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SOP Guidelines for Quality Systems

Standard operating procedures (SOPs) provide step-by-step instructions for quality systems, operations, and maintenance. SOPs establish uniform practices, ensure regulatory compliance, and improve performance. They define requirements for document structure, including headers with title, department, number, and approvals; as well as standardized formatting, pagination, and revision history. SOPs benefit organizations by promoting consistency and efficiency across all departments.

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Prince Moni
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569 views2 pages

SOP Guidelines for Quality Systems

Standard operating procedures (SOPs) provide step-by-step instructions for quality systems, operations, and maintenance. SOPs establish uniform practices, ensure regulatory compliance, and improve performance. They define requirements for document structure, including headers with title, department, number, and approvals; as well as standardized formatting, pagination, and revision history. SOPs benefit organizations by promoting consistency and efficiency across all departments.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SOP ON SOP PROCEDURE

What is Standard Operating Procedure :

It is an authorized written document which describes the step by step instructions


requirements for Quality system, performing operations, non specific to any product,
process or material. It provides detailed procedure about systems applicable to various
operation e.g. Equipment’s / Instrument’s / System’s Operation / Cleaning / Maintenance.

Everybody working in organization has to follow the instruction which are written in
SOP and perform their activities accordingly.

Importance of SOP :

It is important for all industry as it explains about the Practices & procedures which are to
be followed by each department before doing any activity. It plays a major role in every
business of a organization & it is the backbone of all industries and integral part of
Quality Assurance

Parameters of SOP :

Paper Size, ( A4 size) Paper Colour required, (White) Header, (with company logo & site
name with Font Size 11 Arial Bold) SOP text (Arial with Font Size of 11) & Footer
(Arial with Font Size of 11 & Footer format number Arial 10) which may vary
organization to Organization.

Each SOP will have a header (in bold letters) with the following details :

Title: Mention the title of SOP for which being prepared, starting with word “Procedure
for”.

Department: Mention respective department for which SOP is being written.

SOP No. : Mention a unique number to each SOP.


Supersedes: Mention previous version of SOP number with revision number. Write
“Nil”, in case of the new SOP is written

Page No. : Mention the current page number followed by the total page numbers

Effective Date: Mention the date, month and year (DD/MM/YYYY) or (DD/MM/YY)

Review Before: Mention the “Review Before” date, Two years from the Effective Date.

Each SOP will have a Footer (in bold letters) with the following details :

Prepared By: Signature, date, name of person and designation shall be put who has
written the procedure.

Reviewed By: Signature, date, name of person and designation shall be put who has
reviewed the procedure.

Approved By: Signature, date, name of person and designation shall be put who has
approved the procedure.

Format No. : All pages will have unique format number on the bottom right hand side
corner outside the border.

Each SOP will have a middle portion (body) with the following subheadings :

Objective: State the aim for writing the SOP & restrict the purpose to one sentence or
maximum two sentences statement, starting with the word “To”. This elaborates the
usefulness of the SOP (elaborates on “What / Why”).

Scope: State the scope for which the SOP will be applicable. The scope may be
applicable for processes / equipment / policies.

Responsibility: State the designation of the person(s) who is / are responsible for activity
(competent enough / operating personnel / executing personnel).

Definition(s): Write the definition of the key / important words used in the SOP

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