SMASH ENTERPRISES

Gat No.189, Jyotibanagar, Talawade,

Pune 411062

APEX QUALITY MANUAL

ISO 9001: 2015

ISSUE No – 1

ISSUE DATE (FIRST) – 01/09/2017

ISSUED BY

ISO COORDINATOR

APPROVED BY

CEO
 Section 1 - [i] CONTENTS

Section ISO Description Rev

No. 9001:2015 No.
Clauses

1 I Contents 0
2 Ii Amendment Records 0
3 Iii Abbreviations 0
4 1 Introduction 0
1.1 About SMASH 0
1.2 Vision Statement 0
1.3 Organization 0
1.4 Process Approach 0
1.5 Risk Based Thinking 0
5 2 Scope 0
6 3 Exclusions 0
7 4 Context of the organization 0
4.1 Understanding the organization (SMASH) and its context 0
4.2 Understanding the needs and expectations of interested parties 0
4.3 Determining the scope of the quality management system 0
4.4 Quality management system and its processes 0
8 5 Leadership 0
5.1 Leadership and commitment 0
5.2 Quality Policy 0
5.3 Organizational roles, responsibilities and authorities 0
9 6 Planning 0
6.1 Actions to address risks and opportunities 0
6.2 Quality objectives and planning to achieve them 0
6.3 Planning of changes 0
10 7 Support 0
7.1 Resources 0
7.2 Competence 0
7.3 Awareness 0
7.4 Communication 0
7.5 Documented information 0
11 8 Operation 0
8.1 Operational planning and control 0
8.2 Requirements for products and services 0
8.3 Design and development of products and services 0
8.4 Control of externally provided processes, products and services 0
8.5 Production and service provision 0
8.6 Release of products and services 0
8.7 Control of nonconforming outputs 0
12 9 Performance evaluation 0
9.1 Monitoring, measurement, analysis and evaluation 0
9.2 Internal audit 0
9.3 Management review 0
13 10 Improvement 0
 10.1 General 0
10.2 Nonconformity and corrective action 0
10.3 Continual improvement 0
14 Annexure 0
 Section 2 - [ii] AMENDMENT RECORDS

Sr. Section Rev. Date Revision Details Reason

No. No.
 Section 3 - [iii] ABBREVIATIONS

AQM - Apex Quality Manual

QMS - Quality Management System

MD - Managing Director

IA - Internal Audit

ISO - International Organization for Standardization

QR - Quality Records
 Section 4 - [1] INTRODUCTION

[1.1] ABOUT SMASH

SMASH ENTERPRISES (SMASH)

SMASH ENTERPRISES (SMASH) is a proprietary Company, which started its operations in

December 2002 by Mr. Shashikant Ghone, a person with expertise in specialized welding.
SMASH works in the following areas,

 Heavy fabrication of components and welded assemblies

 Manufacturing of pressure parts
 Specialized welding, coating etc for improving surface properties of a product

SMASH does both manufacturing of components as per the customers requirement and carrying out
welding and/or other operations as specified by the customers, on the components supplied by them.

[1.2] VISION STATEMENT

To become a reliable source for welding, coating and other similar surface treatments for
improving surface properties of a material against corrosion, erosion, wear etc.

[1.3] ORGANIZATION

Organization structure of SMASH is shown in Annexure 1 to this manual

[1.4] PROCESS APPROACH

SMASH has adopted Process approach to plan its processes and their interactions.

PDCA cycle is employed for the management of processes.

Processes involved in manufacturing and carrying out welding and other processes as per customers
requirements include,
 understanding customers’ requirements,
 procurement of raw material and consumables
 manufacturing of products as per the customer’s specifications or carrying out welding and other
processes as per customers requirements
 Inspection and testing as required by the customers
 Dispatch

Typical processes and their interaction is shown in Annexure 2 to this manual

Process approach enables proper understanding, planning and management of processes and their
interactions so as to achieve the intended results and progress in strategic direction of the organization

[1.5] RISK BASED THINKING

Risk-based thinking is embedded in the planning and execution of various processes of the organization
for increasing the effectiveness of the quality management system.

