Standard Operating Procedure for compiling the Machinery Directive 2006/42/EC technical file and EN ISO 12100:2010 risk assessment for EVSE hardware shipped China → Saudi Arabia. Vertical: Electric Vehicle Supply Equipment.
This SOP governs the assembly of the Machinery Directive 2006/42/EC technical file for fixed or semi-fixed EVSE units exported from manufacturers in the People's Republic of China to end users in the Kingdom of Saudi Arabia under DAP Jeddah or DAP Riyadh (Incoterms 2020) [Claim | Src: ICC Incoterms 2020 | https://iccwbo.org/business-solutions/incoterms-rules/incoterms-2020/ | accessed 2026-09-21]. It applies whenever the goods are placed on the EU/EEA market or the Kingdom of Saudi Arabia requires a CE-style technical file as part of the conformity evidence package [Claim | Src: Regulation (EU) 2024/1689 (Machinery Regulation, recast) and EUR-Lex consolidated Machinery Directive page | https://eur-lex.europa.eu/eli/dir/2006/42/oj | accessed 2026-09-21].
The risk-assessment methodology follows EN ISO 12100:2010, the type-B safety standard for general principles for design — risk assessment and risk reduction [Claim | Src: ISO/TC 199 catalogue entry for ISO 12100:2010 | https://www.iso.org/standard/51528.html | accessed 2026-09-21]. Electrical safety verification follows EN 60204-1:2018 for the electrical equipment of machines [Claim | Src: IEC Webstore entry for IEC 60204-1:2016 (adopted as EN 60204-1) | https://webstore.iec.ch/publication/26037 | accessed 2026-09-21].
| Filename (literal) | Purpose |
|---|---|
| OEM_ServiceManual_EVSE_[model].pdf | Source-of-truth drawings, BOM, and safety information from the manufacturer. |
| RiskAssessment_ENISO12100_Worksheet.xlsx | Hazard list, severity, probability, risk-reduction measures. |
| HarmonisedStandardsMatrix_v01.xlsx | Applied EN/IEC clauses with edition dates. |
| DoC_MachineryDirective_2006-42-EC.pdf | Declaration of Conformity template, populated per unit. |
| AQL_Report_ISO2859-1_Lot[n].pdf | Inspection report for the production lot. |
| CE_Marking_Artwork_v01.dwg | CE graphic with height ≥ 5 mm per Annex III. |
| CommercialInvoice_DAP_Jeddah.pdf | Shipping commercial document. |
| PackingList_CN_to_SA.xlsx | Carton-level serial number trace. |
| Step # | Action | Owner | Input doc | Output doc | Done-when |
|---|---|---|---|---|---|
| 1 | Receive OEM technical file package (manual, BOM, DoC template, harmonised standards list). | Compliance Lead | OEM_ServiceManual_EVSE_[model].pdf | File index entry opened in TFS register | Index row created with receipt date, OEM contact, model code. |
| 2 | Verify Machinery Directive 2006/42/EC scope and select conformity assessment route (Module A self-certification, or Module B+C/D). | Compliance Lead | OEM_ServiceManual_EVSE_[model].pdf | Scope memo (1 page, signed) | Scope memo references Annex I hazards and the chosen route. |
| 3 | Compile the harmonised standards matrix listing EN ISO 12100:2010, EN 60204-1, EN 61851-1, EN 61000-6-2/6-4 where applicable. | Compliance Lead | OEM_ServiceManual_EVSE_[model].pdf | HarmonisedStandardsMatrix_v01.xlsx | Each clause has edition date and pass/fail tick. |
| 4 | Draft the risk assessment per EN ISO 12100:2010: iterate hazard identification, severity, probability, risk reduction. | Compliance Lead | RiskAssessment_ENISO12100_Worksheet.xlsx (blank) | RiskAssessment_ENISO12100_Worksheet.xlsx (filled) | Every hazard has residual-risk score ≤ acceptable threshold. |
| 5 | Send risk assessment, general assembly drawings, and BOM to OEM for review and revision marking. | Compliance Lead | RiskAssessment_ENISO12100_Worksheet.xlsx (filled) | OEM review transmittal email + tracked PDF | OEM returns the package with at least one signed revision page. |
| 6 | Receive OEM sign-off; apply CE marking artwork with height ≥ 5 mm per Annex III of 2006/42/EC. | Compliance Lead | CE_Marking_Artwork_v01.dwg | Marked-up drawing set with CE graphic callout | CE graphic callout dimensioned on at least one view. |
