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SU ZHOU JENITEK PRECISION DEVICE CO.,LTD. Quality Control

Certification
Good quality Medical Device Contract Assembly for sales
Good quality Medical Device Contract Assembly for sales
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QC Profile
Incoming Quality Control

The quality department is responsible for the IQC process which is used to control suppliers, verify incoming materials and handle material quality problems.

This prevents nonconforming product material to be unintentionally used.

 

Specific tasks of IQC include:

· Perform approved vendor checklist

· Evaluate supplier quality records

· Perform sampling and inspection of incoming materials

· Monitor quality control of inspected properties and alert engineering staff of deviations

· Continuous enhancement of the IQC process

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

 

In-Process Quality Control (IPQC)

The IPQC process is used to control the manufacturing process, assembly and testing, helping to decrease the occurrence of defects and to document how any

defects that occur should be handled.

 

Specific tasks of IPQC include:

· Perform inspections on assembled and in-process materials according to inspection STD

· Conduct in-line automated and manual inspections in the production process

· Ensure the conformance of process setup

· Utilize statistical control techniques and watch for significant deviations

· Perform in-process audits to ensure methods are up to standard and to identify factors needing improvement.

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

 

Final Quality Control (FQC)

The quality department is also responsible for the FQC process. FQC is a comprehensive inspection that evaluates the products whether they are acceptable or

not with IQC and IPQC which ensures the validity of previous processes.

 

Specific tasks of FQC include:

· Perform visual and functional inspection

· Apply sampling-based or 100% inspection

· Conduct reliability testing

· Submit failure analysis reports and alert engineering staff

· Archive LHR document

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

 

Outgoing Quality Control (OQC)

The OQC is the last gate before products are delivered to customers. This very important process ensures our shipments are defect-free, LHR is reviewed, and

the delivery information is checked. Products are permitted to be released after the quality manager signs the confirmation.

 

Specific tasks of OQC include:

· Perform visual, dimension and functional inspection

· Apply sampling-based or 100% inspection

· Review and finish LHR document

· Check delivery information

· Quality manager authentication

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

Certifications
  • SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

    Standard:ISO13485

    Number:SX 60131801 0001

    Issue Date:2013-10-16

    Expiry Date:2021-10-13

    Scope/Range:Contract Manufacture of Process Engineering Solutions for Metal & Plastic Components,PCBA,Assemblies and Devices for Medical Devices

    Issued By:TUVRheinland

  • SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

    Standard:ISO9001

    Number:116578

    Issue Date:2017-11-30

    Expiry Date:2018-11-06

    Scope/Range:Design,manufacture and sale of components & assemblies for medical precision devices and mechanical products

    Issued By:Sira Certification Service

  • SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

    Standard:ISO14001

    Number:116577

    Issue Date:2017-11-30

    Expiry Date:2018-11-06

    Scope/Range:Design,manufacture and sale of components & assemblies for medical precision devices and mechanical electrical products

    Issued By:Sira Certification Service

  • SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

    Standard:OHSAS18001

    Number:SSQC14211S0168R0

    Issue Date:2017-11-30

    Expiry Date:2018-11-06

    Scope/Range:Design,manufacture and sale of components & assemblies for medical precision devices and mechanical electrical products

    Issued By:Sira Certification Service

Contact Details
SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

Contact Person: Ms. Hong Gao

Tel: 86-512-66806001

Fax: 86-512-66806002

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