Risks are due to uncertainty associated with the outcome of the actions. “Risk based thinking” involves
identification of risks and planning, implementing and monitoring of various actions for the mitigation of
the identified risks. This is done by analyzing past performance and trends and by collecting and
analyzing relevant information from internal and external sources.

Risk-based thinking enables the organization to determine and act on those factors which can adversely
affect the performance of the organization and also take advantage of the favorable factors which could
help in enhancing the performance of the organization.
 Section 5 - [2] SCOPE

The scope is as below.

Manufacturing of Heavy Fabricated components ,Pressure Parts, & provide services of Specialized
welding & Metallizing.

The boundaries and the applicability of the quality management system is limited to the following.

 The Quality Management System has been established in accordance with ISO 9001:2015
standard. It provides guidelines for the complying with the requirements of the standard, meeting
statutory and regulatory requirements, that are applicable, meeting customer expectations and
achieving intended results.

 The quality management system applies to all processes and activities carried out by SMASH or
outsourced by SMASH..

 Scope is limited to issues that are considered to be relevant to the quality management system and
the objectives of SMASH are external issues like Legal, Technological, Market related and
Competition related and internal issues like issues related to organizational values and
performance

 Scope is limited to the interested parties namely Customers, Suppliers, Employees and employer,
etc. and their expectations.
 Section 6 - [3] EXCLUSIONS

The following clauses of ISO 9001:2015 are not applicable according to the business process of SMASH
and therefore they have been excluded from the system.

[Clause 8.3] - Design and development of products and services

Justification – SMASH manufactures components as per the drawings and specifications

provided by the customers and also carries out welding, coating, machining etc on the
components supplied by the customers strictly as per the customers’ requirements. Thus SMASH
does not design or develop its products and hence this clause is not applicable
 Section 7 - [4] CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization (SMASH) and its context

SMASH determines the external and internal issues that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended results of its quality management system. They
include
 External issues like technological, legal, Market related and
 Internal such as Organizational values and culture etc.

These issues are documented in Risk management Data Table and are taken in to consideration while
identifying and analyzing risks

SMASH monitors and reviews these issues in Management Reviews

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the SMASH’s ability to consistently provide best services that
meet customer and applicable statutory and regulatory requirements, SMASH has identified the
followings, as interested parties that are relevant to its quality management system and the relevant
requirements of these interested parties.

Customers, Suppliers, employees, Employer, etc.

SMASH reviews this list of interested parties in Management review meeting so as to check their
continued relevance and need for change, if any.

The information of the interested parties and their requirements is documented in Risk Management
Format. This document is reviewed in management review meeting.

4.3 Determining the scope of Quality Management System

SMASH has determined the boundaries and applicability of the quality management system to establish
its scope for certification and has considered the followings while doing so

1. the external and internal issues

2. the requirements of relevant interested parties
3. the products and services provided by SMASH.
4. the requirements of ISO 9001:2015 standard, which are applicable and not applicable.

Scope of certification and exclusions are as stated in section [2] and [3] above.

4.4 Quality Management System and its processes

SMASH has established a quality management system, including the processes needed and their
interactions, in accordance with the requirements of ISO 9001:2015.

Documented information of Quality Management system includes the followings

 Process inputs, process outputs, process interactions
 Procedures and Work instructions for various process wherever needed
 Role of Management for providing leadership
 Resource requirement
 Planning and execution of product realization process
 Monitoring and measurement of relevant performance indicators
 Organizational Roles, Responsibilities and Authorities
 Identification and Analysis of risks
 Improvement Actions

Documented information is maintained and managed as per the procedures for “Control of Documents”
and “Control of Records”
 Section 8 - [5] LEADERSHIP

5.1 Leadership and commitment

Top management of SMASH demonstrates leadership and commitment with respect to the quality
management system through;

1. providing guidance and taking accountability for the effectiveness of the quality management
system
2. establishing Quality policy and Objectives
3. ensuring the integration of the quality management system requirements into the organization’s
business processes
4. promoting the use of the process approach and risk-based thinking
5. providing the resources needed for the quality management system
6. communicating the importance of effective quality management and of conforming to the quality
management system requirements;
7. ensuring that the quality management system achieves its intended results;
8. engaging, directing and supporting persons to contribute
9. Promoting continual improvement
10. supporting other relevant management roles to demonstrate their leadership

Top management of SMASH also demonstrates leadership and commitment with respect to customer
focus through,
 understanding and meeting customer requirements and applicable statutory and regulatory
requirements
 taking appropriate actions for the mitigation of risks and using opportunities
 focusing and enhancing customer satisfaction

5.2 Quality Policy

Top management of SMASH has established, implemented and maintained a quality policy.

