QUALITY SYSTEM MANUAL

EPATHUSA

(QSM/ EPATHUSA /01)

Issue No: 01 Date: September 15, 2017

Revision: 01 Date: September 15, 2017

Prepared By

Issued & Controlled By

Approved By

Designation

Process expert team

Hari

Anitha

TABLE OF CONTENTS 
0 REVISION HISTORY  3 
0 INTRODUCTION & SCOPE  3 
1 INTRODUCTION  3 
2 EPATHUSA IT CORPORATE PROFILE  3 
3 SCOPE  4 
4 EXCLUSIONS  4 
0. TERMS & DEFINITIONS  5 
0. QUALITY MANAGEMENT SYSTEM  7 
1 GENERAL  7 
1.1 SEQUENCES OF INTERACTION OF IDENTIFIED PROCESSES  7 
2 DOCUMENTATION REQUIREMENTS  8 
2.1 GENERAL  8 
2.3 CONTROL OF DOCUMENTS  9 
PROJECT/ FUNCTIONAL DOCUMENT AND DATA CONTROL  9 
2.4 CONTROL OF QUALITY RECORDS  10 
0. MANAGEMENT RESPONSIBILITY  11 
1 MANAGEMENT COMMITMENT  11 
2 CUSTOMER FOCUS  11 
3 QUALITY POLICY  12 
4 PLANNING  13 
4.1 QUALITY OBJECTIVES  13 
4.2 QUALITY MANAGEMENT SYSTEM PLANNING  13 
5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION  14 
5.1 RESPONSIBILITY AND AUTHORITY  14 
5.2 MANAGEMENT REPRESENTATIVE  15 
5.3 INTERNAL COMMUNICATION  15 
6 MANAGEMENT REVIEW  16 
6.1 MANAGEMENT REVIEW MEETINGS  16 
6.2 REVIEW INPUT (AGENDA)  16 
6.3 REVIEW OUTPUT  16 
0. RESOURCE MANAGEMENT  17 
1 PROVISION OF RESOURCES  17 
2 HUMAN RESOURCES  17 
2.1 GENERAL  17 
2.2 COMPETENCE, TRAINING AND AWARENESS  17 
3 INFRASTRUCTURE  17 
4 WORK ENVIRONMENT  17 
0. PRODUCT REALIZATION  18 
1 PLANNING OF REALIZATION  18 
2 CUSTOMER RELATED PROCESSES  18 
2.1 DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT  18 

       QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01) 
 
  Page 2 of 32                                                                                Rev.:1.0, Dt: March 15, 2018 
 
2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT  19 
2.3 CUSTOMER COMMUNICATION  19 
3 DESIGN AND DEVELOPMENT PLANNING  19 
4 PURCHASING  20 
4.1 PURCHASING PROCESS  20 
4.2 PURCHASING INFORMATION  20 
4.3 VERIFICATION OF THE PURCHASED PRODUCT  21 
5 PRODUCTION AND SERVICE PROVISION  21 
5.1 CONTROL OF PRODUCTION & SERVICE PROVISION  21 
5.2 VALIDATION OF PROCESS FOR PRODUCTION & SERVICE PROVISION  21 
5.3 IDENTIFICATION AND TRACEABILITY  21 
5.4 CUSTOMER PROPERTY  22 
5.5 PRESERVATION OF PRODUCT  22 
6 CONTROLLING OF MEASURING & MONITORING EQUIPMENTS  22 
0. MEASUREMENT, ANALYSIS AND IMPROVEMENT  23 
1 GENERAL  23 
2 MONITORING AND MEASUREMENT  23 
2.1 CUSTOMER SATISFACTION  23 
2.2 INTERNAL AUDIT  23 
2.3 MONITORING AND MEASUREMENT OF PROCESSES  24 
2.4 MONITORING AND MEASUREMENT OF PRODUCT  24 
3 CONTROL OF NONCONFORMING PRODUCT  24 
4 ANALYSIS OF DATA  25 
5 IMPROVEMENT  25 
5.1 CONTINUAL IMPROVEMENT  25 
5.2 CORRECTIVE ACTION  25 
5.3 PREVENTIVE ACTION  26 
ANNEXURE I - SEQUENCE AND INTERACTION OF PROCESS  27 
ANNEXURE – II ORGANIZATION CHART  28 
ANNEXURE – III REFERENCES  30 
ANNEXURE IV - QUALITY OBJECTIVES  31 
 
 
 

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 3 of 32 Rev.:1.0, Dt: March 15, 2018

1.0 REVISION HISTORY

Date

Nature of Change

Brief Reason for Change

Page / Section

Where Changes

Made

New

Revision

No

15/sep/2017

Baseline document

1.0

2.0 INTRODUCTION & SCOPE

2.1 INTRODUCTION

The Organization’s Quality Management System Manual describes its unique and specific conformance

to the requirements of 9001, Quality Management Systems - Requirements. Each section represents

organization’s vision of quality as seen through the requirements of the standard, needs of customers

and internally defined quality goals and objectives.

