Company Name.

Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
YIT-001-01 1 of 1

YAHKA INFORTRONICS PVT LTD

QUALITY MANUAL
ISO 13485:2016

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
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Content

Introduction....................................................................................................................................................... 4
1 Scope............................................................................................................................................................ 4
1.1 General.................................................................................................................................................. 4
1.2 Exclusions............................................................................................................................................. 4
2 References.................................................................................................................................................... 4
3 Terms and definitions.................................................................................................................................... 4
4 Quality management system......................................................................................................................... 5
4.1 General.................................................................................................................................................. 5
4.2 Documentation requirements................................................................................................................. 6
5 Management responsibility............................................................................................................................ 7
5.3 Quality policy and objectives................................................................................................................. 7
5.4 Responsibility, authority and communication......................................................................................... 9
6 Resource management................................................................................................................................. 9
6.2 Human resources.................................................................................................................................. 9
6.3 Infrastructure........................................................................................................................................ 10
6.4 Work environment and contaminated products...................................................................................10
6.5 Data protection.................................................................................................................................... 10
7 Product realization....................................................................................................................................... 10
7.1 Planning of product realization............................................................................................................ 10
7.2 Customer-related processes................................................................................................................ 11
7.3 Design and development..................................................................................................................... 12
7.4 Purchasing........................................................................................................................................... 12
7.5 Production and service provision......................................................................................................... 13
7.6 Control of monitoring and measuring equipment.................................................................................16
8 Measurement, analysis and improvements................................................................................................. 17
8.2 Monitoring and measurement.............................................................................................................. 17
8.3 Control of nonconforming product........................................................................................................ 17

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 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
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8.4 Data analysis....................................................................................................................................... 17

8.5 Improvement........................................................................................................................................ 18

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
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 Company Name. Document Number
YID-QM-2021/01
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01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
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INTRODUCTION
M/s.Yashka Infotronics is a product design, engineering and manufacturing company with expertise in designing
and building complex scientific and industrial equipment.
The purpose of this quality manual is to inform employees and other stakeholders about the quality management
system (QMS) implemented at M/s Yashka Infotronics Pvt ltd hereinafter will be termed as Yashka in this entire
documents.
This Quality Manual specifies requirements that YASHKA uses to address customer satisfaction, to meet
customer and applicable regulatory and statutory requirements and to meet ISO 13485:2016 requirements and is
supported by additional procedures where necessary.

Please note that this document gives an overview only. Employees must read and understand QMS procedures
relevant for their area.

1 SCOPE

1.1 GENERAL
YASHKA’s QMS covers all parts of the company and all processes with influence on quality and safety of
products marketed by the company.

YASHKA manufactures the following products (as per YIT-QM-2021/01):

 ICVS: Mini advance Bipap machine
 ICVS Pro: Mini NIV Ventilator.
 ICVS Pro+: Mini NIV Ventilator with Limited IV option.
 HVS: Neonatal, Pediatric and Adult Ventilator (Limited patient wt.)
 HVS Pro: Advanced Neonatal with Bubble CPAP, HFOV.
 AVS: Advanced Universal Ventilator with compressor.
 AVS Pro: Advanced Universal Ventilator with compressor and auto flow control and emergency
operation.
 AVS Lite: Advanced Universal Ventilator without compressor.

1.2 EXCLUSIONS
YASHKA does not manufacture sterile products and implantable medical devices.

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without the owners prior and written consent.
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 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
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2 REFERENCES
The QMS is designed to meet the requirements of Council Directive (EU) 93/42/EEC Annex II to comply with the
legislation and regulatory requirements.

A major update of the QMS was introduced in 2021 to meet the updated requirements of ISO 13485:2016”
Medical devices – Quality management systems – Requirements for regulatory purposes”.

3 TERMS AND DEFINITIONS

The QMS procedures are written in English.

For the purposes of this manual, the terms and definitions given in ISO 13485 apply, together with the following
terms, used to describe the supply chain.

