Chapter 8.3 Quality Manual

Document No.
QM/01
Quality Revision No. 00
Manual
Global Chemical Inc. Date 01.08.2018
Page No. 1 of 38
1.0 Company Profile
Global Chemical Inc.

Dubai
Quality Manual
QM 01
Quality System ISO 9001:2015
Issue Number 01
Issue Date 01.08.2018
Copyright 2018 @ Punyam Academy | sales@punyamacademy.com | +91-98250 31523 Page 1 of 38

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1.0 ABC Chemical Inc. Company profile
The Company is manufacturing Dyes. The Company has a vast experience in the
manufacturing of Synthetic Organic Dyes. Products reach to the customer after
undergoing a rigid inspection, strictly as per customer requirements in his defined
application. At all stages of the manufacturing, a proper care is taken to prevent the
pollution and keep healthy environment in and around the plant.
At present, the Company has an efficient organization comprising a team of dedicated
professional personnel in all areas of management. All products released by the Company
are strictly checked as per the customer defined requirements during the entire
processing.
And yes, as ABC, we never fail to match the delivery schedules and always believe in
timely supply of materials to our valued customers.
The key to our success is….
 Capacity to execute large orders.
 Quality matches customer requirements.
 Dedicated teamwork.
 Committed to timely supply.
 Commitment to the protection of intellectual property
1.1 Scope of Certificate
The manual is prepared as per the guidelines of ISO 9001:2015 for Research,
development, manufacture and supply of Synthetic organic dyes. The ISO 9001:2015
system has been implemented for;
Research, development, manufacture and supply of

Synthetic Organic Dyes
1.2 Non Applicable clauses
 All clauses are applicable to our company.
1.3 Authorization statement
Company is committed to the establishment and maintenance of Quality Management
Systems given in this manual and implemented by the company to meet the requirements
of ISO 9001:2015.
Mr. Morris William (QMS Head) has been appointed as a QMS Coordinator of the
Company. The QMS Coordinator is responsible for ensuring compliance with the QMS
requirements stipulated in this manual. He is authorized to ensure that the Quality
management System is established, implemented, and maintained by the company.
Managing Directors and CEO need to give full support and co-operation to the QMS
Coordinator and he is authorized to ensure that the system is implemented. All Functional
Head must implement the system.
Authorized By
Top Management

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Chapter: 02  Table of Contents
Chapter Page ISO 9001
Subject
No. No. Clause Reference
Section – 1
1. Company Profile 1–3 -----
2. Table of Contents 4–5 ------
3. Control and Distribution 6–7 ------
Section – 2
Context of the Organization 4.0
Understanding the organization and its context 4.1
Understanding the needs and expectations of
4. interested parties 8–9 4.2
Determining the scope of the quality management
system 4.3
Quality management system and its processes 4.4
Leadership 5.0
Leadership & Commitment 5.1
5. Policy 10 – 14
5.2
Organizational roles, responsibilities and authorities 5.3
Planning 6.0
Action to address risks and opportunities 6.1
6. 15 – 16
Quality objectives and planning to achieve them 6.2
Planning of changes 6.3
Support 7.0
Resources 7.1
Competence 7.2
7. 17 – 22
Awareness 7.3
Communication 7.4
Documented information 7.5
Operation 8.0
Operational planning and control 8.1
Requirements for products and services 8.2
Design and development of products and services 8.3
8. Control of externally provided processes, products 23 – 29 8.4
and services
Production and service provision 8.5
Release of products and services 8.6
8.7
Control of nonconforming outputs
Performance evaluation 9.0
Monitoring, measurement, analysis and evaluation 9.1
9. 30 – 32
Internal audit 9.2
Management review 9.3

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Improvement 10.0
General 10.1
10. 33 – 34
Nonconformity and corrective action 10.2
Continual improvement 10.3
Annexure
ANX–I List of Documented information 35 ==============
ANX–II Glossary of terms 36 ==============
ANX–III Interaction of Process 37 ==============
ANX–IV Quality Policy 38 ==============
ANX–V Organization structure 39 ==============

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Chapter: 03  Control and Distribution
3.1 Structure of Quality Manual
This manual is prepared according to the table of contents. Each chapter begins with page
1 and the numbering continues within the chapter and not throughout the manual. This has
been done to facilitate future addition / deletion of pages.
The manual is supported by documented information to establish good quality system
covering Process Flow Chart (PFC) and Standard Operating Procedure (SOP), exhibits or
test methods. In addition, a separate list of Process Flow Chart and formats are referred in
this manual and it is given in annexure – I and a glossary of terms are given in annexure –
II. Also overview of process flow of our activity is documented in flow chart given in the
annexure – III.
The manual is issued in loose leaf and is accessible to the staff and customers.
The implementation of this manual is mandatory for all departments. The changes made in
this manual are effected through the document control and must be approved by the Top
Management.
3.2 Responsibility
Top Management approves Front / Cover page of the Quality Manual. The control and
maintenance of this manual is the responsibility of Management Representative who is
maintaining master list of manual. Also when any changes / amendment is there, then the
same page is got reviewed by Top Management and change note is approved before
issue of such changed / amended page to the concern copy holder.
3.3 References
 ISO 9001:2015  Quality Management Systems – Requirements
3.4 Distribution
Quality Manuals are distributed to the various departments on a “controlled” basis.
Controlled copies are the one, which are subject to incorporation of "revisions". Those in
which, the amendment is not reflected / communicated are known as "uncontrolled"
copies.
"Controlled" Copies of the Quality Manual are stamped “Controlled Copy “on 1st page of
manual and given a unique copy number for maintenance purpose. The soft copy of
controlled copy is distributed by keeping it in common QMS folder read only for access to
HOD
Management Representative maintains Master list and distribution list for issue of Quality
Manual and accordingly copies are distributed with copy number to Copy Holders.
Amendments and revised pages of quality manual are issued by Management
Representative through a "Change Note" to holders of controlled copies of the manual.
Upon receipt of such revisions, the recipient will replace the pages by the revised ones.
"Uncontrolled" Copies may be issued by the Management Representative to the
prospective customers and others on the request of the HOD but the recipient shall not be
issued the amendments / revisions.
Management Representative is responsible to fill up amendment sheet in line with any
amendment and all the information regarding revisions is distributed to copy Holders. If
any amendment due to change in page number is done then the table of contents is
amended accordingly.

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3.5 Numbering and Documented information for Quality Management System
 The number for Quality Manual is given as QM 01, where 01 indicates Level 01
document of QMS.
 Quality Manual is divided into two sections – section 1 and 2. Section 1 deals with
general information and has chapters numbered 1 to 3. Section 2 addresses the
Quality management system elements of ISO 9001:2015 from chapter 4 to chapter 10
thus chapter on Leadership is numbered 5 which is also element 5 of ISO 9001:2015
and so on.
 A running number identifies complete manual and rev No. is given on each page, i. e if
any single page of the manual is updated then the issue no of the page remains as
issue no one and the same page rev no is updated to next. i.e. 00 to 01 and the same
is recorded on the amendment record sheet of manual. Initially Revision no. Is
considered, as 00. For any page-wise amendment revision number of the page is
changed to 01 for Page wise revision. Total nine amendments are possible in single
page of single chapter. If it crosses nine amendments then whole revision of Quality
Manual is changed to next no. i.e. 01 becomes 02 and so on. All such amendments are
recorded below.
3.6 Amendment Record Sheet
Replace New New

Amd. Chapter Page Signature of
current Rev. Rev. Reason for change
No. no. no. copy holder
Rev. no. no. date
Note
 All the pages other than those listed above are currently in the revision Number 00. If any
changes are done then the next revision no. is given and is recorded on the page listed above.
 To check the validity of the complete manual, confirm current revision status of this page with
Management Representative and cross check with sheets changed.

