ITVC GLOBAL · BUSINESS SERVICES
This ITVC checklist was prepared for the historical EN ISO 13485:2012 edition. Retain it as a reference and determine current documentation requirements from the applicable standard, activities and regulatory obligations.
These 45 topics are a reference checklist, not a requirement to issue 45 separate documents. The readiness column is for the organization’s own assessment.
| No. | Document title | Ready (Y/N) |
|---|---|---|
| 1 | Quality policy | |
| 2 | Quality objectives | |
| 3 | Quality manual | |
| 4 | Document and data control procedure | |
| 5 | Records control procedure | |
| 6 | Management review procedure | |
| 7 | Recruitment procedure | |
| 8 | Training procedure | |
| 9 | Equipment maintenance procedure | |
| 10 | Equipment repair procedure | |
| 11 | Work environment management procedure | |
| 12 | Protective equipment and personal hygiene controls | |
| 13 | Contract review procedure | |
| 14 | Supplier evaluation procedure | |
| 15 | Purchasing procedure | |
| 16 | Incoming inspection procedure | |
| 17 | Material and assembly component specifications | |
| 18 | Product specifications | |
| 19 | First product approval procedure | |
| 20 | Process technology instructions | |
| 21 | Manufacturing procedure | |
| 22 | Assembly procedure | |
| 23 | Product inspection procedure | |
| 24 | Product batch identification procedure | |
| 25 | Product labelling and packaging procedure | |
| 26 | Product cleanliness and contamination control procedure | |
| 27 | Product sterilization procedure | |
| 28 | After-sales service procedure | |
| 29 | Product traceability procedure | |
| 30 | Product recall procedure | |
| 31 | Product risk assessment procedure | |
| 32 | 4M change management procedure | |
| 33 | Special process control procedure | |
| 34 | Raw material and finished goods warehouse receipt and dispatch procedure | |
| 35 | Customer property management procedure | |
| 36 | Product regulatory compliance evaluation procedure | |
| 37 | Inspection and measuring equipment control procedure | |
| 38 | Customer complaint handling procedure | |
| 39 | Internal audit procedure | |
| 40 | Nonconforming product control procedure | |
| 41 | Corrective action procedure | |
| 42 | Preventive action procedure | |
| 43 | Job descriptions for each position | |
| 44 | Competency requirements for each position | |
| 45 | Other relevant documents |
ITVC GLOBAL · SERVICE ENQUIRIES
Share your requirements and preferred timing. ITVC will review your enquiry and discuss a suitable service scope.
Hotline: 0914 564 579
Ho Chi Minh City: 0859 553 986
Email: itvc.haiphong@itvc-global.com
Head office: 6th Floor, 22 Ly Tu Trong, Hong Bang Ward, Hai Phong, Vietnam.
CÔNG TY TNHH ITVC TOÀN CẦU
Tầng 6, Số 22 Lý Tự Trọng, Phường Hồng Bàng, TP Hải Phòng.
Tel: 02253 261 208 - Hotline: 0914 564 579
Fax: 02253 292 718
Phương thức thanh toán
CHI NHÁNH TẠI TP. HỒ CHÍ MINH
1073/63B Đường Cách Mạng Tháng Tám, Phường Tân Sơn Nhất, TP Hồ Chí Minh
Tel: 0859 553 986
Email: energy3.itvc@itvc-global.com
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