaps between a Supplier’s QMS and LH requirements specified in QRS-01 and to document how the Supplier intends to fulfilLH Contractual requirements as detailed in the QRS-01 and associated modules (see §1 of QRS-108). So, a supplier is requested to review the QP after each new issue of QRS-01 and related modules for implementation of changes, and/or when relevant changes occur in the Supplier processes or articles.
The revised QP needs to be resubmitted to LH. Anyway, the Supplier has to regularly update the Annexes of the QP and to submit them to LH.
New Supplier e-learning Platform: which is the main purpose? Who and how can use it?
This is a new platform (March 2021) primarily realized for LH suppliers, to be trained on QRS-01 and facilitate understanding and implementation of these requirements. Access to the platform is password controlled. You may have already received an account from LH. If not, there is an enrolment window where you can apply, providing your contacts data and Supplier Company data.
Registration link: https://qrs01supplier.leonardocompany.com/moodle/local/selfregistration/index.php
Access link for already registered users: https://QRS01supplier.leonardocompany.com
Once you are profiled and access is granted, you can take training on each QRS-XXX module, as applicable for your scope of approval, take a final questionnaire and get a certificate for each module. Access is possible for Suppliers already approved, Suppliers under approval and new candidates for Approval. Enrolment is also open to Regulatory Authorities, Customers, Certification Bodies and other Organizations/Guests providing an acceptable reason.
When access is granted, all the functionalities are enabled. At the end of the training, all are encouraged to complete a feedback survey questionnaire.
For a specific Supplier, multiple access is allowed (several employees can apply) in order to encourage and facilitate spread of training and awareness as necessary within their Organization.
Where a “Supplier SAP code” is requested during the enrolment, please type the 21XXXXXX code that you can find in your statement of approval or in any Purchase Order. In case you are not an approved supplier (or for other organizations), this field is not applicable and can be left empty.
Which are the artefacts required to the supplier, for the major phases (TRR Qualification, HW EFA, SW TRR, SW EFA) relevant to the D&D of the Avionics system in accordance with QRS-115?
To better clarify the QRS-115 regarding the D&D of the Avionics Systems with Software and Complex HW, the points below explain the steps to be performed to deliver an avionic system for Experimental Flight Approval (EFA). In particular, the necessary Supplier Data Requirements List (SDRL) required to satisfy QRS-115 for the System, QRS-116 for the Software and QRS-117 for the Complex HW, in order to have a consistent delivery package.
Formal system TRR for approval of Environmental/EMC EFA Qualification Tests execution:
- Qualification Test Procedures (ENV/EMC)
- Qualification by similarity Report
- ATP during qualification tests
- Test Article Conformity (TAC)
- Test Authorization Form (TAF)
- Software Configuration Index for Environmental/EMC EFA Test (Description, Problem Reports, Limitations, etc.)
- Hardware Configuration Index
HW EFA Qualification:
- Hardware Configuration Index (Updated with possible limitations)
- QTR/ATR
- Preliminary Declaration of Designed Performance (PDDP) (only of HW part number if SW is field loadable)
SW TRR (Release of EFA SW):
- SW Test Proposal
- Software Configuration Index
SW EFA Qualification (linked to System Flight Readiness Review): The SW EFA release must be the same release submitted at the SW TRR*
- Software Configuration Index updated with possible limitations detected during formal tests
- SW Test Report
- PDDP of SW part number (only if SW is field loadable)
* The SW TRR and the SW EFA reviews will be performed on the same software baseline, the TRR aiming to finalize the tests definitions, the EFA review aiming to collect test results and known limitations. If before tests execution software modifications are requested, a new TRR review and new software baseline definition is mandatory, before executing the software EFA review.
What about EMAR 145 certification for Italian MoD programs?
1. Background
The Italian MoD have issued the AER.P-145 regulation, based on the EMAR145 regulation releasedby EDA, which imposes that all the part delivered to the Italian Armed Forces after MRO activitiesshall be released by the Airworthiness Certificate EMAR Form 1. For dual use parts, EASA Form 1 orequivalent is considered acceptable.
In order to do so, a supplier is requested to obtain the EMAR certification, directly through theItalian MoD or through a national Military Airworthiness Authority, provided there is a mutualrecognition between the Countries.
Whereas such mutual recognition is not yet in place or for specific vendors agreed with the ItalianMoD (e.g. Low volume, few involved P/N’s), LHD will release the relevant EMAR Form1, based on itsown approval.
2. Rationale
LHD shall show compliance with the EMAR145 regulation in terms of surveillance of the vendors,therefore the following policy shall be applied:
a) The vendor shall provide a QAP, in the terms and forms decided by LHD, describing thecompliance of the extant Quality System to the requirement set for in the draft QAP, based onthe EMAR 145 requirement. It is not requested to prepare a specific Maintenance Organization
Exposition nor attend specific training courses;
b) LHD will periodically audit the vendor to verify such compliance;
c) LHD reserves the right to perform witnessing of the test of the part to verify the compliance ofthe process.
3. Delivery of the parts
After formal approval of the QAP, each parts shall be delivered with a set of documentationincluding, but not limited to, CoC, Work Report, Test Report, list of applied modification (SB) andrepair, to allow LHD verify the physical status of the component and the configuration achieved.