Quality Manual As 9100 C

Defsys Solutions ( India) Pvt. Ltd.
QUALITY MANAGEMENT SYSTEM MANUAL
(AS PER REQUIREMENTS OF AS 9100: 2009 & ISO 9001:2008)
Issue No. : 01
Doc ID. : QM-01
Gen. Date : 01.04.2015
Copy No. : 01
Approved By :
Defsys Solutions (India) Pvt. Ltd.

Sohna Road, Gurgaon
Issue No. Rev. date Page No Rev No. Doc. ID No

01 - 1 00 QM-01
Prepared by Approved by Control status
©Copyrighted Material
CONTENTS PAGE NO.
Section A - Cover Page - 1

Contents - 2
Section B - Amendment Details - 3
Section C - Company Profile - 4
Section D - MR Appointment - 5
Section E - Quality Policy - 6
Section F - Quality Objectives - 7
Section G - Scope of registration & exclusions - 8
Section H - Process Scope - 9
Section 1 - Scope - 10
Section 2 - Normative References - 11
Section 3 - Terms and Definitions - 13
Section 4 - Quality Management System - 17
Section 5 - Management Responsibility - 20
Section 6 - Resource Management - 22
Section 7 - Product Realization - 24
Section 8 - Measurement, Analysis and Improvement - 44
Annexure I Organization Chart - 59

Annexure II Process Interaction - 60
Annexure III Responsibilities & Authorities - 61
Annexure IV List of System Procedures - 62

01 - 2 00 QM-01
Section B
Amendment Details
S.No. Page No. Amendment Details Recommended By Rev. No.

01 - 3 00 QM-01
Section C
Company Profile

01 - 4 00 QM-01
Section- D
APPOINTMENT OF MANAGEMENT REPRESENTATIVE
01st April, 2015

CIRCULAR
SUB: MANAGEMENT REPRESENTATIVE FOR AS 9100:2009.

Management is pleased to appoint Mr. Vivek Vinod as Management Representative
for AS 9100:2009. He shall have the responsibility and authority that includes
ensuring that the processes needed for the Quality Management System are
established, implemented and maintained. He will also report to Top Management
on the performance of the Quality Management System and any need for
improvement. He will also ensure the promotion of awareness of customer
requirements throughout the organization.
The above is in addition to his existing responsibilities of Production. All are
requested to extend their full cooperation to ensure the effective and efficient
implementation of Quality Management System.
Executive Director
Defsys Solutions (India) Pvt. Ltd.

01 - 5 00 QM-01
Section E
QUALITY POLICY
Defsys is committed to continually

improve the Quality of it’s products and
services leading to total Customer
satisfaction and business growth through
technological up-gradation, capability
enhancement of it’s all employees, their
commitment and team work.
APPROVED BY
EXECUTIVE DIRECTOR

01 - 6 00 QM-01
Section F
Quality Objectives
Attached Next

01 - 7 00 QM-01
Section G
APPLICABLE STANDARD
The quality management system has been established complying with the requirements of
AS 9100: 2009.
“SCOPE”
“Design and manufacturing of integrated
electronics Systems for Aerospace Applications”
EXCLUSIONS AND JUSTIFICATIONS

Not Applicable

01 - 8 00 QM-01
SECTION - H
1.0 PROCESS SCOPE
1.1 Administration and Management
a) Human Resource Development
b) Quality Management System
1.2 Marketing and Customer Contact
a) Marketing and Business Development
b) Contract Review and Customer Communications
c) Customer Complaints and Customer Satisfaction
d) Delivery Monitoring and Control
1.3 Quality Planning
a) Process and Quality Planning
1.4 Supplier Development
a) Supplier Evaluation
b) Purchase Control
1.5 Production Planning & Control
a) Process Monitoring and Improvement
b) Product Preservation and Handling
c) Product Identification and Traceability
1.6 Product Quality Monitoring and Improvement
a) Receiving inspection
b) Measurement System Monitoring and Analysis.
1.7 Records:
Process Interaction Annexure “ II”

01 - 9 00 QM-01
SECTION-01 General
This manual is applicable throughout the company. It defines the Company’s

Management policies with regard to the application of Quality Management Systems
in all areas of activities and its business environment, changes in that environment,
or risks associated with that Product/Processes, which have influence on the quality
of the products supplied to our customers. This manual has been developed in
accordance to AS 9100:2009 to assess the organization‘s ability to meet customer,
statutory and regulatory requirements applicable to the product,
The manual has been prepared based on AS 9100:2009 and is designated to be

used as a basic reference document which outlines in broad terms, the controls
operated to ensure that the requirements of Quality Management Standard can be
met.
Implementation of the policies defined herein is by means of Quality Management

System Procedures, which define specific responsibilities and detail the essential
controls that must be exercised in carrying out the various activities during the
course of contract/activities.
To reduce need for revision of this manual, reference is made in the text to those
particular procedures, in which the required control is located. This manual,
therefore, will not be subject to revision frequently. However, the edition number
of the Manual may be changed subject to any modifications/revision of
International Standard.

01 - 10 00 QM-01
SECTION-02 Normative References
In further developing the systems and procedures operated in order to meet the
requirements of customers, it was considered essential that the documented
systems be capable of being cross-referenced to the Respective Standard applied
by customers. The manual section headings therefore are as those of AS 9100:
2009, which is now the Standard most widely, recognized internationally. However,
besides the systems and procedures are specific to the requirements of AS
9100:2009, but also have built in flexibility to enable any Quality Assurance
Standard invoked by a customer to be fully met.
The functions of this manual are:

a) To define the management policies with respect to Quality Assurance and
enable identification of the procedures which outline the controls for the
various elements of the Quality Management Systems and together with the
Manual.
b) To ensure uniformity of understanding and performance.
c) To provide a training document and to ensure continuity of the system when

personnel change
d) To act as a reference base against which the practices and procedures can be
audited both internally and by customers/certification bodies enabling
corrective action to be taken when non-conformance or inadequacy is found.
Copies of this Manual (Uncontrolled) are readily available to customers for
information purposes. It is however company policy that the detailed
procedures/instructions by which the Quality Management System is
implemented are confidential documents. They are not generally submitted to
customers for review.
Although, certain procedures may be submitted when agreed for contractual
purposes.
The procedures are available at company premises for customers’ representatives
to carry out evaluation/audit, customers’ surveillance or inspection and test on
which they may be employed.

01 - 11 00 QM-01
2.1 MANUAL CONTROL
Company policies with respect to the application of Management Systems are

defined at the highest level applicable to the services and products of the Company.
Any change to the policies defined by lowering the Standards would warrant a
complete withdrawal of the Manual by the Management Representative.
All changes to the systems for whatever reason and notification of applicable
changes to approving authorities are fully controlled through respective procedures.
The manual is approved by ED and is then issued by Management Representative.
The Management Representative is authorized by the (ED) to carry out the

activities of preparing, issuing, maintaining and updating of the MANUAL. The
Management Representative carried out the distribution of the manual and
maintains the Master Copy of the MANUAL, which bears the signature of the
Approving Authority in original. The copies issued to the concerned individuals are
copied from the Master and bear a rubber stamp ‘CONTROLLED’ in on each page of
the manual. The copies bearing ‘CONTROLLED’ stamp in are the authorized copies
and photocopying of the controlled copies is not permitted.
Any additional copies of the manual required for external agencies are issued by
the Management Representative and such copies of the manual issued are stamped
‘UNCONTROLLED’. These uncontrolled copies do not come under the preview of
document amendment procedure and are not used within the company.
Whenever the manual is revised, it is revised to the next edition number and
distributed by the Management Representative. It is the responsibility of the
holder of the controlled copy to return the earlier Edition to the Management
Representative, who ensures that the same are destroyed. One copy of the earlier
edition duly marked as ‘OBSOLETE’ is retained by the Management Representative
for reference.

