Ashtavinayaka Technocrafts

Private Limited

QUALITY MANAGEMENT SYSTEM MANUAL

ISO 9001:2015
Works & Office address
Ashtavinayaka Technocrafts Private Limited, Survey No. 682/1, At
Post, Undrel, Tal-Daskroi, Ahmedabad – 382433, Gujarat

Website: www.ashtavinayaka.com
Email: kdmc53@gmail.com

Document No. : QMS-01

Effective date : 01.04.2016

Issue Number : 01

Total Pages : 41
Copy No. : 01

Designation of Copy Holder : MR

Control Status : Controlled / Uncontrolled

Scope
Manufacturing & Supply of SS Process equipment’s for Dairy, Food, Chemical, Pharmaceutical & Beverage
Industries.

Prepared by Reviewed & Approved by

Designation MR Director/Partner
Name Mr. Santosh Rajput Jitendra K Patil
Sign
 Section – A: - Table of Contents
Chapter Total Rev. 9001:2015
Title / Contents
No Pages No. Clause No.
Section-A Table of Contents 01 00 -
Section-B Updating History 03 00 -
Section-C Organization Profile 04 00 -
Section-D Scope 06 00 -
Section-E Normative references 08 00 -
Section-F Terms & Definition 09 00 -
01 Context of the Organization 11 00 4
Understanding the organization and its context 11 00 4.1
Understanding the needs and expectations of interested parties 11 00 4.2
Determining the scope of the QMS 12 00 4.3
Quality management system and its processes. 12 00 4.4
02 Leadership 14 00 5
Leadership and commitments 14 00 5.1
Quality Policy 15 00 5.2
Organizational roles, responsibilities and authorities. 15 00 5.3
03 Planning 17 00 6.
Actions to address risks and opportunities 17 00 6.1
Quality objectives and planning to achieve them 18 00 6.2
Planning of changes. 19 00 6.3
04 Support 20 00 7
Resource 20 00 7.1
Competence 23 00 7.2
Awareness 23 00 7.3
Communications 24 00 7.4
Documented information 24 00 7.5
05 Operations 27 00 8
Operational Planning and control 27 00 8.1
Requirements for products and services 27 00 8.2
Design and Development of Products and Services 29 00 8.3
Control of Externally provided processes, products and services 31 00 8.4
Production and Service provisions 32 00 8.5
Release of products and Services 34 00 8.6

Total Rev. 9001:2015

Chapter Title / Contents
Pages No. Clause No.
No
Control of Non-conforming outputs. 35 00 8.7
06 Performance Evaluation 36 00 9
Monitoring, measurement, analysis and evaluation 36 00 9.1
Internal audit 37 00 9.2
Management review 38 00 9.3
07 Improvement 39 00 10
General 39 00 10.1
Non conformity and corrective actions 39 00 10.2
Continual Improvement 40 00 10.3
ANX-I List of Quality Procedures 41 00 -
ANX-II Sequence and Interactions 42 00 -
ANX-III Organization Chart 43 00 -
ANX-IV Quality Policy 44 00 5.2
 Section – B: - Updating History
Updating Chapter Page Current Updated
Updating date Details of change
No. no. no. revision no. Revision No.
1 Section -D 07 00 01 01.08.2018 Change in company
address
2
3
4
5
6
7
8
9
10
11

Quality Manual Controlled Copy Issue register

Sr no. Issue to Issue Number Status Remarks
1
2
3
4
 5
6
7
8
9
10

Section – C: - Organization Profile

Ashtavinayaka Technocrafts Pvt. Ltd is an Engineering organization engaged into Manufacture and Supply of SS Dairy/Food,
Chemical and Beverage processing equipment.

We also manufacture Tanks and Pressure Vessels as per customer’s requirements and Drawing.

Our organization is backed with technocrats with vast experience in the similar field while working with various reputed
companies in various dept. like Production, Project and Marketing.

We have our own manufacturing unit Ashtavinayaka Technocrafts Pvt. Ltd. Survey No. 682/1, At Post, Undrel, Tal-
Daskroi, Ahmedabad – 382433, Gujarat equipped with all the facilities to Manufacture S.S and M.S fabrication Jobs.

We have an excellent team of enthusiastic technically competent Engineers and Workers to look after Production, Design,
and Marketing and after Sales and Service.
 Section – D: - Scope
This manual is description of quality management system. It provides a description of the philosophy of quality and a
structure from which all other actions and methods will be accomplished in regard to the quality of our products and
services. This document alone does not guarantee an effective quality management system however, our people
interacting with quality concepts and methods will provide a system of quality that is dynamic and founded on continually
improving the way we do business.

The Management Team approves all concepts and principles in this manual. Assignments are made relative to ownership
of specific sections of the quality system. Overall responsibility for effective implementation of the quality system is
assigned to the Management Representative.

This manual is distributed among our functions. If required uncontrolled copy of this manual is provided to the customer or
supplier under request. The concepts contained herein are practical ideas and explanations of how we manages quality of
organization. The practical implementation is contained in our Quality Procedures (Level II) and Standard Operating
Procedures / Work Instructions / Process flow chart / Process approach (Level III).

The Standard Operating Procedures / Work Instructions / Process flow chart / Process approach (Level III) is our proprietary
approach to implementing the concepts of the Quality Manual. Quality Management System is designed to comply with all
sections of ISO 9001 version 2015.

Note: This Quality Management System Manual contains provisions, which through reference in this text constitute
compliance to the International Standard, namely ISO 9001 version 2015. For dated references, subsequent amendments
to, or revisions of, any of these publications do not apply. However, management will investigate the possibility of
applying the most recent edition of the International Standard.

Clause Not Applicable:

ISO 9001:2015
SR.NO Clause Description Justification for Not Applicable
Clause no

Design & Development of Products & We manufacture our product as per

1 8.3
Services customer approved design

Outsource Process:

Sr. Process outsourced Reason for outsource Control

No.

1 Profile Cutting Resource not available Drawing provided and Inward

inspection
2 Calibration services Shivan Calibration & services Calibration work done only from
NABL certified vendor

3 Perforation Resource not available Drawing provided and Inward

inspection

4 Chemical composition Metalab Enterprise Material testing from NABL certified

testing lab

5 Contract internal 4C Consulting Pvt. Ltd. Auditors shall be a certified Internal

Auditing Auditor having certificate

All audit reports shall be reviewed

prior to internal distribution

6 Welding Eli Aavishkar Group AWS Approved

 Authorization Statement

We are committed to the establishment and maintenance of Quality Management System given in this manual and
implemented by the company to meet the requirements of ISO 9001:2015.

The members of Organization shall strictly adhere to the various Quality Procedures and Work Instructions as supported by
the policies outlined in this manual.

Mr. Santosh Rajput has been appointed as Management Representative of the Organization. The Management
Representative is responsible for ensuring compliance with the quality requirements stipulated in this manual. He is
authorized to ensure that the quality system is established, implemented and maintained by the company. Top
management shall give full support and co-operation to Management Representative. In absence of Mr. Santosh Rajput,
Mr. Rahul Bharambe will be management representative.