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Chapter: 04  Context of the organization
4.1 Understanding the organization and its context
Global Chemical Inc. is involved in the Production of Synthetic Organic Dyes. Our purpose
and strategic direction from our top management is to increase the volume of the business
and increase the profit margin. By implementing the Quality management system we
intend to increase our business turnover by developing new products, reducing cost of our
manufacturing by process modification and optimized use of our resources, produce
quality products and complying with legal requirements applicable to us. All this intention is
given as Quantifiable objectives given in this manual as documented information. We had
listed our internal and external issues as listed below considering above intention of
implementing the QMS.
We had listed our internal and external issues and its relevant risk in our risk analysis
sheet E/SYS/01 separately considering above intention of implementing the QMS.
An internal & external issue listed in risks analysis sheet are some internal and
external issues and Management Representative is updating this list and will
discuss it in management review meeting.
4.2 Understanding the needs and expectations of interested parties
The organization has determined interested parties that are relevant to the quality
management system. Interested parties and their needs and expectation are identified in
Exhibit E/SYS/02.
The requirements of all these interested parties relevant to QMS are identified in Exhibits
E/SYS/02.
Their requirements and information are reviewed are monitored by Functional heads
in their areas and if any specific requirements are identified then informed to
Management Representative to take further actions.
4.3 Determining the scope of the quality management system

We had determined the boundaries and applicability of the quality management system
and the scope is documented as below.
Documented Information for Scope:
Our Scope of QMS
Research, development, manufacture and supply of

Synthetic Organic Dyes
When determining this documented information on scope, we have considered:
a) The external and internal issues as listed in above para 4.1;
b) The requirements of relevant interested parties as listed in above para 4.2;
c) The Products and services provided by company.

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4.4 Quality management system and its processes
4.4.1 The organization had established the QMS system as described in this Quality manual. It
is implemented, and maintained and continually improved in accordance with the
requirements of the ISO 9001:2015. The macro level activity and process with interlinkage
is given in annexure-III
The organization has defined various QMS processes and the process approach
(E/SYS/02/xxx) for quality management system and their application throughout
organization is documented and it include;
 Inputs required and outputs expected from these process
 Sequence and interaction of these process
 Responsibilities and authorities for these process
 Risks and opportunities as determined for each processes in accordance with the
requirements of QMS
Organizations have evaluated these processes based on feedback from Functional Heads
and discussion in management review meeting and implement the changes, if any, at least
once in a year to achieve their intended result. The criteria and method to evaluate all this
processes are defined monitored to improve the processes and the QMS. Necessary
resources are provided for this processes and job description are prepared to assign
responsibility and authority.
4.4.2 The organization has defined the process approach, exhibits and Standard operating
procedure to support the operation of its processes. Organization has retain the
documented information in the filled forms as per mentioned in process approach matrix
output to have confidence that the processes are being carried out as per plan. The list of
process approach and forms maintained to implement the quality management system is
given in Annex I.

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Chapter: 05  Leadership
5.1 Leadership & Commitment
5.1.1 General
The Top Management attends various meetings and provides evidence of its commitment
to the development and implementation of the Quality Management System for continual
improving its effectiveness. He demonstrates the commitment and leadership as given
below:
 Taking accountability of the effectiveness of the QMS and review company objectives.
 The Quality Policy and Quality objectives are established, kept as documented
information in this Quality Manual and provided for ready reference to the employee.
They are compatible with the strategic direction and the context of the organization;
 Integration of QMS requirements in to Organization’s business processes and
preparing process documents.
 Preparing process exhibits with risk and opportunities. Also company level risk with
mitigation plan is prepared and given in risk template and monitored for
implementation. Promoting awareness of the process approach and risk based
thinking;
 Ensuring that the resources needed for QMS are available and discussed in formal /
informal meetings;
 Communicating the importance of effective Quality management and of conforming to
QMS requirements during internal meetings and management review meetings;
 Ensuring that the QMS achieves its intended results and verifying the same with the
help of internal audits and objective reviews;
 Engaging, directing and supporting persons to contribute to the effectiveness of the
quality management system;
 Promoting improvement;
 Supporting other relevant management roles to demonstrate leadership as it applies to
their areas of responsibility as identified in job description of Top Management.
 Once in a Six Month management review are conducted for review of our activities
and is attended by Top Management.
We had identified resource requirements and provided adequate in house resources in
terms of qualified personnel, test equipment and facility for operation and testing. Top
Management is responsible for providing appropriate resources and trained personnel for
effective implementation of the Quality Management System in their respective areas.
Management Representative reports to Management for any need of resources.
5.1.2 Customer Focus
Top Management is demonstrating leadership and commitment with respect to
customer focus by ensuring that:
 Customer requirements and applicable statutory and regulatory requirements are
determined, understood and met.
 The risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed in risk template
for overall risk and opportunities and process flow exhibits for process level risk and
opportunities.

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 Promotion of the importance of meeting customer as well as regulatory and legal
requirement is communicated across the organization. Focus of enhancing customer
satisfaction is maintained.
Based on routine contract review documents as well as communication and customer
survey the customer needs and expectation is determined and documented. All these data
are processed and converted into customer requirements and conveyed to the concern
person. While preparing customer requirements consideration is given for obligations
related to product as well as product related regulatory and legal requirements. Top
Management ensures that customer needs and expectations are determined and customer
requirements are fulfilled for enhancing customer satisfaction.
5.2 Policy
5.2.1 Establishing the quality policy
We have defined a quality policy as given below in terms of the characteristics of the
business, the organization, our location and technology. It is appropriate for the purpose
and context of the organization and provides frame work to set quality objectives. The
Quality Policy and objectives are documented in ANX - IV.
5.2.1.1 Company Business Objective
Company has defined business objective in support of Quality Policy.
 Customer satisfaction
5.2.2 Communicating the Quality Policy
All the employees are advised to undergo Quality Policy training on joining the company as
well as made aware of it immediately after preparation or modification. Management
Representative ensures that the respective employees understand the Quality Policy and
comply with the Quality Management system documented information. Also display of the
Quality policy at prime location is done and kept in this manual in para 5.2.1 as
documented information. The Quality policy is kept on web site and reception as
appropriate as well as given to all the interested parties like employees, external providers,
distributors etc. The Quality policy is reviewed once in a Year for continually improvement
of the effectiveness of the Quality Management System in management review meeting.
5.3 Organizational roles, responsibilities and authorities
Top management has assigned relevant roles as given in organization structure. For the
entire person the job description is prepared with authority and responsibility.
(a.) Top Management has defined responsibilities, authorities and their interrelation for all the
persons and communicated within the organization. All staff members are responsible for
maintaining the quality of their own work and for informing their Respective Heads for any
conditions, which are adverse to the quality of the work being produced or adverse to the
satisfactory operation of the quality system. A detailed Organization structure is prepared
and supported in Anx – V to this manual.
(b.) Personnel in Company at various level are responsible and have the authority within their
defined areas of control for:
 The quality of work carried out.
 Initiating action to prevent the occurrence of product Non–Conformance.
 Identifying and recording quality problems.
 Initiating, recommending and providing solutions to quality problems.
 To verify the effectiveness of the solutions.