01 - 12 00 QM-01
Section 3 Terms & Definitions

Terms:
Company : Defsys Solutions ( India) Pvt. Ltd.

Supplier : One who is providing materials and Services to the
Company.
Definitions:
Product :
Product is defined as “results of a process”.
Process:
Process is defined as “set of inter-related or interacting activities which
transforms Inputs into outputs”.
Quality :
Degree to which a set of inherent characteristics fulfils customer
expectation and needs (requirements).
Customer Satisfaction:
Customer’s perception of the degree to which the customer’s requirements
have been fulfilled.
Quality Management System
Management systems to direct and control on organization with regard to
quality.

01 - 13 00 QM-01
Continual Improvement
Recurring activity to increase the ability to fulfil requirements.
Effectiveness
Extent to which planned activities are realized and planned results achieved.
Efficiency
Relationship between the result achieved and the resources used.
Continual Improvement
Process of enhancing the environmental management system to achieve
improvements in overall environmental performance in line with organization’s
environmental policy
Hazard
Source or situation with a potential for harm in terms of injury or ill health, damage
to property, damage to the work place environment or a combination of these
Safety
Freedom from unacceptable risk of harm
Abbreviations :
The abbreviations used in this manual are given below:

QMS - Quality Management System
Doc – Document
QM - Quality Management System Manual
ISO – International Organization for Standardization
AS - Aerospace
TS - Technical Specification
RMS – Raw Material Store
MKT - Marketing
GM – General Manager
Prod - Production

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PPC - Production Planning & Control

PPAP – Production Part Approval Process
R&D - Research & Development
CFT – Cross Functional Team
H - Head
CRC – Cost Reduction Committee
PUR - Purchase
I/C – In charge
Q.A. - Quality Assurance
FGS – Finish Goods Store
BP – Business Plan
Note : The abbreviations used in the procedures are detailed in the respective
Departmental Manuals

01 - 15 00 QM-01
3.1 Risk
An undesirable situation or circumstances that have both a likelihood of occurring

and a potentially negative consequence.
3.2 Special Requirements
Those requirements identified by the customer, or determined by the organization,

which have high risks to being achieved, thus requiring their inclusion in the risk
management process. Factors used in the determination of special requirements
include product or process complexity, past experience and product or process
maturity. Examples of special requirements include performance requirements
imposed by the customer that are at the limit of the industry’s capability, or
requirements determined by the organization to be at the limit of its technical or
process capabilities.
3.3 Critical Items

Those items (e.g., functions, parts, software, characteristics, processes) having
significant effect on the product realization and use of the product; including
safety, performance, form, fit, function, producibility, service, life, etc.; that
require specific actions to ensure they are adequately managed. Examples of critical
items include safety critical items, fracture critical items, mission critical items,
key characteristics, etc.
3.4 Key Characteristics

The An attribute or features whose variation has a significant effect on product
fit, form, function, performance, service life, or producibility, that
requires specific actions for the purpose of controlling variation.

01 - 16 00 QM-01
SECTION-4
This section describes the process of establishing Quality Management System in
the organization including identification and control of requisite documentation and
records.
DEFSYS’s quality management system also addresses customer and applicable
statutory and regulatory quality management system requirements in next sub
segments of this manual.
4.1 General Requirements
a) The QMS described in this manual is based on the company’s business
processes identified and requirements of AS 9100:2009 international
standard.
b) The sequence of these processes and their interaction is established.
c) Necessary actions to achieve the planned results are implemented and
resources provided leading to continual improvement.
d) Detailed procedures and criteria are established as required to control the
processes to ensure availability of resources.
e) Monitoring, measurement and analysis of the relevant processes.
f) Implementing necessary action to achieve planned result and essential
improvement of those processes are essential.
g) The organization structure required to carry out the processes appears at
Annexure- II of the manual.
h) Control of Out sourced Processes Where any processes that affect product
conformity with requirements are outsourced, the company ensures
management of such processes.
S.No. Activity Concerned Procedure
01 Calibration QA/P/03
02 Transportation Agreements
Processes needed for the QMS referred to above include processes for
management activities, provision of resources, product realization and
measurement.

01 - 17 00 QM-01
4.2 Documentation Requirement

4.2.1 The QMS documentation is established to ensure compliance to the
requirements of this international Standard and effectively carrying out the
company’s business processes utilizing available competence of the personnel.
The documentation includes:
a) Company Quality Policy and Objectives
b) Quality Manual
c) QMS Procedures
d) Procedures and other documents for control of the business processes
e) Quality Records required by the AS 9100:2009 International Standard.
Company also ensures that all the relevant documents that all the concerned
personnel will be having access to and will be aware of relevant quality management
system documentation and changes.
4.2.2 Quality Manual
This Quality Manual includes Quality Policy, Quality Objectives, interaction

between the QMS processes, Organisation Chart, Job description of management
and quality personnel reference to QMS and control procedures.
4.2.3 Control of Documents
A list of QMS and other operating procedures identified for meeting requirements
of this international standard and effectively controlling the business processes of
the organisation is annexed as Annexure -IV. These procedures are referred in
the relevant sections of the manual. Reference to other Level-III documents like
Work Instructions, Drawings, and Specification Sheets etc is made in the relevant
procedures as appropriate. Document Control Procedure is established to define the
controls needed.

01 - 18 00 QM-01
a) To approve documents for adequacy prior to issue

b) To review and update as necessary and re-approve documents
c) To ensure that changes and the current revision status of documents are
identified
d) To ensure that relevant versions of applicable documents are available at
points of use
e) To ensure that documents remain legible and readily identifiable

f) To ensure documents of external origin are identified and their distribution
controlled and
g) To prevent the unintended use of obsolete documents and to apply suitable
identification to them if they are retained for any purpose.
Details of methods, responsibilities and documentation are provided in documented

procedure:
Procedure for Control of Documents MR/P/01
4.2.4 Control of Records
Quality records as required by this international standard and to provide

evidence of conformity to requirements shall be maintained as per
documented procedure Control of Quality Records. Quality records shall
remain legible, readily identifiable, and easily retrievable and protected till
disposed off after established retention time.
DEFSYS’s procedure for controlling of records defines the method for
controlling records that are created by and / or retained by company’s
suppliers.
Procedure for Control of records MR/P/02

01 - 19 00 QM-01
SECTION-5
5.0 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment: This section describes the means by which the
Company acknowledges its responsibility and emphasis’s its commitment for
the development and implementation of the quality management system and
continually improving its effectiveness.
5.2 Customer Focus: The top management has ensured that product conformity
and on time delivery performance are measured and that appropriate action
are taken if planned results are not or will not be achieved.
The Management of the company ensures that customer and legal / statutory
requirements are determined and fulfilled with the aim of enhancing
customer / employees / statutory bodies satisfaction. While reviewing the
requirements, the implied needs and expectations of the customer / society
are also identified. The same are conveyed to the respective functions for
ensuring that these are met. As a part of Management Review (Refer 5.6
below), focus is made for communicating such requirements to all Functions
for percolating them down the line in their departments and ensuring their
conformance.
5.3 Quality Policy: The top management has established which is in line with the
business process of the organization with a focus on continual improvement at
the Quality Management System.
The Quality Policy is controlled and the same is prominently displayed and
communicated to all employees for better understanding.

