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Quality policy and objectives

Quality system

1. Implement iso9001:2015 quality management system

2. implement iso13485:2016 medical device quality management system requirements for regulationsCustomer requirements.

Quality policy

People oriented, continuous improvement;
Based on quality and pursuing excellence;
Scientific and rigorous, high quality and high efficiency;

Quality goal

A) On time delivery rate is 100%;
B) Customer complaint rate ≤ 2%, customer feedback response rate 100%;
C) The qualified rate of process (IQC, IPQC, oqc) quality spot check is over 98%.
D) Scrap rate ≤ 1%

Product quality planning and control

1.Product manufacturing and control process; see attachment.Production flow chart and order review.xlsx025 process inspection control procedure.doc
2.Product risk assessment; see attachment.1301-00-9602 risk management report (1). Doc
3.Product process; see attachment.Ef02 control document \ ef02 process flow.xlsx
4.Product process diagram; see attachment.Ef02 control file \ ef02 process diagram.pdf
5.Product quality control plan; see attachment.Ef02 control file \ ef02's control plan.xlsx
6.Product FMEA; see attachment.Ef02 control file \ ef02 fmea.xls
7.Sip of each process of the product; see the attachment.Ef02 control document \ ef02 CNC SIP (1). Xlsef02 control document \ ef02 finished product appearance inspection instruction.xlsx
8.Quality sampling standard and anodizing inspection standard; see the attachment.General spot check standard of quality department (Chengyu) 2018.09.20f.doc general anodizing inspection standard a (Chengyu). Doc
9.Raw material feeding control process; see attachment.Incoming quality control flow chart 02.pdf
10.Delivery quality control process; see the attachment.016 finished product inspection control procedure.doc

Main testing equipment

Name of testing equipment	Equipment condition	Quality assurance capability	Number	Use status of testing equipment
Three coordinates	Normal	Ensure the precise dimension and geometrical tolerance of products	1 stations	Normal
The 2.5 dimension	Normal	Ensure the precise dimension and geometrical tolerance of products	1 stations	Normal
Altimeter	Normal	Check the accuracy and size of products	3 stations	Normal
Normal	Projector	Projector	1 stations	Normal
Quadratic element	Normal	Ensure the precise dimension and geometrical tolerance of products	2 stations	Normal
Rockwell hardness tester	Normal	Test the hardness of raw materials and products after heat treatment	1 stations	Normal
Film thickness gauge	Normal	Test product coating thickness	1 stations	Normal

Measurement accuracy and calibration standard of main testing equipment

Serial number	Entry name	Size range	Measurement accuracy(mm)	Best correction capability(mm)	Calibration standard
1	Plug gauge	Diameter 10mm~50mm	0.001	0.002	ISO/IEC17025 Secondary length correction
2	Plug gauge	Diameter 10mm~50mm	0.001	0.001
3	Caliper (digital display)	0 ~ 150 mm (resolution: 0.01)	0.01	0.02
4	Caliper (head)	0 ~ 150 mm (resolution: 0.02)	0.02	0.04
5	Outside diameter micrometer (digital display)	0 ~ 50mm (resolution: 0.001)	0.001	0.003
6	Three point inner diameter micrometer (scale type)	0 ~ 50mm (resolution: 0.002)	0.002	0.004
7	Surface roughness standard	Ra:≦4μm		Ra:0.16μm
8	Three coordinate mh3d	440490390	0.0035	0.005	GB/T16857.2/ISO10360-2
9	The 2.5 circle	400300200	0.002	0.004	ISO/IEC17025 Secondary length correction
10	The 2.5 circle	400*300	0.002	0.004
11	Altimeter (TESA）	0~700mm	0.001	0.002
12	Altimeter (Sanfeng）	0~600mm	0.001	0.002
13	Hardness tester	20-88HRA 20-100HRB 20-70HRC	0.5 Rockwell unit	1 Rockwell unit	GB/T230.1-2004/ISO6508.2
14	Projector	300200150	0.003	0.005	ISO/IEC17025 Secondary length correction

Calibration list of main testing equipment