Mr. Mr. Ghanshyam J Jangle

Director
Ashtavinayaka Technocrafts

Scope of Certificate

The manual is prepared as per guidelines of ISO 9001:2015 for Management of Manufacturing & Supply of SS Process
equipment’s for Dairy, Food, Chemical, and Pharmaceutical & Beverage Industries. The ISO 9001:2015 has been
implemented for:

Scope

Manufacturing & Supply of SS Process equipments for Dairy, Food, Chemical, Pharmaceutical & Beverage
Industries.

Quality management system is implemented as per above scope within the boundaries of:
Survey No. 682/1, At Post, Undrel, Tal- Daskroi, Ahmedabad -38433, Gujarat
 Section – E: - Normative Reference
Reference Standards

ISO 9000:2015 Quality management System – Fundamentals and Vocabulary

Section – F: - Terms & Definitions

 Product Result of a process (This could be services/ software/ hardware/ Processed Materials)

Process A set of interrelated or interacting activities, which transform inputs into outputs.

Quality Degree to which a set of inherent characteristics fulfill requirements.

Distinguishing feature, qualitative or quantitative (physical, sensory, behavioral, temporal, Ergonomic,

Characteristic
functional)

Requirements Need or expectation that is state, generally implied or obligatory.

Ability of an organization, system or process to realize a product that will fulfill the requirements for
Capability
that product.

Document Information and its supporting medium. A set of documents, is called documentation.

Record Document stating results achieved or providing evidence of activities performed.

Part of quality management focused on setting quality objectives and specifying necessary
Quality Planning
operational processes and related resources to fulfill the quality objectives.
Document specifying which procedures and associated resources shall be applied by whom and
Quality Plan
when to a specific, product, process or contract.
Conformity Fulfillment of a requirement.

Non-conformity Non-fulfillment of a requirement.

Correction Action to eliminate a detected non-conformity.

Corrective Action Action to eliminate the causes of a detected nonconformity or other undesirable situation.

Glossary of Terms

Sr. No. Abbreviation For

Top Management Managing Director
QP Quality Procedures
QMS Quality Management System
QMS Quality Management System
 MR Management Representative
Purchase Head , Production Head , Store Head , Marketing Head , Quality Head
Functional Heads

NCRD Non Conformity Review & Disposition

IQA NCR Internal Quality Audit Non Conformity Report
AVL Approved Vendor List
RM Raw Materials
NC Non Conformance
CN Change Note
ATPL Ashtavinayaka Technocraft Pvt. Ltd.

Chapter - 1: - Context of the Organization

(ISO 9001:2015 Clause No: - 4)

Understanding the Organization and Its Context (ISO 9001:2015 Clause No: - 4.1)

We have reviewed and analyzed key aspects of ourselves and stakeholders to determine the strategic direction of the
company. This involves

 Understanding our core products and services, and scope of management system.

 Identifying “interested parties” (stakeholders) who receive our Products or Services, or who may be impacted by
us, or those parties who may otherwise have a significant interest in our company. These parties are identified as
define in format namely QMS/IP.

 Understanding internal and external issues that are of concern to us and our interested parties; also identified in
QMS/IL. Many such issues are identified through an analysis of risks facing to us or to our interested parties. Such
issues are monitored and updated as appropriate, and discussed as part of management reviews.
  An organization’s external context includes its outside stakeholders as well as any external factors that influence
the selection of its objectives (goals and targets) or its ability to meet its goals.

 An organization’s internal context includes its internal stakeholders, its approach to governance, its contractual
relationships with its customers, and its capabilities and culture.

 This information is then used by senior management to determine the company’s strategic direction. This is
defined in records of management review, and periodically updated as conditions and situations change.

Understanding the needs and Expectations of Interested Parties

(ISO 9001:2015 Clause No: - 4.2)

 We have defined the external and internal issues that are relevant to our products and services that meet
customer and applicable statutory and regulatory requirements. , i.e. what are the relevant issues, both inside and
outside, that have an impact on what the organization does, that would affect its ability to achieve the intended
outcome(s) of its management system.

 The ‘issue’ covers not only problems, but also important topics for the management system to address, such as
any market assurance and governance goals that the organization might set for its management system.

 An interested party is a person or organization that can affect, be affected by, or perceive themselves to be
affected by a decision or activity that’s within the scope of the management system.

 There will be those external interested parties that impose specific legal, regulatory or contractual requirements
in an organization.

 This information is then used by senior management to determine the company’s strategic direction. This is
defined in records of management review, and periodically updated as conditions and situations change.

Determining the Scope of the Quality management System

(ISO 9001:2015 Clause No: - 4.3)

As define in Section – D of this quality manual.

Scope of the [Quality Manual Doc Title]

This manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international
standard, as well as to demonstrate how the company complies with that standard.
This manual does not follow the numbering structure of ISO 9001. Instead, refer the table of content to cross reference
between the sections of this manual and the clauses of ISO 9001:2015.
Quality management System and Its Processes

(ISO 9001:2015 Clause No: - 4.4)

(ISO 9001:2015 Sub Clause: - 4.4.1)

We have established, documented, implemented and maintained a Quality Management System including their
processes needed and their interactions and continually improved its effectiveness in accordance with the
requirements of ISO 9001:2015.
 The Organization has identified the critical processes needed for the QMS, their sequence and interaction and
their application throughout the organization. (Annex – III – Sequence and Interaction)

 The criteria and methods needed to ensure effectiveness of operation and control of processes are established
and monitored through Quality Objectives, Quality Plan.

 Necessary resources and information are available to support operation and monitoring of the processes.

 The processes are monitored, measured and analyzed.

 The responsibilities and authorities for this processes are also assigned and communicated.

 Addressed the risk and opportunities

 These processes are evaluated and the necessary actions are implemented to achieve planned results and
continual improvement of these processes.

 All these processes are managed in accordance to requirements of ISO 9001:2015.

 All the processes are improved as per the requirement of Quality Management System.

We have defined a process approach for our management system. By identifying the Departmental processes within
the company, and then managing each of these discretely, this reduces the potential for nonconforming products and
services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real
time, by actions taken within each of the top-level processes.
The following Process approaches have been identified:
 Process Approach for Customer complaints Handling

 Process Approach for Customer Satisfaction Measurement

 Process Approach for Maintenance

 Process Approach for Store & dispatch

 Process Approach for Purchase

 Process Approach for Sales & Marketing

 Process Approach for Production

 Process Approach for HR & Training

Each process is supported by other activities, such as tasks or sub-processes. Monitoring and control of top level
processes ensures effective implementation and control of all subordinate tasks or sub-processes.
Each top-level process has in detailed description which defines:
 applicable inputs and outputs

 Process owner(s)

 Applicable responsibilities and authorities

 applicable risks and opportunities

 Critical and supporting resources

 Criteria and methods employed to ensure the effectiveness of the process

 Quality objectives related to that process

(ISO 9001:2015 Sub Clause: - 4.4.2)

The written documents are prepared as per list given below considering the size of organization, type of activities, the
complexity of processes and their interactions and the competence of personnel, risks and opportunities .