01 - 20 00 QM-01
5.4 Planning
5.4.1 Quality Objectives: Overall quality Objectives and department/functional
Quality objectives are established to meet product requirements and these
objectives are measurable and are consistent with the quality policy.
5.4.2 Quality Management System Planning: QMS planning is carried out to

meet the Quality objective requirements and the integrity of QMS is
maintained when changed to the QMS are planned and implemented.
5.5 Responsibility, authority and communication

5.5.1 Responsibility and Authority: An organization chart (Annexure-III) duly
authorized by the ED is available for general information on the functions,
their inter-relation and lines of command.
5.5.2 Management Representative: MR has been nominated having the
responsibility to establish, implement and maintain the QMS report to top
management regarding QMS effectiveness and promote awareness of
customer requirements throughout the organization.
• Management representative is having organizational freedom and
unrestricted areas to top management to resolve quality management
issues.
• Management representative is responsible for liaison with external
parties on matter4s relating to the quality management system.
5.5.3 Internal and external communication processes are established in the

relevant QMS and operating procedures. However management ensures
appropriate communication throughout the company through routine team
briefings, other meetings or displaying at notice boards/work places.

01 - 21 00 QM-01
5.6 Management Review
5.6.1 The ED reviews the QMS with the management review group at least
once in six months to assess its suitability, adequacy and
effectiveness and to identify opportunities and need for changes in the
QMS, Quality Policy and Objectives.
5.6.2 The MR collects and summarizes information for input to management review
as per the minimum agenda points specified in the standard and includes
other points in consultation with ED.
5.6.3 The management review outputs such as decisions taken against the inputs
and actions planned for improvement of the effectiveness of the quality
management system and its processes, improvement of product related to
customer requirements and the resource needed for fulfilling the same ate
recorded and circulated to the concerned.
Ref. Procedure:
MR/P/03 MANAGEMENT REVIEW
SECTION - 6
6.1 Provision of Resources
6.1.1 Needed resources shall be identified and provided to ensure implementation

and effective maintenance of the QMS and enhancement of customer
satisfaction.

01 - 22 00 QM-01
6.2 Human Resources
6.2.1 Appropriate education, training, skills and experience needed is determined in

accordance with the processes. Adequate and competent human resources
are provided to carry out these processes. Required training is provided to
improve the desired skill and competency. Effectiveness of such technical
training is evaluated and established.
6.2.2 Competence, Training and Awareness

DEFSYS has defined the followings
• A minimum competence criterion has been defined for every
designation in the company for performing work affecting conformity
to product requirements.
• Identification of Training requirements and evaluation of the given
trainings have been immerged in QMS.
• Defined Quality Objectives communicated to the every concerned
person.
Ref. Procedures:
HR/P/01 TRAINING
6.3 Infrastructure
Requirement of infrastructure like building, workspace, process equipment

(hardware and software), utilities and supporting services like transport and
communication shall be determined, provided and maintained.
This also includes facilities/machines/equipment to carry out various
processes and to achieve conformity to the product requirements. it is the
responsibility of the supplier to ensure that the preventive & breakdown
maintenance of machines/equipments is done as per requirement.

01 - 23 00 QM-01
Ref. Procedures:
MNT/P/01 MAINTENANCE
6.4 Work Environment
Work environments needed to achieve product quality are identified,

provided and maintained. ESD controlled areas are available for production.
SECTION 7.0 PRODUCT REALIZATIONS
7.1 Planning of Product Realization
The processes needed for product realization shall be planned and developed
for each product and shall be consistent to the established processes of the
QMS.
In planning product realization, DEFSYS has determined the following, as

appropriate
The Quality Plan list down all the processes in correct sequence and establish
the requirement of:-
• Material specifications
• Quality objectives
• Product and process characteristics
• The documentation required
• Verification and monitoring specifying acceptance criteria

01 - 24 00 QM-01
Records to provide evidence of achievement of product and process

characteristics
Quality Objectives and requirements for the product include consideration of
aspects such as :
• Product and personal safety
• Reliability, availability and maintainability.
• Producibility and inspectability
• Suitability of parts and materials used in the product
• Selection and development of embedded software, and
• Recycling of final disposal of the product at the end of its life.
Configuration management appropriate to the product;
Resources to support the use and maintenance of the product.
The Quality Plan is documented and approved by the customer if

contractually required.
7.1.1 Project Management
As appropriate to the company and the product, DEFSYS has planned and
managed product realization a structured and controlled manner to meet
requirements at acceptable risk, within resource and schedule constraints.
Ref. Procedure:
MKT/P/01 Business Development ( Marketing / Projects)
7.1.2 Risk Management
Company has established, implemented and maintained a process for managing

risk to the achievement applicable requirements, that included as appropriate
to the organization and the product
• Assignment of responsibilities for risk management
• Definition of risk criteria ( e.g. Likelihood, consequences, risk
acceptance),

01 - 25 00 QM-01
• Identification , assessment and communication of risks throughout

product realization,
• Identification, implementation and management of actions to mitigate
risks that exceed the defined risk acceptance criteria , and
• Acceptance of risks remaining after implementation of mitigation
actions
Ref. Records:
ENGG/P/02 Risk Management
7.1.3 Configuration Management
Company has established, implemented and maintaining a configuration management

process that includes, as appropriate to the product
• Configuration management planning,

• Configuration identification
• Change control
• Configuration status accounting and
• Configuration Audit
For defining above segment ISO 10007 guidelines are considered.

Ref. records:
ENGG/P/03 Configuration Management
7.1.4 Control of Work Transfers
As company is not involved in any kind of outsourcing activities but some internal
work transfers are being done for controlling those transfers DEFSYS is having a
list of authorized persons for controlling the works and approval of activities.
Ref. records:
PUR/P/01 PURCHASING

01 - 26 00 QM-01
7.2 CUSTOMER-RELATED PROCESSES
7.2.1 Customer related processes include determination of customer requirements,

his implied needs, applicable statutory and regulatory requirements,
organization’s capability assessment, tendering, and continuous interaction
with the customer, delivery monitoring, customer feedback, monitoring
customer complaints and order amendments.
Company has determined the requirements related to the product with the
special requirements.
7.2.2 Upon receipt of an order contract or invitation to tender and prior to the
acceptance of the order or contract or submission of the tender a review of
the customer’s requirements shall be undertaken.
• Company has defined the product requirements.
• Contract or order requirements differing from those previously
expressed are resolved,
• Company has the ability to meet the defined product requirements.
• Special requirements of the product are determined, and
• Risks ( e.g. new technology, short delivery time frame) have been
identified.
• Whenever the product requirements are changed, the company will
ensure that relevant documents are amended and that concerned
persons are made aware of the changed requirements.
7.2.3 Customer Communication

This review shall determine the following: -
a) Scope of work,
b) Customer specifications of product and delivery;
c) Statutory and regulatory requirements;

01 - 27 00 QM-01
d) Any additional requirements;

e) Applicable national and in-house standards and procedures;
f) Organization’s capabilities (process, quality assurance and supplier
requirements);
g) All aspects of quality documentation.
On completion of the review should any resource by unavailable or any

requirement need amplification, appropriate action is taken until the situation
has been satisfactorily resolved. Records of review shall be maintained.
Appropriate, the organization liaisons with the customer to ensure that the
specified requirements are clearly understood and can be met.
Orders or contracts revised due to such liaison or received as a result of a

successful tender will be compared with the records of review and/or tender
submitted to ensure compatibility.
All orders are approved prior to the commencement of any work.
When an amendment to a contract or order is received relevant

documentation is amended and the details of the change will be quickly and
correctly transferred to the concerned functions within the Company for
implementation.
Customer communication including complaints and other feedback shall be

routed through the head marketing.
RECORDS:
MKT/P/02 CUSTOMER SATISFACTION
MR/P/05 HANDLING OF CUSTMER COMPLAINTS AND CUSTOMER
RETURN PRODUCT

01 - 28 00 QM-01
7.3 Design and development
The Organization is involved in design activities related with the product.