SUPPLIER: Our Subcontractors

YASHKA: Yashka Infotronics Pvt ltd.
CUSTOMER: Our Customers

Throughout the text of this Quality Manual, wherever the term “product” occurs, it can also mean
“service”. Wherever requirements are specified as applying to “medical devices”, the requirements
apply equally to related services as supplied by the organization. Definitions provided in national
regulations can differ slightly and take precedence.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
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 Company Name. Document Number
YID-QM-2021/01
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4 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL

4.1.1 The organization shall document a quality management system and maintain its effectiveness
in accordance with the requirements of this International Standard and applicable regulatory
requirements. The organization shall establish, implement and maintain any requirement, procedure,
activity or arrangement required to be documented by this International Standard or applicable
regulatory requirements. The organization shall document the role(s) undertaken by the organization
under the applicable regulatory requirements.

4.1.2 The organization shall:

a) determine the processes needed for the quality management system and the application of these
processes throughout the organization taking into account the roles undertaken by the organization;

b) apply a risk-based approach to the control of the appropriate processes needed for the quality
management system;

c) determine the sequence and interaction of these processes.

4.1.3 For each quality management system process, the organization shall:

a) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective

b) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes;

c) implement actions necessary to achieve planned results and maintain the effectiveness of these
processes;

d) monitor, measure as appropriate, and analyses these processes;

e) establish and maintain records needed to demonstrate conformance to this International Standard

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 Company Name. Document Number
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and compliance with applicable regulatory requirements (see 4.2.5).

4.1.4 The organization shall manage these quality management system processes in accordance
with the requirements of this International Standard and applicable regulatory requirements.
Changes to be made to these processes shall be:

a) evaluated for their impact on the quality management system;

b) evaluated for their impact on the medical devices produced under this quality management
system;

c) controlled in accordance with the requirements of this International Standard and applicable
regulatory requirements.

4.1.5 When the organization chooses to outsource any process that affects product conformity to
requirements, it shall monitor and ensure control over such processes. The organization shall retain
responsibility of conformity to this International Standard and to customer and applicable regulatory
requirements for outsourced processes. The controls shall be proportionate to the risk involved and
the ability of the external party to meet the requirements in accordance with 7.4 The controls shall
include written quality agreements.

4.1.6 The organization shall document procedures for the validation of the application of computer
software used in the quality management system. Such software applications shall be validated prior
to initial use and, as appropriate, after changes to such software or its application. The specific
approach and activities associated with software validation and revalidation shall be proportionate to
the risk associated with the use of the software. Records of such activities shall be maintained (see
4.2.5).

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
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 Company Name. Document Number
YID-QM-2021/01
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01 1.10.21
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The QMS is designed in accordance with the requirements of ISO 13485:2016 and applicable
regulatory requirements and the QMS processes are structured to follow the chapter numbering in
ISO 13485:2016 as shown below.

1 Scope
Products
2 References 5 Management 7 Product realization
3 Terminology 6 Resources
4 QMS

8 Measurements,
analysis and
improvements

7 Product realization 7.6 Control of

monitoring and
measuring equipment

7.1 Planning of product 7.3 Design and 7.5 Production and 7.2 Customer‐related
realization development service provision processes

7.5.4 Servicing
7.4 Purchasing activities

8 Measurement, analysis and improvement

8.2 Monitoring and measurement

(Feedback, complaints, internal audits, monitoring and
measurement of processes/products)

8.3 Control of
8.4 Analysis of data nonconforming 8.5 Improvement
product (corrective and preventive actions)

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 Company Name. Document Number
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Figure 1 – Processes at YASHKA

As indicated in, Figure 1 resources (6) and management (5) is provided to the product realization (7)
in order to ensure that output from product realization is found acceptable according to the
expectations from customers and to meet relevant regulatory requirements.
The core of the QMS is the product realization process (7), which can be divided into the following
sub processes: Product realization starts with a planning process (7.1) which delivers input to the
design and development process (7.3) and output from this process is transferred

to production (7.5) for physical manufacturing. Additionally, design transfer contains information to be
used for purchasing (7.4) and servicing (7.5.4) to ensure proper training of sales partners, service
partners and service technicians (installation and service). During production, the quality of products
is ensured through appropriate control of monitoring and measuring equipment (7.6). Output from the
production is delivered to the customers, and appropriate customer-related processes (7.2) are
established to ensure that important feedback regarding products are fed-back into the organization.
Products are maintained throughout the entire product lifetime and will be subject to continuous
measurements, analysis and improvements/corrective and preventive actions (8) (post-marked
surveillance activities) in order to constantly improve product quality and ensure compliance with
regulatory requirements.

