BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR PURCHASING
SOP No. DEPARTMENT REV. NO. EFFECTIVE. DATE REVIEW DATE PAGE No.
BL-ST-002 STORE 02 10.11.2015 09.11.2017 1 of 4
1.0 PURPOSE
The purpose of this procedure is to ensure that the purchased product conforms to the
organization and customers’ requirements.
2.0 SCOPE
The scope of this procedure is limited to the selection, evaluation of suppliers, issuance of
purchase orders and verification of purchased products.
3.0 RESPONSIBILTY
Store Head
4.0 PROCEDURE
4.1 Purchasing process
4.1.1 The organization controls its purchasing processes to ensure that purchased
products conform to specified requirements of the organization. The control is
exercised by purchasing items from selected suppliers on the basis of their ability
to meet specified requirements including Quality Management System and
specific Quality Assurance requirements.
4.1.2 The type and extent of control applied to the supplier and the purchased product
depends upon the effect of the purchased product on subsequent product
realization process or the final product.
4.1.3 The organization evaluates and selects suppliers based on their ability to supply
product / service in accordance with the organization’s requirements. Criteria for
selection of various suppliers and methodology for their evaluation are defined as
per succeeding paragraphs. The results of evaluations and follow-up actions are
recorded and maintained.
4.1.4 Potential suppliers are generally selected based on any of the following
conditions:-
4.1.4.1 Site Visit: Assessment of the supplier’s organization including
verification of process capability, manpower and machine adequacy
and Quality System. (This requirement may be waived in the case of
reputed suppliers or that it proved not feasible or the suppliers have
been certified to ISO 9000).
4.1.4.2 Supplier Appraisal Form: Suppliers are requested to complete a set of
questionnaire, Form No. BL-ST-002-01X (Appraisal Form) pertaining
to capability and quality management system and thereafter to be
evaluated by the relevant functions.
PREPARED BY APPROVED BY
Format: BL-F-QS-001A
BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR PURCHASING
SOP No. DEPARTMENT REV. NO. EFFECTIVE. DATE REVIEW DATE PAGE No.
BL-ST-002 STORE 02 10.11.2015 09.11.2017 2 of 4
4.1.4.3 Inspection: Inspection at source or on receipt, and acceptance of the
first lot of product / sample ordered.
4.1.4.4 Recommendations: Upon recommendations by Departmental Heads
and other senior officers of the company based on market reputation
of the supplier and / or their experience.
4.1.5 The initial Enlistment of Suppliers has been done on the basis of one of the criteria
mentioned above and those vendors who have been supplying the goods since
long time and whose performance has been found to be good have been enlisted.
4.1.6 All newly sourced suppliers are subjected to Technical Evaluation and final
approval by the Manager Quality, where required other departments are involved
in review processes.
4.1.7 Following the successful evaluation, the supplier is qualified as an Approved
Supplier and the Store Department includes these suppliers in the existing
“Approved Suppliers List” which generally contains following information.
4.1.7.1 Company Name / Address/contact No.
4.1.7.2 Product or Services which may be purchased.
4.1.8 The company assures that the suppliers’ quality controls are effective. Deviation
from the specification in the Purchased Product can result in significant changes in
the characteristics or performance of the finished product.
4.1.9 Supplier’s performance is evaluated and re-evaluated on an ongoing basis to
ensure that the supplier continues to comply with the company’s technical and
quality requirements.
4.1.10 Where a supplier persistently supplies late or defective items, or is unwilling to
make efforts to improve performance, the Purchase Department annotates the
approved supplier list to indicate that the supplier is not used.
4.1.11 The performance of suppliers are evaluated once in every year, preferably in the
month of April / May with respect to the Quality and Delivery Rating accordance
with Form No. BL-ST-002-02X (Supplier Rating) by Store Department.
4.1.12 Records of suppliers whose performance is not found to be satisfactory are
forwarded to the Plant Manager /Quality manager for review and action.
4.1.13 Approved Supplier List is maintained by Store Department. The “Approved
Supplier List” is updated after every addition or deletion and updated copy is
printed every two years or earlier as decided by the Plant Manager/Quality Head.
PREPARED BY APPROVED BY
Format: BL-F-QS-001A
BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR PURCHASING
SOP No. DEPARTMENT REV. NO. EFFECTIVE. DATE REVIEW DATE PAGE No.
BL-ST-002 STORE 02 10.11.2015 09.11.2017 3 of 4
4.2 Purchasing Information
4.2.2 Purchasing documents contain clear information describing the product / service
to be purchased indicating scope of supply, technical data / drawing /
specifications, inspection requirements, quality requirements, delivery details etc.
as applicable and also include (where appropriate):-
4.2.2.1 Requirements for approval of product, procedures and equipment.
4.2.2.2 Requirements of Quality Management System.
4.2.3 The Requisitioner raises a Purchase Indent for the purchase of goods / items etc.
required and submits to the Purchase Department, duly completed and approved
for necessary action. Specification, if not already in the record, for the items to
be procured is clearly defined by the Requisitioner.
4.2.4 Store department shall raise the Purchase order against the Purchase indent, if
Purchase Indent is not initiated ( i.e. for services, maintenance, repairing,
construction etc.) the Purchase Department identifies the requirement from the
Stock List / Inventory and raises the work order accordingly.
4.2.5 The Purchase Order Form is a typical one and data may change due to nature of
product being ordered.
4.2.6 Store Department ensures that purchases as far as possible are made from the
Approved Suppliers only unless otherwise specifically authorized.
4.2.7 Attach required compliance test specification of all incoming Packaging, raw,
brought out material with Purchase order and verify material against material test
specification provided to supplier along with PO.
4.2.8 For any urgent / emergency purchases, the goods / items or services may be
procured from the supplier who is not in the approved list. However, in all such
cases a prior approval from QA & the management is obtained.
4.2.9 The Purchase Orders clearly define any special conditions required for storage or
transport of the purchased materials that could significantly affect the safety,
effectiveness or intended use of the product.
4.2.10 The Purchase Orders/ work orders are reviewed and verified for completeness and
adequacy and approved by the Managing Director / HOD- Store as required.
4.2.11 Should there be any change or amendment to the original purchase order/work
order, the purchase department generates a revised PO/ WO or amendment to
the PO/WO. In such cases, the Store Department is responsible for co-ordination
with the supplier to ensure that the revised PO/WO is acknowledged and accepted
by them.
4.3 Verification of purchased product
PREPARED BY APPROVED BY
Format: BL-F-QS-001A
BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR PURCHASING
SOP No. DEPARTMENT REV. NO. EFFECTIVE. DATE REVIEW DATE PAGE No.
BL-ST-002 STORE 02 10.11.2015 09.11.2017 4 of 4
4.3.2 The organization establishes and implements the activities necessary for ensuring
that the purchased product and / or service meet specified requirements. This is
achieved either through verification of the product or service upon receipt or
performing inspection / verification activity at supplier’s premises during
manufacturing and / or on finished products as per Quality Control Procedure.
5.0 APPLICABLE FORMS
Appraisal Form BL-ST-002-01X
Supplier Rating BL-ST-002-02X
Where X denote the current version /revision no.
6.0 REFERENCE
Quality Manual ISO – 9001
7.0 ABBREVIATIONS
N/A
8.0 SAFETY AND PRECAUTION
NIL.
9.0 DISTRIBUTION
Department No. of Copies
Quality Assurance Master Copy
Store Controlled Document 01
PREPARED BY APPROVED BY
Format: BL-F-QS-001A