2.2 EPATHUSA IT CORPORATE PROFILE

Attach Corporate Profile

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 4 of 32 Rev.:1.0, Dt: March 15, 2018

2.3 SCOPE

SCOPE OF ISO 9001:2015 CERTIFICATION IS

IT Application support and staffing services

2.4 EXCLUSIONS

NIL

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 5 of 32 Rev.:1.0, Dt: March 15, 2018

3.0. TERMS & DEFINITIONS

Term

Definition

Acceptance

Criteria

Defined limits based on characteristics, materials, products or services

Audit

A systematic and independent examination to determine whether quality

activities and related results comply with planned arrangements and whether

these arrangements are implemented effectively and are suitable to achieve

objectives.

Conformance

Compliance with specified requirements.

Control

To exercise authority over and regulate.

Control Feature

A Documented activity to ensure conformance with specific requirements.

Corrective

Action

Measures taken to rectify conditions adverse to quality and to minimize

recurrence

CAPA

A form used to document corrective, preventive and improvements plans.

Effect

The Non – fulfillment of intended requirements.

Documentation

Recorded Information

Failure

Any condition which prevents the product or service from meeting

Specification

Finding

Objective evidence that a control feature of the approved quality program was

not implemented

Testing

Activities such as measuring, examining, testing. Gauging one or more

characteristics of a product or service and comparing these with specified

requirements to determine conformity.

Non Conformity

The non – fulfillment requirements

Observation

Evidence that a survey able/ auditable element exists which is not contrary to

documented requirements but may warrant further qualification or

improvement.

System

Procedure

A document that specifies or describes how an activity is to be performed. It

may include methods to be used, equipment to be used and sequence of

operations

Quality

Conformance to requirements.

Quality

Assurance

All those Planned and systematic actions necessary to provide adequate

confidence that a product or service will satisfy given requirements for quality

Quality Control

The operational Techniques and activities that are used to fulfill requirements

for quality.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 6 of 32 Rev.:1.0, Dt: March 15, 2018

Quality System

The Organizational structure, responsibilities, procedures, process and

resources for implementing the total management system

Quality System

Review

Top management performs a formal evaluation of the status and adequacy of

the quality system in relation to the quality policy and new objectives resulting

from changing circumstances

Specification

A document that prescribes the requirements with which the product or service

has to conform

Traceability

The Ability to trace the history, application or location of an item or activity, or

similar items or activities, by means of recorded identification

Verify

To determine conformance to specified requirements.

ABBREVIATIONS:

BD

Business Development

DOC

Document

HOD

Head Of The Department

HR

Human Resource Development

IA

Internal Audit

MR

Management Representative

MRM

Management Review Meeting

PROJ

Projects

PUR

Purchase

QA

Quality Assurance

QF

Quality Format

QMS

Quality Management System

QSM

Quality System Manual

QSP

Quality System Procedure

EPATHUSA

N&S

Network and System Administration

Admin

Administration

MD

Director

PL

Project Leader

SDH

Solution Delivery Head

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 7 of 32 Rev.:1.0, Dt: March 15, 2018

4.0. QUALITY MANAGEMENT SYSTEM

4.1 GENERAL

EPATHUSA has established documented and implemented a quality management system, maintains the

same and continually improves its effectiveness in accordance with the requirements of ISO 9001:2015.

Following general requirements have been taken care of:

• Processes needed for the quality management system and their application throughout the organization

have been determined.

• Sequences of interaction of these processes have been determined.

• Criteria and methods needed have been determined to ensure that both the operations and control of

these processes are effective.

• The top management ensures the availability of resources and information necessary to support the

operation and monitoring of these processes

• The organization monitors, measures and analyzes these processes.

• Actions necessary to achieve planned results and continual improvement of these processes are

implemented

• Processes needed for the quality management system as determined are managed by the organization in

accordance with the applicable appropriate requirements of ISO 9001:2015.

Quality System in EPATHUSA covers the processes in the following sections:

❖ Top Management

❖ Business Development

❖ Projects

❖ Quality Assurance (Testing)

❖ Network & Administration

❖ HR

❖ Support Services (Purchase)

❖ Internal Audit

❖ Management Review

❖ Corrective and Preventive Action

4.1.1 SEQUENCES OF INTERACTION OF IDENTIFIED PROCESSES

Refer Annexure I

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 8 of 32 Rev.:1.0, Dt: March 15, 2018

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

The EPATHUSA Quality Management System has been defined in three levels.

Level 1 is the EPATHUSA Quality Management System Manual (this document). This Manual

documents the company policies and provides the relationship of the organization’s Quality Management

System to the requirements of ISO 9001:2015.

Level 2 is the Process Manual contains quality system standard operating procedures (SOPs), work

instructions / guidelines that may be issued as required.

Level 3 is various records used in the system that may be maintained as required.

The depth and detail required for the documentation is determined by Management and is dependent

upon the complexity and interaction of the processes and the skills and training needed by personnel

performing the activity.

ISO 9001 Documentation Hierarchy

QUALITY MANUAL

PROCESS MANUAL

(Procedures, guidelines and

Forms & Formats)

RECORDS

1ST Level

3rd Level

2nd Level

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 9 of 32 Rev.:1.0, Dt: March 15, 2018

4.2.2 QUALITY MANUAL

EPATHUSA has established and maintains a quality System manual (this manual of which this portion

is a part), which includes;

• Scope of the quality management system, including details of and justification for any exclusions

(see Section-2)

• The system procedures for the quality management system as required by ISO 9001:2015.

• A description of the interaction between the processes of the quality management system (see

chapter 4.1.1)

4.2.3 CONTROL OF DOCUMENTS

Management Representative controls the preparation, revision, review, approval and release of the QMS

documents.