ENGG/P/01 Design & Development ( R&D)
7.3.1 Design & Development Planning

DEFSYS is engaged in product design and development.
D&E department adopt the following steps for developing the product.
a) Project review (Feasibility check/ BOM/ Technical aspects/ available
sources /Risk Assessments/customer specifications). Design input sheet is
referred for project review.
b) The design & Engineering department follows development stages like
design input, output, verification and validations.
c) Responsibilities and authorities related to product development have been
properly defined. Plz refer to : Annexure III.
For developing the prototype or sample related to the said project. Design and
Development ( R&d) department develops a design plan for properly executing the
all related stages of development.
Refer Design Plan. (Specifically being designed for every individual article no. /
Project no.)
The design and development projects are carried out on the basis of safety and
functional objectives of the product in accordance with customer, statutory and
regulatory requirements.
Design Plan consider the ability to product , inspect , test and maintain the product.

01 - 29 00 QM-01
CFT (Cross Functional Team) which comprises all the coordinators from individual
departments ( like D&E, MKT, PUR, Quality, Prod etc.). CFT Team coordinates all
the requirements related to design & development. All the required communications
are communicated through the formal meeting.
Regular review of product design project is monitored through design plan.
Design and development review, verification and validation of developed prototype

have their own individual purposes. All said activities are conducted and recorded
separately.
7.3.2 Design & Development inputs
CFT Team monitors development stages of Input of required specification for

prototype. For reviewing, the inputs following points are covered.
a) Functional and performance requirements
b) Applicable statutory and regulatory requirements
c) Where applicable, information derived from previous similar designs and
d) Other requirements, which are essential for design and development.
The inputs shall be reviewed for adequacy. Requirements shall be complete.
Unambiguous and not in conflict with each other.
7.3.3 Design & Development outputs
DESIGN AND DEVELOPMENT ( R&D) department closely monitors output stage of

design & development.
Specifically following aspects/ activities are monitored as output...
• Concept visualization
• Block Diagram
• Circuit schematic and mechanical drawings ( as App.)
• B.O.M
• PCB Layout ( As App.)

01 - 30 00 QM-01
• Wiring diagram ( as App.)

• Test Procedures ( ATP)
All above-mentioned aspects are in crucial category for output stage of Design &
development stage.
Related data of output stage is recorded in the prescribed formats and this stage
is monitored and reviewed through design plan.
As a systematic approach, following criteria are also considered for the same.
a) meet the input requirements for design and development
b) provide appropriate information for purchasing, production and service
provision,
c) contain or reference product acceptance criteria,
d) specify the characteristics of the product that are essential for its safe and
proper use and
e) Specify as applicable any critical items including any key characteristics and
specific action to be taken for these items.
All the related activities and specific technical requirements are being controlled
by ATP document. This document has all the requirements related to the product.
7.3.4 Design and Development review
Following aspects also being considered for the same.

a) To evaluate the ability of the results of design and development to meet
requirements.
b) To identify any problems and purpose necessary actions and
c) Progress is monitored through Design Plan and the project leader authorizes
progress of D&D.
All concerned responsible persons are nominated through design plan. The Project
leader is maintaining records of the periodic CFT meetings.

01 - 31 00 QM-01
Prototype development consist the followings.

• Material indent, Approval & procurement
• Test Equipment / test jigs as per ATP
• Mechanical Parts / PCB Fabrication ( as app.)
• Electrical & Mechanical Assembly
• Testing of Sub Assembly levels
• System Integration ( Packaging )
• System Level Testing
7.3.5 Design and Development Verification

Verification of the developed prototype is done through the performance
verification by inspection of output. Defined ATP is referred for the same.
7.3.6 Design and Development Validation

Validation of prototype is performed in accordance with planned arrangements
(refer to Design Plan) to ensure that the resulting product is capable of meeting
the requirements for the specified application or intended use, where known,
wherever practicable. Validation is completed prior to the delivery or
implementation of the product. All the related records are maintained.
Following activities are involved..
• By simulated testing or independent lab testing
• Customer Evaluation / Approval
7.3.6.1 Design and Development Verification and Validation Testing
Defined ATP is referred for verification and validation testings of the prototype.
For criteria is followed for the same.
a) Test Plans or specifications identify the product being tested and the
resources being used, define test objectives and conditions, parameters
to be recorded and relevant acceptance criteria,
b) Test procedures describe the method of operation, the performance of
the test and the recording of the results

01 - 32 00 QM-01
c) The correct configuration of the product is submitted for the test.

d) The requirements of the test plan and the test procedures are observed
and
e) The acceptance criteria are met.
7.3.6.2 Design and Development Verification and Validation Documentation

At the completion of design and or development, DEFSYS ensures that reports,
calculations, test results etc., demonstrate that the product definition meets the
specification requirements for all identified operational conditions.
7.3.7 Control of Design and development changes

Changes in Design or related specifications are controlled through technical
distribution records. Other related control is being done through configuration
management procedure.
ENGG/P/01 Design and Development (R&D)
7.4 PURCHASING
7.4.1 To ensure that the purchased product conforms to specified requirements,

the type and extent of controls exercised at the supplier’s end depend on the
effect of purchased product on subsequent processes or the final product.
The suppliers are selected on the basis of their ability to supply products as
per the company’s requirements.
Company will be responsible for the conformity of all product purchased from
suppliers, including product from sources defined by the customer.
• During the process of supplier selection and evaluation supplier quality

Data from objective is being considered.
• DEFSYS is maintaining a register of its suppliers that includes approval
status and the scope of approval.

01 - 33 00 QM-01
• Necessary actions have been defined in purchasing procedure to take

when dealing with suppliers that do not meet requirements.
• Risks have been determined which can be occurred during the selecting
and using of suppliers.
7.4.2 The suppliers are evaluated as per the established criteria of process control
measures and availability of necessary resources including human resources
and quality management systems. Their performance is regularly monitored
and corrective actions as appropriate planned, executed and evaluated.
Periodic re-evaluation of their quality management systems done and records
maintained. Following are the basic points which are being considered for
purchasing information.
• The identification and revision status of specifications, drawings,
process requirements, inspection/verification instructions and other
relevant technical data.
• Requirements for design, test, inspection, verification ( including
production process verification) , use of statistical techniques for
product acceptance, and related instructions for acceptance by
• the organization, and as applicable critical items including key
characteristics.
• Requirements for test specimens for design approval,
inspection/verification, investigation or auditing.
• Requirements regarding the need for the supplier to notify the
company of nonconforming product, obtain organization approval for
nonconforming product disposition,
• Records retention requirements and
• DEFSYS is allowing access to its customers and regulatory authorities
to the applicable areas of all facilities at any level of the supply chain,
involved in the order and to all applicable records.

