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Quality Control SFRI
Quality Control SFRI
PROFORMA FOR EQUIPMENT AND QUALITY CONTROL
EMPLOYED BY THE MANUFACTURER
Ref No: EST(4)TENDER/34/2021‐22 for 3 Part Hematology Cell Counter Dated 10th Aug 2021
NAME OF THE TENDERER: UNISON BIOMED PVT LTD, BANGLORE
(Note: All details should relate to the manufacturer for the items offered for supply)
1. Name & full address of the Manufacturer: SFRI SARL France
2. (a) Telephone & Fax No +33 055 6688050 Office/Factory/Works
(b) Telex No. Office/Factory/Works
(c) Telegraphic address:
3. Location of the manufacturing factory. FRANCE
4. Details of Industrial License, wherever required as per statutory regulations. ISO 13485
5. Details of important Plant & Machinery functioning in each dept. (Monographs &
description pamphlets be supplied if available). CRO, Automatic Leath Machines, CNC
Machines, Analogue meters, Digital meters for vacuum, voltage, current etc…PCB
Manufacturing plant, Automatic Plant for Electrode manufacturing, Automatic Plant for
Reagent manufacturing etc.
6. Details of the process of manufacture in the factory. As per design of Instruments, on
the chassis all the components being brought and assembling done as per SOP defined. After
finishing of assembly, the instrument goes into Quality control check for final packing.
7. Details & stocks of raw materials held. Sufficient for manufacturing the Instruments.
8. Production capacity of item(s) quoted for, with the existing Plant & Machinery
8.1 Normal – 200 units
8.2 Maximum – 250 units
9. Details of arrangement for quality control of products such as laboratory, testing
equipment etc.
a) For incoming materials & bought out components: There is a separate department who
checks all incoming materials before handing over to production department
b) For Process Control: It is being done by designated staff
c) For final product evaluation: After production all the instruments pass through final
product evaluation and then only released for sales
10. Details of staff:
10.1 Details of technical supervisory staff in charge of production & quality control. 05
10.2 Skilled labour employed. 30
10.3 Unskilled labour employed. 50
10.4 Maximum No. of workers (skilled & unskilled) employed on any day during the 18
months preceding the date of Tender. 65
11. Whether Goods are tested to any standard specification? If so, copies of original test
certificates should be submitted in triplicate.
a) ISO 13485 Certified Company
b) CE Approved product
12. Is the Manufacturer registered with the Directorate General of Supplies and Disposals, New
Delhi 110 001, India? If so, furnish full particulars of registration, period of currency etc. with a
copy of the certificate of registration. NO
Yours faithfully,
for and on behalf of SFRI Sarl,
The Chief Executive Officer
(Gilles Mougin)