All QMS documents, new and revised are reviewed and approved prior to release. Director authorizes the

all level of QMS documents

A new version of QMS Documents is released afresh after changes have been identified. MR controls the

distribution and issue of QMS documents and ensures that the pertinent versions of the documents are

available for use and obsolete documents are withdrawn from copyholders and dispose them as

documented in procedure for control of documents

Project/ Functional Document and Data Control

Project/ Functional documents are reviewed by a designated reviewer and approved by the Functional

Heads. The approved documents are released after authorization by the Functional head.

Documents are released afresh after a practical number of changes have been made. The nature of

changes is identified using a revision list, where practicable.

The MR/ Functional heads are responsible for the control, distribution and issue of documents and to

ensure that:

• The pertinent versions of the documents are available for use

• Obsolete documents are withdrawn

• The Master List of project documents is available for reference

• Document and data changes

System Administration Department looks after data security and safety aspects. Backups are taken at

regular intervals to provide safety in the event of any untoward incident or calamity. The group ensures

access to confidential information, files and directories on the network based on appropriate access

authority.

MR / Director/ Functional heads decide the permissions for access to all project/ departmental related

documents/ data and intimate the N&A group.

Reference: QSP for Control of Documents - Process Manual MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 10 of 32 Rev.:1.0, Dt: March 15, 2018

4.2.4 CONTROL OF QUALITY RECORDS

Quality records established to prove evidence of conformity to requirements and of the effective

operation of the quality management system shall be controlled.

Project Quality Records are created and maintained by the Solution Delivery Head/TL while the project is

in progress. After the completion of the project, SDH maintains the archives of the project records

For an ongoing maintenance project, the Technical Leader maintains Quality Records related to

maintenance requests for the period specified in “Document & Data Control Process” after acceptance of

the completion by the client.

Following the completion of all contractual obligations, the organization retains project Quality Records

for a minimum period of 1 Year along with all other Project assets before they are disposed off.

The MR maintains internal audit plans and records for a period of three years

QMS Documents, QMS Review Records are retained till next version released

The respective Functional Head maintains Quality Records generated by the functions. The period of

retention is specified in the Document “Master List of Quality Records” maintained by the MR.

All records should be legible and protected from loss or damage. Access to Project Quality Records

during their retention period is granted to the client, if the Contract provides for such access.

Reference: QSP for Control of Records - QSP/ EPATHUSA/MR/02 in Process Manual MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 11 of 32 Rev.:1.0, Dt: March 15, 2018

5.0. MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

Top management has been actively involved in implementing the quality management system (QMS). It has

provided the vision and strategic direction for the growth of the QMS, and established quality objectives and

the quality policy.

To continue to provide leadership and show commitment to the improvement of the QMS, management will

do the following.

• Communicate the importance of meeting customer, statutory, and regulatory requirements

• Establish quality objectives

• Establish the quality policy

• Conduct periodical management reviews, and

• Ensure the availability of resources.

5.2 CUSTOMER FOCUS

The organization ensures that customer satisfaction requirements are determined and are met with the aim of

enhancing customer satisfaction (see 7.2.1 and 8.2.1). The Organization focusing on customer by identifying

their needs and requirements through customer satisfaction survey reports collected frequently. Currently the

organizations identifies customer needs as below based on past experience,

❖ In time delivery

❖ Best Service and Support

❖ Error/ Bug free applications.

The customer needs are reviewed frequently, normally in every management review meetings or after

periodical meetings with customer by top management.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 12 of 32 Rev.:1.0, Dt: March 15, 2018

5.3 QUALITY POLICY

EPATHUSA management has established the following quality policy, ensuring that it provides a

framework for establishing and reviewing quality objectives.

Vision:

To be the most reliable outsourcing partner in the world

Mission:

To help customers in effectively outsourcing their services to India by making deliveries on time,

within budget, exceeding quality goals and totally customized to the IT & Business requirements of our

customers

Quality Policy:

To be competitive and flexible in providing services by continually striving to exceed customer

expectations

Objectives:

✓ Meet and exceed customer expectations

✓ Continuously develop the competence of the associates

✓ Continuously measure process performance and initiate improvements

✓ Deliver services on time & with in budget

✓ Ensuring and enhancing customer satisfaction

Rev.: 1.0 Director

Date: March 21, 2018 EPATHUSA

EPATHUSA management ensures that the quality policy is communicated and understood by all employees

and that the policy is implemented throughout the company. Quality Policy is communicated to employees

through the New Employee Orientation Program, the Quality Management System Manual and posters located

throughout the organization premises. The Quality Policy is reviewed for continued suitability at Management

Review Meetings.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 13 of 32 Rev.:1.0, Dt: March 15, 2018

5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

The organization ensures that quality objectives, including those needed to meet requirements for [see

7.1], are established at relevant functions and levels within the organization. The quality objectives are

required to be measurable and consistent with the quality policy. The management review committee or

the Director will identifies relevant functions and levels and establish measurable objectives for them

within the overall framework of the quality policy.

Refer: Quality Objectives Annexure IV

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

Organization ensures that

• Planning of Quality Management System is carried out in order to meet the requirements given in

4.1 as well as the quality objectives.

• The integrity of quality management system is maintained when changes to the QMS are planned

and implemented

• Quality planning within EPATHUSA is an integral part of several Quality Procedures

culminating in establishing the Quality Objectives.