As required by ISO 13483:2016 a risk-based approach has been used throughout this QMS.
The processes described in Figure 1 are performed internally at YASHKA or outsourced to suppliers
or sales and service partners as described below in Table 1.

Table 1 – Outsourced processes

Process
Sale of products
Installation of products that require installation
After sales service of products that require installation
Repair of products that require installation
Manufacturing of Yashka specified components

The control of outsourced processes shall be proportionate to the risk associated to the process/product

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without the owners prior and written consent.
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 Company Name. Document Number
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involved is described in the QMS.

All IT systems used in the QMS shall be identified and the responsible employee shall – a proportionate to the
risk associated – validate the software prior to the initial use or after changes to the software.

4.2 DOCUMENTATION REQUIREMENTS

The QMS elements are divided into 8 categories:
I. Quality manual (this document)

II. Procedures

III. Instructions

IV. Work instructions – incl. inspection and test instructions

V. Forms

VI. Templates

VII. Databases

VIII. Medical device file

A procedure describes how a process is accomplished and by whom, and who has responsibility for individual
steps in the process.

Instructions describe in details how a specific task shall be handled. Instructions are identified with “I” and a
serial number enclosed in {} as for example {I-0001 End customer satisfaction survey}. Work instructions
contain detailed step-by-step instructions on how to accomplish a specific – mainly manufacturing – job, task or
assignment. Work instructions may include inspection and test instructions that describe how a product or
process is inspected and/or how the products are tested. Work instructions are identified with “WI” and a serial
number enclosed in {}1.

Forms are used for data collection or control of a process. Forms are identified with “F” and a serial number
enclosed in {}.

Templates are used to assure standardized documents and procedures. Templates are identified
with “T” and a serial number enclosed in {}.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
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 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
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Tittle Issue Date
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Databases contain and structure information relevant to the QMS. Databases are identified with “D” and a
serial number enclosed in {}.
An important database is {D-0015 Instructions, templates and forms} that contain a list of all instructions,
work instructions, forms, templates and databases belonging to the QMS.

For each product manufactured, YASHKA shall create and maintain a medical device file with a description of
the intended use, the medical device classification according to MDD, an overview of the markets/regions
where the products are marketed, and a folder with the medical device file used to demonstrate conformity with
EN ISO 13485:2016 and compliance with relevant legislation and applicable regulatory requirements.

QMS procedures, instructions and work instructions shall be maintained in Sherlock and other QMS documents
in SharePoint – see {D-0015 Instructions, templates and forms}.

QMS documents are created by an author appointed by the process owner and reviewed prior to final approval.
The author shall specify a review-frequency and a person responsible for the periodic review.

When a document in Sherlock is approved, it cannot be changed. If change is required, a new version of the
document shall be created.

All documents and records created as part of the QMS or the medical device file of a product, shall be filed for
a certain amount of time depending on the type of document/record and product in question.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
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 Company Name. Document Number
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5 MANAGEMENT RESPONSIBILITY

5.3 QUALITY POLICY AND OBJECTIVES

This quality policy applies to all activities performed at YASHKA.

Further we shall – in all we do – comply with this QMS and we shall continuously review, improve
and maintain the system to ensure that it works effectively. Management has defined YASHKA’s
mission as:

YASHKA’s solutions secure the highest return on investment for dental practices by enabling the practitioners
to perform the highest quality treatments on safe and calm patients while protecting the practitioners’ health
and maximizing their productivity.

The mission statement emphasizes that dental practices should expect a high return on investment by
acquiring dental equipment solutions from YASHKA– even though the initial investment often will be higher
than when investing in “ordinary” dental equipment solutions.

The mission statement is made operational by means of the XO WHEEL – a product

development and communication tool.

Further a vision has been defined:

To be the top-ranking supplier of quality dental treatment solutions.

By “top-ranking” we do not mean the biggest, but rather the most interesting and forward looking
manufacturer of dental treatment solutions.

We shall strive to create and supply products with the best possible quality still maintaining a competitive
sales price level.

