I. 在《合格供应商名录》中选择供应商。Select suppliers from Qualified Supplier List.

1. 供应商1 Supplier 1

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

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

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

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

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

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

  • 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?

  • 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.?

  • 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.

  • 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?

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

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

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

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

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

  • 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?

  • 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.?

  • 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.

  • 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?

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

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

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

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

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

  • 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?

  • 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.?

  • 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.

  • 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》?

II. 根据查看供应商分类选择对应的检查项目。Select the corresponding inspection items according to the supplier classification.

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

  • 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.

  • 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

  • 4. COC/COA

  • 5. MSDS

  • 6. 生物相容性报告 Biocompatibility report

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

  • 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.

  • 3. COC/COA

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

  • 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.

  • 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)

  • 4. COC/COA

  • 5. MSDS

  • 6. 生物相容性报告 Biocompatibility report

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

  • 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.

  • 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)

  • 4. COC/COA

  • 5. MSDS

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

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

  • 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.

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

  • 4. COC/COA

  • 5. MSDS

  • 6. 生物相容性报告 Biocompatibility report

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

6. 气体(注意:有效期)Gas (Note: Expiry Date)

  • 1. 营业执照 The business license

  • 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.

  • 3. COC/COA

  • 4. MSDS

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

  • 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.

  • 3. COC/COA

  • 4. MSDS

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

  • 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.

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

  • 4. COC/COA

  • 5. MSDS

  • 6. 生物相容性报告 Biocompatibility report

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

  • 1. 营业执照 The business license

  • 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.

  • 3. COC/COA

  • 4. MSDS

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

  • 1. 营业执照 The business license

  • 2. CNAS/CMA

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

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

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

  • 1. 营业执照 The business license

  • 2. ISO 11135

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