Certifications
已取得認證與適用規範
已取得
ISO 9001
一般品質管理
已取得
IATF 16949
汽車品質管理
已取得
ISO 13485
醫療器材品質
已取得
ISO 14001
環境管理系統
已取得
ISO 45001
職業安全衛生
已取得
QC 080000
有害物質管理
已取得
UL / CQC
產品安全認證
已取得
RBA
責任商業聯盟
預定取得
ISO 27001
資訊安全
Timeline
認證取得歷程
2008
ISO 9001、UL 產品認證
2011
ISO 14001、CQC 產品認證
2023
QC 080000（有害物質管理）
2025
IATF 16949、ISO 45001、ISO 13485
預定
ISO 27001（資訊安全）
PDCA
品質管理流程
企劃・設計・稽核
- 品質策劃：APQP / PPAP / FMEA / MSA；工程管理：SPC / FMEA
- 設計審查／製程審查／產品品質審查
- 內部稽核：依 IATF16949 / VDA（每年1次）
- 管理審查：每年1次 ／ 外部稽核：每年1次
製程與出貨保證
- 關鍵製程識別（FMEA/CP）、關鍵參數嚴格化、EDS 資料累積
- 追溯：條碼＋MES、100% 自動檢查、雷射/油墨標識
- 製程中：IPQC 抽檢、Holding time 管理
- 成品：100% 電測、100% AVI 外觀、FA 分析持續改善
Equipment
檢測・評估設備
全自動二次元影像量測儀
尺寸・形狀量測
偏光金相顯微鏡
截面觀察・鍍層厚度評估
XRF 螢光分析儀
元素分析・膜厚評估
灼熱絲 / 針焰 / 耐漏電起痕
阻燃・耐漏電
自動外觀檢查機（AVI）
全數外觀檢查
恆溫恆濕試驗箱
可靠性試驗
KPI
2025 年品質KPI目標值
※ 2層板測試直通率另以 ≧98.5% 進行個別管理。
2485 Principle
客戶對應：2485 原則
2h
一次回應
快速・積極的初動對應
24h
正式一次報告
防止策・改善案・庫存風險評估
48h
第2〜3次回應
暫行對策・原因分析（4D）
5日
最終報告
8D 報告書提交
體制與技術交流
- 重大問題24小時內升級至責任主管〜總經理
- 2小時內召集改善團隊（營業・品質・技術）
- 設置 QCC 專案團隊，定期進行技術會議
2024 Improvement
2024 年改善體制
重要職位增員
QCC 專案推進
刮傷對策（Q2）
- 不良分層與高風險部門識別
- 搬送路線／操作 SOP 最佳化
- 生產端導入評估機制與指揮強化
W14 0.32%→W25 0.15%降低 53%
工藝・自動包裝專案（Q3）
- 工程設計、設備選定、流程最佳化、參數優化
- 降低材料／能源／人工成本並提升一次合格率
啟動初期共提出 37件 降本提案
設備改造・新設
2024/03
智慧產線連結（浸鍍塗裝機）
2024/05
大型板自動 V-CUT 機
2024/07
智慧產線 IR 爐
2024/08
Inline AOI
2024/10
單面板智慧產線（2條）
2024/11
單面板 Inline AOI
2025 Plan
2025 年品質系統推進計畫
4M Management
不合格品管理 / 4M 變更管理
不合格品控制
- 發現 → 隔離 → 評估 → MRB 判定 → 處置（返工／挑選／報廢）
- 落實 CAR 矯正措施與再發防止，並以標識防止流出
4M 變更管理
- 變更申請 → 風險評估 → 核准 → 驗證 → 展開 → 效果評估
- 涵蓋工程、設備、治具、人員與材料變更，標準化工廠／客戶通知
※ 本頁面為依社內資料整理之摘要，規格與運用可能依案件與時期有所不同。
Quality Management
Certification & Quality —
Quality Management System
Chengde's quality system, international certifications, KPI framework, and continuous improvement structure
Certifications
Certifications and Applicable Standards
Certified
ISO 9001
General quality management
Certified
IATF 16949
Automotive quality
Certified
ISO 13485
Medical devices
Certified
ISO 14001
Environmental management
Certified
ISO 45001
Occupational safety
Certified
QC 080000
Hazardous substance
Certified
UL / CQC
Product safety
Certified
RBA
Responsible business
Planned
ISO 27001
Information security
Timeline
Certification History
2008
ISO 9001, UL Product Certification
2011
ISO 14001, CQC Product Certification
2023
QC 080000 (Hazardous Substance Management)
2025
IATF 16949, ISO 45001, ISO 13485
Planned
ISO 27001 (Information Security)
PDCA
Quality Control Flow
Planning, Design, and Audit
- Quality planning: APQP / PPAP / FMEA / MSA; Process control: SPC / FMEA
- Design review / process review / product quality review
- Internal audit: IATF16949 / VDA-aligned (annually)
- Management review: annually / external audit: annually
Process and Shipment Assurance
- Critical process identification (FMEA/CP), tightened parameters, EDS data accumulation
- Traceability: barcode + MES, 100% automated inspection, laser / ink marking
