QC – Quality control

Quality Management System Assessment

1.Business License

2.Organization Charts 

3.Flowchart of Processes with Critical Control Points 

4.Procedures of Document and Record Control

5.Procedure / Records of Management Review 

6.Procedure / Records of Internal Audit 

7.Procedure / Records of Nonconforming (NC) Products Control

8.Procedures / Records of Corrective Action

9.Records of Product Design / Development Release

10.Procedure / Records of Product Change Management

11.Specifications / Certificates of Products / Materials 

12.Product Bill of Materials(BOM) 

13.Records of Pre-Production Meeting 

14.Records of Pilot Production / Improvement

15.Procedures / Records of Supplier Approval

16.List of Approved Suppliers 

17.Records of Incoming Inventory / First-In First-Out (FIFO) 

18.Records of Productions 

19.Records of Shipments 

20.Procedure / Records of Incoming Quality Control (IQC)

21.Work Instructions (WI) 

22.Procedure / Records of In-Process Quality Control (IPQC) 

23.Procedure / Records of Outgoing Quality Control (OQC/FQC) 

24.Procedure / Records of Sharp Tool Control 

25.Procedure / Records of Needle Control (If Applicable) 

26.Procedure / Records of Metal Detection (If Applicable) 

27.Procedure / Records of Anti-Static Control Measures (If Applicable) 

28.Work instruction of Hi-Pot Test for Electricals (If Applicable) 

29.Test Instructions and Records

30.List of Test Equipment 

31.Procedures / Records of Calibration

32.Records of Customer Complaint Handling

33.Records of Quality Trainings