• Data presented in management review meetings is used to provide input for quality planning and

continual improvement. Quality planning may include

o Quality objectives

o The process of the quality management system

o The resources needed

o Continual improvement of the system

Reference:

QSP for Management Review (QSP/ EPATHUSA/MR/03) Given in Process Manual - MR

QSP for Corrective and Preventive Action – QSP/ EPATHUSA/MR/05 Given in Process Manual - MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 14 of 32 Rev.:1.0, Dt: March 15, 2018

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

The organization has defined the responsibilities, authorities and their interrelationship in this QSM and

communicated the same within the organization through this manual.

Organization chart and roles & responsibilities refer annexure II

INTER RELATIONSHIP MATRIX

Description

ISO Cl Ref.

No

Top

Mgmt

MR

Projects

BD

QA

Admin

N& A

HR

Control of documents and Records

4.2.3, 4.2.4

S

P

S

Define Quality Policy & Objectives

5.3, 5.4.1

P

S

Responsibility Assignment

5.5.1

P

Nomination of the Management

representative

5.5.2

P

Internal Communication

5.5.3

S

P

S

Management Review

5.6

P

S

Provision of resources

6.1

P

S

Competence, training and awareness

6.2.2

S

P

Infrastructure

6.3

S

P

Work Environment

6.4

P

S

Customer Related Process

7.2

S

P

Design and Development

7.3

P

S

Purchasing

7.4

P

Control of Production and Service

75.1

P

S

Process Validation

7.5.2

Excluded From The System

Product Identification and Traceability

7.5.3

P

S

Handling & Customer Property

7.5.4

P

S

Handling, Storage and Preservation of

Product / Goods

7.5.5

P

Instrument Calibration

7.6

Excluded From The System

Customer Satisfaction

8.2.1

S

P

S

Internal Audit

8.2.2

P

Measurement of Process

8.2.3

P

Measurement of Product

8.2.4

S

P

Control of non conforming product

8.3

S

P

Data Analysis

8.4

P

Corrective and Preventive action

8.5.2, 8.5.3

P

P: Primary S: Support

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 15 of 32 Rev.:1.0, Dt: March 15, 2018

5.5.2 MANAGEMENT REPRESENTATIVE

(She is authorized to nominate officers to assist him in this job from amongst the officers of the

company. These appointees shall carry out the assigned responsibilities under his direction and

guidance)

Sayed Naved is hereby appointed as the Management Representative for the quality management system

covered under this manual and its associated documents. The authority and responsibility of the MR is

defined in the Responsibility & Authority section (See sec. 5.5.1 of this QSM). The duties of MR can be

summarized under the following statements of responsibility:

• Ensuring that processes needed for the quality management system are established, implemented

and maintained

• Reporting to top management on the performance of the quality management system and any need

for improvement

• Ensuring the promotion of awareness of customer requirements throughout the organization.

• Interacting with external parties (certification body and the consultant) on matters relating to

quality management system.

5.5.3 INTERNAL COMMUNICATION

The organization has ensured that appropriate communication processes have been established within the

organization and that communication takes place regarding the effectiveness of quality management

system (Refer Table given below).

There are other communication forums and means available like internal mailing, various management

meetings, team briefings and use of circulars, notice board etc.

COMMUNICATION MATRIX

Information to communicate

Top

Mgmt

MR

Projects

BD

QA

Admin

N& A

HR

Internal Audit Plan and Schedule

A

O

I

MRM Minutes

A

O

I

Customer Complaints

I

NR

I

O

D

NR

Training Intimation

A

O

I

O

Project Conformation

A

NR

D

O

I

NR

I

NR

Project Planning

A

NR

O D

I

NR

I

NR

A - Approved O – Origin D – Destination I- Information NR – Not Required

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 16 of 32 Rev.:1.0, Dt: March 15, 2018

5.6 MANAGEMENT REVIEW

5.6.1 MANAGEMENT REVIEW MEETINGS

Management review meetings are conducted at least once in every 6 months at the end of each internal

audit, or more frequently when required by the Director involving all functional heads responsible for

quality management to ensure the continuing suitability, adequacy and effectiveness of the quality

management system. The main purpose of conducting the reviews of the quality management system is

to assess opportunities for improvement and the need for changes to the quality management system,

including the quality policy and quality objectives. Records of management review are maintained.

5.6.2 REVIEW INPUT (Agenda)

• Follow-up actions from previous management reviews.

• Results of internal/external audits.

• Customer feedback (including grievances/complaints)

• Performance of Suppliers

• Process performance and conformity

• Status of corrective and preventive actions

• Changes that could affect the quality management system, and

• Recommendations for improvement.

• Any other agenda with the consent of the Director / Participants

• Resource Needs

• Quality Policy Suitability

• Quality Objective Analysis

• Trainings Records

Note:

Meeting points discussed in periodic other meetings (such as performance review and Team meetings

conducted by Director are considered as having been discussed in the MR. Meeting. The records of such

meeting are considered part of the management review records.

5.6.3 REVIEW OUTPUT

The output from the management review and other meetings, which is recorded as minutes, includes any

decisions and actions related to;

• Improvement of the effectiveness of the quality management system and it’s processes,

• Improvement of related to customer requirements, and

• Resource needs.

