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ISO 9001:2015
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
Table of Contents:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
7.3 Awareness
7.4 Communication
7.5 Documented Information
7.5.2 Creating and Updating
7.5.3 Control of Documented Information
8 Operation
8.1 Operational Planning and Control
8.2 Requirements For Products & Services
8.2.1 Customer Communication
Determination of Requirements Related to Products and
8.2.2 Services
8.2.3 Review of Requirements Related to Products and Services
8.2.4 Changes to Requirements For Products and Services
8.3 Design and Development
8.4 Control of Externally Provided Processes, Products & Services
8.4.2 Type and Extent of Control of External Provision
8.4.3 Information for External Providers
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
8.5.2 Identification and Traceability
8.5.3 Property Belonging to Customers or External Partners
8.5.4 Preservation
8.5.5 Post-Delivery Activities
8.5.6 Control of Changes
8.6 Release of Products and Services
Control of Nonconforming Process Outputs, Products and
8.7 Services
9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis and Evaluation
9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
9.2 Internal Audit
9.3 Management Review
9.3.2 Management Review Inputs
9.3.3 Management Review Outputs
10 Improvement
10.2 Nonconformity and Corrective Action
10.3 Continual Improvement
INTRODUCTION:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
M.R. Hy-Tek Equipment Pvt. Ltd. has made the Business to develop and effectively
implement the Quality Management Systems (QMS) across office and its factory.
The implementation of the QMS is to improve the customer satisfaction and meet the
business strategy in the concerned areas.
The QMS Manual is considered the normative basis of reference to the International
Standard and shall be used internally to provide an overview of ISO 9001:2015 (E)
requirements and how they apply at the organisation.
The QMS Manual is used externally to introduce the elements of our QMS to our
customers and other external service providers to the extent necessary .
The Organisation has adopted and realizes the benefits of Quality Management
Principles into our daily activities. The intent of the Quality Management Principles is to
provide a foundation to continually improve the products and services, performances.
Subsequent sections of the QMS Manual will provide our commitments of the following
QMP elements:
• Customer needs expectations and approvals.
• Leadership of the management,
• Communication within the organisation and factory;
• Process improvements,
• System Improvement;
• Risk & opportunity as well as evidence-based decision making;
• Feasibility of fabrication process.
PROCESS APPROACH:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
“Organisation” has adopted the “Process Approach” into our daily operations including
the PDCA Cycle.
M.R. Hy-Tek Equipment Pvt. Ltd. considered the utilization of Risk-Based Thinking in
the QMS, when developing, implementing, and improving the effectiveness of our
Quality Management System for provision of integrated systems for process industries.
This approach will enable M.R. Hy-Tek Equipment Pvt. Ltd. to enhance the overall
performance of the Company by effectively controlling the relationships, and the
interdependencies among the QMS processes.
RISKED-BASED THINKING:
M.R. Hy-Tek Equipment Pvt. Ltd effectively plans and implements various actions to
address risks and opportunities to maximize the outcomes including, but not limited to
achieving improved results and preventing negative effects of our products, services
and QMS.
1. Scope of QMS:
The scope: The intent of our QMS is to define and communicate our commitment to
continually enhance customer satisfaction through:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
2. Normative References:
The following documents in part or whole, are normatively referenced or used in the
preparation of this document and are indispensable for its application. For
references, documents references numbers shall be applicable.
International Standard ISO 9001:2015(E) Quality Management Systems
Requirements, Quality Management Fundamentals and Vocabulary.
IS/ BIS Standards / Other stds, if required or applicable, is referred for the product
specifications.
For the purpose of this document, the terms and definitions provided in ISO
9000:2015.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
regulatory requirements, M.R. Hy-Tek Equipment Pvt. Ltd. has determined the
following:
The interested parties relevant to the QMS;
M.R. Hy-Tek Equipment Pvt. Ltd. has determined the boundaries and the
applicability of the QMS and how it relates to our Business Core Competency.
The Scope of our QMS shall always be available to internal and external parties
and maintained as documented information. The QMS was determined,
designed and implemented to cover and support the Said Scope:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
The QMS is maintained and continually improved through the use of the quality
policy, quality objectives, customer feedback, and supplier feedback, analysis of
data, Improvements and management review meetings.
M.R. Hy-Tek Equipment Pvt. Ltd. utilizes Quality System Procedures (QSP)/
Quality plans to provide our employees and external providers (Suppliers), to
meet the scope of QMS activities.