The Quality management system documentation includes both documents and records.

 Documented information – written information used to describe how an activity is done.

 Retain documented information - Record – captured evidence of an activity having been done.

Chapter - 2: - Leadership (ISO 9001:2015 Clause No: - 5)

Leadership and Commitment (ISO 9001:2015 Clause No: - 5.1)

(ISO 9001:2015 Sub Clause: - General: 5.1.1)

Top Management provides evidence of its leadership and commitment to the development and implementation of the
management system and continually improving its effectiveness by:
 Taking accountability of the effectiveness of the management system;

 The importance of meeting customer as well as statutory and regulatory requirements is communicated across
the organization. Such requirements are identified, documented and provided for follow up to the concern
Functional Heads.

 promoting awareness of the process approach

 communicating the importance of effective quality management and of conforming to the management system
requirements;

 Ensuring that the integration of the QMS requirements into the organization’s business process such as purchase,
dispatch, maintenance, production, QC, and Sales and Marketing.

 The Quality Policy is established, documented in Chapter – 2 Clause No: - 5.2 of this Quality Manual and displayed
in various areas for ready reference to the employees.

 Quality Objectives are ensured and established and are compatible with the organization internal and external
context and strategic direction of the organization.

 At least once in a year management reviews are conducted for review of activities
 Has identified resource requirements and has provided adequate in house resources in terms of qualified
personnel, test equipment and facility for production 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.

 Ensuring that the management system achieves its intended results;

 Engaging, directing and supporting persons to contribute to the effectiveness of the management system;

 Promoting continual improvement;

 Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility.

(ISO 9001:2015 Sub Clause: - Customer Focus: 5.1.2)

We adopt a customer-first approach which ensures that customer needs and expectations are determined, converted
into requirements and are met with the aim of enhancing customer satisfaction.
This is accomplished by assuring:
 Based on routine contract review documents as well as communication and customer survey, the customer needs
and expectation are determined. 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
statutory and regulatory requirements.

 Top Management ensures that customer needs and expectations are determined and customer requirements are
fulfilled for enhancing customer satisfaction.

Policy (ISO 9001:2015 Clause No: - 5.2)

(ISO 9001:2015 Sub Clause: - Establishing the Quality Policy: 5.2.1)

Top Management has developed the Quality Policy, defined as below, that governs day-to-day operations to ensure
quality performance and it supports the organization’s business mission, vision and goal.
 The Quality Policy is released as a standalone document as it is appropriate to the purpose and context of the
organization & supports its strategic direction.

 Each statement in your quality policy result in one or more quality objectives. Top management is clearly involved
in providing direction, establishing and reviewing these objectives.

 Also the Quality policy includes the commitment to satisfy applicable requirements pertaining to the customer as
well as statutory and regulatory requirements.

 It also includes a commitment to continual improvement to the Quality Management system.

(ISO 9001:2015 Sub Clause: - Communicating the Quality Policy: 5.2.2)

All the employees are advised to undergo quality policy training on joining the company. Also display of the quality
policy at prime location is done. The quality policy is reviewed once in a year for continually improve the effectiveness
of the Quality Management System in management review meeting. Proper document control for the quality Policy is
established by effective date of issue. Quality Policy is also available to relevant interested parties based on the top
Management’s approval.

Organizational Roles, Responsibilities and Authorities (ISO 9001:2015 Clause No: - 5.3)
Top Management has defined responsibilities, authorities and their interrelation for all the persons and communicated
and understood within the organization. All staff members are responsible for maintaining the quality condition 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.
Personnel in our organization 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.

 Controlling further processing until all conditions are satisfactory.

 Ensuring that the integrity of the management system is maintained when changes are planned and implemented.

 Top Management and Functional Heads continuously monitors the activities by reviewing records to verify
effective implementation of the system.

 He / She will report to the Top Management on the performance of the quality system for review and
improvement in the quality system.

 Management will promote awareness of customer requirements throughout the organization.

 The organization chart for our company, showing the interrelation of all the personnel who manage, perform and
verify the work ensuring quality, is given in ANX - IV of this Quality Manual.

 Authority and responsibility for all the concerned persons is documented in job description and communicated to
them in order to facilitate effective Quality Management System. Also copies of job description and specifications
are given to the concerned.

 In case of vacancy / absenteeism the delegation of authority shall be upward and responsibility goes downward
unless otherwise specified in the documents.
 Chapter - 3: - Planning (ISO 9001:2015 & Clause No: - 6)
Actions to address Risks and Opportunities (ISO 9001:2015 Clause No: - 6.1)

(ISO 9001:2015 Sub Clause: - General: 6.1.1)

We have integrated the actions to address these risks and opportunities into its QMS processes using the PDCA cycle
through all processes of QMS. We have considered risks and opportunities when taking actions within the
management system, as well as when implementing or improving the management system; likewise, these are
considered relative to products and services. The risks and opportunities are addressed to determine:
When planning QMS, we have considered the risks and opportunities presented by external and internal issues as well
as the needs and expectations of interested parties, relevant to its purpose and strategic direction.
Risk Management is implemented at all levels of an organization, from the strategic to the operational level. The result
of risk assessment are considered in documenting the plans for process operation and risk control.
 Gives assurance that the QMS can achieve its intended results.

 Opportunities can derive from favorable circumstances that can lead to the use of new practices, launch new
products, enter new markets, address new clients, reduce waste or improve productivity, grow relationships, use
new technology and other desirable and viable opportunities to facilitate the organization in achieving its strategic
direction and enhance customer satisfaction.

 consider the risks and opportunities presented by external and internal issues as well as the needs and
expectations of interested parties, relevant to its purpose and strategic direction Means to address risks may
include avoiding risk, taking risk in order to avail an opportunity, removing the source of the risk, changing the
likelihood or consequences, sharing the risk, or making an informed decision to retain the risk.

(ISO 9001:2015 Sub Clause: - General: 6.1.2)

The organization also plans and do monitoring and measurement of these actions and gathering, analyzing and
evaluating appropriate data and information to determine the effectiveness of such actions. This planning is
periodically reviewed and updated as necessary when taking corrective actions or at management reviews. These
actions shall be proportional to the potential impact on the conformity of products and services.

Quality Objectives and planning to achieve them

(ISO 9001:2015 Clause No: - 6.2)

 (ISO 9001:2015 Sub Clause: - Objective: 6.2.1)

Quantifiable QMS Objectives are established based on documented Quality Policy given above at relevant functions,
levels and processes to meet product, organization environment condition and customer requirements. The quality
objectives are:
 Consistent with the quality Policy

 Measurable

 Based on the applicable customer, statutory and regulatory requirements.

 Relevant to the conformity of products & service quality and for enhancement of the customer satisfaction.

 The quantifiable criteria are dynamic and reviewed in management review meeting our commitment to continual
improvement.