01 - 34 00 QM-01
7.4.3 Purchasing documents contain a clear description of the product or service

required including where appropriate:
• Requirements of approval of product, procedure, process and

equipment.
• Requirements for qualification of personnel
• Quality Management System requirements
Such description contains as appropriate catalogue, identification codes and

titles, process requirements and any other relevant data.
Following are the points will be include during the verification of purchased
product;
• Obtaining objective evidence of the conformity of the product from

the supplier.
• Inspection and audit at the supplier’s premises,
• Review of the required documentation,
• Inspection of products upon receipt, and
• Delegation of verification to the supplier certification,
Where purchased product is released for production use pending completion

of all required verification activities, it is being identified and recorded to
allow recall and replacement if it is subsequently found that the product does
not meet requirements.
If product verification is to be carried out at the supplier’s premises by the

organisation or customer’s representative, it is clearly mentioned in the
purchase documents along with the method of product release.

01 - 35 00 QM-01
All purchasing documents are reviewed for adequacy and approved prior to
release to the supplier.
Ref. Procedure:
PUR/P/01 PURCHASING
PUR/P/02 EVALUATION & SELECTION OF SUPPLIERS
PUR/P/03 SUPPLIERS QMS DEVELOPMENT
PUR/P/04 SUPPLIER MONITORING
VERIFICATION OF PURCHASED PRODUCTS,
QA/P/01
INPROCESS AND FINISHED PRODUCTS
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 Control of Production and service provision

The Company plans and carries out production and service provision under controlled
conditions. At the time of product planning, the applicable controlled conditions are
identified and the same are provided at the relevant stages of processing through
Work Standards. This may include:
a) The availability of information in Inspection Plans / Work

Standards(S.O.P.) / Work Instructions/ routers which describes the
characteristics of the products / processes at relevant stages,
b) The availability of job set-up work instructions at the site of use,
c) The use of suitable equipment which are competent and suitable for the
relevant processes,
d) The availability and use of monitoring and measuring equipments for the
identified characteristics,
e) The implementation of monitoring and measurement, and
f) The implementation of release criteria, delivery and post-delivery
activities.

01 - 36 00 QM-01
g) Accountability of all product during production ( e.g. parts quantities,
split orders, non confirming product),
h) Evidence that all production and inspection/ verification operations have
been completed as planned, or as otherwise documented and authorized,
i) Provision for the prevention, detection and removal of foreign objects,
j) Monitoring and control of utilities and suppliers ( e.g. water, compressed
air, electricity, chemical products) to the extent then affect conformity
to product requirements , and
k) Criteria for workmanship, specified in the clearest practical way ( e.g.
written standards, representative samples, illustrations)
Planning is considered as appropriate
- Establishing, implementing and maintaining appropriate processes
to manage critical items including process controls where key
characteristics have been identified.
- Designing, manufacturing and using tolling to measure variable
data,
- Identifying in process inspection/ verification points when
adequate verification of conformance cannot be performed at
later stages of realization and,
- Special processes.

01 - 37 00 QM-01
7.5.1.1 Production Process Verification

Company provides a representative item from the first production run of a
new part or assembly to verify that the production processes (Configuration
Management ), production documentation and tooling are capable of producing
parts and assemblies that meet requirements. This process shall be repeated
changes that invalidate original results.
7.5.1.2 Control of Production Process Changes

Engineering In charge is authorized to approve changes to production
processes which shall be identified. The organization shall identify and obtain
acceptance of changes that require customer and/or regulatory authority
approval in accordance with contract or regulatory requirements. The
organization shall control and document changes affecting processes,
production equipment, tools, or software program. The results of changes to
production processes shall be assessed to confirm that the desired effect
has been achieved without adverse effects to product conformity.
7.5.1.3 Control of Production Equipment, tools and software programs:

Production equipment, tools and software programs used to automate and
control/monitor product realization processes, shall be validated prior to
release for production and shall be maintained. Storage requirements,
including periodic preservation/condition checks, shall be established defined
for production equipment or tooling in storage.
7.5.1.4 Post Delivery Support

Post delivery support shall provide as applicable for the
• Collection and analysis of in service data,
• Actions to be taken, including investigation and reporting, when
problems are detected after delivery,
• Control and updating of technical documentation,
• Approval, control and use of repair schemes, and
• Controls required for off- site work.

01 - 38 00 QM-01
7.5.2 Validation of Processes for Production and Service Provision
DEFSYS is having the following Special Processes.

1. Soldering
2. Wire Crimping
All the special processes are being validated through defined process
parameters.
7.5.3 Identification and Traceability
The Company provides product identification and traceability, which requires that
product, be identifiable to the applicable specifications.
Raw materials and Bought Out consumables are identified by tag / placard giving
details of material, applicable grade / specifications / part name / part number.
DEFSYS is maintaining the unique identification nos. for product configuration with
rev nos. of the actual product configuration.
Process intermediates and other items are identifiable by keeping them at

identified locations / shape / part number through tags. The products are also
identified through the data maintained in QMS Records and are traceable to Date
of Testing. The traceability is marked on the product/ packaging (as applicable) and
the same is also provided on the documents given to the customers.
As an acceptance media, DEFSYS is only using signatures and QC passed/ approved

stamp. Authority for the same has been identified department wise as appropriate.
For Traceability DEFSYS is using the followings.

- Identification is being maintained throughout the product life,
- The ability to trace all products manufactured from the same batch of raw
material, or from the same manufacturing batch, to the destination( e.g.
delivery, scrap)

01 - 39 00 QM-01
- For an assembly, to trace its components to the assembly and then to the
next higher assembly, and
- For a product, a sequential record of its production (manufacture, assembly.
Assembly/ verification) to be retrievable.
Procedure No:
QA/P/02 IDENTIFICATION & TRACEABILITY
7.5.4 Customer Property
As Company is engaged in Electronic Systems and Sub-Assemblies works so

Customer provides the drawings/ some design inputs related to the requirements,
all external origin documents (Customer Drawings) are controlled through Control of
External Origin records. As far as the provided material is concerned, after
finishing the job material is returned to the customer.
7.5.5 Preservation of Product
The Company has established “Documented Procedures” for preserving the product
requirements from receipt of materials through internal processing
upto the delivery of finished products to the intended destination. These
procedures include the product identification, handling, packaging, storage and
protection of the products.
Though specific responsibilities are defined in the relevant procedures, yet every
employee is responsible for safe handling of the products at various stages of
processing. It is ensured that the handling, storage and transportation of products
be controlled to prevent damage, deterioration or loss. When necessary, for
particular items, special instructions are issued and monitoring is carried out to
check satisfactory implementation. The appropriate handling of products is followed
to avoid any deterioration of quality of product while in transit.