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without the owners prior and written consent.
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 Company Name. Document Number
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By quality we mean that the products fulfill their mission (helping dental practices treat patients as explained
above), that the products have a good and timeless design, that the materials used are of the right quality
and that the finish is extraordinary. For us high quality means that the products are reliable and can be used
for many years and therefore live up the customers and the society’s circular economy expectations.

In relation to all processes taking place at YASHKA we shall ensure that requirements from customers
and authorities are identified and met.

Wherever appropriate risk management considerations shall be implemented to identify possible

risks and relevant risk mitigation measures.

The following quality objectives have been decided:

Table 2 – Quality objectives

Objective
The number of satisfied end customers’ shall increase with 5 % per year
The customer complaints shall decrease with 5 % per quarter
Warranty costs shall not exceed 1 % of the revenue
More than 95 % of critical spare parts ordered before the end of a working day, are
shipped the following working day

The measurement results shall be studied at evaluation meetings and presented to the employees
at information meetings.

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without the owners prior and written consent.
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 Company Name. Document Number
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5.4 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

Below the organizational structure of YASHKA is defined.

The Management team (indicated with orange color in the figure below) manages the processes
handled by the organization.

Figure 2 – Organizational structure (2018-11-01)

The organization is structured in a number of teams.

The tasks and responsibilities shall be described in a job profile or a job description.

The manufacturing processes are structured in manufacturing teams and each team is managed
by a team leader.

Quality Manager is appointed as responsible for the QMS and must report to the CEO
concerning the function of the system and major necessary changes.

Each quarter, Quality Manager organizes an evaluation meeting to evaluate the QMS – especially the
system’s ability to ensure that customer and authority requirements are met. In addition to the
management review meeting at least one management meeting shall be organized each month by CEO.
The meeting shall – in addition to general management issues
– handle quality management issues.

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without the owners prior and written consent.
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6 RESOURCE MANAGEMENT

6.2 HUMAN RESOURCES

The QMS has special focus on employee education and/or training and each manager shall make sure that the
employees at all-time have the right skills to perform the job.
Training shall be classified according to the risk associated with the training and the effectiveness of the
training shall be documented.

CEO shall at least two times per year arrange an information meeting for all employees.
6.3 INFRASTRUCTURE
Each manager shall, based on the associated risk, ensure that buildings, workspace and associated utilities,
process equipment and information systems relevant for the QMS in the manager’s area is designed to enable
the employees to manufacture products that fulfill the requirements.

IT Administrator shall document all IT systems used at YASHKA including all relevant information necessary to
safely operate and maintain the systems, ensure that that data is protected against unauthorized access and
that all data files are backed up.

6.4 WORK ENVIRONMENT AND CONTAMINATED PRODUCTS

All workstations shall be designed so that the employees can work in healthy postures and the lightning shall
be designed to assure visible control of the products.

6.5 DATA PROTECTION

Employee data and customer data shall be handled in accordance with the company’s data protection policy.

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without the owners prior and written consent.
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7 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION

The design and development effort is governed by a stage-gate model that divides the product realization
into stages separated by gates. At each gate, the continuation of the process is decided by the
management.

Design & development

Design reviews

Configuration management

Risk management
Stage 2 DESIGN

Stage 0 Product planning Stage 1 CONCEPT

Ideation
Analysis Product requirements Design Formal Production Post‐

Stage 4 Production, PMS

Scoping Risk management activities testing: market surveillance Post
Planning Regulatory Construction Verification market clinical followup
Intended requirements Risk management Validation
use User Standards Prototyping

& PMCF
needs assessment Usability Usability
Prioritizatio engineering engineering
n (early involvment of Integration testing
users) System testing
Stage 3 TEST

0 1 2 3

Project Design Design Design

description input output transfer

Figure 3 – Stage gate model

The stage-gate model divides the product realization effort into the three following major components,
which are executed in the specified order:

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 Product Planning
 Design & Development (CONCEPT, DESIGN & TEST)
 Production/manufacturing + post-market surveillance (PMS) and post-market clinical follow-up (PMCF)

The stage-gate model presented in Figure 3.