| 7 | Perform lot inspection at the OEM plant against ISO 2859-1:1999, AQL 1.5 General Inspection Level II [Claim | Src: ISO/TC 69 catalogue entry for ISO 2859-1:1999 | https://www.iso.org/standard/1146.html | accessed 2026-09-21]. | Quality Lead | Production lot pull | AQL_Report_ISO2859-1_Lot[n].pdf | Report records lot size, sample size, Ac/Re numbers, and disposition. |
| 8 | Sign Declaration of Conformity naming responsible person, applied directives, and harmonised standards. | Compliance Lead | DoC_MachineryDirective_2006-42-EC.pdf (template) | DoC_MachineryDirective_2006-42-EC.pdf (signed) | DoC signed and dated; PDF is not editable. |
| 9 | Assemble final technical file as one PDF with table of contents, version-control page, and document checklist. | Compliance Lead | All upstream outputs | TechnicalFile_EVSE_[model]_[serial].pdf | PDF opens, TOC links resolve, file size < 100 MB. |
| 10 | Archive the technical file for the retention period stated in 2006/42/EC and notify Logistics Lead that the file is released for export. | Compliance Lead | TechnicalFile_EVSE_[model]_[serial].pdf | Archive record + release email to Logistics Lead | Archive location, retention date, and release email are logged. |
| 11 | Book consignment under ICC Incoterms 2020 DAP Jeddah or DAP Riyadh; attach file cover sheet to the commercial invoice; forward haulier booking. | Logistics Lead | TechnicalFile_EVSE_[model]_[serial].pdf (cover sheet) + CommercialInvoice_DAP_Jeddah.pdf | Booking confirmation + shipper's letter of instruction | Booking reference is logged in the shipment register and the consignee is notified. |
| Day | Activity | Dependency |
|---|---|---|
| D + 0 | Step 1 — receive OEM technical file package. | None (start). |
| D + 2 | Step 2 — scope verification and route selection. | Depends on Step 1. |
| D + 4 | Step 3 — harmonised standards matrix. | Depends on Step 2. |
| D + 7 | Step 4 — draft risk assessment. | Depends on Step 3. |
| D + 8 | Step 5 — send to OEM for sign-off. | Depends on Step 4. |
| D + 11 | Step 6 — receive OEM sign-off and apply CE marking. | Depends on Step 5. |
| D + 13 | Step 7 — AQL inspection at OEM plant. | Depends on production lot being released to inspection. |
| D + 15 | Step 8 — sign Declaration of Conformity. | Depends on Steps 6 and 7. |
| D + 17 | Step 9 — compile final technical file PDF. | Depends on Step 8. |
| D + 18 | Step 10 — archive and release to Logistics. | Depends on Step 9. |
| D + 20 | Step 11 — book DAP Jeddah / DAP Riyadh shipment. | Depends on Step 10 and consignee's delivery slot. |
HS code for the EVSE unit (charging station for electric vehicles) is 8537.10 — "Boards, panels, consoles, desks, cabinets and other bases, equipped with two or more apparatus for switching, protecting, connecting to or controlling electrical circuits, for a voltage not exceeding 1,000 V" — commonly used for EV charging stations and accepted by the SFDA customs portal and the Saudi ZATCA single-window for goods classification [Claim | Src: Saudi ZATCA HS Code Inquiry (official customs portal) | https://www.zatca.gov.sa/en/rulings/pages/hscode-inquiry.aspx | accessed 2026-09-21]. Spare parts fall under heading 8538 ("parts suitable for use solely or principally with the apparatus of heading 8537") [Claim | Src: WCO Harmonized Commodity Description and Coding System, Explanatory Notes to Chapter 85 | http://www.wcoomd.org/en/topics/nomenclature/instrument-and-tools/hs-nomenclature-2022-edition.aspx | accessed 2026-09-21].
| Cost line | Status | Notes |
|---|---|---|
| Notified Body certificate (Module B, if applicable) | UNCERTAIN | Quoted per OEM request; certificate number not yet issued. |
| AQL inspection day-rate | indicative | Indicative day-rate provided on RFQ; final rate depends on lot size. |
| Translation of the technical file to Arabic (consignee requirement) | indicative | Indicative per-page rate; final quote depends on document length. |
| Saudi import duty (HS 8537.10) | PENDING — lookup | Verify on ZATCA HS Code Inquiry at time of shipment. |
| SASO IECEE certificate fee | PENDING — lookup | Verify on SASO Product Safety portal at time of shipment. |
| Sea freight CN → Jeddah (40' HC, indicative) | indicative | Indicative only; final rate depends on sailing schedule. |