[Organization logo] [Organization name] Ref. [No.

Understanding the organization and its context

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to the organization coding system
Version Version Date
Revision No. Revision Date
Author Signature
Reviewed by Signature
Approved by Signature

Distribution & Retrieval

Copy Returned
No. Date Distributed to Signature
Date Signature

Change
Page Change description Created Reviewed Approved
No.
Date
What changed? Why changed? by by by

Records related to this document

Storage
Sr.
Ref. No. Record name Retention Responsibility
No. Location
interval
Internal and external
1
issues
2 Interested parties
Reviewing information
3 about the interested
parties and their
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relevant requirements
Product & processes
4
index
5 Process definition
[Process name]
6 sequence &
interactions

Documented information Disposition

Ref.
Date Responsibility Approved by Reason
No.

Table of Contents
List of Abbreviations ..................................................................................................................3
Preface ........................................................................................................................................5
[Organization name] Profile ...................................................................................................5
Mission of the [organization name] .......................................................................................5
Vision of the [organization name] ..........................................................................................5
Organization Policy .................................................................................................................5
Quality Policy ..........................................................................................................................5
Quality Objectives ..................................................................................................................5
[Organization name] Strategies ..............................................................................................5
[Organization name] structure ...............................................................................................5
Organization chart ..................................................................................................................6
Scope ..........................................................................................................................................7
Context of the organization........................................................................................................7
Internal and external issues ...................................................................................................7
The scope of the quality management system (QMS) ...............................................................8
Exclusions ...............................................................................................................................8
Quality Management System and its Processes.........................................................................9

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List of Abbreviations
Avg. Average
B/D Breakdown
Blc Balance
C Conformity
C/A Corrective Action
CAR Corrective Action Report
CE Chief Engineer
DRG Drawing
Dept. Department
Exp. Experience
Ext. Extension
FMEA Failure Mode and Effect Analysis
HoD Head of Department
Hrs Hours
HR Human Resources
ID. No. Identification number
IQA Internal Quality Audit
Maint. Maintenance
M/C Machine

MD Managing Director

Mgmt. Management

MOD Model

MR Management Review / Management Representative

MRM Management Review Meeting

NC Nonconformance
OFI Opportunity for Improvement
Op Operation
PPE Personal Protective Equipment
QA Quality Assurance
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QMS Quality Management System

Ref. Reference
Rev. Revision
RoHS Records / use of; non-hazardous
SCAR Supplier Corrective Action Request
Sign. Signature
SOP Standard Operating Procedure
TTL Total of total
WEEE Waste of Electrical and Electronic Equipment
WIP Work Instruction Process
w.r.t. with respect to
yrs Years

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Preface

[Organization name] Profile

[Mention all information e.g. (field of work, scope, address, etc.) identifying the
organization as an abstract]

Mission of the [organization name]

[[Organization name] top management] must establish strategic quality management

policies, directives and objectives consistent with the purpose and capabilities of the
organization]

Vision of the [organization name]

[The organization should have clarity in their mission and vision]

Organization Policy

[The organization general policy]

Quality Policy

[The quality policies and quality objectives are to be established for the
quality management systems that are compatible with the strategic direction of
the organization. Policies should be developed in line with the mission]

Quality Objectives

[The objectives are to be in line with the vision of the company]

[Organization name] Strategies

[The strategies are to be developed and modified from time to time depending on the
situation by keeping the target of achieving the vision. The organization needs to
specify the strategies for the year and give yearly targets]

[Organization name] structure

[Top management must establish the organizational structure and internal

environment that motivates personnel to achieve the organization’s quality
management goals and objectives]

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Organizational chart

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Scope

This quality manual describes the requirements for the quality management system to
enable [organization name] to:

 demonstrate its ability to consistently provide product / service that meets

customer and applicable statutory and regulatory requirements (legal
requirements);
 enhance customer satisfaction through the effective application of the system,
including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.

Context of the organization

[Determine internal and external issues relevant to the organization’s purpose,

strategic direction and that affect ability to achieve desired results of its quality
management system]

[[Job title] is responsible for monitoring and reviewing the information about these
issues]

Internal and external issues

[Determine the internal and external environments within which the organization
seeks to achieve its sustainability goals and that may influence the way in which it
manages risks]. It may include:

 Positive and negative factors or conditions for considerations.

 (International, national, regional or local) issues arising from legal,
technological, competitive, market, cultural, social and economic
environments.
 Issues related to values, culture knowledge and performance of the
organization.

You can analyze the internal and external issues through PEST (Political, Economic,
Social, and Technology Factors) and SWOT (Strength, Weakness, Opportunity, and
Threat) analysis.

PEST

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Political Factors (P) Economic Factors (E)

1- 1-
2- 2-
3- 3-
Social Factors (S) Technology Factors (T)
1- 1-
2- 2-
3- 3-

SWOT

Strength (S) Weakness (W)

1- 1-
2- 2-
3- 3-
Opportunity (O) Threat (T)
1- 1-
2- 2-
3- 3-

The scope of the quality management system (QMS)

[Organization’s name] determines the boundaries and applicability of the QMS to

establish its scope considering defined external and internal issues, requirements of
relevant interested parties, and the organization's products and services types
providing any requirement justification of the ISO 9001-2015 that it is not applicable
to its QMS scope.

[To derive the scope you need to identify organization’s purpose, vision, mission,
values, and strategic direction]

The boundaries of QMS […]

The scope […]

Exclusions

[You can only exclude a requirement, if that is not applicable and does not affect the
product quality. The following clauses and requirements of QMS scope and ISO
9001:2015 are not applicable to [organization's name] business]

No. /
Scope requirement / Clause title Reason of exclusion
Clause no.

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Quality Management System and its Processes

[The organization must establish, implement, maintain and continually improve its
quality management system as per the requirement of the ISO 9001:2015 standard by
determining the process needed and its application throughout the organization]

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