7.2 CUSTOMER-RELATED PROCESSES

The products are sold via sales partners and service partners to end-customers that may be small dental
practices or large dental practices as shown below in Figure 4.

Figure 4 – XO CARE’s customers

Products that require installation are installed and serviced via sales partners and service partners.
Service partners handle transport, installation, instruction of end-customers, after sales service and repair of
products. Service partners may (passively) sell products to the end-customers.
In addition to the tasks handled by service partners, the sales partners actively sell products to end-
customers. The term customer refers partners or end-customers.

Generally, YASHKA products are not manufactured to meet specific customer requirements but are designed
by YASHKA based on communication with customers, ideas created inside the organization, regulatory
requirements, feedback and complaints.

Ideas to new products or improvement of existing products are generated when YASHKA employees spend
time with customers and other end users, visit dental exhibitions or meetings arranged by dental associations,
study dental magazines, other relevant literature and end- customer surveys.

The procedure describes how partners are selected, that a written agreement shall be made, that partner

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employees shall be registered and trained and how partners shall be reviewed.

Further the CRM system – for storing information on partners, partner employees and end- customers – is
described.
Also, requirements for compilation and communication of price lists, review of customer data and general
conditions related to the delivery of the products are defined.

Further the procedure describes provision for processing of customer orders and handling of returned goods.

7.3 DESIGN AND DEVELOPMENT

This section incorporates the requirements for product development and is initiated by a design and
development planning as shown in Figure 3.

The purpose of the planning is to ensure that the design process is appropriately controlled and that the quality
objectives are met.
Design and development planning is an ongoing activity that continues throughout the entire CONCEPT,
DESIGN and TEST stages.

In the CONCEPT phase, product conceptual descriptions shall be elaborated, expanded, and transformed into
a complete set of design input requirements which are written to an engineering level of detail.

Design output is the result of the design effort. Design output is generated as output from the DESIGN stage
and is the basis for the medical device file.

In the TEST stage, device verification may be executed as a combination of in-house testing performed by
YASHKAA/S staff, and tests performed by external third-party test houses.

Design validation shall be performed under defined operating conditions on initial production unit(s), lots, or
batches, or their equivalents.

Finally, the project manager shall release the medical device file and transfer the project to production.

The described change management process shall also be used to implement changes to existing products.

7.4 PURCHASING
The first part of this procedure describes how a supplier shall be selected, evaluated and how the collaboration
shall be started.

Evaluation of a new supplier shall be done in accordance to the risk of the item to be supplied. Purchased
items shall be classified in relation to the potential risk related to the item:
 Critical XO specified components

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
YIT-001-01 1 of 1

 Critical components
 Non critical XO specified components
 Non critical components

For critical components – or components where supply failure is estimated to have huge negative economic
impact – preferably at least two alternative suppliers of a component or product shall be selected.
When a supplier is approved a written agreement shall be made and all relevant documents shall be
maintained.

When the collaboration with a supplier has been established the procedure described how the purchasing
process shall be handled.

All suppliers of critical components and suppliers that supply components/products for more MDKK 1 per year
shall be re-evaluated at a frequency corresponding to the associated risk.
If the re-evaluation of a supplier of critical XO specified components and suppliers that supply
components/products for MDKK 2 or more per year, shows that corrective actions are required, the re-
evaluation shall be followed up by an audit at the supplier’s address.

All purchases shall be based on verified and updated specifications.

If a supplier requests to modify the technical specifications of an item this shall be approved by XO CARE.

Depending on the type of supplier and the potential risk associated with the supplied items, the suppliers shall
be controlled using one or more of these control types:
 A declaration from the supplier that confirms the supplied items are in compliance with the required
specifications
 A test report made by the supplier documenting that the supplied components/products are in compliance
with the required specification
 The supplier controls and documents the control of critical components
 The components/products are subject to technical inspection at XO CARE
 The supplier has established a certified quality management system

7.5 PRODUCTION AND SERVICE PROVISION

CONTROL OF PRODUCTION
The production shall be planned to match production capacity and customer demand.

When a new product is being developed or an existing product is modified, Project Manager shall in the
DESIGN stage of the overall stage-gate model (see Figure 3) in collaboration with Manufacturing
establish/revise the production specifications.