• Training Needs

Reference:

QSP for Management Review (QSP/ EPATHUSA/MR/03) in Process Manual MR

QSP for Corrective and Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 17 of 32 Rev.:1.0, Dt: March 15, 2018

6.0. RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES

The organization has determined and provided the resources, which includes people, infrastructure, work

environment, information, suppliers, material and financial resources needed for implementing and

maintaining the quality management system and continually improve its effectiveness and enhancing

customer satisfaction by meeting customer requirements.

6.2 HUMAN RESOURCES

6.2.1 GENERAL

All employees, including members of management, performing work that affects the quality of any

service related to the organizations are hired on the basis of appropriate education, training, skills and

experience.

Appropriate procedures have been established for the recruitment of permanent and temporary staff.

Verification of candidate qualifications and/or experience normally precedes confirmation of an

appointment. Staff orientation, appraisal, training and development are carried out and recorded in

accordance with documented procedures to ensure that the Organization:

• Employs staff with relevant qualifications and experience;

• Enhances and up-dates the skills of its staff;

6.2.2 COMPETENCE, TRAINING AND AWARENESS

a) Determine the necessary competence for personnel performing work affecting conformity to product

requirements

b) Provide training or take other action to achieve the necessary competence.

The Head HR with the help of other respective department heads, Determines the necessary competence

for personnel performing work affecting product quality,

• Provides training or take other actions to satisfy these needs,

• Ensures effectiveness of the action taken

• Ensures that its personnel are aware of the operation and importance of their activities and how they

contribute to the achievement of quality objectives, and

• Maintains appropriate records of education, training skills and experience.

Reference: Reference: Process Manual – Human Resources

6.3 INFRASTRUCTURE

The organization has determined, provided and maintains the infrastructure needed to achieve conformity to

product requirements. This includes:

a) Buildings, work space and associated utilities,

b) Process equipment (both hardware and software), and

c) Supporting services such as transport, communication or information systems (EPBX, PHONES etc).

Reference: Reference: Process Manual – Network & Administration

6.4 WORK ENVIRONMENT

The human and physical factors of the work environment needed to achieving conformity to product

requirements are determined and managed. Consideration of such factors includes health and safety conditions,

work methods, handling methods, and ambient working conditions and other factors (such as noise,

temperature, and humidity, lighting or weather). These considerations are also reviewed during Management

Review Meetings

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 18 of 32 Rev.:1.0, Dt: March 15, 2018

7.0. PRODUCT REALIZATION

7.1 PLANNING OF REALIZATION

The planning for realization is accomplished by implementing quality standards during contract review,

purchasing, project Development, testing and delivery in accordance with established procedures and

guidelines

These activities include the following to achieve the required level of quality:

• Determining Quality objectives

• Review/acceptance criteria for customer orders, tender submittals and contracts,

• The need to establish processes and documents and to provide resources specific to product

• Required verification, validation, monitoring, measurement inspection and test activities specific

to the product and the criteria for product acceptance

• Identification, control, and calibration of process and test equipment,

• Establishment of product identification and traceability,

• Identification of handling, storage, packaging and shipping requirements,

• Assignment and training of qualified personnel, and

• Identification and preparation of quality records.

The quality management system documented in this QSM and referred documents represent the Quality Plan

for realization of the service presently provided by the organization. Important processes of this plan have

been listed in chapter 4 of this manual and described in this manual or it’s associated documents

appropriately. As and when new activities or services are added, either this documentation shall be updated,

or specific quality plan shall be prepared specifying the processes and the resources to be applied if the

present documentation is not found sufficient to that end.

References: (Following documents represent output of the planning for the current activities)

• This QSM of which this chapter is a part

• Quality System Procedures & Guidelines

• Quality Records

7.2 CUSTOMER RELATED PROCESSES

7.2.1 DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT

All enquiry / order received, or lead generated by BD personnel; they meet MD to determine the

requirements specified by the customer

In this meeting the following points are taken as input,

• Requirements specified by the customer, including the requirements of delivery and post-delivery

activities include, for example, action under warranty provisions, contractual obligations such

maintenance services, and supplementary services as recycling or final disposal,

• Requirements not stated by the customer but necessary for specified use or known intended use (from

past experience with the customers),

• Statutory and regulatory requirements applicable to the product (from governmental requirements and

applicable Standards), and

• Any additional requirements considered necessary by the organization.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 19 of 32 Rev.:1.0, Dt: March 15, 2018

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

The Organization reviews the requirements related to projects and service before submitting the proposal

or accepting the order or changes or amendments to the orders.

The MD / SDH reviews the requirements to ensure that:

• Project requirements / deliverables are clearly defined,

• Contract or order requirements differing from those previously expressed are resolved, and

• The organization has the ability to meet defined requirements.

Changes to product requirements have to be in writing and the same shall be communicated to concern

departmental heads

7.2.3 CUSTOMER COMMUNICATION

The Director / Business Development Personnel / Projects Team communicate with the customer

organization regarding;

a) Enquiries, contracts or order handling, including amendments, and

b) Clarifications regarding project during development

c) Customer feedback including customer complaints

Refer: Reference: Process Manual – Business Development

7.3 DESIGN AND DEVELOPMENT PLANNING

7.3.1 DESIGN AND DEVELOPMENT PLANNING

Once project confirmation received from business development, project team prepares project planning in

which detailed scheduling is done for design and development

Project Manager in consulting with SDH identifies the team.