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 Controlling further processing until all conditions are satisfactory.
The responsibilities and authorities of the organization chart are described as below:
TOP MANAGEMENT:
Responsibility:
a) Overall responsibility of the plant.
b) Recruitment & Interview of the employee / worker.
c) Overall responsible for implemented quality management system.
d) Maintaining of Original Machine Drawing files (Standard One).
e) Comply all statutory & Regulatory requirements of the plant.
Authority:
a) Make key decisions and can supersede decisions taken by others
b) Approve purchase of capital goods.
c) Approve the formulated quality management system.
d) Final authority in all policies of the company.
e) Approve the Key decision taken by the production department.
MARKETING/DESPATCH IN-CHARGE:
Responsibility:
a) Marketing (sourcing new customers) - Domestic by phone and internet surfing.
b) Marketing (sourcing new customers) - Overseas market by phone and internet surfing.
c) Issue of quotation.
d) Maintaining Order Confirmation File (domestic + exports) duly received from the
customer, tech. specs, drawing sample etc (both domestic & export)
e) Truck Booking for Domestic & Export Dispatch
f) Liaison and handling prospective customers
g) Handling and resolving customer complaints
h) Execution of work orders in time
i) Handle Vacuum tank related maintenance work issues and its outsourcing.
Authority:
a) Approve recruitment of marketing department.
b) Sanction marketing transactions at work.
c) Approve the rate of product.
d) Approve the marketing plan.
DISPATCH IN-CHARGE:
Responsibility:
a) Overall responsibility of the dispatch department.
b) Recruitment of dispatch department.
c) Man power management.
d) Review of Data collection of dispatch department.
e) Coordination with external customer
f) Prepare and approve Billing
g) Prepare customer Master
Authority:
a) Approve recruitment of dispatch department.
b) Sanction dispatch transactions at work.
c) Approve Leave of Department Person
MAINTANANCE IN-CHARGE:
Responsibility:
a) Maintain Harmonic cultures in the company
b) Recruitment of maintenance personnel at works

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c) Execution of work in time
d) Overall responsible for maintenance of the organization
e) To plan manpower of maintenance dept.
f) Impart regular maintenance training.
g) Overall responsible for requirement of spares and its management.
h) Co-ordinate with production, dispatch & marketing department.
i) To maintain plant and machinery and general house keeping.
Authority:
a) Approve all purchases of material and services
b) Approve recruitment of maintenance personnel at works
c) Approve the formulated quality management system
d) Approve leave of concern dept personal.
e) Approve the key decision taken by maintenance team.
PRODUCTION IN-CHARGE:
Responsibility:
a) Provide overall Management of the ongoing Production operations including
b) Inventory
c) Control, Scheduling, Documentation, Equipment Maintenance, Calibration, and
d) Quality Control/Inspection.
e) Assist in creation of efficient processes through hands-on development and training.
f) Track quality of all processes through analysis of recorded data and formation of
g) Additional test-points. Correlate results with requirements/specifications.
h) Report directly to Unit Head.
i) Co ordinate with other Departments
Authority:
a) Approve Management of change
b) Approve changes suggested by the production team.
c) Prepare shift schedule
d) Prepare technical report.
PURCHASE IN-CHARGE:
Responsibility:
a) Procurement of all material and services required for the organization
b) Manage supplier development
c) Overall responsible for purchase of the organization
d) Inform concern department about the goods received.
e) Track the payment of purchase product.
f) Prepare PO & other purchase document.
Authority:
a) Approve all purchases of material and services
b) Approve recruitment personnel of purchase dept.
c) Approve the formulated quality management system.
STORES IN-CHARGE:
Responsibility:
a) select the good supplier for buying the materials
b) check the purchase requisition note
c) keep the proper store records(bin card, stores ledger,)
d) Maintain proper stock levels of materials( minimum, maximum, average, danger,
reorder level)
e) Prepare the stock turnover ratio.
f) Avoid the stores losses(normal, abnormal)
g) Use the proper methods for an issue of materials in to the production department

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Authority:
a) Overall in-charge of stores.
b) Handle all issue related to stores.
ADMINISTARTIVE IN-CHARGE:
Responsibility:
a) Administer contracts
b) Maintain the level management system
c) Review of Remittances of Government Dues
d) Prepare & Supervise Payroll work
e) Review Payroll Report
f) Overall all responsible for statutory & regulatory compliance.
g) To Handle All Legal Aspects
h) House keeping
i) Training
J) Visitor Gate Pass Management
Authority:
a) Approve the rules to run plant smoothly.
b) Approve the shift schedule
c) Approve the manpower legal requirement.

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Chapter: 06  Planning
6.1 Actions to address risks and opportunities
We had consider the internal and external issues referred in exhibit E/SYS/01 and based
on that we had identified risk and opportunity and is available as documented information
as listed below.
1. Risk Analysis Sheet is prepared for overall major risk with mitigation plan is identified.
2. Minor process wise risk and opportunity is identified and documented in process wise
process flow exhibit.
The risk and opportunities identified is addressing:
 To ensure the quality management system can achieve its intended outcome;
 To enhance desirable effects
 To prevent, or reduce, undesired effects
 To achieve continual improvement
 To plan actions to address these risks and opportunities
 To integrate and implement the actions into its quality management system
processes; and
 To evaluate the effectiveness of these actions.
In the risk sheet and process flow chart risk mitigation actions are also identified and
documented. The system is identified for multiplication factor of occurrence and severity
and legal as well as customer concern is taken in to account. Accordingly risk is divided in
to high, medium and low as a part of planning, if any risk reaches to high level then actions
are initiated as per risk plan given in the risk analysis sheet. The effectiveness of action
taken is reviewed by Management Representative for major risk and for process related
risk by HOD on monthly basis. Necessary action against such risk is to reduce the risk,
retain the risk or creating opportunities by adding new products, new market, new
customers, new technology or new partnership etc
6.2 Quality objectives and planning to achieve them
6.2.1 The quality objectives are prepared based on quality policy, measurable and
relevant to product or service related and for enhancement of business objectives
like customer satisfaction.
 From the company level objectives the functional objectives are prepared and
Functional Head monitor the objectives status on monthly basis in objective monitoring
sheet. The objectives are communicated to all concern person by Functional Head and
are updated annually based on discussion in management review meeting.
 Quantifiable quality Objectives are established based on documented quality policy
given above at relevant function and consistent with the quality policy. The quantifiable
criteria are dynamic and reviewed in management review meeting for our commitment
to continual improvement.
6.2.2 The objective management plan is prepared to achieve the quality objectives, the
Objective plan includes:
a) What will be done;
b) What resources require;
c) Responsibility;
d) Time when completed; and method of evaluation of results

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6.3 Planning of changes
Top Management will review the quality management plan at regular frequency and
determines the need for changes to quality management system is require or not. The
changes in QMS is done in a planned way
When the changes are excising quality management system, organization takes into
consideration of;
a) Purpose of changes and its potential consequences
b) Integrity of the quality management system is maintained
c) Availability of recourses and
d) Based allocation or reallocation the authority and responsibility is revised in job
description

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Chapter: 07  Support
7.1 Resources
7.1.1 General
Company has identified resource requirements and has provided timely resources in terms
of qualified personnel, test equipment, plant and machinery, facility for production and
testing. The resource for implementation and maintenance of Quality Management System
as well as improving its effectiveness is provided. The adequate resources to enhance
customer satisfaction by meeting customer requirements is identified and provided at
Company
Adequacies of these resources are reviewed, for example during
 Management Review
 Contract Review
 Internal Quality Audit Results
 Customer Complaint Review
Management Representatives consider the capabilities and constraints on, existing internal
resources.
In cases in house resources are limited then services of external providers are taken.
7.1.2 People
Personnel assigned to work affecting conformity to product requirement are suitably
trained and / or experienced. Their work competence is checked based on applicable
education, training, skills and experience. For effective implementation of QMS and
operation and control of processes competent persons are provided.
7.1.3 Infrastructure
Appropriate facilities are determined, available and maintained to achieve conformity of
product and services. At present we had adequate infrastructure for QMS implementation
as listed below.
a) Buildings and associated utilities;
b) Equipment, including hardware and software; relevant machinery, testing equipments
c) Transportation resources;
d) Information and communication technology and all computers are connected with LAN.
7.1.4 Environment for the operation of processes
The Company ensures that proper layout, adequate ventilation, lighting, housekeeping
systems and safety devices maintain the work environment neatly where appropriate.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The organization has determine and provide the resources needed to ensure valid and
reliable results for monitoring of processes or product testing is used to verify the
conformity of products to requirements. In selecting the measuring and monitoring
equipment the product and process tolerance is considered and accurate machinery and
equipments are kept in place and adequacy is reviewed by HOD. The frequency of
preventive maintenance is decided and implemented. The documented information of
preventive maintenance records are maintained to ensure continuing fitness of
equipments. The preventive maintenance checklist is prepared based machine