 All such objectives and targets are measurable and consistent with Quality policy including the commitment to
meet customer satisfaction, compliance with the applicable legal requirements and other requirements, which are
the basis for continual improvement.

 The objectives are made for relevant functions and level within the organization.

 The objectives are communicated to each functions and processes and updated as and when required.

(ISO 9001:2015 Sub Clause: - Planning actions to achieve objectives: 6.2.2)

At the planning of achievement of the Quality objectives, the top management has defined:
 Objectives from each process wise and make summary for the same.
 For each objectives require resources are identified and given to concern person for better achieving of objectives.
 Management has decide that each process owner will be responsible for their process identified objectives.
 All identified objectives are completes define time limit as shown in quality objectives sheet.
 Result for achieving or not achieving of all identified objectives will be discuss on every MRM and evaluation for
the same will discussed and verified.
Planning of Changes (ISO 9001:2015 Clause No: - 6.3)

When the organization determines the need for changes to the management system or its processes, these changes
are planned, implemented, and then verified for effectiveness; at the time of planning we shall consider
 The purpose of the changes and their potential consequences.
 The integrity of the QMS.
 The availability of the resources.
 The allocation and reallocation of responsibilities and authorities.
Documents are changed in accordance with procedure P-QMS-02 Procedure for Documents Control.
 Chapter - 4: - Support (ISO 9001:2015 Clause No: - 7)
Resources (ISO 9001:2015 Clause No: - 7.1)

(ISO 9001:2015 Sub Clause: - General: 7.1.1)

We have identified resource requirements and has provided timely resources in terms of qualified personnel, test
equipment and facility for production and testing. The resources for implementation and maintenance of Quality
Management System as well as improving its effectiveness are provided. The adequate resources to enhance customer
satisfaction by meeting customer requirements is identified and provided .Adequacies of these resources are
reviewed, for example, during
 Supplier audit.
 Management Review
 Contract Review
 Internal Quality Audit Results
 Customer Complaint Review
Resource allocation is done with consideration of the capability and constraints on existing internal resources, as well
as needs related to supplier expectations.
Resources and resource allocation are assessed during management reviews.

(ISO 9001:2015 Sub Clause: - People: 7.1.2)

Personnel assigned to tasks are suitably trained and / or experienced. Their work competence is checked based on
applicable education, training, skills and experience.

(ISO 9001:2015 Sub Clause: - Infrastructure: 7.1.3)

Appropriate facilities are identified, provided and maintained to achieve conformity of product like buildings,
workspace and associated facilities, equipment, hardware and software and supporting services like transport,
Information and communication technology etc.
Where equipment is used for critical measurement activities, such as inspection and testing, these shall be subject to
control and either calibration or verification;
Calibration and measurement traceability is not employed for all measurement devices. Instead, we have determined
which devices will be subject to calibration based on its processes, products and services, or in order to comply with
specifications or requirements. These decisions are also based on the importance of a measurement, and
considerations of risk.
(ISO 9001:2015 Sub Clause: - Environment for the Operation of Processes: 7.1.4)

Appropriate work environment is identified to achieve conformity of product, organization environmental condition
and provided considering human and physical factors.
We have provided a clean, safe and well lit working environment. The team manages the work environment needed
to achieve conformity to product requirements. Specific environmental requirements for products are determined
during quality planning and are documented in subordinate procedures, work instructions, or job documentation.
Human factors are considered to the extent that they directly impact on the quality of products and services.
Note: Social, psychological and safety aspects of the work environment are managed through activities outside of the
scope of the management system. Only work environment aspects which can directly affect process efficiency or
product and service quality are managed through the management system.
(ISO 9001:2015 Sub Clause: - Monitoring & measuring resources: 7.1.5)

(ISO 9001:2015 General: 7.1.5.1)

Top management ensures that it provides sufficient resources for the effective operation of the management system,
as well its identified processes. We have identified resource requirements and has provided timely resources in terms
of qualified personnel, test equipment and facility for production and testing. The resources for implementation and
maintenance of Quality Management System as well as improving its effectiveness are provided.
Staff members performing work affecting product quality are competent on the basis of appropriate education,
training, skills and experience. The documented procedure defines these activities in detail.
Functional Heads ensures that employees are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives.
Suitable quality system awareness programs are arranged for all the employees of the company to ensure that the
requirements are well understood at all level.
All the new recruits are 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 for HR and Training and
documented.
Training and subsequent communication ensure that staff are aware of:
 the quality policy;
 relevant quality objectives;
 their contribution to the effectiveness of the management system, including the benefits of improved
performance;
 The implications of not conforming to the management system requirements.

(ISO 9001:2015 Measurement Traceability: 7.1.5.2)

Appropriate measuring and test equipment / instruments, etc. capable of necessary accuracy and precision are used at
the work places to assure conformity of product to specified requirements. Equipment’s are calibrated at the regular
intervals and the tolerances 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 calibration system established and maintained are as under:
 Equipment used in our company are selected based on capability, accuracy and precision of the measurement
required to be made.
 The instruments are calibrated at regular intervals as per schedules or prior to use and recorded. All the critical
equipment 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 parties
having traceability with national / international standards. In the absence of establishing such traceability, it is
calibrated through some recognized parties or as per established procedure.
  Procedures are established and details are given for calibration methods, frequency, equipment identification
system etc. The records of calibration are maintained. Calibration status of the equipment is identified by
stickers / tags / records to recall back when calibration is due.
 In case any equipment is found out of calibration, the validity of previous inspection shall be assessed and
necessary corrective action is taken.
 Test equipment are calibrated under suitable environmental conditions.
 Equipment are handled in a manner to avoid damage and deterioration during handling, maintenance and
storage. Trained persons should handle the equipment to ensure the validity of calibration. The measuring and
monitoring devices are safeguarded to eliminate the possibility of invalidation of the calibration or are subjected
to calibration before use.
 New or repaired equipment and devices 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 of specified requirements are validated prior to
use.
(ISO 9001:2015 Sub Clause: - Organizational Knowledge: 7.1.6)

The organization has determined the knowledge necessary for the operation of its processes and to achieve
conformity of product and services. Organizations has a system for determining, collecting and making
available meaningful data for the operation of its processes to achieve conformity of its products and services. 
We have established the process for considering and controlling past, existing and additional knowledge needs to take
account of the organization’s context, including its size and complexity, the risks and  opportunities it needs to address,
and the need for accessibility of knowledge.
Through common forum and meeting we share lesson learned from each customer, complaints / feedbacks, new
product details, market review and promote the mentoring, hidden knowledge capture and knowledge sharing. All
knowledge shall be maintained in concern process owner mails and they keep some hard copy for reference purpose
(If require).
Management has identified and developed organization knowledge benchmarking and organization knowledge
strategy, sufficient to identify the critical knowledge needed to deliver quality products and services and the main
knowledge gaps. This gaps can be fulfilled by internal and external sources e.g.
 Internal sources: intellectual property; knowledge gained from experience, lesson learned from failures and
successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements
in processes, products and services.
 External sources: Standards, meeting, conferences, seminars, workshops gathering knowledge from customers or
external providers.
We have safeguarded the organization from loss of knowledge which may occur due to staff turnover; failure to
capture and share information. We encourage the team by experience; mentoring; benchmarking

Competence (ISO 9001:2015 Clause No: - 7.2)

The authorized person identifies competency of employees performing activities affecting quality of products and
ability to fulfill its compliance obligations based on performance review and provides necessary training and on the job
training for their staff for upgrading their knowledge and skills. Also during routine work due to change in area of work
or any other reason the training needs are identified and provided. Functional Heads ensures that employees are
aware of the relevance and importance of their activities and how they contribute to the achievement of the quality
objectives.
Suitable quality system awareness programs are arranged for all the employees of the company to ensure that the
requirements are well understood at all level.
All the new recruits are 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 for HR and Training and
documented.
Appropriate records for the education, experience, training and qualification are maintained in HR records.