In the course of addressing technical, logistical/managerial and financial concerns that impact project

design-process activities, the organization consistently exercises its organizational interfaces.

7.3.2 DESIGN AND DEVELOPMENT INPUT

The design input is collected from the specification provided by client or from the output of the study

made by the Project Team. The Software Requirement Specification (SRS) is prepared which is reviewed

and approved by the SDH.

SRS forms the basis for the subsequent design and construction phases. The SDH effects any changes to

approved SRS, only after due impact analysis is done and approval of the changes.

7.3.3 DESIGN AND DEVELOPMENT OUTPUT

Organization captures design-output data in design review minutes and customer reviews, as needed.

These reviews are performed specifically to verify that design-output meets or exceeds design-input

requirements. The design document is prepared by Project Leader (PL) in which design output, pseudo

code is documented.

Design document is approved by SDH and same is forwarded to customer for review revision history is

maintained for any changes made after approval.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 20 of 32 Rev.:1.0, Dt: March 15, 2018

7.3.4 DESIGN AND DEVELOPMENT REVIEW

Design document is reviewed by customer. During periodical review meetings SDH reviews the project

status to conform whether the output is meeting the design requirements

Follow up actions are identified and initiated against the review output and the action plan is

communicated to team members by internal email/Team meetings. Records of these reviews are

maintained by team leader

7.3.5 DESIGN AND DEVELOPMENT VERIFICATION

Design is verified during testing of project by QA team, test reports are prepared and if any failed cases

found the same shall be handled by project team.

Test reports / bug reports are reviewed by SDH Periodically to ensure that bugs are handled properly.

7.3.6 DESIGN AND DEVELOPMENT VALIDATION

Testing the project as per test plan prepared during project management plan validates design. Testing

team tests the project thoroughly and raises the failed cases in design and performance of the project.

Design and development team handles the errors raised by test team. Until testing team gives clearance

the project is not delivered to customer.

7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

All design changes either initiated by organization or requested by the customer are reviewed and

implemented. The review of design changes includes evaluation of the changes on project performance

and function. The SDH is authorized to approve the design changes.

Reference: QSP Project Execution (QSP/ EPATHUSA/PR/02) in Process Manual PROJECTS

7.4 PURCHASING

7.4.1 PURCHASING PROCESS

Organization’s purchasing processes are defined and controlled. Admin department makes efforts to

obtain high quality systems or peripherals on time by ensuring that the required technical specifications

defined in the purchasing documents provided to suppliers.

All suppliers are evaluated periodically for their ability to deliver quality products on a time. Suppliers

who cannot meet the contractual requirements for quality and delivery may be removed from the

Approved Suppliers List. Records of the results of evaluation and subsequent action arising from such

evaluation shall be maintained.

7.4.2 PURCHASING INFORMATION

Purchasing information describes that are to be purchased, including where appropriate;

• Requirement for approval of product, procedures, processes and

• Quality management system requirements

The organization ensures the adequacy of specified requirements prior to their communication to the

supplier.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 21 of 32 Rev.:1.0, Dt: March 15, 2018

7.4.3 VERIFICATION OF THE PURCHASED PRODUCT

The inspection and other activities to ensure that the purchased product meets specified technical

requirements are carried out.

Where applicable, the verification is done at supplier’s premises by the organization which is intimated to

the supplier in the purchasing information along with the method of release.

Reference: Process Manual –Purchase

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION & SERVICE PROVISION

The Organization plans and executes the activities under controlled conditions.

These conditions include, as applicable or necessary:

• Information describing requirements of the project

• Guidelines and templates where necessary

• Reviewing the project status periodically

• Evaluating competence of the team and provide trainings for skill up gradation

• Preparing Test plan and testing the project as per plan

• Release, delivery and post delivery activities

Reference: Process Manual – Projects

7.5.2 VALIDATION OF PROCESS FOR PRODUCTION & SERVICE PROVISION

This clause is excluded from system. Refer section 2.4 for details

7.5.3 IDENTIFICATION AND TRACEABILITY

The organization shall identify the product status with respect to monitoring and measuring requirements

throughout product realization.

Where traceability is a requirement, the organization shall control the unique identification of the product

and maintain records (see 4.2.4)

Identification of Assets (Computers, Network Components, ACs etc)

Each equipment in the organization is identified with unique number and same is dEPATHUSAayed on

the asset / equipment

Project Codification

Once the contract is signed or order received from customer, SDH allocates project code to the project

and the same code is used in all relevant records. This project code is referred in all correspondences with

customer regarding this project as well in internal communications and mails

The following format is used to codify the each project

AAAA-BBB-CCC-MON-YY

AAAA- Customer Short Name

BBB- Project Number

CCC- Project Short Name

MON-Month

YY- Year

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 22 of 32 Rev.:1.0, Dt: March 15, 2018

7.5.4 CUSTOMER PROPERTY

Customer supplied products (Could be Hardware, Software, Tools, Documents and intellectual property if

any) are inspected for suitability and functionality by the SDH/ Project Manager before use and those

found unsuitable for use are recorded and reported to the client for suitable action. The SDH maintains

the records of all customer-supplied products being used in the project. On completion of the project,

client-supplied products are returned to the client or disposed of as mutually agreed upon.

7.5.5 PRESERVATION OF PRODUCT

The process for handling, packaging, storage, preservation and delivery have been established and

maintained to prevent damage, deterioration or unintended use during internal processing and delivery of

product.