- In-process: IPQC sampling, holding time control
- Finished goods: 100% electrical test, 100% AVI, continuous FA-driven improvement
Equipment
Inspection and Evaluation Equipment
Fully Automatic 2D Image Measuring System
Dimensional and shape measurement
Polarized Metallographic Microscope
Cross-section and plating thickness
X-ray Fluorescence Spectrometer (XRF)
Element analysis and coating thickness
Glow Wire / Needle Flame / Tracking Resistance
Flame retardancy testing
Automatic Visual Inspection (AVI)
100% visual inspection
Constant Temp. / Humidity Chamber
Reliability testing
KPI
2025 Quality KPI Targets
* For 2-layer boards, test straight-through rate is additionally managed with a target of ≥98.5%.
2485 Principle
Customer Response: 2485 Principle
2h
Initial response
Fast and proactive first action
24h
Formal first report
Preventive actions, improvement plan, stock risk assessment
48h
2nd–3rd response
Containment actions / root cause analysis (4D)
5 days
Final report
8D report submission
Escalation and Technical Exchange
- Critical issues escalated to responsible managers through general manager within 24 hours
- Improvement team (sales, quality, engineering) convened within 2 hours
- Dedicated QCC team and regular technical meetings
2024 Improvement
2024 Improvement Framework
Additional Staffing in Key Positions
QCC Projects
Scratch Defect Countermeasures (Q2)
- Defect stratification and high-risk section identification
- Optimized transport routes and handling SOP
- Production-end evaluation mechanism and stronger line control
W14 0.32%→W25 0.15%53% reduction
Process & Self-Packaging Project (Q3)
- Process design, equipment selection, flow optimization, parameter optimization
- Reduced material / energy / labor cost, improved first-pass yield
Initial phase: 37 cost-reduction ideas submitted
Equipment Upgrades and New Installations
2024/03
Smart-line connection (immersion coating machine)
2024/05
Automatic V-CUT machine for large panels
2024/07
Smart-line IR furnace
2024/08
Inline AOI
2024/10
Smart line for single-sided boards (2 lines)
2024/11
Inline AOI for single-sided boards
2025 Plan
2025 Quality System Promotion Plan
4M Management
Nonconforming Product Control / 4M Change Management
Control of Nonconforming Products
- Detection → segregation → evaluation → MRB decision → disposition (rework / sorting / scrap)
- Thorough CAR corrective action, prevention of recurrence, marking to prevent escape
4M Change Management
- Change proposal → risk assessment → approval → validation → deployment → effectiveness review
- Covers process, equipment, tooling, personnel, and material changes with standardized notification
Contact
Request Quality Materials / Consultation
Contact us for audit support, evidence submission, or detailed operational flows.
* This page is a summary based on internal materials. Specifications and operations may vary depending on project and timing.