A new or modified product is released for manufacturing when an engineering change notice is approved and
published.
This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
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The engineering change notice form specifies – based on risk assessment considerations – the following:
 If the process shall be described by means of a work instruction
 Special requirements concerning process equipment
 If the work instruction shall include a control activity
 If the work instruction shall include provisions on how to clean the finished product
 Who shall write the work instruction and create models
 Who shall approve work instruction and reference models
 If the employee that shall perform the process needs special training Work

instructions shall be available at the point of use.

Only the latest versions of the work instructions shall be available and outdated versions shall be disposed.

The manufacturing processes shall constantly be monitored and improved using Lean white board meetings.

It shall be verified that the process equipment chosen, makes it possible to manufacture products with the
specified requirements, and if appropriate dedicated tool boxes and tool boards shall be used for a process.
All process equipment that need service shall be serviced as appropriate.

To protect product surfaces, work tables shall be covered with a soft material.
Electronic components and printed circuits shall either be enclosed in antistatic packing or handled on tables
covered with antistatic mats connected to protective earth

The manufacturing environment in general shall be clean and the indoor climate shall be comfortable (e.g.
temperature air humidity and lightning).
Manufacturing rooms where processes like gluing and soldering is performed shall acceptable by means
of ventilation etc.

Stored items shall be handled proportionate to the risk associated with the items.
An item stored in A warehouse shall be marked with item number and assemblies shall be stored at
Manufacturing as near as possible to the work station where they are needed.
Nonconforming items shall be stored in C warehouse and shall be clearly marked as nonconforming.
Items that require special storing conditions (e.g. temperature) shall be stored as required in a warehouse
and handled according to the FIFO principle.

Sterile products shall be stored as prescribed by the supplier and the pickings must not be opened.

The manufacturing processes shall be followed by a control activity (process control) if this is required in the
work instruction.

Pre-shipment control with a complete test of functions and electric safety shall be done for the following
products:

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
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 XO Units
 XO ODONTOSURGE
 XO ODONTOSON

Spare parts, accessories and consumables shall be verified to comply with specified requirements before
delivery.

Monitoring and measurement equipment shall be available where necessary.

All products that shall be transported shall be packed to ensure sufficient protection during transportation and
storage.
Painted components shall be packed individually in cell air foam bags or parts-specific packaging.
Printed circuits shall be packed in antistatic bags and large printed circuits shall be packed in special designed
printed circuit boxes.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
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All consignments shall be marked with relevant customer data and XO’s order number.

At delivery it shall be ensured that a consignment is complete, and it shall be controlled that the product
specification comply with the customer order specification
If relevant it shall be controlled that accompanying documents are supplied in the language listed on the order.

Return goods may be contaminated and shall be sterilized or disinfected before inspection and repair.

Further the procedure describes how a product shall be phased out.

SERVICING ACTIVITIES
External servicing processes such as installation, servicing and repair of products that require installation
(units) supplied by YASHKA are done by partners.

Accompanying documents (instructions for use, installation instructions, service instructions, spare parts lists
etc.) shall be designed and maintained.

Critical spare parts (spare part that is necessary for a product to function) shall be identified. Service notes

informing partner service technicians about:

 Product modifications
 New products
 Changes in installation or servicing of the products
 Or other relevant issues
shall be created.

Accompanying documents and service notes shall be posted on xo-care.com and distributed to relevant
partner employees.

Technical training programs for partner service technicians in installing and servicing the products shall be
created and published.

Major partners shall be audited and it shall be verified that their service technicians are trained, that they have
the right tools, that they have enough spare parts in stock, that they only use original spare parts and
consumables, that the installation and after sales service is done as required and finally that the partner returns
installation reports documenting the address of the end-customer.

It shall be ensured that the installation instructions and installation report include provisions making it
possible for the service technician to test that the product functions correctly and to instruct the end-
customer in using, maintaining and disinfection the product.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
YIT-001-01 1 of 1

When necessary and at least every 24th month a technical evaluation meeting with service technicians from
selected partners shall be organized.

VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE

PROVISION
All products sold to customers shall be verified before shipment and production processes shall therefore not
be validated.

Installation and technical service on units is outsourced to partners as described in 7.2 and validated by
YASHKA as described in 7.2 and 7.5.4.