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manufacturer suggestion and followed to ensure timely preventive maintenance is
implemented. For any breakdown the machinery and equipment is attended and
documented information is maintained in equipment history records.
7.1.5.2 Measurement traceability
Appropriate measuring and test equipment / instruments / software / measurement
equipment, etc. Capable of necessary accuracy and precision are used at the work places
to assure conformity of product to specified requirements. They are calibrated at the
regular intervals and the acceptance criteria is established on the basis of stability,
purpose and usage, thereby ensuring that it is capable of getting the necessary accuracy
and measurement requirements.
The salient features of the measurement traceability and calibration system established
and maintained are as under:
Equipments used in our company are selected based on capability, accuracy and precision
of the measurement required to be made. Test equipments are calibrated under suitable
environmental conditions.
a) The instruments are calibrated and adjusted at regular intervals as per schedules or
prior to use and recorded. All the critical equipments get calibrated against certified
equipment having a known valid relationship to nationally / internationally recognized
standard by trained company personnel or by employing services of outside calibration
laboratory having traceability with national / international standards. In the absence of
establishing such traceability, it is calibrated by in houses methods or some basis and
documented information is maintained. The equipments used for monitoring and
measurement are also included for calibration/verification as per established system
and record maintained. Also computer software used to satisfy intended application is
included and verification. The frequency of calibration is decided and Management
Representative ensures the tit is calibrated timely
b) All equipments are given instrument Identification number and stickers/tags are put for
identification of inst id#, calibration due date, calibrated on and status after calibration.
The records of calibration are maintained. Calibration status of the equipments is
identified by stickers / tags / records to recall back when calibration is due.
c) Equipments are handled in a manner to avoid damage and deterioration during
handling, maintenance and storage. Trained persons should handle the equipments to
ensure the validity of calibration. The measuring and monitoring equipments are
safeguarded to eliminate the possibility of invalidation of the calibration or are
subjected to calibration before use. New or repaired equipments and equipments used
for inspection are subjected to an initial inspection for accuracy or are proven prior to
release for use in testing.
In case any equipment is found out of calibration, the validity of previous inspection or
results of measurement after calibration is found outside tolerance then it is be assessed
and necessary action is taken to repair it. Till that time it is not used for monitoring and
measurement. New or repaired equipments and equipments used for inspection are
subjected to an initial inspection for accuracy or are proven prior to release for use in
testing.
If Software will be used in future for measuring and monitoring have specified
requirements are validated prior to use.

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7.1.6 Organizational knowledge
The organization determines the knowledge necessary for the operation of its processes
and to achieve conformity of products and services and documented in Exhibit E/SYS/04.
Such knowledge is gained with the help of experienced competent persons in the
organization or arranging the seminars and training programs in house.
When addressing changing needs and trends, QMS Coordinator considers the current
knowledge and determines how to acquire or access any necessary additional knowledge
and required updates. For sharing the knowledge the help desk is created and all past
failures and reasons are created as a part of lessons learned as well as successful
projects details and process improvement cases. Our product external test standards,
industry journals and other books are kept in the small library to upgrade organizational
knowledge. Also HODS are attending the conferences and seminars and industry trade
shows as well as exhibitions and provide in house presentation on knowledge sharing.
There is a lot of undocumented knowledge and experience is shared in the organization
during our internal meetings.
7.2 Competence
The Management Representative identifies competency of employees performing activities
affecting conformity of product requirement based on performance review and provides
necessary training and on the job training for their staff for upgrading their knowledge and
achieve the necessary Competency. The skill matrix and competency matrix and training
records are prepared as documented information. Also during routine work due to change
in area of work or any other reason the training needs are identified and provided.
Also ensure that the necessary competence has been achieved and appropriate records
for the education, experience, training and qualification are maintained in competency
matrix.
The new employee is trained properly in the identified area as described in the Process
Approach. The effectiveness of the training provided and action taken is evaluated as per
established Process Approach. The competence and training is also evaluated and
provided for contracted employees
7.3 Awareness
Functional Heads ensures that persons doing work under our control are aware of the
quality policy, relevant quality objectives, importance of their activities and how they
contribute to the effectiveness of QMS, benefits of improved performance and implications
of non conforming with the QMS requirements.
Suitable quality system awareness programmes are arranged for all the persons to ensure
that the requirements are well understood at all level.
7.4 Communication
The organization ensures internal and external communication between Functional Heads
and various levels of employees regarding the processes of the Quality Management
System and their effectiveness. Such communication related to QMS includes
a) On what it will communicate;
b) When to communicate;
c) Whom to communicate;
d) How to communicate;

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e) Who communicates?
7.5 Documented Information
7.5.1 General
Company has established, documented, implemented and maintained a Quality
Management System and continually improved its effectiveness in accordance with the
requirements of ISO 9001:2015 standard.
 We have determined the critical processes needed for the QMS and their application
throughout the organisation and listed in the process flow Annexure – III.
 For each and every processes process flow chart with input and output matrix and risk
and opportunity is established as process flow exhibits.
 Macro level QMS is documented in this Quality manual against how ISO 9001:2015 is
implemented. This manual is also known as the Quality Manual, which outlines the
scope, structure and general principles of the operation of Quality Management
System and serves as a declaration of the intentions of the top management to satisfy
various clauses of ISO 9001.
 The standard operating procedures and exhibits are documented as good
manufacturing practices.
 Forms are prepared and filled up to retain documented information.
 The list of forms and process flow charts are given in Annexure I.
7.5.2 Creating and updating
The written documents are prepared in Company as per list given below considering the
size of organisation, type of activities, the complexity of processes and their interactions
and the competence of personnel.
 Documented Statement of Quality Policy and Quality Objectives.
 Quality Manual.
 Process flow exhibits, Standard operating procedures and Exhibits.
 Quality Records (Few records are also maintained in the Electronic Media).
All documented information is identified by date, rev no, approved by title of document and
some identification number as per document identification and codification. All documented
information is kept in English and it is used in soft copy or hard copy in paper form.
All the documented information is reviewed and approved for suitability and adequacy by
authorized person as listed below.
Table – 1 Responsibility Matrix For Documents
Responsibility
Type Of Document Maintaining document

Document Review Modification And
Master list and issuing as
Approval
per distribution
Management
1. Quality Manual Top Management
Representative
2. Process Flow chart Management Representative / Management

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Table – 1 Responsibility Matrix For Documents
Responsibility
Type Of Document Maintaining document

Document Review Modification And
Master list and issuing as
Approval
per distribution
Functional Heads Representative
3. Standard operating procedures Management Representative / Management
/ Exhibits Functional Heads Representative
4. Applicable Standards/ Management
Customer Specification, And Management Representative For Representative
Documents Of External Origin Follow–up
(External)
Management Representative / Management
5. Formats,
Functional Heads Representative
Note: - Master copy of all the documents are kept with Management Representative, who is
authorized to issue and distribute the same.
7.5.3 Control of documented information

