*sample report* qc_covid... · export markets: markets y/n us/north america european union south...

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COVID-19 Medical Personal Protective Equipment (PPE) Supplier Verification *Sample Report* North America +1-813-252-4770 Latin America +52-81-2721-0928 Europe & Middle-East +49-8179-998-7593 Asia & Asia Pacific +886-2-2832-2990 India +91-120-4291971 Website www.proqc.com Contact Pro QC at [email protected] “By opting to receive a copy of this sample Report from Pro QC, users accept and agree to be bound by the clause on Confidential Information outlined in the General Terms and Conditions of Service. This sample report is provided by Pro QC International to prospective clients for reference purposes only. Users may not share or re-distributed this Sample Report with third parties, nor use or alter, in part or whole, the structure or content of this Sample Report for use other than as intended herein.”

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COVID-19 Medical Personal Protective Equipment (PPE) Supplier Verification

*Sample Report*

North America

+1-813-252-4770

Latin America +52-81-2721-0928

Europe & Middle-East

+49-8179-998-7593

Asia & Asia Pacific +886-2-2832-2990

India

+91-120-4291971

Website www.proqc.com

Contact Pro QC at [email protected]

“By opting to receive a copy of this sample Report from Pro QC, users accept and agree to be bound by the clause on Confidential Information outlined in the General Terms and Conditions of Service. This sample report is provided by Pro QC International to prospective clients for reference purposes only. Users may not share or re-distributed this Sample Report with third parties, nor use or alter, in part or whole, the structure or content of this Sample Report for use other than as intended herein.”

Rev

1

Assessment Date

1/0/1900

Supplier Information:

Supplier Name:

Supplier Address:

Supplier Address:

Phone Number:

Fax Number:

E-mail:

Year Established: Business License No.

Production Area: m^2 Warehouse Area: m^2

*Include Photo

Type of Ownership

Owner Name: E-mail:

Owner Name: E-mail:

Owner Name: E-mail:

COVID-19 Medical Personal Protective Equipment (PPE)

Supplier Profile

Please select one

A. General Information

Supplier Name

0

Report Number

0

Pro QC's Recommendation

Does the factory has a COVID-19 virus prevention plan (e.g. government manual)?

VERIFIED: The supplier is a legit Medical PPE manufacturer. During the visit, Pro QC representative was able to verify all

the products were available on-site.

ON-HOLD: The supplier is a legit Medical PPE manufacturer. However, during the visit, Pro QC representative only able to

verify some of the products were available on-site.

NOT VERIFIED: The supplier is not a manufacturer of Medical PPE and/or is only a reseller of Medical PPE.

0

0

Photo of Main Gate Photo of Building Entrance

Rev

1

Assessment Date

1/0/1900

COVID-19 Medical Personal Protective Equipment (PPE)

Supplier Profile

Supplier Name

0

Report Number

0

*Please include a photo of the certificate in the Photo Report.

Standard Y/N

ISO 9001:2015

ISO 13485:2016

GMP for Medical

Devices

Others [write name]

Others [write name]

Capacity per Day

days

Does the factory have a cleanroom? If yes, class level of cleanroom:

What is the factory's average lead time from PO placement to delivery of production parts?

How many production lines are in the factory?

Product Name Quantity In-stockProduct Certificate No.

B. Certificates

Certificate Number Expiration Date

Factory Certificates:

*Please include a photos of the product and the certificate in the Photo Report.

Photo of Manufacturing/Cleanroom Area Photo of Finished Product Warehouse

Medical PPE Information (Non-US markets):

Rev

1

Assessment Date

1/0/1900

COVID-19 Medical Personal Protective Equipment (PPE)

Supplier Profile

Supplier Name

0

Report Number

0

*Please include a photo of the certificate in the Photo Report.

FDA Registration Owner/Operator Number:

Export Markets:

Markets Y/N

US/North America

European Union

South America

Domestic

Others

Photo of FDA Registration Photo of GMP for Medical Devices Certificate

D. Exporting Markets

Factory Certificates (for US Market ONLY):

Product Certificates (for US Market ONLY):

Listing Number Proprietary Name Model

C. United States (US) Market Only

Units Exported % of Business Volume

Rev

1

Assessment Date

1/0/1900

COVID-19 Medical Personal Protective Equipment (PPE)

Supplier Profile

Supplier Name

0

Report Number

0

Production and Quality Assurance & Quality Control:

E. Employee Information

Total # of Employees:

Total # of Inspectors:

Total # of Auditors:

Total # of Machine Maintenance:

Total # of Lab Technicians:

Total # of Production Employees:

Total # of Assembly Employees:

Total # of Packaging Employees:

0

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Others [write name]

A. FACTORY CERTIFICATES

ISO 9001:2015 ISO 13485:2016

GMP for Medical Devices COVID-19 Virus Prevention Plan

Others [write name]

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Product - Photo Product - Certificate

Product - Photo Product - Certificate

Product - Photo Product - Certificate

B. PRODUCT PHOTO & CERTIFICATE

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Product - Photo Product - Certificate

Product - Photo Product - Certificate

Product - Photo Product - Certificate

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Product - Photo Product - Certificate

Product - Photo Product - Certificate

Product - Photo Product - Certificate

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Product - Certificate

Product - Photo Product - Certificate

Product - Photo Product - Certificate

Product - Photo

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Photo Photo

Photo Photo

Product - Photo Product - Certificate

C. ADDITIONAL PHOTOS

1

COVID-19 Medical Personal Protective Equipment (PPE) Rev.

Photo Report

Supplier Name Audit Date Report No.

0 1900/1/0 0

Photo Photo