The Quality Policy statement is as below

QUALITY POLICY

Smash Enterprises aims to ensure that the needs of its customers are clearly understood and met through
close liaison at all stages of the work.

Smash Enterprises strives to

•comply with all applicable statutory & regulatory requirements.

•continuously improve the effectiveness of this quality Management system and make best use of its
management resources in all Quality matters.

•takes due care to ensure that activities are safe for employees.
•works closely with its customers and suppliers to achieve desired performance.

•Adopt a forward looking view while taking business decisions.

Mr.Meghan Ghone

For Smash Enterprises

5.3 Organizational Roles, Responsibility and Authorities

Top management of SMASH has defined the responsibilities and authorities for relevant roles in the
document “Responsibility and Authority” and the same has been shared / communicated with the
concerned personnel. This document provides guidelines for executing various tasks related to complying
with this Quality Management system achieving intended outputs.

Top Management of SMASH has appointed Mr. Saurabh Ghone as “ISO Coordinator” for providing
assistance to the top management for monitoring and coordinating various activities related to quality
management system.

Tasks of ISO Coordinator include the followings.

1. Implement and maintain the quality management system in accordance with the requirements of
ISO 9001:2015 and report performance to the management.

2. Plan, schedule and conduct internal Quality Audits, initiate and co-ordinate Management Review
Meetings and maintain relevant records

3. Maintain documents and records related to quality management system and ensure integrity of the
system whenever changes are made.

4. Ensure the promotion of customer focus.

5. Liaise with the certifying bodies for assessment activities.

 Section 9 - [6] PLANNING

6.1 Actions to address risks and opportunities

SMASH has established a procedure “Context of the Organization & Risk management”.

While planning for the quality management system, SMASH has taken into considerations the context of
organization, the external and internal issues, expectations of interested parties (stake holders),
conformity of products and service to customers’ requirements and risks in achieving intended outputs.

Risks and opportunities are addressed to have the assurance that the quality management system can
achieve its intended results, enhance desirable effects and reduce or prevent undesired effects and achieve
improvement;

The planning of risk management is carried out as per the following guidelines

 Issues and expectations of stake holders are identified.

 Risks and opportunities are identified in relation to customer requirements, statutory and
regulatory requirements and intended business outputs.
 Severity of risk is estimated by looking at the probability of occurrence, and its likely impact or
consequence
 Identification and execution of ‘risk mitigation’ actions proportional to the severity of risk i.e.
probability of occurrence and the potential impact of risk on performance.
 Integrating these actions in to quality management system
 Monitoring and review

6.2 Quality Objective

Quality objectives are decided for the whole organization and/or for relevant functions once in a year.
While deciding the objectives care is taken to ensure that Objectives,

 are consistent with the quality policy;

 are measurable;
 take into account applicable requirements;
 relevant to conformity of products and services and to enhancement of customer satisfaction;
 are monitored;
 are communicated;
 are updated as appropriate.

Quality objectives for the current year and the method of calculation and monitoring are documented in a
file called “Quality Objectives”

Persons responsible for achieving the objectives plan and monitor the performance at the decided
frequency. Corrective actions to improve the performance are identified and taken whenever performance
is not up to the mark.
6.3 Planning of changes
Whenever there is a need to make changes to the quality management system, the changes are made in a
planned manner according to the procedure defined for “Planning for Changes”

While making any change in the quality management system, the following points are taken in to
consideration.

 the purpose of the changes and their potential consequences

 the integrity of the quality management system; (See 7.5 of this Quality Manual)
 the availability of resources
 Section 10 - [7] SUPPORT

7.1 Resource

7.1.1 General
SMASH determines and makes provision of the resources that are needed for meeting customers’
requirements and also for the establishment, implementation, maintenance of quality management system
and its continual improvement of the QMS. Provision of resources is done by taking into considerations
the feasibility of making them available internally and / or from external sources. Actions are also taken
for the maintenance of resources wherever necessary.