7.5.3.1 All the documented information relating to the Quality System requirements are controlled
as per details given below.
A) They are reviewed for adequacy and are approved by authorized persons as per table-1
B) The documents are updated as necessary, reviewed and re-approved by the same
authority. Copies of superseded documents are identified and retained as necessary to
maintain specified / required traceability.
C) The current revision status of the document is identified by revision number. Also the latest
changes are identified by suitable marking. Each document or data will have its revision
status by rev number or revised date as applicable. Such changes are distributed to
authorized Copy Holders of the document. Any revision is affected by changing rev no. of
particular page for quality manual / document for all other documented information
D) The respective Functional Heads / Management Representative are responsible for

ensuring that the latest relevant versions of applicable documents are available at point of
use where and when it is needed. They will also ensure that documents remain legible,
readily identifiable and retrievable. Such documented information is also protected from
loss of confidentiality, improper use or loss of integrity
E) All the controlled documents have been identified, legible and system of preparation,
issue, distribution and maintenance of documented information.
F) The Management Representative is ensuring that all external documents those needed for
use in the QMS is identified and proper control is established. Similar controls shall apply
to the external documents necessary for the planning and operation of the quality
management system. The external documents are identified and distribution is controlled.
external documents referred to are those needed for use in the QMS
G) Master list and distribution list with current revision of documents (latest revision number)
and distribution list of all the documents is maintained for all the documented information to

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prevent unintended use of obsolete documents. If any obsolete documents are kept for
future reference then stamp of obsolete document is put on the document.
7.5.3.2 Control of documented information

Company has established a system to define the control needed for identification, storage,
protection, retrieval, retention and disposition of documented information (records)
they are kept legible, retrievable and readily identifiable. The system is described as
below.
A) For all the documented information the current revision status and distribution list is
maintained in master list and distribution list of records. The access, retrieval and user
details are given in master list of records.
B) Proper control is established for storage and preservation of documented information to

ensure that such information is available when it is needed. The hard copy of documented
information is stored in cupboard or safe places with HOD/authorized person; It is ensured
that records are legible and properly preserved during storage. The soft copy is kept with
authorized access control by password and back up is taken weekly.
C) Control of changes (e.g. version control) is established with the help of change note and
revision number is changed to identify the latest copy of documented information.
D) Retention and disposition; The retention period for documented information is identified
and after retention period it is tear off or r burned for disposal of hard copy of documented
information. The soft copy is deleted.
Documented information of external origin determined by the organization to be necessary

for the planning and operation of the quality management system is identified as
appropriate, and listed in master list of documents. The latest copy of such documented
information is collected and distributed to concern person.
Documented information retained as evidence of conformity is protected from unintended

alterations by password protection or kept in cupboard with lock
The system is applicable for hard copy of records as well as records maintained in
electronic media. All the formats used as Quality Records are properly identified and
controlled.

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Chapter: 08  Operation
8.1 Operational planning and control
Planning for sequence of processes and sub processes is consistent with our QMS
requirements and documented in the inspection test plan / Process Approach Documents.
Our activity process flow chart is given in annexure  III of this manual.
We plan, implement and control the processes as per the details given below.
 Functional level objectives are defined and monthly basis monitored to establish control
on the processes
 Determining the requirements for the products and services and prepared documented
information for product specifications. It includes criteria of processes in process time
cycle sheets as well as acceptance criteria for incoming product, in process stages
and finish product
 Necessary resources are provided and ensured by Management Representative to
achieve conformity to the product and service requirements;
 All the manufacturing processes are controlled and output documented information is
generated as defined in process flow documented information. Evidence of all such
documented information as listed in format table given in Annexure-I to establish
confidence that the processes have been carried out as planned as well as
demonstrate the conformity of products and services to their requirements
Management Representative and Functional Heads control planned changes and review
the consequences of unintended changes, taking action to mitigate any adverse effects, as
necessary.
The control for outsourced process is done as per established system and as per controls
identified by functional heads.
8.2 Requirements for products and services
8.2.1 Customer communication
Company has identified and implemented arrangements for communication with
customers related to:
a) Products and services information by providing company profile and product brochures
as well as giving free samples and information on our web sites.
b) Inquiries, contracts or order handling including amendments by e mails.
c) Customer feedback related to products and services including customer complaints.
Management Representative has establish process for handling of customer feedback
as per process flow
d) Handling and controlling customer property
e) Established specific requirements for contingency actions, when relevant.
8.2.2 Determining the requirements for products and services
In Company Customer requirements for the product and services are determined as given
below.
a) The requirements for the products and services are defined, including:
1) Any applicable statutory and regulatory requirements;
2) Those considered necessary by Marketing HOD;
b) We can meet the claims for the products and services we offer.

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8.2.3 Review of the requirements for products and services
8.2.3.1 Marketing team ensure that we had the ability to meet the requirements for products and
services offered to customers. We conduct a review before committing to supply products
and services to a customer, our contract review activity includes review for:
a) Requirements specified by the customer, including the requirements for delivery and
post delivery activities;
b) Requirements not stated by the customer, but necessary for the specified or intended
use, when known;
c) Requirements specified by the organization;
d) Statutory and regulatory requirements applicable to the products and services;
e) Contract or order requirements differing from those previously expressed.
We ensure that contract or order requirements differing from those previously defined by
us are resolved. In such cases we mutually agree and give amendments as necessary
For internal orders and branch transfer there is no need for such contract review.
A) As soon as customer inquiries are received for their requirement, marketing team review it
to ensure that customer’s requirements are clearly identified, understood and whether they
can be met. If customer provides no documented statement of the requirements then
customer requirements are confirmed before acceptance. Matters that are not clear
including contract / order requirements previously expressed are resolved with the
customer. Normally our customers understand Our Product by Name, Specifications, Qty.,
and Delivery and specify in their documents / verbally convey.
B) The internal contract review is carried out as described in Process Approach to assess
capability for supply of the product and meet product requirements. In case there is any
difference in the specifications of the customer then it can be resolved by carrying out the
changes as required by the customer.
C) Prior to commitment to supply a product to the customer, customer orders (written / verbal)
are reviewed to ensure that:
 Customer requirements are clearly documented;
 Any variation from the contract is resolved; and
 Company can meet all contractual requirements.
D) Amendment To A Contract
Subsequent contract variations are documented and subject to similar review. Any
amendment to the contract is identified and confirmed with the customer. It is conveyed to
the concerned person for changed requirements.
The documented info related to contract is maintained.
8.2.3.2 We retain documented information related to Contract:
a) On the results of the review;

b) On any new requirements for the products and services.
Such details are retained by sending E mail/Work Order/Acceptance of customer purchase

order/Order confirmation as documented information.

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8.2.4 Changes to requirements for products and services
If any amendment to the order is asked by us or by customer to change the requirements
for products and services then E mails/our revised order confirmation/work order/customer
purchase order with acceptance etc is amended, and that relevant persons are made
aware of the changed requirements.
8.3 Design and development of products and services
Not applicable.
8.4 Control of externally provided processes, products, services
8.4.1 General
We ensure that externally provided processes, products and services conform to the
requirements.
The Purchase head determine the controls to be applied to externally provide processes,
products and services when:
a) Products and services from external providers are intended for incorporation into the
organization’s own products and services;
b) Products and services are provided directly to the customer(s) by external providers on
behalf of the organization;
c) A process, or part of a process, is provided by an external provider as a result of a
decision by the organization.
Suitable controls are established in externally provided process to ensure externally
provided process, products, services conforms to requirements. The type and extend of
control are dependent on quality of the final product as and necessary evaluation and
reevaluation of external provider is done as described in the Process Approach. The
system for selection and evaluation of external providers / suppliers / subcontractors has
been established on the basis of their ability to externally provided processes, products,
services in accordance with Organization requirements. The documented information is
maintained in the form of External Providers List for all the different category of processes,
products, services as well as results of evaluations and follow-up actions. It is updated
once in Six Months based on vendor rating (Re–evaluation of critical items of externally
provided processes, products, services) and if any external provider is not performing well
for quality and delivery or legal issues then they are given warning or removed from the list
as per established system given in purchase activity process flow chart.
8.4.2 Type and extent of control
Normally our customers never ask to verify our externally provided processes, products,
services at subcontractor's / supplier’s premises as well as we are not inspecting our
product at subcontractor's / supplier’s premises. But in future our customer or we proposes
to perform verification activities at the external providers / subcontractor's / supplier’s
premises then suitable arrangement at external providers / subcontractor's / supplier’s
place and method of product release is conveyed to vendor as a part of purchasing
information.
The incoming inspection and testing or verification of all the products is done as per
inspection test plan to establish control on external provider.
The Purchase head ensure that externally provided processes, products and services do
not adversely affect the organization’s ability to consistently deliver conforming products
and services to its customers as per details given below.