Awareness (ISO 9001:2015 Clause No: - 7.3)

Senior management ensures that it provides sufficient staffing for the effective operation of the management system,
as well its identified processes.
Staff members performing work affecting product quality, quality policy, compliance obligations aspects are
competent on the basis of appropriate education, training, skills and experience. The documented procedure defines
these activities in detail.
Training and subsequent communication ensure that staff are aware of:
 the quality policy;
 relevant quality objectives;
 their contribution to the effectiveness of the management system, including the benefits of improved
performance;
 The implications of not conforming to the management system requirements and organization’s compliance
obligations.

Communication (ISO 9001:2015 Clause No: - 7.4)

(ISO 9001:2015 Sub Clause: - General: 7.4.1)

 Top Management ensures internal and external communication takes place regarding the effectiveness of the
management system.
Internal communication methods include:
 use of corrective action processes to report nonconformities or suggestions for improvement
 use of the results of analysis of data
 meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS
 use of the results of the internal audit process
 regular company meetings with all employees
 Organization compliance obligations
 internal emails
 memos to employee
 Senior management’s “open door” policy which allows any employee access to Senior Management for
discussions on improving the quality system.

Sr.
What When With Whom How to Who
No.
INTERNAL COMMUNICATION
use of corrective action processes to
report nonconformities or suggestions As & when Concern Telephonic, E-
1. for improvement required department mails

As & when Concern Telephonic, E-

2. use of the results of analysis of data
required department mails
meetings (periodic, scheduled and/or As & when Concern Telephonic, E-
3.
unscheduled) required department mails

4.
results of the internal audit process

regular company meetings As & when Concern Telephonic, E-

5.
required department mails
As & when Concern Telephonic, E-
6. Organization compliance obligations
required department mails
As & when Concern Telephonic, E-
7. internal emails & memos to employee
required department mails
Senior management’s “open door”
policy which allows any employee
access to Senior Management for As & when Telephonic, E-
8. Directgor
discussions on improving the quality required mails
system.

EXTERNAL COMMUNICATION
Supplier and service provider As & when Concern Telephonic, E-
9.
required department mails
10.
Customers - - -
Neighboring Industries As & when Concern Telephonic, E-
11.
required department mails
12.
Public - - -
Legal And Statutory and Regulatory
13. Agencies - - -

Contractors and Subcontractors As & when Concern Telephonic, E-

14.
required department mails
Above communication will be communicate as per requirement occur. It will be communicate as & when require,
Communication will be done to concern personal as per the matter of communication. Communication can be done in any
form as per the requirement occur. Concern process owner are responsible to communicate related interested parties
after discussion with management.
Documented Information (ISO 9001:2015 Clause No: - 7.5)

(ISO 9001:2015 Sub Clause: - General: 7.5.1)

The written documents are prepared as per list given below considering the size of organization, type of activities, the
complexity of processes and their interactions, the competence of personnel and organization compliance obligations.
 Documented statement of Quality Policy and Quality Objectives
 Quality Manual
 Quality Procedures
 Work Instructions and Exhibits (process flow charts) to ensure the effective planning, operation and control of its
processes
 Quality Records (few records are also maintained in the electronic media).

(ISO 9001:2015 Sub Clause: - Creating and updating: 7.5.2)

&
(ISO 9001:2015 Sub Clause: - Control of Documented Information: 7.5.3)

All the documented information relating to the Quality System requirements are controlled as per documented
procedure. They are reviewed for adequacy and are approved by authorized persons as per documented procedure P-
QMS-02 Procedure for Documents Control.
 The documented information 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.
 The respective Functional Heads / Management Representative are responsible for ensuring that the latest
relevant versions of applicable documented information are available at point of use. They will also ensure that
documented information remain legible, readily identifiable and retrievable.
 All the documented information have been identified, legible and system of preparation, issue, distribution and
maintenance of documented information has been described in the procedure.
 Similar controls shall apply to the external documents like standards, customer data and documents of external
origin. The external documents are identified and Storage / distribution is controlled.
 Master list cum distribution list with current revision of documented information (latest revision number) and
distribution list of all the documented information is maintained for all the documents to prevent unintended use
of obsolete documented information. If any obsolete documented information are kept for future reference, then
stamp of obsolete document is put on the document.
 All documented information, which are generated in various areas inclusive of those received as "Test Certificates
or Calibration Certificates" are maintained to demonstrate the effective operation of the Quality System. The
records are kept legible, identifiable and retrievable. The detail system for identification, collection, storage,
protection, filing, retrieval, retention time and disposition of retained information is described in the Quality
Procedure. The system is applicable for hard copy of records as well as records maintained in electronic media. All
the formats used as retained information are properly identified and controlled. In case of any change or updation
is required it shall be authorized and approved by the document owner.
  The current revision status of the document is identified by revision number. Also the latest changes are identified
by suitable marking (Bold & italic font). Each documented information or data will have its revision status by
revision number. Such changes shall be distributed to authorized copy holders of the documented information

Updating & control of documented information for Quality Manual

A running number identifies each page of manual. When any revision becomes necessary, it is highlighted in bold and
italic font and the same is recorded on the updating history of manual. Initially revision no. is considered as 00 and if
total manual is revised then revision no. is changed to revision no. 01 & also prepare document change note for the
same. All such amendments are recorded in the updating history sheet given in the section B. Total nine amendment
are allowed in single revision no. after completion of nine amendment revision number will be change. Where issue no
is showing last copy issuing number. Issue number register is maintain in section B.
Note: - Quality Manual shall be revised any time in case of major changes.
Quality Manual is 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 its all pages and given a unique copy
number for maintenance purpose.
Management Representative maintains Master list cum distribution list for issuance 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 Top Management but the recipient shall not be issued the amendments / revisions.
Management Representative is responsible to fill up updating history 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.
Related Quality Procedure

 PRO – QMS – 02 Procedure for Control of Documented Information.

 PRO – QMS – 04 Procedure for Control of retained information.