Hardware Peripherals

Hardware peripherals are stored in identified locations and controlled by administration department.

Original Software CDs

Original software such as operating systems and other languages are maintained and controlled by SDH /

N&A team. The CDs are properly labeled for easy identification and stored in secured racks and while

deciding storage location it is ensured that the location is waterproof and shock proof etc. List of software

available is maintained by N&A personnel for information

Project Backups

N&A personnel control the project backup CDs with proper labeling. Director / SDH takes decision to

dispose the OLD backup CDs. Once in a month the full project backup is taken and the CD is stored in

safe place to protect the data from any damage

Reference: Process Manual – Network & Administration

Process Manual – Project Execution

7.6 CONTROLLING OF MEASURING & MONITORING EQUIPMENTS

This clause is excluded from QMS. Ref Sec 2.4 for Details

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 23 of 32 Rev.:1.0, Dt: March 15, 2018

8.0. MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL

The organization plans and implements the monitoring, measurement, analysis and improvement processes

needed;

• To demonstrate the conformity of the product,

• To ensure conformity of the quality management system, and

• To continually improve the effectiveness of the quality management system.

This includes determination of applicable methods including statistical techniques and extent of their use.

8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

As one of the measurements of performance of the quality management system, the organization monitors

information relating to customer perception as to whether the organization has fulfilled customer

requirements.

Once in 3 months/after completion of project Customer Satisfaction Survey (CSS) report is received,

SDH analyze the rating given by client. If rating is below satisfaction level, the issue is discussed in

management review meeting and corrective actions are initiated.

Reference. : Process Manual – Business Development

8.2.2 INTERNAL AUDIT

The organization conducts internal audits once in 6 months to determine whether the quality management

system;

a) Conforms to the planned arrangements, to the requirements of this International standard and to the

quality management system requirements established by the organization, and

b) Is effectively implemented and maintained.

An audit program is planned, taking into consideration the status and importance of the processes and

areas to be audited, as well as results of previous audits. The audit criteria, scope, frequency and methods

are defined. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit

process. Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and

maintaining records are defined in a documented procedure.

The management responsible for the area being audited ensures that actions are taken without unjustified

delay to eliminate detected nonconformities and their causes.

Follow-up activities include the verification of the actions taken and the reporting of verification results.

Reference: QSP for Internal Audit QSP/ EPATHUSA/MR/04 in Process Manual -MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 24 of 32 Rev.:1.0, Dt: March 15, 2018

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

The organization has applied suitable methods for monitoring, and where applicable, measurement of the

quality management system processes. These methods demonstrate the ability of the processes to achieve

planned results. When planned results are not achieved, correction and corrective actions are taken, as

appropriate to ensure conformity of the product.

Following Quality management system processes have been identified for monitoring and measurement

as appropriate:

o Customer Satisfaction

o Internal Audit of Quality Management System

o Project Analysis

o Supplier Performance

o Process Measurements as given in individual department process maps

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT

The organization’s quality assurance team (testing team) test the project before delivery to client or

intermediate stages of development based on test plan prepared while design planning.

The QA team gives the detailed report on project and design and development team handle the bugs and

again re-build is submitted to testing team for final conformation.

Product/ project is not released for delivery or further processing until all planned arrangements (see 7.1)

have been satisfactorily completed, unless otherwise approved by a relevant authority, and where

applicable, by the customer.

8.3 CONTROL OF NONCONFORMING PRODUCT

Non-conformance reported in products / projects is documented.

The software items that are impacted by the non-conformances are identified. If required, persons using the

product are notified.

The impact of the non-conformances is evaluated. If required, access to the non-conforming software items

is restricted and they are prevented from further use. The non-conforming product is disposed of, in one of

the following ways-

o Reworking and correcting the defect

o Deferring it to a further release

o Obtaining a concession from the client or as provided in the contract

o Rejecting the existing product and redeveloping it afresh

a) By taking action to eliminate the detected nonconformity,

b) By authorizing its use, release or acceptance under concession by appropriate authority and,

when applicable, by the customer,

c)By taking action to preclude its original intended use or application.

Non-conformity with QMS/ Project Management Plans

Non-conformities are raised during Internal Audits, Surprise Audits, and External Audits or on occurrence of

difference in the QMS processes and implementation.

The SDH/Project Manager where the non-conformity Report (NCR) is raised identifies the corrective and

preventive action. MR tracks to closure all NCR's raised and ensures effective implementation of corrective

and preventive actions agreed.

The NCR trends and analysis is presented in the Management Review meeting for review and organization

level action required if any.

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 25 of 32 Rev.:1.0, Dt: March 15, 2018

Reference:

QSP for Purchase

QSP for Network & System Administration

QSP for Testing

8.4 ANALYSIS OF DATA

The organization determines, collects and analyzes appropriate data to demonstrate the suitability and

effectiveness of the quality management system and to evaluate where continual improvement of the quality

management system can be made. This includes data generated as a result of monitoring and measurement

and from other relevant sources.

The analysis of data provides information relating to;

• Customer satisfaction,(see 8.2.1)

• Conformance to requirements, (see 8.2.4)

• Characteristics and trends of processes and products including opportunities for preventive

actions, and

Against Process Measurements given in Annexure II, the trends are prepared either in tabular or graphical

format periodically, preferably before each round of Internal Audit and HoDs submit the data in MRM for

review

Internal Audits

Internal Audit Summary Reports is prepared by MR after each round of Internal Audit and submits in

Management Review.