01 - 40 00 QM-01
Appropriate storage facilities are provided for materials and products for their
safe upkeep, prevent damage and deterioration of the product requirements
including suitable preservation wherever necessary. Condition of product in stock is
assessed at appropriate interval. Receipt and issue from stores are
Preservation requirement of the product which is being manufactured by DEFSYS

are in accordance to the product / applicable statutory and regulatory requirements
for the followings.
a) Cleaning
b) Prevention, detection and removal of foreign objects,
c) Special handling for sensitive products,
d) Marketing & Labeling including safety warnings.
e) Shelf Life Control and stock Rotation and
f) Special handling for hazardous materials.
approved by authorized personnel. All raw materials are issued preferably on First
in First Out basis.
Ref. Procedures:
ST/P/01 STORE (RECIVED & ISSUE)
ST/P/02 HANDLING, STORAGE & PRESERVATION
7.6 Control of Monitoring & Measuring Equipments
DEFSYS is maintain the register of the monitoring and measuring equipments

and process has been defined for their calibration/ verification including the
details of equipment type, unique identification, location, frequency of
checks, check method and acceptance criteria.

01 - 41 00 QM-01
Monitoring and measuring equipment includes but is not limited to test

hardware, test software, automated test equipment, and plotters used to
produce inspection data. It also includes personally owned and customer
supplied equipment used to provide evidence of product conformity.
DEFSYS ensures that environmental conditions are suitable for the

calibration, inspection, measurement and testing being carried out.
Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and
test equipment, need to provide evidence of conformity of product to
a) Adjusted or re-adjusted if found to be out of calibration, as necessary;
b) Identified to enable calibration status through status stickers or calibration
records;
c) Safeguarded from adjustments, as applicable, that would invalidate the
measurement result;
d) Protected from damage and deterioration during handling, maintenance and

storage by imparting training to the users of such Equipments.
In case a Equipment is found to be out of calibration / validation, the information is

given to user department for assessing and recording the validity of the previous
measuring results. The Company takes appropriate actions on the equipment and any
product affected by such measurements. Records of the results of calibration and
verification are maintained.
DEFSYS has established, implemented and maintaining a process for the recall of
monitoring and measurement equipment requiring calibration or verification.

01 - 42 00 QM-01
determined requirements, including customer-owned equipment include

- equipment identification, including the measurement standard against
which the equipment is calibrated.
revisions following engineering changes,
- any out-of-specification readings as received for calibration /
verification,
- an assessment of the impact of out-of-specification condition,
- statement of conformity to specification after calibration/ verification, and
- notification to the customer if suspect product or material has been shipped.
External laboratory
External/commercial/independent laboratory facilities used for inspection, test
or calibration services by the organization shall have a defined laboratory scope
that includes the capability to perform the required inspection, test or
calibration, and either
- there shall be evidence that the external laboratory is acceptable to the

customer, or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
Procedure: …
QA/P/03 CONTROL OF MME

01 - 43 00 QM-01
Clause No- 8.0 Measurement, Analysis and Improvement
8.1 General
The company has planned and implemented the Monitoring, Measurement, Analysis
and Improvement processes for demonstrating conformity of the product including
ensuring the conformity of the Quality Management Systems, and continually
improving the effectiveness of QMS. One of the methods
chosen by the company is Statistical Techniques. The applicable methods like
Sampling Plans, Control Charts and monitoring of processes have been determined .
For such characteristics, which pertain to safety critical, fit functions and
performance of the product, the company uses statistical techniques and the same
are referred in work standards. These are analyzed and necessary actions taken to
improve the process performance.
8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction
The Company has established a “Documented Procedure” to determine

“Customers Perception (Dissatisfaction Indicators)” once in a year. The
methods for obtaining and using the information have been determined
through customer / legal requirements, which are transformed into
“Customer Satisfaction Indicators” for knowing the customer perception.
Regional Survey or knowing the details from users is used as a methodology
for customer perception.
Based on the feedback received from the customers on the identified

indicators, customer dissatisfaction levels are determined.

01 - 44 00 QM-01
For the improvement of these indicators, identified team comprising of Head

of Sections, based on the current status of the activities, find out route
cause through “Problem Solving Techniques” and the decisions are taken.
These decisions are communicated to the respective departmental heads for
taking necessary corrective actions.
Concerned Departmental Heads take the suggested actions and inform the
results to Functional Head (QA) and the same are verified by the internal
auditors. The records of these results including the actions taken are
discussed in the Management Review Committee Meetings by Management
Representative (QMS).
Customer satisfaction with the organization is also monitored through continual

evaluation of performance of the realization process. Performance indicators are
based on objective data and include, but not be limited to:
- delivered part quality performance
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight), and
Customer notifications related to quality or delivery issues.
The organization monitors the performance of manufacturing processes to
demonstrate compliance with customer requirements for product requirements
and efficiency of the process.
Functional Head (QA) maintains a trend graph of customer satisfaction and
ensures that the trend is always on a rising pattern.
Procedure: …
MKT/P/02 CUSTOMER SATISFACTION

01 - 45 00 QM-01
8.2.2 Internal Audit
The Company has established a “Documented Procedure” to ensure that planned

arrangements, requirements of AS 9100C:2009 requirements as established by
company having influence on product requirements are subjected to internal audits
at a pre-determined schedule ( At least once in six months) to verify the compliance
with all aspects of Quality Management Systems Requirements. The procedure
defines the responsibilities and requirements for planning and conducting audits,
and for reporting results in Management Review Meetings including maintaining
records.
The internal audits are planned and coordinated to ensure that entire QMS is
audited at a specified frequency. The procedure defines to establish the audit
criteria, scope, frequency and methods of auditing.
The auditors are selected in a manner to ensure objectivity and impartiality of the
audit process. A schedule for audits, based on the status and importance of the
process and results of earlier non-conformances observed, is prepared and
responsibility assigned to the personnel for conducting the audits. It is ensured
that Auditors do not audit their own work activities. The auditors, during the audit,
apart from verifying the activities by using “Check Lists” for the individual
department, may also verify the results of earlier non-conformances. The audit
reports are documented. The reports of the audits form the basis of taking
suitable corrective and preventive actions by concerned Dept Heads who take the
required corrective action without any undue delay i.e. immediate actions are
started on such non-conformances, which may result into reducing customer
satisfaction level / perception and deviate statutory and regulatory requirements
including desired goals / objectives.
Other non-conformances are prioritized and accordingly actions are started to

avoid their recurrence. Follow-up activities include the verification of the
corrective actions taken either by actual verification at site or by verifying the
related documentation, depending upon the criticality of the non-conformances.

01 - 46 00 QM-01
The results of the action taken are reviewed and discussed in Management Review
Meeting.
The audit is carried out for each manufacturing process to determine its
effectiveness and products at appropriate stages of production and delivery to
verify conformity to all specified requirements, such as product dimensions,
functionality, packaging and labeling at a defined frequency.
Internal audits include all quality management related processes, support processes,
environment management system related processes, health and safety related
processes, and are scheduled according to an annual plan. Based on the internal/
external audit results the frequency of the audit is rescheduled and the plan is
revised accordingly.
It is ensured through appropriate training’s that internal auditors who
perform/conduct the audit are qualified to audit the requirements of the
international standards ( AS 9100:2009)
Procedure:
MR/P/04 INTERNAL QMS AUDIT
8.2.3 Monitoring and Measurement of Processes
The company has defined the parameters for the different processes
adopted for meeting the customer requirements. All processes are suitably
monitored by respective Heads / Section Heads of Departments in order to
ensure that the requirements meet Internal / external customer.
Procedure: PROD/P/01…… Production planning and control

The Company has developed systems and identified suitable methods for
monitoring all such processes and in case of departments, such as Planning,
Production and meeting Delivery requirements, the indicators have been
defined and the same are mentioned in either Operational Control
Procedures, Work Standards and / or Work Instructions.