Chapter - 5: - Operation (ISO 9001:2015 Clause No: - 8)

Operational Planning and Control (ISO 9001:2015 Clause No: - 8.1)

We have planned and developed the processes needed for product realization & organization condition. Planning of
product realization is consistent with the requirements of the other processes of the management system. Such
planning considers the information related to the context of the organization, current resources and capabilities, as
well as product and service requirements.
Planning for sequence of processes and sub processes is consistent with the QMS requirements of Organization and
documented in the Quality Plan / Process Approach documents. The sequence and interaction of processes of
Organization is given in annexure - III of this manual.
In planning process for realization of product, we have determined the following, as appropriate.
 The requirements for the products and services are determined.
  Need to establish documents and process, and provide resources specific to the product.
 Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria
for product acceptance are covered through Quality Plans.
 The retained information that is necessary to provide confidence of conformity of the processes and resulting
product to fulfill requirements.
 Quality objectives and requirements for the product.
So we plans and develops the processes needed for product realization. Planning of product realization is consistent
with the requirements of the other processes of the management system. Such planning considers the information
related to the context of the organization, current resources and capabilities, as well as product and service
requirements.
Changes to operational processes are done in accordance with the document [Change Management Doc Procedure
for Change management P-QMS-08. We ensure that the outsource processes are also controlled and monitored as
per the purchase process approach.
Requirement for products & services (ISO 9001:2015 Clause No: - 8.2)

Sub Clause: - Customer Communication: 8.2.1

The Customer requirements are identified and implemented, communication is also done, it includes.
 Product requirements specified by the customer including the requirements for availability, delivery and post-
delivery activities(Installation, commissioning, Services),
 Handling enquiries, contract or orders, including changes.
 Customer feedback and customer complaints relating to products and service.
 In case of emergency what is contingency actions
 Any additional requirements determined by the organization.

Sub Clause: - Determining the requirements for products and Services: 8.2.2

We have determined the requirements for products and services which are as below:
 Product requirements not specified by the customer but necessary for intended or specified use;
 Obligations related to product, including legal and regulatory requirements.
 Meeting the claims and other requirements.

Sub Clause: - Review of the requirements for products & services: 8.2.3

8.2.3.1
As soon as customer inquiries are received for their requirement, it shall be reviewed to ensure that customer’s
requirements are clearly identified, understood and whether they can be met (availability of such product / services in
standard product / service list). If customer provides no documented statement of the requirements, then customer
requirements are confirmed before acceptance verbally or in written. Matters that are not clear including contract /
order requirements previously expressed are resolved with the customer. Normally our customers understand our
product by name, type, specifications, capacity, qty., delivery and specify in their documents / verbally convey.
 8.2.3.2
Prior to commitment to supply a product to the customer, customer orders (PO / E mail / Telephonic order) are
reviewed to ensure that:
 Customer requirements are clearly documented;
 Any variation from the contract is resolved; and
 We can meet all contractual requirements.
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.
All the records related to contract (e.g. PO of customer) are maintained.

Sub Clause: - Changes to requirement for product & services: 8.2.4

We ensure that all the documented information is amended and the concern persons are aware of the changes
requirements for the product and service, it include but not limited to this only ‘;
 Where the customer requests changes to active work, the changes are also captured, reviewed and approved
prior to committing to the change.
 The change considers the impact on work already delivered, work underway, and planned work.
 Problems or concerns over implementing the change will be communicated by Sales team with the customer.
Such changes may require renegotiation of contracts.
 If changes are agreed upon, the Sales team will work with the affected departments to implement the change. The
disposition of existing work shall be determined by management, along with input from the customer.
 Where changes are required by us, these will be negotiated with the customer before implementation, and a
record of the customer’s acceptance maintained.

Design & Development of product and services (ISO 9001:2015 Clause No: - 8.3)

(ISO 9001:2015 Sub Clause: - General: 8.3.1)

This clause is not Applicable to the organization & justification is mentioned in Section-D Scope.

Control of Externally provided processes, products and Services (ISO 9001:2015 Clause No: - 8.4)

(ISO 9001:2015 Sub Clause: - General: 8.4.1)

Suitable controls are established in purchasing process to ensure externally provided processes, products and services
conforms to requirements. The type and extend of control are dependent on quality of the final product as described
in the process approach and Quality plans. For each externally provided processes, products and services we have
determined the controls based on their type and extent as well as risk matrix for the each of externally provided
processes, products and Services.
 Products and services from external providers are intended for incorporation into organization’s own products
and services;
 Products and services are provided directly to the customer by external providers on behalf of organization.
 A process, or part of a process, is provided by an external provider as a result of decision by the organization.
The system and criteria for evaluation, selection, monitoring of performances and re-evaluation of external providers
based on their ability to supply product, processes and services in accordance with organization requirements in
process approach - Purchase are defined and developed. The documented information are maintained in the form of
approved supplier list for all the different category of purchases of products, processes and services as well as results
of evaluations and follow-up actions. It is updated once in Year based on vendor rating.

(ISO 9001:2015 Sub Clause: - Type and Extent of Controls: 8.4.2)

Through the consistent quality planning and processes we ensure that the;
 Externally provided processes remain within the control of its QMS.
 Quality plan is prepared for external service, product or process providers and for the resulting outputs intended
to apply.
 Also we have considered :
- The potential impact of the externally provided processes, products and services on the
organization’s ability to consistently meet customer and applicable statutory and regulatory
requirements.
- The effectiveness of the control applied by the external provider.

(ISO 9001:2015 Sub Clause: - Information for External providers: 8.4.3)

Authorized person as per process approach reviews the purchase document for adequacy of details, quantity,
description of goods as applicable prior to release and approval. He ensures that purchasing data is clearly written in
the purchasing documents to avoid ambiguity and is correctly understood by the suppliers. It also includes purchasing
activity for services hired by Organization. The purchasing documents contains the data which includes any items or all
as described below and it must be communicated to external providers:
 Product, processes and services to be provided.
 Approval of Reference of specifications, qualification of product, procedures, processes, equipment, and
personnel, method, release of products and services.
 Competency, if required for specific approval or qualification of personnel’s.
 The external providers’ interactions with the organization.
 Quality Management System requirements
 Controls and monitoring to be applied.
 Verification and validation planning that the organization, or its customer intends to perform at the external
provider’s premises.
 The clear description with relevant specification / reference of standards, wherever applicable and any other
information given in the purchase documents

Production and Service Provision (ISO 9001:2015 Clause No: - 8.5)

(ISO 9001:2015 Sub Clause: - Control of production and service provision: 8.5.1)

