PURCHASING AND SUPPLIERS APPROVAL

1.0. Purpose.

1.1 This procedure defines the control of materials/services purchased by the company and ensures
that only approved suppliers supply goods/services to the company

2.0. Applicability.

This procedure applies to all products, materials/components to be used in the products and services
purchased by the company and the suppliers of these products, material, services.

3.0. Responsibility:

It is responsibility of Export Manager to ensure that the procedure is followed.

4.0. Procedures.

4.1. Purchasing of all types (purchasing of materials, components, products, services etc.) is made from
the approved suppliers.

4.2.1. Approval of suppliers is performed by one of the following methods:

a. any supplier holding a nationally or internationally recognized approval may be

automatically included

b. any supplier who can demonstrate a history of satisfactory supply to the company may be
included

any supplier assessed by a representative of BIO-BIZ (PRIVATE) LIMITED or by completion of the Quality
Questionnaire or by providing company profile etc.

any supplier recommended by a customer of BIO-BIZ (PRIVATE) LIMITED for a specific contract only may
be included.

e. any supplier may be used if he is the sole source of supply of the product/service required; in
this instance special inspection instructions may be issued

4.2.2. If any product and service is upgraded revaluation of the concerned suppliers will be performed
by the QA Manager using form 04/B.

4.3. A list of approved suppliers is maintained by the QA Manager and a copy of this list is available
to all persons engaged in purchasing activities.

4.4. QA Manager also maintains records of assessment of suppliers and subsequent follow-up
actions including completed quality questionnaire, if any, visit assessment report, company profile etc.
4.5 All purchase orders are issued in written form on Purchase Order Form #04 for Purchasing
including purchase of stainless steel material, filed devices, polished devices, components like stainless
steel wire, stainless steel rivets and stainless steel screws.

4.5.1. All purchase orders show full details of the product/material required and are signed and

dated by the QA Manager. The supplier may be requested to issue/sign Certificates of Conformity. Upon
receipt of purchased materials/ products the accompanied documents, if any will be reviewed for their
adequacy.

SOP # 04

Revision level : 00/Nov 15, 2019

Copy # SM/01

Page # 2 of 2

PURCHASING AND SUPPLIERS APPROVAL

4.5.2. All purchase Orders are reviewed and approved by Export Manager for adequacy of the

specified requirements prior to release.

4.5.3. For suppliers processes like, heat treatment, electro polishing, Fitting, Polishing, calibration etc.
Request Form # 04/A is issued to the concerned suppliers along with the products.

4.5.4. Copies of all purchase orders/request forms issued and certificate of conformity are held on file
for reference purposes either in purchasing file or in the file of production record of relevant lot.

4.5.5. If there is need of inspection/verification of any products at the suppliers premises by BIO-BIZ
(PRIVATE) LIMITED or its client, this is identified on the relevant purchasing documents like Purchase
Order/Request form.

4.6. The suppliers who fail to maintain required standards of performance lose their approved status.

4.7. Performance of the suppliers is monitored by the Export Manager using Form # 04/C

. The procedures detailed above do not necessarily apply to suppliers of "non-quality"

related products, i.e. office stationary, etc.

4.9. The supplier who will supply sub-standard products/material more than three times in a

year will be re-evaluated.

4.10. All suppliers of the organization shall sign written quality agreement with the organization as per
Form# 04/E.

5.0. References

5.1. ISO 13485: 2016- 7.4, Sec- 820-50 of cGMP as set forth in Quality System Regulation (QSR) which is
part 820 of 21

CFR, Quality Manual Section # 4.3