01 - 47 00 QM-01
These indicators are monitored and measured at the specified frequency as

mentioned in the above documents to ensure that these processes achieve
the planned results.
When planned results are not achieved, the non-conforming outputs (products
/ services / information) are corrected (by re-worked / repaired) and the
suitable corrective actions, as applicable as per the “Reaction Plans” are
taken to ensure conformity of the products (outputs).
Monitoring and measurement of manufacturing processes

Process studies on all new manufacturing (including assembly or sequencing)
processes to verify process capability and to provide additional input for
process control is carried out through established methods. The results of
process studies are documented with specifications, where applicable, for
means of production, measurement and test, and maintenance instructions.
These documents includes
objectives for manufacturing process capability reliability, maintainability

and availability, as well as acceptance criteria.
The organization maintains manufacturing process capability or performance
as specified by the customer part approval process requirements.
It is ensured that the control plans and process flow diagrams are
implemented, including adherence to the specified:
- measurement techniques,
- sampling plans,
- acceptance criteria, and
- reaction plans when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, are
recorded at appropriate stages.

01 - 48 00 QM-01
Initiation of reaction plans as mentioned in the control plan for

characteristics that are either not statistically capable or are unstable is
done. These reaction plans include containment of product and 100%
inspection as appropriate. A corrective action plan is then be completed by
the organization, indicating specific timing and assigned responsibilities to
assure that the process becomes stable and capable. The plan is reviewed
with and approved by the customer when so required.
Records of effective dates of process changes are maintained.
8.2.4 Monitoring and Measurement of Product
The company has defined the characteristics for the different outputs
achieved at appropriate stages of Product Realization for meeting the
customer requirements. All these characteristics are monitored and
measured by designated personnel in respective Departments in order to
ensure that the product (Output) requirements meet Internal / external
customer / legal requirements.
These characteristics have been defined either in the Inspection Plans,
Works Standards, Work Instructions as applicable to the relevant stages of
processes.
For all identified characteristics, the acceptance criteria for the evidence of
conformity have also been defined. The in-process and Final Inspections are
conducted to make evidence for the same. The necessary records are
maintained as given in the above stage documents.
The Company ensures that all Inspection Plans and / or Inspection

requirements are planned & implemented and that their inspection records
demonstrate verification of the characteristics at each stage of processes
indicating conformance to applicable instructions, procedures, inspection
plans, control plans, as applicable.

01 - 49 00 QM-01
The finished product / service / information is verified for conformance to

the specified requirements as per procedures / inspection standards /
Inspection Plan and transferred to designated storage area only after the
inspection testing is performed and found to be conforming. The relevant
records clearly indicating the conformance / non-conformance of the product
and authority for releasing the product are maintained.
Positive recall system is applicable to the company and such materials are
released by providing proper identification. However, the finished product is
dispatched only after the incoming materials are found to be conforming.
Sampling Norms for inspection and testing are indicated in the relevant
procedures / inspection plans. For all materials affecting the quality of
product, inspection and test records are maintained for feed back to
vendors and also for reporting / review at higher management levels.
Procedure:
VERIFICATION OF PURCHASED PRODUCTS,
QA/P/01
INPROCESS AND FINISHED PRODUCTS
ENGG/P/01 DESIGN AND DEVELOPMENT ( R&D)
8.3 Control of Nonconforming Product / Activities

The company has established “Documented Procedures” to ensure that
products / activities which do not conform to its specified requirements are
suitably identified and controlled to prevent their unintended use or delivery
(Control of non conforming products is covered under the procedure for
verification of purchased products, in-process and final inspection). The
related responsibilities and authorities and manner for dealing with such
nonconforming products / activities have also been defined in the procedure.
This procedure also defines the controls for dealing with the nonconforming
products / activities by one or more of the following ways;

01 - 50 00 QM-01
a) by prioritizing the nonconformance, analyzing them and taking

immediate action, based on their criticality, for their elimination;
b) by authorizing its use, release or acceptance under concession by an
company authorized personnel. The process parameters are adjusted
based on evaluation of the non-conforming products / activities at
intermediate stages.
c) by taking action to prelude its original intended use or application,
d) by taking action appropriate top the effects, or potential effects, of
the non conformity when nonconforming product is detected after
delivery or use has started.
- DEFSYS’s nonconforming product control process provides for timely
reporting of delivered nonconforming product.
e) by taking actions necessary to contain the effect of the nonconformity
on other processes or products.
Dispositions of use as is or repair shall only be used after approval by
an authorized representative of the organization responsible for
design.
DEFSYS does not use dispositions of use as is or repair, unless specifically
authorized by the customer, if the non conformity results in a departure
from the contract requirements.
Product dispositions for scrap are conspicuously and permanently marked, or

positively controlled, until physically rendered unusable.
Non-conforming products / activities are duly identified and the products are
kept at designated locations. Such products are reworked / repaired and re-
tested before transferring them to OK storage area.
The records indicating the nature of non-conformities and the subsequent

actions taken for reducing and eliminating them are maintained. The trends
of nonconformance are periodically reviewed for deciding continuous
improvements in the products and processes.

01 - 51 00 QM-01
The concessions given for release of nonconforming product by Company

Authorized Personnel are maintained as QMS Records. Customer concession
or deviation is taken prior to further processing whenever the product or
manufacturing process is different form that which is currently approved.
Record of the expiration date or quantity authorized are maintained by QA
department and compliance with the original or superseding specifications
and requirements when the authorization expires is ensured. Material shipped
on an authorization is properly identified on each shipping container. If any
supplier requests for any concession or deviation the same is got approved by
the customer before submission.
In case the nonconforming products are corrected, the products /
information are re-verified for the requirements in which these were found
to be nonconforming in order to demonstrate the conformity to the
requirements. In case the nonconformance in the product is detected after
the same have been delivered to the customer or their use have started, the
company examines the criticality of such characteristics which have been

observed to be nonconforming and based on their criticality take appropriate
actions. Such nonconformance, which are critical and major in nature are
informed to the customer and if required, the same are withdrawn from
them. Fresh conforming products are substituted to this effect. The
potential effects of the nonconformity are also analyzed and appropriate
actions are taken. Products with unidentified or suspect status are classified
as non-conforming products.
Procedure: …QA/P/04.…. Control of non conforming products.
At appropriate stages rework Instructions are made available including re-

inspection requirements. These instructions are accessible to the personnel
who are authorized to carry out rework and re-inspection.

