供应链管理部审核清单 Checklist for Supplier Chain Department

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  Address

1. 供应商1 Supplier 1

• 1. 是否有《供应商调查表》？Is there a supplier survey?

  Yes

  No

  N/A

• 2. 是否有《样品评估表》？Is there a sample evaluation form?

  Yes

  No

  N/A

• 2.1. 是否有对应的验证报告？Is there a corresponding verification report?

  Yes

  No

  N/A

• 3. 是否有《供应商审核报告》？Is there a supplier audit report?

  Yes

  No

  N/A

• 4. 是否有首次《供应商评审记录表》？Is there an initial supplier review record?

  Yes

  No

  N/A

• 5. 是否签订质量协议且在有效期内？Is a quality agreement signed and valid?

  Yes

  No

  N/A

• 6. 是否有年度审核计划？且按计划进行审核并有审核记录？Is there an annual audit plan? Are audits conducted according to plan and have audit records?

  Yes

  No

  N/A

• 7. 随机查看3份采购订单，查看是否有COC等要求？Randomly check 3 purchase orders to see if there are COC requirements, etc.?

  Yes

  No

  N/A

• 8. 查看项目7中的采购订单是否记录于《采购日报表》中且记录满足要求？Check whether the purchase order in item 7 is recorded in the Purchase Daily Report and the records meet the requirements.

  Yes

  No

  N/A

• 9. 是否有被质量法规部开过不符合？是否有《供应商质量反馈报告》？

2. 供应商2 Supplier 2

• 1. 是否有《供应商调查表》？Is there a supplier survey?

  Yes

  No

  N/A

• 2. 是否有《样品评估表》？Is there a sample evaluation form?

  Yes

  No

  N/A

• 2.1. 是否有对应的验证报告？Is there a corresponding verification report?

  Yes

  No

  N/A

• 3. 是否有《供应商审核报告》？Is there a supplier audit report?

  Yes

  No

  N/A

• 4. 是否有首次《供应商评审记录表》？Is there an initial supplier review record?

  Yes

  No

  N/A

• 5. 是否签订质量协议且在有效期内？Is a quality agreement signed and valid?

  Yes

  No

  N/A

• 6. 是否有年度审核计划？且按计划进行审核并有审核记录？Is there an annual audit plan? Are audits conducted according to plan and have audit records?

  Yes

  No

  N/A

• 7. 随机查看3份采购订单，查看是否有COC等要求？Randomly check 3 purchase orders to see if there are COC requirements, etc.?

  Yes

  No

  N/A

• 8. 查看项目7中的采购订单是否记录于《采购日报表》中且记录满足要求？Check whether the purchase order in item 7 is recorded in the Purchase Daily Report and the records meet the requirements.

  Yes

  No

  N/A

• 9. 是否有被质量法规部开过不符合？是否有《供应商质量反馈报告》？

3. 供应商3 Supplier 3

• 1. 是否有《供应商调查表》？Is there a supplier survey?

  Yes

  No

  N/A

• 2. 是否有《样品评估表》？Is there a sample evaluation form?

  Yes

  No

  N/A

• 2.1. 是否有对应的验证报告？Is there a corresponding verification report?

  Yes

  No

  N/A

• 3. 是否有《供应商审核报告》？Is there a supplier audit report?

  Yes

  No

  N/A

• 4. 是否有首次《供应商评审记录表》？Is there an initial supplier review record?

  Yes

  No

  N/A

• 5. 是否签订质量协议且在有效期内？Is a quality agreement signed and valid?

  Yes

  No

  N/A

• 6. 是否有年度审核计划？且按计划进行审核并有审核记录？Is there an annual audit plan? Are audits conducted according to plan and have audit records?

  Yes

  No

  N/A

• 7. 随机查看3份采购订单，查看是否有COC等要求？Randomly check 3 purchase orders to see if there are COC requirements, etc.?

  Yes

  No

  N/A

• 8. 查看项目7中的采购订单是否记录于《采购日报表》中且记录满足要求？Check whether the purchase order in item 7 is recorded in the Purchase Daily Report and the records meet the requirements.