The organization controls and implement production and service operation through.
 The availability of documented information that specifies
 - The characteristics of the product to be produced, the services to be provided are the activities to be
performed.
- The results to be achieved.
 Availability and use of suitable monitoring and measuring resources.
 Documented work instructions / process control charts/ Quality plants / check sheets are made to define the
manner of production, approval of process, monitoring and control of suitable process.
 Suitable infrastructure and environment for the operations of processes;
 Appointment of competent persons or specific qualification as per the requirements.
 The validation, and periodic revalidations records defined arrangements are made for such processes for
validation, which include the items listed below as applicable.
1. Qualification of Processes
2. Qualification of Equipment and Personnel
3. Use of Defined Methodologies and Procedures
4. Requirements of Records
The processes carried out to manufacture the product are validated in the case where the resulting output cannot be
verified by subsequent measurement and monitoring. This includes any processes where deficiencies may become
apparent only after the product is in use or the service has been delivered. If at any stage the product is not fully
verified by subsequent inspection and tests, then the process stage is monitored continuously for its process control
parameters to demonstrate the ability of the processes to achieve planned results.
 Established maintenance system, maintenance of equipment for production is done and records are maintained.
 On the process control and utility equipment appropriate measuring and test equipment / instruments, etc.
capable of necessary accuracy and precision are used at the work places.
 Actions to prevent human error.
 The implementation of release, delivery and post-delivery activities.
 The criteria for workmanship are dependent on implementation and monitoring of process control parameters
and are checked as per the same.
 The implementation of defined processes for release, delivery and applicable post- delivery activity (only query
and complaints solution) is done.
 Manufacturing and service processes are followed as per the defined process approach.
(ISO 9001:2015 Sub Clause: - Identification and Traceability: 8.5.2)

 All critical product or services, from the time of receipt until dispatch (Consumption) are identified by one or more
of the followings.
- Job no.
- Make, brand name etc.,
- Others as applicable or as specified by the customers.
 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 to consumption 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 not specified requirement of our customers. However the same is maintained during
operation by providing sample and batch no / Job no throughout the product realization.
 All the products or services at any stage are having inspection and test status for measurement and monitoring
requirements.
 (ISO 9001:2015 Sub Clause: - Property belonging to customers or external providers: 8.5.3)

 Customer or external provider’s property like, product specifications, Drawings, lay - outs etc. as applicable may
be received by the Company for production use and providing better services.
 Materials inspected & checked. All the acceptance criteria of the received materials are considered as per defined
specifications, if not provided by the customer or in some case inspection may not be require.
 After necessary inspection and testing of the accepted customer or external providers properties are
systematically stored in the designated place with due care. Such customer properties are identified by the name
of customer or external service provider with detail specifications.
 Customer properties from receipt onwards are treated as per the routine process and are controlled according to
the requirements. Any product or materials that is damaged, lost, non-conforming or otherwise unsuitable for use
is recorded and reported to the customer or external providers.
 Verification by the company does not absolve the customer of the responsibility to provide an acceptable product.
(ISO 9001:2015 Sub Clause: - Preservation: 8.5.4)

The organization preserves conformity of product with customer requirements during internal processing and delivery
to the intended destination including identification, packaging, storage and protection.
 Identification:
All material to be stored are identifies and controlled as detailed in section 8.5.2
 Handling:
Personnel are trained in the handling of products during receipt, preservation and delivery so as to prevent
damage or deterioration and with emphasis on safety
 Storage:
Accepted/ rejected / Hold materials are stored in specified area and receipt and issue of such material is
controlled.
The material stored is verified periodically to detect damage or deterioration.
 Packaging And Preservation:
Products are preserved in stores to prevent damage/ deterioration. Products pending delivery are also preserved
to prevent damage deterioration.
 Delivery:
Finished product is dispatched to customers through identified transports or as specified by customers. Adequate
care is taken to ensure the products are handled with care and to prevent damage or deterioration.

(ISO 9001:2015 Sub Clause: - Post-delivery activities: 8.5.5)

We conducts the following activities which are considered “post-delivery activities”:

 Installation
 Commissioning
 Maintenance Service (under warranty, over warranty, AMC, causal service, Inspection)
While considering the post-delivery activities we ensure that we meet with the products and services
requirements based on that we ensure
 Statutory and regulatory requirements related to product and services ( If any)
 Potential undesired consequences associated with our products and services
 Nature, use and intended lifetime of products, and services.
  Customer requirements.
 Customer feedback.
Post-delivery activities are conducted in compliance with the define management system.
(ISO 9001:2015 Sub Clause: - Control of Changes: 8.5.6)

We reviews and controls both planned and unplanned changes to processes to the extent necessary to ensure
continuing conformity with all requirements.
Process change management is defined in the document [Procedure for Change Management – P-QMS-08]

Release of products and Services (ISO 9001:2015 Clause No: - 8.6)

Acceptance criteria for [Products or Services.] are defined in appropriate subordinate documentation for each product
category. Reviews, inspections and tests are conducted at appropriate stages to verify that the product and service
requirements have been met. This is done before [Products or Services.] are released or services are delivered.
In case of urgent release only authorized person can release the products and as appropriate to applicable customer’s
requirements.
The documented information for release is marinated and retained. Which include;
 Evidence of conformity with the appropriate criteria established.
 Traceability to the persons authorizing the release.
Control of Non – Conforming Outputs (ISO 9001:2015 Clause No: - 8.7)

The detail procedure is established for identification, documentation, evaluation, segregation and disposition of non-
conforming incoming, in process and the final product or services (or output of any stages of production /servicing) in
production and inspection area. The concerned persons are informed for disposal of non-conforming output.
The non-conforming Outputs are reviewed after inspection in accordance with the documented procedure and subject
to decision taken as per following:
Non-conforming incoming material at inward may be kept in the rejection area or rejection stores or returned to
supplier on immediate basis. In case of minor rework able nonconformity, the decision to rework or segregate shall be
taken by authorized person. However, in case of major nonconformity, disposal of nonconforming product shall be
done as per NCRD (Non conformity Review & Disposition). The decision to dispose the nonconforming output shall be
with QA/ QC In charge. The decision includes:
 Re–graded for alternative application / correction
 Segregation, containment, return or suspension or provision of products and services.
 Informing the customer.
 Obtaining authorization for acceptance under concession.
If nonconforming output is identified after delivery or use has started, then organization takes appropriate action
regarding the consequences of the nonconformity. All the Re–worked products are re-inspected for specified
requirement as described in documented procedure. The details of non-conformity and concession accepted by the
customer, end user or other body as applicable should be reported and recorded.
Documented information in the form of records is maintained for disposal of non-conforming material and acceptance
of re-inspected material. The documentation for non-confirming output includes:
 Details about non conformity.
 Action taken
 Any concession obtained.
 Authorized person deciding the action in respect of the non-conformity.
 Related Quality Procedure
 P-QMS-02 Procedure for control of Documented Information.
 P-QMS-04 Control of Retained Information
 P-QMS-08-Procedure for Change Management

Chapter - 6: - Performance Evaluation

(ISO 9001:2015 Clause No: - 9)

Monitoring, measurement, analysis and evaluation (ISO 9001:2015 Clause No: - 9.1)

(ISO 9001:2015 Sub Clause: - General: 9.1.1)

We have identified and implemented quality requirements for monitoring and measurement and monitoring activities
needed to assure conformity and achieve improvement. This includes need and use of applicable methodologies
including statistical. For each processes it is defined
 What needs to be monitored and measured?
 Methods of monitoring, measurement, analysis and evaluation needed to ensure valid results.
 When the monitoring and measuring shall be performed.
 When the results from monitoring and measurement shall be analysis and evaluated.
Various information are retained - like list of equipment, skill persons, equipment calibration certificates, etc. are
reviewed and the compatibility of facilities (including documents) is ensured by the Management to achieve the
required quality at planning stage.
We have evaluated the performance and the effectiveness of the Quality Management System and retained the
appropriate documented information as an evidence of the results.
(ISO 9001:2015 Sub Clause: - Customer Satisfaction: 9.1.2)

As one of the measurements of the performance of the management system, we monitors information relating to
customer perception as to whether the organization has met customer requirements. The methods for obtaining and
using this information include:
 Edit list as Needed
 recording customer complaints
 product rejections or returns
 repeat orders for product
 changing volume of orders for product
  trends in on-time delivery
 contract review
 obtain customer scorecards from certain customers
 submittal of customer satisfaction surveys
At interval of at least once in a year customer survey is taken to collect information on customer satisfaction. Such
information is analyzed to measure satisfaction / dissatisfaction levels of customer and discussed in the Management
Review Meeting.