Supplier performance (7.4)

Reference:

QSP for Management Review (QSP/ EPATHUSA/MR/03) in Process Manual MR

QSP for Corrective and Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR

8.5 IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT

The organization continually improves the effectiveness of the quality management system through the

use of quality policy, quality objectives, and audit results, analysis of data, corrective and preventive

actions and management review.

8.5.2 CORRECTIVE ACTION

The organization takes corrective actions to eliminate the cause of nonconformities in order to prevent

recurrence. Corrective actions taken are appropriate to the effects of nonconformities encountered.

A documented procedure has been established to define requirements for;

a. Reviewing nonconformities (including customer complaints)

b. Determining cause of nonconformities,

c. Evaluating the need for action to ensure that nonconformities do not recur,

d. Determining and implementing action needed,

e. Records of the actions taken (see 4.2.4), and

f. Review of the effectiveness corrective actions taken

Reference:

QSP for Corrective & Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 26 of 32 Rev.:1.0, Dt: March 15, 2018

8.5.3 PREVENTIVE ACTION

The organization determines action to eliminate the causes of potential nonconformities in order to

prevent their occurrence. Preventive actions taken are appropriate to the effects of potential problems.

A documented procedure has been established to define requirements for;

a. Determining potential nonconformities and their causes,

b. Evaluating the need for action to prevent occurrence of nonconformities,

c. Determining and implementing action needed,

d. Records of results of actions taken (see 4.2.4), and

e. Review of the effectiveness preventive actions taken

Reference:

QSP for Corrective & Preventive Action (QSP/ EPATHUSA/MR/05) in Process Manual MR

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 27 of 32 Rev.:1.0, Dt: March 15, 2018

ANNEXURE I - SEQUENCE AND INTERACTION OF PROCESS

CUSTOMER REQUIREMENT

MANAGEMENT RESPONSIBILITY(Management Review)

Business

Development

RESOURCE MANAGEMENT

Project

management

Testing

Delivery /

Uploading

Network

Administration

Purchase

HR

Contract Review,

Complaints

Handling &

Collecting

Feedback

Review Customer

Requirements and

project planning

Project Execution

(Coding, Database

Design and Unit

Testing)

Testing by

manual testing

Network Support

& Systems

Maintenance

Recruitment

Training

Purchasing

Against

Indents from

N & A and

Projects depts.

PRODUCT REALIZATION

MEASUREMENT, ANALYSIS AND IMPROVEMENT

Review PPI

Review PPI and

Supp

Performance

Review PPI and

Training

Effectiveness

INTERNAL AUDIT

CORRECTIVE AND PREVENTIVE ACTION

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 28 of 32 Rev.:1.0, Dt: March 15, 2018

ANNEXURE – II ORGANIZATION CHART

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 29 of 32 Rev.:1.0, Dt: March 15, 2018

Responsibilities & Authorities

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 30 of 32 Rev.:1.0, Dt: March 15, 2018

ANNEXURE – III REFERENCES

Sl. No

Document Name

Document Number

1.

QSP for Control of Documents

QSP/EPATHUSA/MR/01

2.

QSP for Control of Records

QSP/EPATHUSA/MR/02

3.

QSP for Management Review

QSP/EPATHUSA/MR/03

4.

Process Manual – HR (QSP for HR)

QSP/EPATHUSA/HR/01

5.

Process Manual – Business Development

QSP/EPATHUSA/BD/01

6.

Process Manual – Purchase (QSP for Purchase)

QSP/EPATHUSA/PUR/01

7.

Process Manual – Projects

NA

8.

Process Manual – Network & Administration(QSP for

Network &System Administration)

QSP/EPATHUSA/N&A/01

9.

QSP for Internal Audit

QSP/EPATHUSA/MR/04

10.

QSP for Corrective & Preventive Action

QSP/EPATHUSA/MR/05

QUALITY SYSTEM MANUAL (QSM/ ePATHUSA/01)

Page 31 of 32 Rev.:1.0, Dt: March 15, 2018

ANNEXURE IV - QUALITY OBJECTIVES

Organizational Objectives

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

Customer satisfaction

90%

1 Year

Customer satisfaction Survey

reports

Customer complaints

Nil

1Year

Customer complaints register

reports

Delivery schedule adhence

80%

1Year

Daily work report

New technology

Departmental Objectives

Marketing

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

Customer satisfaction

90%

1 Year

Customer satisfaction Survey

reports

Number of customer to be

added

5

1 Year

Customer list

Production

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

Delivery schedule adhence

80%

1Year

Daily work report

Maintenance

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

Break down Hour

2% of total working hours

1Year

Break down register

HR

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

To Provide trainings to

employees

At least 4 Hours Qtr for

each staff member

6 months

Training register

MR

OBJECTIVE

GOAL

TIME FRAME

RECORDS TO REFER

Internal Audit Effectiveness

Number of Repeated

(Same Nature) NC to be

minimized

1Year

Internal audit report

Document Control

Effectiveness

Number of NCs on

Document control in

external / internal audits –

Max 1

1Year

Internal audit report

QUALITY SYSTEM MANUAL

QUALITY%20SYSTEM%20MANUAL

Navigation menu

Versions of this User Manual:

Views

Navigation