Resource requirement is determined and met in the following areas.

7.1,2 People
Provision of competent persons necessary for the effective implementation of quality management system
and of various processes

7.1.3 Infrastructure
Provision of buildings and associated utilities, equipment, including hardware and software,
transportation resources, information and communication technology.

7.1.4 Environment for the operation of processes

Appropriate actions on factors related to physical environment in work places and factors related to social
and psychological environment which may affect proper execution of processes and process control

7.1.5 Monitoring and measuring resources

Monitoring and measuring devices which are used for monitoring and control of processes as well as for
monitoring and control of product quality.

The following points are taken in to consideration while providing resources for monitoring and
measurement.

 Inspection, measuring and test equipment are selected by ensuring their suitability and in
accordance with the measurement requirements. A master list showing the type of equipment,
unique identification number, location of use, frequency of calibration etc. is maintained.
 Handling, storage and maintenance of the instruments is carried out as per the stipulated
practice to ensure their continued fitness for the purpose.
 Calibration activity is carried out either in-house or by using external agencies. Equipment
having a valid relationship with national or international standards is used for calibration. In
case of nonavailability of such traceability, own standards are prepared and approved by the
department head responsible for calibration. Records of calibration are maintained by the
concerned authority.
  The calibration status is identified by putting stickers on the instruments.
 If, at any time an instrument is found to be unfit or out of calibration, the concerned persons
review the validity of the material / product already passed and takes necessary corrective
actions.
 Where computer software is used for monitoring and measurement of quality or quality related
process parameters, the same is calibrated / validated as per the method prescribed by the
supplier prior to its use.

Documented information (documents and records) are maintained as an evidence to show the compliance
with the requirements of quality management system.

7.1.6 Organizational Knowledge

Need for Knowledge, which is necessary for the operation of various processes and to achieve conformity
of products and services is identified by the management of SMASH from time to time and actions are
taken to make the knowledge available and to maintain the same.

SMASH takes appropriate actions for additions and updating of the knowledge by looking at the available
knowledge and changing needs and trends.

Sources of knowledge are both internal sources (inputs from parent Company, intellectual property;
knowledge gained from experience; lessons learned, undocumented knowledge and experience; the
results of improvements etc.) and external sources (standards; academia, knowledge from customers or
external providers).

Documentation of knowledge related documents is carried out as per the procedure for control of
documents and records.

7.2 Competence

7.2.1 Determination of competence

Competency required for carrying out various functions is determined and documented in the document
“Competency and Skills”.
Competency of person is on the basis of education, training or experience.
Wherever applicable appropriate actions to acquire the necessary competence are identified through
Training needs by the top management / Functional heads by taking in to considerations the competence
available, the competence required and the organizational needs. Training is provided in different ways
as found appropriate.

Effectiveness of training is measured by Personal Performance Review process.

Appropriate records of education, training, skill, experience etc are maintained by concerned HOD/
Personnel department.

7.3 Awareness
SMASH ensures that persons doing work under the organization’s control are aware of:

 the quality policy;

 relevant quality objectives;
 their contribution to the effectiveness of the quality management system, including the benefits of
improved performance;
 the implications of not conforming with the quality management system requirements

Awareness is created and assessed through verbal and written communication, meetings, group
discussions etc.

7.4 Communication
Proper communication is necessary for the effective implementation and control of any process and
SMASH has determined the ways of carrying out internal and external communications relevant to the
quality management system, including what to communicate, how to communicate, whom to
communicate etc.

Communication can be both internal i.e. within the organization and external i.e. with outsiders.

Various methods of communication like telephone calls, e mails, letters, Notice boards, meeting etc are
used to ensure proper communication.

Effectiveness of communication is checked by taking feedback

7.5 Documented Information

Documented information is maintained as per the requirement of ISO 9001:2015 standard and as per the
organizational requirements for the effectiveness of quality management system.

Documented information is classified as

 Documents – internal and of external origin and
 Records.