01 - 52 00 QM-01
8.4 Analysis of Data
The company determines, collects and analyses appropriate data to

demonstrate the suitability and effectiveness of the Quality Management
Systems and evaluates for deciding the continual improvement of QMS. The
data is collected at the specified periodicity as per data analysis plan and the
same is provided to Management Representative – QMS by the designated
Executives. The data is compiled by management representative to indicate
the effectiveness. This data is analyzed during the Management Review
Meetings to decide the Improvement Management Programs (KPIs).
The “Analysis of Data” includes:
• The data generated as a result of product / process monitoring and

measurement in the company;
• The Data collected from other relevant sources, e.g. Bench Marking Data
from relevant sources for similar products, if applicable.
During the Management Review Meetings, the data is analyzed as a minimum for
focusing the information relating to:
a) Customer satisfaction
b) Conformance to product requirements,
c) Characteristics and their trends in processes and of products
d) Opportunities for preventive action, and
e) Suppliers Data who provide the materials and services.
Trends in quality and operational performance are compared with progress

toward objectives and lead to action to support the following:

01 - 53 00 QM-01
- development of priorities for prompt solutions to customer-related problems;

- determination of key customer-related trends and correlation for status
review, decision-making and longer term planning;
- an information system for the timely reporting of product information arising
from usage.
8.5 Improvement
8.5.1 Continual improvement
The company a QMS to utilize the analysis of product / process related data
and continually enhances for making improvements for the effectiveness of
the Quality Management Systems.
KPIs are identified by making use of QMS Policy, QMS Objectives, feedback
for improvements through audit results, analysis of data, corrective and
preventive actions and the discussions held in Management Review Meetings.
The KPIs may be identified using following applicable indicators:

• Unscheduled Break-Down Time
• Consumption of resources like Power, Oils, Paints
• Process Set up time
• Non-value added use of Floor space
• Excessive Variation
• Process Averages not centered on target values (Bilateral Specifications)

01 - 54 00 QM-01
• Excessive Handling and storage

• New Target values to optimize product / processes
• Customer Dissatisfaction e.g. Complaints / Returns / Mis-shipment,
incomplete orders, etc
• Inventory Management
• Delivery Problems from Suppliers
• On time delivery of products to customer / dealers
• Variation in Production Planned and Actual Produced
• Quality Management Systems improvement,
• Quality Problems from Suppliers
• Improvement in Supplier Rating
• Improvement in Safe and Healthy Working Conditions
The respective Heads of departments are communicated through KPIs. The

Heads of Departments find out the contributors for these projects and
analyze the route cause for the same. They prepare the action plans on the
KPIs. The progress on these KPIs are monitored by Respective Management
Representative and the same are reported in Management Review Committee
Meetings.
8.5.2 Corrective action
The company has established a “Documented Procedure” for taking actions to

eliminate the cause of non-conformities in order to prevent their recurrence
of significant problems by analysis of non-conformance records, supplier
performance records etc.

01 - 55 00 QM-01
Through this procedure, it is ensured that controls are exercised for :
Reviewing the non-conformities (including warranty claim QMS & customer

complaints),
Determining the causes of non-conformities by using problem solving
techniques,
Evaluating the need for action based on criticality of the activities to ensure
that non-conformities do not recur,
Determining, deciding the corrective action needed based on root cause
analysis and implementing the same,
Maintaining the records of the results from the action taken and
Reviewing corrective action taken for their effectiveness.
When supplier is responsible for non conformity, Corrective actions will be

flown down to the supplier.
Specific actions when those actions will not be achieved with in prescribed
time limit.
In case of nonconforming product exists based on the causes of non
conformities have been determined in the procedure.
All customer complaints and customer returned products, reports of product /
process non-conformities identified during the process for Quality are analyzed,
using disciplined problem solving methods; causes relating to product process and
quality systems are established; and corrective actions are taken to eliminate
the causes. The corrective actions are also taken to
eliminate the cause of non-conformities in similar areas. The effectiveness of

the corrective action is verified from the quality of subsequent product /
processes / audits.

01 - 56 00 QM-01
Trends in Non-conformities observed in internal audits, incoming inspections,

production process, final inspection and customer complaint, delivery
performance; process capability; vendor delivery performance; customer
satisfaction; accidents; variations observed in environmental characteristics
etc. are analyzed and necessary actions taken to eliminate potential causes of
non-conformities. While taking corrective actions problem solving techniques are
used leading to root cause identification and elimination, possible mistake
proofing methods are identified and used. Effectiveness of the corrective
action is verified, changes in QMS documents are made and summary of the
corrective actions taken are submitted in Management Review.
Customer/field returns or rejections are analyzed and records of analysis are

maintained and made available to the customer on request. Necessary corrective
actions are taken to prevent recurrence.
Procedure: …QA/P/05… Corrective & Preventive Action
8.5.3 Preventive action
The company has established a “Documented Procedure” or determining

actions for eliminating the causes of potential non-conformities in order to
prevent their occurrence. The QMS Records are examined and based on their
trends, potential non-conformances are identified. Appropriate Preventive
Actions to the effects of the potential problems are decided.
Through this procedure, it is ensured that controls are exercised for
Determining potential non-conformities and their causes,
Evaluating the need for action based on potential problems in the
activities to ensure that non-conformities may not occur,
Determining the causes of non-conformities by using problem solving
techniques,

01 - 57 00 QM-01
Evaluating the need for action based on criticality of the activities to

ensure that non-conformities do not reoccur.
Determining, deciding the preventive action needed based on root cause

analysis and implementing the same,
Maintaining the records of the results from the action taken and
Reviewing preventive action taken for their effectiveness. Such as
opportunities include risk management, error proofing, failure mode and
effect analysis (FMEA), and information on product problems reported by
external sources.
The trends on special product characteristics including the accidents,

environmental indicators are maintained and examined periodically for
considering the potential non-conformances. These are analyzed using
Disciplined Problem Solving Methods for causes relating to product / process.
The necessary preventive actions are also suggested for eliminating the
potential non-conformances. The suggested actions are taken and if the same
are found to be adequate, same actions is also taken in similar areas. The
effectiveness of the preventive action is verified from the subsequent
products / processes / audits.
Procedure : …QA/P/05… Corrective & Preventive Action

01 - 58 00 QM-01
ANNEXURE I
Organisation Chart
Attached Next

01 - 59 00 QM-01
Annexure II
Process Interaction
Attached Next

01 - 60 00 QM-01
Annexure III
Responsibility and Authority
Attached Next

01 - 61 00 QM-01
Annexure IV
List of System Procedures
Attached Next

01 - 62 00 QM-01

Quality Manual As 9100 C

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Quality Manual As 9100 C

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Defsys Solutions ( India) Pvt. Ltd.

QUALITY MANAGEMENT SYSTEM MANUAL

(AS PER REQUIREMENTS OF AS 9100: 2009 & ISO 9001:2008)

Defsys Solutions (India) Pvt. Ltd.

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CONTENTS PAGE NO.

Section A - Cover Page - 1

Section C - Company Profile - 4

Section E - Quality Policy - 6

Section F - Quality Objectives - 7

Section G - Scope of registration & exclusions - 8

Section H - Process Scope - 9

Section 3 - Terms and Definitions - 13

Section 4 - Quality Management System - 17

Section 5 - Management Responsibility - 20

Section 6 - Resource Management - 22

Section 7 - Product Realization - 24

Section 8 - Measurement, Analysis and Improvement - 44

Annexure I Organization Chart - 59

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S.No. Page No. Amendment Details Recommended By Rev. No.

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APPOINTMENT OF MANAGEMENT REPRESENTATIVE

01st April, 2015

SUB: MANAGEMENT REPRESENTATIVE FOR AS 9100:2009.

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Defsys is committed to continually

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EXCLUSIONS AND JUSTIFICATIONS

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This manual is applicable throughout the company. It defines the Company’s

The manual has been prepared based on AS 9100:2009 and is designated to be

Implementation of the policies defined herein is by means of Quality Management

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SECTION-02 Normative References

The functions of this manual are:

c) To provide a training document and to ensure continuity of the system when

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2.1 MANUAL CONTROL

Company policies with respect to the application of Management Systems are

The Management Representative is authorized by the (ED) to carry out the

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Section 3 Terms & Definitions

Company : Defsys Solutions ( India) Pvt. Ltd.

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The abbreviations used in this manual are given below:

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