The documents support the achievement of quality compliance for each of the
process steps. We retain Quality System Formats, registers/records, (QSF)
which provides documented information substantiating the process inputs and
outputs have been accomplished as planned.
5 Leadership:
5.1 Leadership and Commitment:
Management has initiated and fully supports the vision and strategic direction for
the continued sustainability and enhancement of the QMS.
The top Management have initiated and fully support the Quality Policy and
Quality Objectives.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
5.2 Policy
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
The ISO coordinator has the following responsibilities & Authorities to:
The “ISO – coordinator/ MR” has the organizational freedom and unrestricted
access to resolve matters pertaining to Quality Management System as well as
to be the Company liaison with external parties, including our Third parties,
customer representatives, customers and vendors on all matters relating to the
QMS.
6 Planning:
When planning: of M.R. Hy-Tek Equipment Pvt. Ltd. QMS, Organisation has
taken into consideration potential issues and has determined the risks and
opportunities that need to be addressed to:
Provide assurance that the QMS can achieve its intended result;
To enhance desirable effects;
To Prevent, or reduce, undesired effects / risks.
To Achieve improvement in the production process
“Organisation” has planned actions to address the above risks and opportunities
and has initiated appropriate procedures to integrate and implement appropriate
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
actions into our QMS including the evaluation of the effectiveness our QMS
processes.
Any actions taken to address risks and opportunities shall be proportionate to the
potential impact on the conformity of products and services.
Quality Objectives:
Quality objectives are strategic, apply to the entire Company and shall:
They apply to all departments and functions having direct responsibility for
activities that require improvement. Performance objectives and goals are
established by management and through employee involvement and monitored
within the framework of management reviews.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
When changes to the QMS are deemed necessary, Organisation shall ensure that
the changes will comply with the requirements of ISO 9001:2015 (E) and shall
consider:
7 Support:
M.R. Hy-Tek Equipment Pvt. Ltd. is fully committed to providing adequate resources
required for the establishment, implementation, maintenance and continual
improvement of our QMS.
Our committed resources include: Competent employees, state of the equipment &
tools, supply sources, work environment and financial resources.
7.2 Resources
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
References:
Manpower list, Experience details,
Training Records.
7.2.2 Infrastructure:
M.R. Hy-Tek Equipment Pvt. Ltd. has determined and provided resources
necessary for the establishment, implementation, maintenance and
continual improvement of the QMS.
Management identifies and manages the human and physical factors of the
work environment considered to be important to control processes and to
achieve conforming of products and services. Evaluations include:
Measurement Traceability:
7.3 Competence:
M.R. Hy-Tek Equipment Pvt. Ltd. has determined to the extent necessary the
below elements of competence for people performing work that may affect the
effectiveness of the QMS.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
• Ensure employees are competent on the basis of their education, training and
experience;
• Initiate job descriptions including specific competency provisions;
• Measure job performance for each employee on an annual basis;
• Provide job and career training programs to the extent necessary;
• Take actions when necessary to assist employees that exhibit less than
desirable results.
7.4 Awareness
M.R. Hy-Tek Equipment Pvt. Ltd. has determined to the extent necessary
persons performing work are:
7.5 Communication
M.R. Hy-Tek Equipment Pvt. Ltd. management has determined internal and
external communication relevant to QMS, including the subject of the
communication, when communication occurs, participant and ways of effective
communication.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
• Original copy of the Quality Manual shall be stamped “MASTER COPY “in
GREEN. This copy shall be kept with MR. Controlled Copies / Uncontrolled
Copies shall be copied from the Master Copy.
• The controlled copies of Quality Manual are identified with “CONTROLLED
COPY “stamp in BLUE on all the pages of Quality Manual.
• The uncontrolled copies of Quality Manual for reference purpose or for
presenting to customer / anyone are issued with the stamp of
“UNCONTROLLED COPY “in RED on all pages of Quality Manual.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
For statutory related: the records or documents are maintained as per the
stated period by the concerned agencies or regulating bodies.
Related Documents:
Contract Review Records / PO copies of customer
Calibration Records / Plans / Certificates
Employee Training & Competence, Personal files
Management Review
Customer Satisfaction/ Feedback reports
Prove out reports / commissioning reports.
8 Operation:
8.1 Operational Planning and Control:
M.R. Hy-Tek Equipment Pvt. Ltd. defines, the expectation and implements
controls for each of our QMS processes. The planning of controls is required to
ensure consistent acceptability of products and services. Planning of jobs or order
wise planning is carried out with bar /schedule- diagram.