Both documents and records are controlled as per the procedure “Control of Documents” and “Control of
Records”

QMS DOCUMENTATION

Level 1
The Apex Quality Manual consists of Company introduction, Quality policy and objectives, Processes,
Organization structure, Responsibilities and Authorities and some details on how the requirements of ISO
9001:2015 standard have been addressed.

Level 2
It consists of procedures, guidelines, work instructions, test methods, Quality plans, Quality
specifications, lists etc.

Level 3
It includes formats, which are used for preparation of records, and to demonstrate conformance of product
to specified requirements and effectiveness of the quality management system.

Annexure 3 to this manual contains a list of salient documents

CONTROL OF DOCUMENTS

As a normal practice all documents are maintained in electronic media.

Access to them for reading is given to all the concerned persons and access for modifying is provided to
the authorized persons. Periodic back ups are taken and use of anti-virus software is made to protect the
documents and data from loss or corruption.

Only the latest version of document is made available in electronic media and obsolete documents kept
for reference only with a remark “OBSOLETE”.

Documents include documents generated internally as well as of external origin. The responsibility of
control of documents is with ISO Coordinator. Master-List of documents (internal and external) is
maintained and updated by ISO Coordinator.

Hard copy of a document may be created for convenience of use and it is the responsibility of concerned
person using it to confirm that its revision status is same as that available in electronic media. Hard copy
of a document may also be created to meet a specific demand or requirement and in such event, approval /
authorization of documents prior to issue is carried out by the concerned authorized person.

Periodic back ups are taken and use of anti-virus software is made to protect them from loss or corruption.

RECORD

Records are maintained for many purposes such as to show the compliance with the requirements of ISO
9001:2015 standard and the quality management system of SMASH, SMASH’s own requirements, to
show compliance with Statutory & regulatory requirements, Customers’ requirements, for reference etc.

CONTROL OF RECORDS

As a normal practice, records are generated and maintained as hard copies and wherever feasible, in
electronic media by the concerned departments. Access to records in electronic media for creating,
reading and retrieving is provided to the authorized persons. Periodic back ups are taken and use of anti-
virus software is made to protect them from loss or corruption.
 A record is identified by the number or the title. Management Representative maintains a list of records
kept by the company. A list of quality records typically specifies the identification number of the record,
title of the record, location and retention period of quality records.

Wherever possible, use of formats is made for the generation and maintenance of records.

In case of records maintained as hard copies, proper filing and storage of the records is ensured for their
ready retrieval.

After the specified retention period the records are either destroyed or transferred to Archives for
reference. All records are reviewed for disposal after completion of their retention period in the month of
April of every year.

Annexure 4 to this manual contains a list of salient records

 Section 11 - [8] OPERATION

8.1 Operational Planning and control

SMASH plans, implements and controls the processes, which are needed to meet the expectations of stake
holders (section 6 of this manual), to mitigate risks, to avail opportunities and to meet the expectations of
customer on products and service.

This is done by determining the requirements of product and service, criteria for processes and product
acceptance, control procedures, resource requirements, documentation requirements, etc.

Output of this exercise is in the form of production plans,

Intentional or unintentional changes in plan are reviewed as and when necessary to check the
consequences and to take actions to mitigate adverse effect

8.2. Requirement for products and services

8.2.1 Customer communication

Communication with customers is carried out for,

 providing information relating to products and services

 handling enquiries, contracts or orders, including changes;
 obtaining customer feedback relating to products and services,
 responding to complaints received from customer and providing appropriate solutions to them
 handling or controlling customer property, (not applicable at present)
 establishing specific requirements for contingency actions, when relevant.

8.2.2 Determining the requirements related to products and services

While determining customers’ requirements for product and services, the concerned personnel ensure that
they are determined to the extent possible, and including the requirements as defined in the Contract
Document, alone with any applicable statutory and regulatory requirements and the requirements
considered necessary by SMASH. It is also ensured that SMASH has ability to meet the claims for the
products and services it offers as defined in the contract document.

8.2.3 Review of requirements related to products and services

SMASH ensures that it has the ability to meet the requirements for products and services to be offered to
customers.

SMASH conduct a review before committing to supply products and services to a customer and such
review includes,
 requirements specified by the customer including requirements for delivery and post delivery
 requirements not stated by the customer but necessary for stated or intended use, when known
 requirements specified by the organization
  statutory and regulatory requirements applicable to products and services
 contract or order requirements differing from those previously expressed.

