PM NETWORK

Plot No. 150/93/B, Maruti Industrial Estate Behind Glow Tech Steel,
Gondal Road, Rajkot 360004
Document STANDARD OPERATING PROCEDURE
Title Procedure for Preparation & Control of Sop
Document No. ZPI/SOP/QA/001 Effective Date : 01/07/2022
Revision No. R-00 Revision Date : 30/06/2025

1.0 PURPOSE
To lay down the procedure for preparation and numbering of documents.

2.0 SCOPE
This procedure is applicable for the preparation and numbering of SOPs/documents, as per the regulatory and
QMS requirement at PM NETWORK, Plot No. 150/93/B, Maruti Industrial Estate Behind Glow Tech Steel, Gondal
Road Rajkot 360004.

3.0 RESPONSIBILITY
3.1 Originating department shall be responsible for preparation, drafting, checking and reviewing of SOPs.
3.2 Originating department head shall be responsible for the reviewing SOP for procedural, technical aspect
and imparting the training of concerned personnel before effective date of SOP.
3.3 Head Quality Assurance shall be responsible for compliance, implementation approval of documents.

4.0 PROCEDURE
4.1 Document Preparation.
4.1.1 All the SOPs shall be prepared in the Format No. ZPI/QA/F1, Rev.00.
4.1.2 All the Forms shall be prepared in the Format No. ZPI/QA/F2, Rev.00.
4.1.3 All the documents shall be written in English language and shall be clear, instructive, sequential,
and unambiguous. Whenever necessary, SOPs shall be translate in the local language i.e. Hindi.
4.1.4 Document shall be typed using style “Regular”, font “Calibri” with font size “10”. Use of capitals,
bold, shall be made whenever appropriate.
4.1.5 Document shall be prepared in Microsoft word with Page margin in page setup shall be; top
“0.5”; bottom “0.5”; left “0.7”; right 0.5”; gutter “0”; header “0.5” and footer “0.5” from the
edges. Paper size shall be A4 size (8.27: X 11.69”).
4.1.6 The line spacing shall be “Single line” with “Justified” aligned, outline level “Body text” and 0
points shall be paragraphed by one line spacing.
4.1.7 During SOP preparation the draft copy shall be circulated within concerned department prior
to approval for preparer signature and reviewer signature with an embossing (or hand written)
indicating the document is draft in the middle of each page of the SOP.
4.1.8 User department shall impart a training to the concerned employees before effecting the SOP.
4.1.9 The user department shall forward the final draft copy of SOP along with training attendance
record and updated softcopy to the QA department for controlling, approval and distribution.
4.1.10 QA department shall take the final print out of SOP with already typed Effective and Review
date in DD/MM/YYYY fashion.
4.1.11 All the documents shall be signed & date with blue ink only.
4.1.12 Documents shall be reviewed every 2 years and shall be revised as and when it needs revision.

4.2 Document Numbering:

4.2.1 SOP no. shall contains ZPI/SOP/XYZ/YYY,
Where, ZPI denotes the company code
SOP denotes Standard Operating Procedure.
XYZ denotes code for Department (refer table-1)
YYY denotes the serial no. i.e. 001, 002, 003 and so on.
E.g.: ZPI/SOP/QA/001.

PREPARED BY APPROVED BY
NAME Zeel Patel Pratik Mehta
DESIGNATION QA Manager Owner
SIGNATURE
Page 1 of 3
 PM NETWORK
Plot No. 150/93/B, Maruti Industrial Estate Behind Glow Tech Steel,
Gondal Road, Rajkot 360004
Document STANDARD OPERATING PROCEDURE
Title Procedure for Preparation & Control of Sop
Document No. ZPI/SOP/QA/001 Effective Date : 01/07/2022
Revision No. R-00 Revision Date : 30/06/2025

Table-1
S.No. Code Department
1. QA Quality Assurance Department
2. QC Quality Control Department
3. PRD Production Department
4. HRD Human Resource Department
5. MNT Maintenance Department
6. PUR Purchase Department
7. STR Store Department

4.2.2 Documents (refer table-2) shall have the numbering in the following manner:
ZPI/QM/ZZ, ZPI/SMF/ZZ
Where, ZPI denotes ZP IMPEX
QM denotes Quality Manual.
SMF denotes Site Master File.
ZZ is the serial no.
E.g. ZPI/QM/01, ZPI/SMF/01
Table-2
S.No. Code File Name
1. SMF Site Master File
2. DMF Device Master File
3. TF Technical File
4. RM Risk Management File
5. CER Clinical Evaluation Report
6. QM Quality Manual

4.2.3 Forms associated and applicable to SOPs shall have the numbering in the following manner:
ZPI/SOP/XYZ/YYY/FZ
Where ZPI/SOP/XYZ/YYY is defined in the clause no. 4.2.1 and
F denotes Format
Z denotes serial number
E.g. ZPI/SOP/QA/001/F1.
4.2.4 Formats shall have the numbering in the following manner:
ZPI/XYZ/FZ
Where ZPI denotes ZP IMPEX
XYZ denotes code for Department (refer table-1)
F denotes Format
Z denotes serial number
E.g. ZPI/QA/F1

4.3 Content (text matter) of the SOPs.

4.3.1 PURPOSE: It defines the purpose/objective of the procedure.
4.3.2 SCOPE: It defines the area of application.
4.3.3 RESPONSIBILITY: Personnel directly associated with the implementation of the document.
4.3.4 PROCEDURE: Details the specified way of carrying out stepwise operation/activities.
PREPARED BY APPROVED BY
NAME Zeel Patel Pratik Mehta
DESIGNATION QA Manager Owner
SIGNATURE
Page 2 of 3
 PM NETWORK
Plot No. 150/93/B, Maruti Industrial Estate Behind Glow Tech Steel,
Gondal Road, Rajkot 360004
Document STANDARD OPERATING PROCEDURE
Title Procedure for Preparation & Control of Sop
Document No. ZPI/SOP/QA/001 Effective Date : 01/07/2022
Revision No. R-00 Revision Date : 30/06/2025

4.3.5 APPLICABLE FORMS: Details of applicable and associated Formats.

4.3.6 REFERENCE: Any guidance documents or standards referred.
4.3.7 ABBREVIATION: Meaning of all the words used in short from.

4.4 Change History Record:

4.4.1 Change History Record for documents shall be maintained in the Form No. ZPI/SOP/QA/001/F1:
Change History Record.

5.0 APPLICABLE FORMS

ZPI/SOP/QA/001/F1: Change History Record

6.0 REFERENCE
ISO 13485:2016 Clause No 4.1, 4.2
MDR Schedule 5th: Clause 4.1, 4.2

7.0 ABBREVATIONS
QM : Quality Manual
SMF : Site Master File
SOP : Standard Operating Procedure
ZPI : ZP IMPEX

PREPARED BY APPROVED BY
NAME Zeel Patel Pratik Mehta
DESIGNATION QA Manager Owner
SIGNATURE
Page 3 of 3