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a) Ensure that externally provided processes remain within the control of our quality
management system;
b) Define both the controls that we intends to apply to an external provider and details
given in external provider list and incoming inspection we apply to the resulting output
of external provider as per inspection test plan ;
c) The purchase head take into consideration:
1) The potential impact of the externally provided processes, products and services on
our ability to consistently meet customer and applicable statutory and regulatory
requirements;
2) The effectiveness of the controls applied by the external provider;
d) As per inspection test plan incoming verification, or other activities, necessary to
ensure that the externally provided processes, products and services meet
requirements are implemented.
We controls production and service operations done through outsourced process through
A) The availability of information that specifies the characteristics of the product.
B) Documented Work Instructions / Process Control Parameters are made to define
the manner of production, approval of process, monitoring and control of suitable
process.
C) As per established maintenance system maintenance of equipment for production
and service operation is done and records are maintained by them for our quarterly
verification.
D) Availability and use of the process control and appropriate measuring and test
equipment / instruments, etc. capable to measure accuracy and precision as
specified in our requirements.
E) The criteria for workmanship are informed to them on implementation and
monitoring of process control parameters and are checked by them and during our
visit we may verify it.
8.4.3 Information for external providers
As per our purchase system the external providers are given purchase order or job
contract as documented information. With the help of such documents we communicate to
external providers any of our requirements depending on type of product/services for:
a) The processes, products and services to be provided;
b) The approval of:
1) Products and services;
2) Methods, processes and equipment;
3) The release of products and services;
c) Competence, including any required qualification of persons;
d) The external providers’ interactions with us;
e) Control and monitoring of the external providers’ performance including vendor rating
applied by us;
f) Verification or validation activities that our customer, intends to perform at the external
providers’ premises.

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8.5 Production and service provision
8.5.1 Control of production and service provision
The Production head controls production and service operations with the help of controlled
conditions as per details given below.
a) The availability of documented information like Standard operating procedures and
Exhibits and process log sheets defining:
1) The characteristics of the products to be produced, the services to be provided, or
the activities to be performed;
2) The results to be achieved;
b) The availability and use of suitable monitoring and measuring equipments like pressure
gauges, thermometers, pressure gauges etc.;
c) The implementation of monitoring and measurement activities at appropriate stages to
verify that criteria for control of processes or outputs, and acceptance criteria for products
and services as per inspection test plan for various stages of inspection, have been met;
d) The use of suitable infrastructure and environment for the operation of processes;
e) The appointment of competent persons
f) At present the organization does not carry out any special process and hence
validation of process is not required.
g) The implementation of actions to prevent human error and many places we had done
automated controls to minimize the human involvement;
h) The implementation of release, delivery and post-delivery activities.
8.5.2 Identification and traceability
All products and services, from the time of receipt until dispatch are identified by one or
more of the followings in stores, manufacturing areas and finish good stores by using
stickers/tags/areas identified or records as suitable for
 Type, name, specification, brand name and other precise identification as
applicable.
 Make, brand name etc.,
 Self identification
 Others as applicable.
IN manufacturing area and stores inspection and test status for inspected, rejected or
waiting for inspection is also maintained. The system is laid down for identification of
materials by writing necessary details on the related records including its inspection and
test status based on the inspection and testing. Materials and all incoming products are
identified from receipt, during manufacturing and dispatch product for name, standards
and applicable references as described above. Any material released under concession or
positive recall system is identified and recorded in related records.
As such traceability is specified requirement of our customers, hence the same is
maintained during the production and services by providing Lot No. / batch number
throughout the manufacturing production process and records to be maintained.
The entire product at incoming, InProcess and final stage of inspection is having inspection
and test status for measurement and monitoring requirements.

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8.5.3 Property belonging to customers or external providers
Customer property list is being maintained as per CONTRACT WITH customer and a
proper sheet for the same is always present with the top management.
External providers property include material, components, tools and equipment, premises,
intellectual property and personal data etc. anything for packing / marking may be received
by the Company from external provider for inclusion of such things in their products as per
contract terms.
Such properties are checked as per the Inspection test plan. Any property that is lost,
damaged or otherwise found to be unsuitable for use, non-conforming is recorded and
reported to the customer or external provider and retain documented information on what
has occurred.
8.5.4 Preservation
Company preserves product and services with customer requirements during internal
processing, servicing and delivery to the intended destination in order to maintained
product conformity requirement including identification, handling, contamination control,
packaging, storage, transmission or transportation, and protection. Also necessary controls
are established on the Shelf life Products.
8.5.5 Post-delivery activities
Product and service requirements specified by the customer including the requirements for
Post-delivery activities included actions under warranty provisions contractual obligations
such as maintenance services are covered under post delivery services and meet the
requirements.
In determining the extent of post-delivery activities that are required, the organization we
consider:
a) Statutory and regulatory requirements;
b) The potential undesired consequences associated with its products and services;
c) The nature, use and intended lifetime of its products and services;
d) Customer requirements;
e) Customer feedback.
8.5.6 Control of changes
The Process Control Parameters are followed in company to ensure critical process
parameters of the Production Processes are monitored and measurement methods are
followed. Also all other identified critical processes are monitored by suitable means to
meet customer requirements. These methods confirm the continuing ability of each
process to satisfy intended use. At any stages changes in processes may be identified by
functional head and such changes are justified by functional head and it is reviewed with
Management Representative and authorized to follow the changes. Such changes may be
temporary for specific order or permanent then in QMS system applicable documented
information is changed.
We review and control changes for production or service provision, to the extent necessary
to ensure continuing conformity with requirements. at any stages changes are identified by
functional head /Management Representative or as a part of improvement then process
change template is prepared as documented information describing the results of the
review of changes, the persons authorizing the change, and any necessary actions arising
from the review.