Concerned SMASH person ensures that contracts or order requirements differing from those previously
defined are resolved.

Records of review are maintained and they include the results of review and any new requirement for the
products and services

8.2.4 Changes to requirements for products and services

In cases of changes in the requirements, it is ensured by the concerned person that changes are recorded
and all the concerned persons are made aware.
8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

As stated in exclusions, this clause is not applicable.

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

8.4.1 General

This activity is commonly known as Purchasing in the organization and product or service provider is
called supplier or vendor.

At present no process concerning manufacturing of the product is outsourced

SMASH ensures that externally provided processes, products and services conform to the requirement

In order to ensure this, appropriate controls are exercised, when,

 The purchased products or services are intended for incorporation in SMASH’s products and
services
 Products and services are provided directly to the customer by SMASH’s supplier
 A process or part of the process is outsourced

Suppliers are selected, monitored, evaluated and reevaluated as per the stated guidelines by SMASH’s
concerned persons. SMASH selects, Control exercised over the suppliers depends upon their ability to
meet SMASH’s expectations.

8.4.2 Types and extent of control

SMASH ensures that its products or services to its customer are not adversely affected by products,
services and processes of its suppliers. For this it ensures that

 Suppliers are asked to follow guide lines of quality management system, given by SMASH
 Appropriate control (such as periodic visits, audits, checking of process and quality related
documents and records, etc) is defined by SMASH over the processes and/or products of supplier
 Potential impact of supplier’s performance on SMASH’s performance and on statutory –
regulatory requirement and controls exercised by the suppliers/ vendors on their work are taken in
to consideration while deciding action.
 Verification and other activities are determined to ensure that supplier’s/ vendor’s product and
service quality meets the requirement

8.4.3 Information for external providers

SMASH ensures that its requirements are adequately defined before communicating the same to
suppliers.

Information to suppliers include,

 The processes, products and services to be provided to SMASH

 Criteria or method used by SMASH for approving products and services, processes, methods,
equipment of supplier/ vendor and criteria to allow release of product or service.

 Competency requirements of supplier

 Expectations on interaction of supplier with SMASH

 Control and monitoring of supplier by SMASH

 Verification or validation of supplier’s processes by SMASH or its customer

8.5 PRODUCTION AND SERVICE PROVISION

8.5.1 Production control

SMASH implements production and service provision under controlled conditions.

Controlled conditions include one or more of the followings wherever applicable:

 the availability of documented information that defines,

o the characteristics of the products to be produced,
o the services to be provided,
o the activities to be performed
o the results to be achieved.

 the availability and use of suitable monitoring and measuring resources

 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, have
been met.

 the use of suitable infrastructure and environment for the operation of processes

 the appointment of competent persons, including any required qualification

 the validation, and periodic revalidation, of the ability to achieve planned results of the processes
for production and service provision, where the resulting output cannot be verified by subsequent
monitoring or measurement.. As on date SMASH has identified the following processes which
need validation and periodic validation.

o Welding
o Surface Coating
o Painting

Validation of these processes has been carried out by conducting trials at various sets of
parameters and then checking the results by destructive testing. Records of the same are
maintained.
Revalidation is done once in 3 years or whenever there is major change in the process or
the requirements.
In addition to this welder are qualified by following “welder qualification procedure to
confirm their competency in different types of welding

 the implementation of actions to prevent human error

 the implementation of release, delivery and post-delivery activities.

8.5.2 Identification and traceability

Wherever Traceability is a specified requirement for welding and other processing done on the
components made or processed by SMASH, traceability as per the requirements is maintained through the
appropriate records and identification of components

Some traceability is also maintained for ease of analysis and investigation of quality related problems, if
encountered.

SMASH uses suitable means like order number/ Job numbers and product number etc. to identify
Components, input material, WIP and output material in production. Records related to process
parameters and quality parameters are maintained with reference to products.

8.5.3 Property belonging to customers or external providers

Examples of Property belonging to customers or external providers include material and components
supplied by the customer for doing welding, processing or other work and also documents such as
drawings, specifications etc.