For processes: appropriate verification programs and the requirement for records
are identified and maintained.
Operational planning and control is required prior to new and/or revised products or
processes being implemented. During the planning phase, management will
identify:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
The output of operational planning and control includes documented quality plans
or job technical sheets, resource requirements, processes, equipment
requirements, procedures, test data, and design outputs.
M.R. Hy-Tek Equipment Pvt. Ltd. has implemented an effective system for
communicating with customers the system includes but is not limited to:
M.R. Hy-Tek Equipment Pvt. Ltd. requires that all customer specific
requirements for products and services are clearly defined by the customer
including but not limited to:
M.R. Hy-Tek Equipment Pvt. Ltd. Ensures, we have the ability to meet the
requirements for products and services to be offered to customers.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
M.R. Hy-Tek Equipment Pvt. Ltd. maintains responsibility for the quality of all
products purchased from external providers, including customer designated
sources. Procedures ensure products and services being provided by external
sources will conform to our customers’ requirements. Our control includes:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
M.R. Hy-Tek Equipment Pvt. Ltd. uses purchase orders to define the
product or services to be purchased. Purchase Orders are created, by
designated individuals within the Company. Purchasing documents are
reviewed for adequacy and approved by purchasing personnel prior to
release. Purchasing documents clearly describe the product or service to be
provided.
Evidence that jobs/ orders execution and inspection operations have been
completed as planned:
The plans provide detailed instruction and guidance for all production and
service phases including the methods and equipment to be used and
workmanship criteria.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
M.R. Hy-Tek Equipment Pvt. Ltd. exercises care with property belonging to
customers or external providers while it is under our control or being used.
8.5.4 Preservation:
• Cleaning/ Housekeeping;
• Prevention, detection and removal of foreign / Non- product materials &
others
• Special handling for sensitive outputs;
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
M.R. Hy-Tek Equipment Pvt. Ltd. shall review and control changes for
production or service operations to the extent necessary to ensure
continuing conformity of customer or internal requirements. Changes for
production may be initiated as a result of:
Management reviews and monitors changes that affect site jobs or outside
services and ensures change documentation and information is distributed
and controlled.
M.R. Hy-Tek Equipment Pvt. Ltd. monitors and measures the characteristics of
the product in receiving inspection, In-process, and final inspection to verify that
requirements have been met. Documented procedures have been established for
Job / product inspection. Documented Records and information of inspection
include evidence of conformity with the acceptance criteria and traceability to the
person authorizing the release. Records of inspection are maintained.
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
Basic documents for inspection are mainly with the issued specifications or
drawings or product catalogue or specifications & data sheets.
M.R. Hy-Tek Equipment Pvt. Ltd. ensures that products or services that do not
conform to established requirements are identified and controlled to prevent their
unintended use or delivery. Records of nonconformities are maintained as required
and include:
• Description of nonconformity;
• Description of actions taken;
• Description of concessions obtained;
• Identification of the authority deciding the action in respect of the
nonconformity;
Related Documents:
• Control of Non-conformance’s
• Change / Amendment Note/ Reports
• Identification & Traceability
• Rework Records / Third party release note(s)
• Inspection Reports / Records
• Preservation/ Stores records
• Purchase Records
• Contract Review Records
• Dispatch records
• Control of Customer property (issue / receipt reports)
9 Performance Evaluation:
M.R. Hy-Tek Equipment Pvt. Ltd. plans and conducts internal audits at
planned intervals. Internal audits are conducted to verify quality activities and
related results comply with planned expectations including customer contractual
requirements and other QMS requirements as deemed necessary and
applicable. The ISO co-ordinator is responsible for organizing and coordinating
the internal audit to ensure that the audit scope, the frequency and methods are
defined, and the following requirements are satisfactorily achieved:
Related Documents:
Risks & Opportunities
Internal Audit
Control of Documents /Master list
Training records /Competency chart
Management review
10 Improvement:
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR
QUALITY MANAGEMENT SYSTEM MANUAL
M.R. Hy-Tek Equipment Doc No: QSM- D- 01,
ISSUE 1, REV :00
Pvt. Ltd. DTD :01/09/2022
Related Documents:
Non-Conformance Reports
Internal audit reports
Management Review records
Analysis of Data
Management Review
Corrective action records
Continual improvement / Data if any
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PREPARED BY : ISO COORDINATOR/MR APPROVED BY : MANAGING DIRECTOR