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8.6 Release of products and services
Inspection test plan has been established for ensuring that all the incoming, InProcess,
final stage products and services are not issued before it has been verified for conformity
of specified requirements, except in the circumstances of positive recall. The amount and
extent of inspection is determined on the basis of recorded evidence of their past
performance. Evidence of conformity with the acceptance criteria is recorded in the
inspection and test records along with authorized person’s signature for release of
products.
Where incoming or in process material is released for urgent production purposes before
inspection, they are positively identified and recorded to permit their recall in the event of
non-conformity.
No products are dispatched until all the testing activities specified in inspection test plan
are completed and authorized person verifies test records. Documentary evidence in the
form of records is maintained at all stages of inspection / verifications to ensure that the
products are inspected as per inspection test plan and passes through the inspection tests
with the desired acceptance criteria.
We retain documented information on the release of products and services as inspection
test report. The inspection test reports include:
a) Evidence of conformity with the acceptance criteria;
b) Traceability to the person(s) authorizing the release and approved by QC
head/authorized person.
8.7 Control of nonconforming outputs
8.7.1 The detail system and exhibit is established for identification, documentation, evaluation,
segregation and disposition of non-conforming incoming, InProcess and the final product
in production and inspection area. The concerned persons are informed for disposal of
non-conforming product and service.
The non-conforming products and services are reviewed after inspection in accordance
with the documented exhibit and subject to decision taken as per following.
a) Correction (Re–Processed / Re–Worked To Meet the Specified Requirements)
b) Segregation, containment, return or suspension of provision of products and services;
c) Informing the customer;
d) Obtaining authorization for acceptance under concession. (Down Gradation / Rejected
and Scrapped)
Top Management is overall responsible for disposal of Finished Products at Final
inspection and testing stage. He is also responsible for taking disposal action on customer
returned products
Top Management and Functional Head is responsible for disposal of In Process in-
spected and final inspected Products. Staff assists them, in routine functions. They are
also responsible for identification; segregation and storage of non–conforming products till
disposal actions are taken.
8.7.2 The details of non-conformity and concession accepted by the customer, end user or other
body as applicable should be reported and recorded. The documented information as non
conformity register is prepared to include details to
a) Describes the nonconformity;

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b) Describes the actions taken;
c) Describes any concessions obtained;
d) Identifies the authority deciding the action in respect of the nonconformity.
Documentary evidence in the form of records is maintained for disposal of non-conforming
material and acceptance of re-inspected material.
Chapter: 09  Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The inspection test plan and operational control plan is prepared and implemented to
identify measurement and monitoring activities needed to assure conformity and achieve
improvement. This includes parameters to be monitored and measured, methods, need
and use of applicable methodologies and when it is monitored and measured. The details
of different stages of inspection, acceptance criteria, sample size etc. are given in
inspection plan and followed by the company. The acceptance criteria are defined and is
monitoring and measurement limit is outside such limits then product is identified as
nonconformity and disposal action is taken. Company has planned and implemented the
monitoring, measurement, analysis and improvement processes needed to evaluate the
effectiveness of QMS and retain the documented information like functional objective
monitoring sheet, inspection reports and process log sheets as evidence.
9.1.2 Customer satisfaction
Once in a year customer survey is taken by sending the customer feedback form to collect
information on customer satisfaction. The customer feedback forms are sent to identified
customer having big volume of business with us or as identified by Management
Representative and not send to all customers. Such information is analyzed to measure
satisfaction levels of customer and discussed in the Management Review Meeting. Also
information on customer satisfaction is collected from the contract review records as a part
of routine activities. We had identify areas of customer satisfaction measurement and
provided in feedback form and customer is informed to give rating from excellent to poor.
Based on analysis for poor and average perception of customer is considered as customer
is not satisfied for that parameter. Thus overall summary is made by analyzing the data
and customer satisfaction index is calculated.
The other method of customer satisfaction measurement includes analysis of customer
data on delivered product, lost business analysis, compliments, warranty claims and dealer
reports.
All this information is reviewed in management review meetings
9.1.3 Analysis and evaluation
The entire HOD analyzes and evaluates the data in their areas for monitoring and
measurement. Some statistical methods are used for data analysis. The results of analysis
are used to evaluate as given below.
a). Conformity to product and service requirements
b). Customer satisfaction index
c). The performance and effectiveness of Quality Management System

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d). Effectiveness of Planning activity
e). The effectiveness of actions taken to address risks and opportunities
f). The performance of external provider
g). The need for improvements to the Quality management system
9.2 Internal audit
Audits are performed regularly and the interval between audits of any particular
department is not greater than Six Months. Unscheduled audits may be carried out at the
discretion of the Top Management or Management Representative based on need.
Internal audit of Quality Management System audit is carried–out At least Once in a Six
Months to
a). Determine whether Quality Management System
1. Conforms to the planned arrangements for Quality Management System
and ISO 9001:2015 requirements,
2. Is implemented and maintained in accordance with the requirements our
Quality Management System as given in this Quality Manual,
3. Is effective in meeting the Quality policy and objectives
b). Provide information on the results of audits to the Top Management for verify
effective implementation of Quality Management System.
Management Representative is responsible for the planning and implementation of the
audit. The auditors, who are selected normally from within the company, will however
assist him. The auditors are selected in such a way that they are trained for auditing and is
not working in the same area, which is to be audited. If need arises, outside auditors can
also be employed at the discretion of Management Representative.
Internal Auditors are responsible to execute audit as per plan and verify the effectiveness
of implementation of Quality Management System
The internal audit is scheduled in the Company on the basis of the status and importance
of activity to be audited and previous audit results. Management Representative prepares
the audit plan covering with scope, schedule and other details. Personnel are nominated
as auditors and provided audit training. It is ensured that the auditors are independent of
the specific activities or areas being audited by them. The audit plan is prepared and
circulated before 1 week of audit execution to ensure availability of HOD and auditors.
The auditor verifies implementation of documented Quality Management System in all the
areas and objective evaluation of the organization structure, working practices, resources,
accuracy of the work, process monitoring and measurement, risk and opportunities
identified and effectiveness, verify documented information etc.
Audit Report and Follow–Up
The Auditor prepares non–conformity report on completion of the audit and the non–
conformity is brought to the notice of auditee. They discuss about the appropriate actions
to be taken and schedule for implementation for Non–Conformance observed. Audit
findings are documented and used as the main formal means of resolving problems
and deficiencies detected in the Quality Management System. The HOD conform agreed
time to close the non conformity and within maximum 45 days internal audit findings are
closed. The copies of such NCR reports are given to auditee and after taking timely
corrective action on NC reports, the auditee calls auditor to verify it and to close NCR.
After verification of action taken the audit findings are closed. During next audit,

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implementation effectiveness of the corrective action taken on NCR’s is reviewed and
documented.
All the audit findings and verification of audit results are reported to the top management
for review and evaluation of the system and also discussed in the management review
meetings. The audit plan/Schedule, audit non conformity reports and clause wise audit
checklist are maintained as an evidence of the implementation of audit programme and
audit results.
9.3 Management review
9.3.1 General
The quality system established and is systematically reviewed for its continuous suitability
and effectiveness in confirming the requirements of ISO 9001-2015 in our company. The
review includes implementation of our Quality Policy and Objectives to identify any area,
which requires improvement, and evaluate need for changes for effective functioning of the
system.
This review is carried out at least once in Six Months by Top Management or their
nominee by holding Management Review Meetings, which are attended by Management
Representative and all Functional Heads.
9.3.2 Management review inputs
The agenda and time and date of management review meeting is circulated to all HODs
and Top Management to attend management review meeting with supporting documents
related to agenda points to discuss in the meeting input to management review includes
current performance and improvement opportunities related to the items listed here under.
a) The status of actions from previous management reviews;
b) Changes in external and internal issues relevant to QMS;
c) Information on the performance and effectiveness of QMS, including trends in:
1) Customer satisfaction and feedback from relevant interested parties and customer
complaints;
2) The extent to which quality objectives have been met;
3) Process performance and conformity of products and services;
4) Nonconformities and corrective actions;
5) Monitoring and measurement results and Review effectiveness of system in achieving
Quality objectives;
6) Audit results;
7) The performance of external providers;
d) Effectiveness of actions to address risks and opportunities
e) Opportunities for improvement
1. Review changes brought in technology, product mix, market, engineering change
etc. That affects system, if any.
2. Review specific issue (if any) for effectiveness and basis for improvement of the
Quality Management System and recommendation for improvement.
9.3.3 Management review outputs
Based on management review process actions emerged for any of the items related to:
 Improvement of the effectiveness of the quality management system and its
processes,
 Improvement of the product related to customer requirements;