(ISO 9001:2015 Sub Clause: - Analysis of Evaluation: 9.1.3)

The data generated during measuring and monitoring activities and other relevant sources are analyzed to provide
information on
 Conformity of products and services.
 Customer satisfaction and / or dissatisfaction
 The performance and effectiveness of the QMS.
 Conformance to customer requirements
 Characteristics of processes, product and their trends
 Suppliers performance and evaluation
 If planning has been implemented effectively.
 Effectiveness of actions taken to address risks and opportunities.
 Performance of external providers.
 Need for improvements to the QMS.

Internal Audit (ISO 9001:2015 Clause No: - 9.2)

(ISO 9001:2015 Sub Clause: - General: 9.2.1)

The internal audit is done at least once in a year to determine whether the Quality Management System conforms to
the ISO 9001:2015 requirements and has been effectively implemented and maintained. 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. The 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.
Sub Clause: - Internal audit programme: 9.2.2

The auditors shall verify implementation of documented quality system and objective evaluation of the organization
structure, procedures, working practices, resources, accuracy of the work, records, importance of the processes
concerned, changes affecting the organization and the results of the previous audits etc. The detail system for planning
and implementing audit to determine effectiveness of the quality is given in the procedure.
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 in
respective any non-conformance observed. Quality audit findings are recorded and used as the main formal means of
resolving problems and deficiencies detected in the quality system. The copies of such NC reports are given to auditee
after taking timely corrective action on NC reports, the auditee calls auditor to verify it and to close NCR. During next
audit, implementation and effectiveness of the corrective action taken on NCRs shall be reviewed and recorded.
All the audit findings and verification of audit results are reported to the top management for review and evaluation of
the system and taking corrective actions. Retain documented information as evidence of the implementation of the
audit programme and the audit results.

Management Review (ISO 9001:2015 Clause No: - 9.3)

(ISO 9001:2015 Sub Clause: - General 9.3.1)

The quality system established in the Organization is systematically reviewed for its continuous suitability, adequacy,
effectiveness and alignment with the strategic direction of the organization and effectiveness in confirming the
requirements of ISO 9001:2015. The review includes implementation of our quality policy and objectives to identify
any areas, which require improvement and evaluate need for changes for effective functioning of the system.
This review is carried out at least once in a year by Top Management or its nominee by holding Management Review
Meetings, which are attended by Management Representative and all Functional representatives. It is the
responsibility of the Management Representative to prepare the agenda and minutes of management review meeting
covering the
 Discussion held,
 Action planned,
 Target date of completion for planned actions.
 Person responsible to complete planned actions.
(ISO 9001:2015 Sub Clause: - Review Input 9.3.2)

Input to management review includes current performance and improvement opportunities related to the items listed
here under.
 Status of actions from previous management reviews.
 Changes in external and internal issues that are relevant the QMS.
 Information on the performance and effectives of the QMS including trends in :
 Customer satisfaction and feedback from relevant interested parties
 The extent to which Quality objectives have been met.
 Process performance and conformity of the products and services.
 Non conformities and corrective actions.
 Monitoring and measurement results.
 Audit Results.
 The performance of external providers.
 The adequacy of resources.
 The effectiveness of action taken to address risks and opportunities.
 Opportunities for improvement.
 (ISO 9001:2015 Sub Clause: - Review Output 9.3.3)

Based on management review process actions emerged for any of the items related to:
 Opportunities for improvements
 Actions needs for changes to the quality management system
 Need for resources

Chapter - 10: - Improvement

(ISO 9001:2015 Clause No: - 10)

General (ISO 9001:2015 Clause No: - 10.1)

Top Management uses the Quality management system to improve its processes, products and services. Such
improvements aim to address the needs and expectations of customers as well as other interested parties, to the
extent possible. Management has determined the opportunities based on the risk register impacts and implemented
necessary actions to meet customer requirements and enhance customer satisfactions. This includes.
 Improvements in products / services to meet current requirements and to address the future needs and
expectation based on technological changes and improvement.
 Correcting, preventing or reducing undesired effects.
 Improving the performance and effectiveness of the QMS.
Non Conformity and Corrective actions (ISO 9001:2015 Clause No: - 10.2)

The detail procedure is established for identification, documentation, evaluation, segregation and disposition of non-
conforming incoming material, in process and the final product or services, customer complaints, internal audit,
supplier evaluation and in any stages of Quality management system implementation.
The concerned persons are informed for disposal of non-conformity arises and are reviewed in accordance with the
documented procedure subject to decisions taken as per the following.
 Reviewing and analyzing the non-conformity.
 Determine the cause of the non-conformity.
 Determining if similar non conformities exist or could potentially occur.
The procedure is documented for corrective action, which includes
 Identification of action for customer complaints and product /process / services non-conformities.
 Investigation of the cause of non-conformities relating to product, process and quality system and recording the
results of the investigation.
 Evaluation for the need of actions to ensure that nonconformity’s does not repeat
 The corrective action needed to eliminate the cause of non-conformities is determined and implemented
 Recording the results of action taken.
 Reviewing the effectiveness of such corrective action is taken.
 Updation in the risk and opportunities determined during planning if required.
 Make changes to the Quality management system.
The corrective actions must be appropriate to the effects of the non-conformities encountered.
Documented information as an evidence in the form of records is maintained for any non-conformity encountered. It
must state:
  The nature of non-conformities and subsequent actions taken.
 The results of any corrective action.

Continual Improvement (ISO 9001:2015 Clause No: - 10.3)

The organization continually monitor and review its processes, products, services to improve the suitability, adequacy
and effectiveness of the QMS uses the management system to improve its processes, products & services. Such
improvements aim to address the needs and expectations of customers as well as other interested parties, to the
extent possible.
Improvement shall be driven by an analysis of data related to:
 conformity of products and services;
 the degree of customer satisfaction;
 the performance and effectiveness of the management system;
 the effectiveness of planning;
 the effectiveness of actions taken to address risks and opportunities;
 the performance of external providers;
If based on above analysis there are needs or opportunities identified that shall be addressed as part of Continual
Improvement.