SMASH exercises adequate care over these items when it is under the control of SMASH.
Depending upon the need and as appropriate, such control includes actions related to
identification, verification, protection and safe guarding of such properties.

8.5.4 Preservation

SMASH follows appropriate methods of preservation of raw materials, WIP and finished products so as
to ensure conformity to requirements and prevent damage to the product quality. Preservation methods
include identification, handling, contamination control, packaging, storage, transportation, and protection.

Raw materials or consumables used and products manufactured do not require any special or controlled
conditions for the preservation and care is taken to avoid damage during storage.

8.5.5 Post-delivery activities

As such there are no post delivery requirements for the products or services offered by SMASH.

However whenever such need arises, SMASH meets requirements for post-delivery activities by taking in
to consideration the following points.

 statutory and regulatory requirements

 the potential undesired consequences associated with its products and services
 the nature, use and intended lifetime of its products and services
 customer feedback
8.5.6 Control of changes

Intentional or unintentional changes may occur during production and the concerned persons of SMASH
reviews and control changes to the extent necessary to ensure continuing conformity with requirements.

Records are maintained of the results of the review of changes, the person authorizing the change, and
any necessary actions arising from the review.

8.6 Release of products and services

Inspection, testing and verification, as the case may be, are carried out during the production and of the
final product to verify its conformance to the stated requirements.

Product is not released for dispatch to distributor and / or customer unless all the inspection, testing and
verification have been completed as per the stated procedure and unless the results are seen and approved
by a relevant authority.

Records of inspection, test, verification results as an evidence of conformity and record of persons
authorizing release are maintained.

8.7 Control of Nonconforming output

SMASH has an established procedure “Control of Nonconforming Products” to ensure that outputs that
do not conform to their requirements are identified and controlled to prevent their unintended use or
delivery.

Nonconformity can occur in products and/ or services and may get detected before or after delivery of
products, and during or after the provision of services. In event of such nonconformity, the concerned
persons take appropriate action based on the nature of the nonconformity and its effect on the conformity
of products and services.

Disposition of nonconforming output can be done in different ways as below.

 Rework/correction;
 Rejection
 Informing the customer and obtaining authorization for acceptance under concession
 Due to the nature of the work done by SMASH, in most of the cases disposition of nonconformity is
carried out by doing rework to remove the nonconformity. Conformity to the requirements is verified
when nonconforming outputs are corrected.

Records related to nonconformance are maintained and they include details of nonconformity, actions
taken, any concessions obtained and identification of the authority deciding the action in respect of the
nonconformity
 Section 12 - [9] PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

SMASH carries out monitoring, measurement, analysis and evaluation of performance and
effectiveness of quality management system as well as of organization’s performance with a view to
identify problems and work for continual improvement.

This activity involves consideration of the followings.

 What should be monitored and measured?

 What are the methods for monitoring, measurement, analysis and evaluation needed to ensure
valid results?
 When the monitoring and measuring should be performed?
 When the results from monitoring and measurement should be analyzed and evaluated?

Records are maintained as evidence of results

9.1.2 Customer satisfaction

SMASH monitors customers’ perceptions of the degree to which their needs and expectations have been
fulfilled by obtaining, monitoring and reviewing this information.

Information is collected by asking feedback from the customers during visits and after delivery of
product. It is also collected from internal data on quality, delivery rework etc.

9.1.3 Analysis and evaluation

SMASH uses simple statistical techniques for the analysis and evaluation of appropriate data and of
information arising from monitoring and measurement. The results of analysis are used to draw inferences
on the followings.

 Product quality and conformity of products and services

 Internal Audit results
 Degree of Customer satisfaction
 Performance and effectiveness of the quality management system
 Effectiveness of Planning activity
 Effectiveness of actions taken to address risks and opportunities
 Suppliers/vendors performance
 Needs for improvement
Findings are discussed in Management review meetings and are used for deciding improvement actions

9.2 Internal Audit

SMASH has established a procedure “Internal Quality Audits” for conducting internal Audits and they are
conducted once every 6 months,

Internal audits are conducted to get information on whether quality management system conforms to the
organization’s own requirements for its quality management system and the requirements of ISO 9001
and whether it is effectively implemented and maintained

Audits are planned taking into consideration the importance and status of the various areas.