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 Need for resources
The above output is documented as a evidence in the MRM as Actions Planned in
management review meeting. It is the responsibility of the Management Representative to
prepare the minutes of management review meeting covering details;
 Discussion held
 Action planned,
 Person responsible to complete planned actions.
Chapter: 10  Improvement
10.1 General
The Management Representative / functional head determine and select Opportunities for
improvement and implements necessary actions to meet customer requirements and
enhance customer satisfaction.
These include:
a) Improving products and services to meet requirements as well as to address future
needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) Improving the performance and effectiveness of the quality management system.
Examples of improvements made in our organization by:
• correction,
• corrective action,
• continual improvement,
• breakthrough change,
• innovation and re-organization
10.2 Nonconformity and corrective action
10.2.1 The company has established the system for identification, documentation, evaluation,
segregation and disposition of non–conformity including audit results and customer
complaints the concerned persons are informed for disposal of non–conformity.
The non–conforming products are reviewed after inspection at stage wise and subject to
decision taken as per following.
Disposal of Non–conforming Products
The Company ensures that products, which do not conform to product requirements, are
Identified and controlled to avoid inadvertent use or delivery. Activity for non-conforming
products describes the controls involved in segregating non-conforming products, Dumping
in air for non-conforming products, Operation in-charge is responsible and authorized for
evaluation, notification and disposal of non-conforming products.
Correction and Corrective action
The corrective action planning should include evaluation of the significance of problems
affecting quality or customer satisfaction. The major or repetitive non–conformities are
identified for taking corrective action in the areas as defined.
a. The Functional Head reviews non–conformities (including customer complaints)
identified in their areas and analysed it.

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b. Functional head is correct it first as based on analysis data.
c. Then root cause of non–conformities are identified in the area like man, machine,
material, management (system), money (Resources).
d. Considering the evaluation and aspects like costs of non–conformance, vs. action
taken, random failure, customer satisfaction etc. need for action is evaluated to ensure
that non–conformities do not recur. For non–conformities of minor nature or random
failure it is recorded in Quality Objectives form and no CAR is raised.
After analysis of the non–conformities or deficiencies for major or repetitive problems
the need for corrective action is taken.
e. Based on root cause analysis corrective action to be taken is determined. If it is
applicable for other department then CAR Form is forwarded to the concern function.
Necessary corrective action is implemented.
f. The results of action taken is recorded in CAR Form and compared for results in non–
conformity V/s results after action taken. If it is found not satisfactory then the whole
process is repeated.
After completion of corrective action form is forwarded to Management Representative for
review corrective action taken. Management Representative shall review effectiveness of
the corrective action to review the adequacy of such measures. The summary of
effectiveness of corrective action is discussed and reviewed in management review
meeting.
10.2.2 The functional head maintains documented information on nonconformity identified
subsequent action taken in nonconformity register. The functional head / Management
Representative correct the nonconformity first and then take corrective action and maintain
records of corrective action taken in Corrective action reports including result of corrective
action taken.
10.3 Continual improvement
The process is laid down for follow up of process for continual improvement of the Quality
Management System. The functional head / Management Representative takes necessary
action for continually improve the suitability, adequacy, and effectiveness of the QMS.
Continuous improvement in the effectiveness of quality management system is achieved
through the use of:
 Well defined Quality policy
 Measurable quality Objectives
 Audits that identify opportunities for improvement
 Analysis of data of product conformance and operational performance, customer
satisfaction and supplier performance
 Corrective and preventive actions
 Management review
 Improvement opportunities are tracked for effective implementation and achievement of
desired results
.

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Annexure – II Glossary of Terms

Sr.
No.
Abbreviation For
1. GCI Global Chemical Inc.
2. Top Management Director
Sales Head, Purchase Head, Works Head, QC Head, Production
3. Functional Heads
Incharge, Stores Incharge, Despatch Incharge etc.
4. QM Quality Manual
5. ANX Annexure
6. QMS Quality Management System
7. NCR Non Conformity Report
8. IQANCR Internal Quality Audit Non Conformity Report
9. AEPL Approved External Provider List
10. CAR Corrective Action Report
11. PFC Process Flow Chart
12. SOP Standard Operating Procedure
13. F Format
14. E Exhibit
15. HOD Head of department/functional heads
16. DI Documented Information

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Annexure – III Interaction of Process
Customer order / enquiry is received by authorized person
Customer enquiry / order is reviewed for the requirements of product, specifications,

packing and delivery requirements
Enquiry is replied by sending offer by Order is recorded in to order

authorized person receiving register
Design review & approval with client

After successful negotiation order is
received / further follow-up for order
is done Order is given to plant for further processing
If order is received then it is treated

as per above method
Production planning is done based on capacity utilization, orders in hand, ready

stock and future order expectation
Raw materials requirements is identified and purchase is informed for purchasing
Materials are purchased from the approved suppliers as per the process for
purchasing
Materials are received; stores unload it and offer for inspection and testing to QC as
per the process for Stores and Quality Control
QC Inspection and Testing of Material as per Quality Plan are done and submit results
to stores & Accepted Materials are issued to Production for manufacturing and packing A
and rejected are sent back to vendors

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Manufacturing of the products as per the defined processes and processes for production
Final Inspection and testing of the products as per the requirements of Quality Plan
After completion of final inspection and testing of the products as per the defined
specifications, Quality Control releases the products for dispatch
Products are dispatched to the customer considering committed delivery schedule. All the
supportive documents asked by the customer are accompanied with the products dispatched
After dispatch, order is closed and all matters related to contract are resolved and contract is
closed.
The Main Processes Identified Based On Above Flow Are Listed Below. Individual Department Wise
Process Flow Are Given In E/SYS/02/###.
1. Marketing 2. Purchasing
3. Management Representative 4. Quality Control
5. Production & services 6. HR / Training
7. Packing and Despatch 8. Stores
The microlevel process flow of above processes and department input and output as well as
sequences and interactions are documented in Exhibit No.  E/SYS/02/###.
The effectiveness of above processes are ensured based on analysis results for criteria of effective
operation and control. The same is fixed on annual basis and reviewed in management review
meeting.

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Annexure – IV Quality Policy
We, at Global Chemical Inc. commit ourselves for supplying products

that would give complete satisfaction to customers.
We will strive to achieve growth and leading position in the market by;
 Supplying consistent quality products to our valued customers
 Complying with all applicable requirements and continually improve
the effectiveness of quality management system
 Creating an environment of teamwork and innovative approach
1st August 2018

Top Management

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Annexure – V Organization structure
Director
General Manager
Factory Manager Maintenance Purchase I/c Accountant

I/c & Store I/c
Production
Supervisor Fitter
Workers

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Document No.

1.0 Company Profile

Global Chemical Inc.

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Research, development, manufacture and supply of

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Replace New New

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4.3 Determining the scope of the quality management system

Research, development, manufacture and supply of

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Table – 1 Responsibility Matrix For Documents

Type Of Document Maintaining document

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Table – 1 Responsibility Matrix For Documents

Type Of Document Maintaining document

7.5.3 Control of documented information

D) The respective Functional Heads / Management Representative are responsible for

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7.5.3.2 Control of documented information

B) Proper control is established for storage and preservation of documented information to

Documented information of external origin determined by the organization to be necessary

Documented information retained as evidence of conformity is protected from unintended

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a) On the results of the review;

Such details are retained by sending E mail/Work Order/Acceptance of customer purchase

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Chapter: 09  Performance Evaluation

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Annexure – II Glossary of Terms

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Annexure – III Interaction of Process

Customer order / enquiry is received by authorized person

Customer enquiry / order is reviewed for the requirements of product, specifications,

Enquiry is replied by sending offer by Order is recorded in to order

Design review & approval with client

If order is received then it is treated

Production planning is done based on capacity utilization, orders in hand, ready

Raw materials requirements is identified and purchase is informed for purchasing

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