For each process equipment with software the software shall be validated prior to the initial use or after
changes to the software. Such validation shall be proportionate to the risk associated with the use of the
software and documented.

IDENTIFICATION
Depending on the associated risk items shall be identified by:
 A unique item number followed up by a short item description
 A marking plate with a unique serial number (units and tabletop instruments only)
 A label with item number and item description in English (items sold to customers)

Further the procedure details the identification of:

 YASHKA specified components
 Casted metal components specified by YASHKA
 Printed circuits
 Patient chairs and operator’s seats
 XO ODONTOSON and XO ODONTOCURE hand pieces
 Software
 Accompanying documents

TRACEABILITY
When an item with a serial number is invoiced to a costumer the serial number is registered on the invoice and
stored together with costumer data in Axapta.

Unit data registered in Axapta is transferred to the CRM system and end-customer data from installation report
are registered.

CUSTOMER PROPERTY
Customer property shall be stored separate from products belonging to YASHKA and the owner of the property
shall be clearly marked.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
YIT-001-01 1 of 1

7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT

All monitoring and measurement equipment relevant to the QMS shall be identified and listed.

Monitoring and measurement equipment with software shall proportionate to the risk be validated
prior to the initial use or after changes to the software.

Monitoring and measurement equipment shall be calibrated with intervals depending on the risk
associated with the relevant product.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENTS

8.2 MONITORING AND MEASUREMENT

After marketing of a product, post-market surveillance shall include feedback from e.g. customers, complaints,
nonconformities, technical evaluation and/or installation reports.

Customer complaints shall be registered, and a Project Manager shall be appointed to handle the processing of
the complaint.

If corrective/preventive action(s) is required further processing shall be according to 8.5.

The Medical Devices Directives requires certain changes of the device or of the quality system to be notified to
the Notified Body.

Internal quality audits shall be planned with a frequency proportionate to the risk of the process.

The audits shall document that quality activities are conducted according to the process described in the QMS,
that the QMS is effective and complies with relevant standards and legislation.

Design and development of new products follows the stage-gate model (see Figure 3) and the status of
planned deliveries throughout the product development phases is documented with phase audits.

8.3 CONTROL OF NONCONFORMING PRODUCT

All products must pass a pre-shipment control before they are released.

The Quality Manager may force a stop of the manufacturing and deliveries to customers in case
nonconformity of a product or process leads to unacceptable risk.

Further the procedure describes how nonconformities originating from supplier faults, construction errors
and/or process errors shall be handled.
This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com
 Company Name. Document Number
YID-QM-2021/01
YASHKA INFOTRONICS Revision Number Date
01 1.10.21
PVT LTD
Tittle Issue Date
ISO13485 Quality 12.11.21
Template Number Manuals Page Number.
YIT-001-01 1 of 1

When a customer complaint is received by YASHKA employee, the employee shall consider if the complaint is
justified. If yes, a customer complaint shall be registered, and further processed.

Incidents where a patient or user has been injured shall be reported to National Competent Authorities.
A Field Safety Corrective Action shall be performed, if corrective action is needed to ensure safety of products
already delivered.

8.4 DATA ANALYSIS

Based on feedback from customers, manufacturing processes, audits, service reports, and/or suppliers, data
shall be analyzed to demonstrate the effectiveness of the QMS.

8.5 IMPROVEMENT
Improvements to products and processes are based on input from customers and employees. All suggestions
for improvements are registered in the idea database.

Improvements which affect product safety, or improvements which are determined to be important by the
Management team (e.g. based on data analysis) shall be handled as CAPA according to {I-0020 CAPA}.

The prioritization of improvements shall be based on the associated risk.

Corrective and preventive action shall be accomplished according to {I-0020 CAPA} and the corrective and
preventive action shall be proportionate to the effects of the nonconformities.

This Document is the property of YASHKA INFOTRONICS PVT LTD. Any communication or reproduction thereof even partial, is prohibited
without the owners prior and written consent.
Yashka Infotronics Pvt ltd, Parkhi Heights, Manngaon, Hinjewadi Phase -3, Pune-411057, Maharashtra. Email:yashkacontacts@gmail.com