  Yes

  No

  N/A

• 9. 是否有被质量法规部开过不符合？是否有《供应商质量反馈报告》？

1. 吸塑纸、吸塑膜、纸塑袋、PE袋 （注意：有效期）Blister Paper, Blister Film, Paper-plastic Bag, PE Bag (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. 吸塑纸、吸塑膜、纸塑袋：洁净车间报告或环境报告 Blister paper, blister film, plastic bag: clean workshop report or environmental report

  Yes

  No

  N/A

• 4. COC/COA

  Yes

  No

  N/A

• 5. MSDS

  Yes

  No

  N/A

• 6. 生物相容性报告 Biocompatibility report

  Yes

  No

  N/A

2. 中盒、外箱、标签、说明书、合格证、不干胶（注意：有效期）Box, Case, Label, Instruction, Certificate, Self-adhesive (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. COC/COA

  Yes

  No

  N/A

3. 硅油、胶塞、胶垫（注意：有效期）Silicone Oil, Gasket, O-ring (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. 硅油：医用级符合性证明（官方、自我声明）Silicone oil: medical grade compliance certificate (official, self-declaration)

  Yes

  No

  N/A

• 4. COC/COA

  Yes

  No

  N/A

• 5. MSDS

  Yes

  No

  N/A

• 6. 生物相容性报告 Biocompatibility report

  Yes

  No

  N/A

4. 油墨、UV胶、环氧树脂胶（注意：有效期）Ink, UV Glue, Epoxy Resin Glue (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. 油墨：医用级符合性证明（官方、自我声明）Ink: medical grade compliance certificate (official, self-declaration)

  Yes

  No

  N/A

• 4. COC/COA

  Yes

  No

  N/A

• 5. MSDS

  Yes

  No

  N/A

• 6. UV胶、环氧树脂胶：生物相容性报告 UV glue, epoxy resin glue: Biocompatibility report

  Yes

  No

  N/A

5. PP、PVC、色粉、色母粒、针管（注意：有效期）PP, PVC, Toner, Masterbatch, Needle Tube (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. 医用级符合性证明（官方、自我声明）Medical grade compliance certificate (official, self-declaration)

  Yes

  No

  N/A

• 4. COC/COA

  Yes

  No

  N/A

• 5. MSDS

  Yes

  No

  N/A

• 6. 生物相容性报告 Biocompatibility report

  Yes

  No

  N/A

• 7. 洁净车间报告或环境报告 Clean workshop report or environmental report

  Yes

  No

  N/A

6. 气体（注意：有效期）Gas (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. COC/COA

  Yes

  No

  N/A

• 4. MSDS

  Yes

  No

  N/A

7. 生物指示剂、化学指示剂（注意：有效期）Biological Indicators, Chemical Indicators (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. COC/COA

  Yes

  No

  N/A

• 4. MSDS

  Yes

  No

  N/A

8. 成品、半成品（注意：有效期）Finished and Semi-finished Products (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. 洁净车间报告或环境报告 Clean workshop report or environmental report

  Yes

  No

  N/A

• 4. COC/COA

  Yes

  No

  N/A

• 5. MSDS

  Yes

  No

  N/A

• 6. 生物相容性报告 Biocompatibility report

  Yes

  No

  N/A

9. 化学试剂（注意：有效期）Chemical Reagents (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. 体系证书，例如：ISO 13485，ISO 9001，GMP等；或认证证书，例如：CE，510k等。System certificates, such as ISO 13485, ISO 9001, GMP, etc. Or certificate, such as CE, 510K, etc.

  Yes

  No

  N/A

• 3. COC/COA

  Yes

  No

  N/A

• 4. MSDS

  Yes

  No

  N/A

10. 计量（注意：有效期）Measurement (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. CNAS/CMA

  Yes

  No

  N/A

• 3. 实验室能力范围 Scope of laboratory capabilities

  Yes

  No

  N/A

• 4. 证书模板，加盖CNAS章 Certificate template with CNAS seal

  Yes

  No

  N/A

11. 灭菌（注意：有效期）Sterilization (Note: Expiry Date)

• 1. 营业执照 The business license

  Yes

  No

  N/A

• 2. ISO 11135

  Yes

  No

  N/A