Audit criteria and scope is defined.

Audit plans are prepared and are circulated in advance. Trained auditors are selected for auditing and it
is ensured that the auditors are independent of the area to be audited.

The non-conformities found during the audit are recorded

It is the responsibility of Functional Head of the audited function to plan and take the appropriate
correction and corrective actions on the nonconformities found without undue delay.

ISO coordinator presents the outcome of internal quality audits in Management review meetings and
weak areas are discussed for deciding necessary improvement actions.

Records of nonconformity reports and corrective actions taken are maintained as evidence of
implementing audit program and audit results.

9.3 Management Review

9.3.1 General

Top management conducts review of the organization’s quality management system, once in 3 months, to
ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction
decided by the parent company.

9.3.2 Management Review Inputs

Management review is planned and carried out taking into consideration the following factors
 the status of actions from previous management reviews
 changes in external and internal issues that are relevant to the quality management system
 information on the performance and effectiveness of the quality management system, including
trends in
o customer satisfaction and feedback from relevant interested parties
o the extent to which quality objectives have been met
 o process performance and conformity of products and services
o nonconformities and corrective actions
o monitoring and measurement results
o audit results
o the performance of external providers
 the adequacy of resources
 the effectiveness of actions taken to address risks and opportunities
 Review of Context of Organization, Internal and external issue and expectations of stake holders
 Opportunities for improvement including actions taken for risk mitigation and for using
opportunities.
 Leadership provided by the Management

9.3.3 Management Review Outputs

The outputs of the management review includes decisions and actions related to
 opportunities for improvement
 any need for changes to the quality management system
 need of resources.

Records of Management Review and review results are maintained as evidence of conducting this
activity.
 Section 13 - 10. IMPROVEMENT

10.1 General

SMASH determines and select opportunities for improvement and implement any necessary actions to
meet customer requirements and enhance customer satisfaction.

Opportunities are identified for,

 improving products and services to meet requirements as well as to address future needs and
expectations
 correcting, preventing or reducing undesired effects
 improving the performance and effectiveness of the quality management system.

Improvements are achieved by making corrections, taking corrective actions, undertaking improvement
projects and working on various initiatives.

10.2 Nonconformity and corrective action

SMASH has established a “Corrective Actions” procedure for taking actions on nonconformities, which
may occur during product realization process or from customer complaints.

In the event of occurrence of nonconformity, the concerned person/persons takes the following actions

 control and correct the nonconformity and deal in an appropriate manner with the consequences
of the nonconformity
 evaluate the need for action to eliminate the cause or causes of the nonconformity to avoid
recurrence of same nonconformity or its occurrence elsewhere by
o reviewing and analyzing the nonconformity;
o determining the causes of the nonconformity;
o determining if similar nonconformities exist, or could potentially occur;

 implement any action needed;

 review the effectiveness of any corrective action taken
 update risks and opportunities determined during planning, if necessary
 make changes to the quality management system, if necessary.

It is ensured that the corrective actions envisaged are appropriate to the effects of the nonconformities
encountered.

Records are maintained as evidence of

 the nature of the nonconformities and any subsequent actions taken;

 the results of any corrective action.
 10.3 Continual Improvement

SMASH continually improve the suitability, adequacy and effectiveness of the quality
management system.

Various inputs such as results of analysis and evaluation of various data related to performance,
the outputs from management review meetings, etc. are used to determine if there are needs or
opportunities for continual improvement.

Top management of SMASH reviews these inputs and the opportunities in Management review
meeting.
 Section 14 - ANNEXURE

DOCUMENTS REFERRED IN THIS MANUAL are listed below for ready reference

1. Organization structure
2. PDCA Cycle, Processes and their interaction
3. Risk management Data Table
4. Responsibility and Authority
5. Quality Objectives
6. Competency and Skills
7. Production Plan
8. List of Salient Documents
9. List of Salient Records
10. Procedure for control of Documents
11. Procedure for Control of records
12. Procedure for Control of Nonconforming products
13. Procedure for Corrective Actions
14. Procedure for Context of the Organization & Risk management
15. Procedure for Planning for Changes

ANNEXURE is available in a separate file