RISK MANUAL

ISO 14971

MF/MR/RM/01 Issue No. 1 Revision No. 0 Effective Date: 01,04, 2022

RISK MANAGMENT MANUAL

ISO 14971
effective from 1th April 2022

MACHINFABRIK INDUSTRIES PVT.LTD

R-90, TTC Industrial Area,
Rabale, Thane-Belapur Road,
Navi-Mumbai - 400701
MAHARASHTRA
INDIA

Approved By Monish Godbole

Director

Arun Singh
Reviewed By Management
Representative

Prepared By Rushikesh Wadnere

IQA-Lead

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Index

Document No. Description Page No.

1.0A Revision record 3

1.0B Distribution Control 4
2.0 Introduction 5
3.0A Abbreviation and Definitions 6
3.0B Scope and Exclusion 7
4.0 Quality management system 8
5.0 Management Responsibility 12
6.0 Resource management 18
7.0 Product realization 20
8.0 Measurement analysis and improvement 30
A. Post Market Surveillance
B. Medical Device Vigilance System
9.0 C. Product Recall 37
D. Change Notification
E. Regulatory Compliance/ Monitoring
Attachments
Annexure 1 – Process Interaction 40
10.0
Annexure 2 – Organogram Chart 41
Annexure 3– QMS Review: 42

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1.0.A. Revision Record
ISSUE Rev No. Of Reference
Document
/ Rev. Description Of Change Revised Date (DCRN /
No.
No. QM NCR)
1/0 All RM Original Issue 0 01.12.08 ---

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1.0.B. Distribution Control

Risk Manual Copy Distribution

Master Copy Management Representative

Control Copy 1 Chairman

Control Copy 2 Regulatory Head

Control Copy 3 Director Technical

Control Copy 4 Director Control

Control Copy 5 Human Resources

Control Copy 6 Planning & Stores

Control Copy 7 Marketing

Control Copy 8 Design

Control Copy 9 Purchase

Control Copy 10 Production

Control Copy 11 Quality Control

Control Copy 12 Customer Support

2.0 Introduction

Machinfabrik Industries Pvt. Ltd. is engaged in ‘Design, manufacturing, installation, commissioning

& servicing of Steam Sterilizer, Closure Processor, Super-Heated Water Spray Sterilizer, Ventilator

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Autoclave, E O Sterilizer, Dry Heat Sterilizer, Washer-Disinfector- Dryer, WFI Still, Pure Steam
Generator, Isolator & Lyophilizer (Freeze Dryer) catering to Pharmaceutical, Hospital & Food
processing industry; For last three decade. The organization is also exporting its products to overseas
customers either directly or through export houses. The organization does not undertake “Batch
Production” of the Equipments as each & every equipment Design & manufactured as per the
customer’s requirements on single unit basis.

The organization has been awarded registration as a SSI Unit eligible for participation in the Central
Government Stores Purchase Program for supply of all types of Sterilizers (Autoclaves), Distillation
Plants and Pure Steam Generators, Washer Disinfectors & Lyophilizers (Freeze Dryers) by National
Small Industries Corporation (NSIC). The organization has been granted license to use Standard
Mark in respect of Steam Sterilizer by Bureau of Indian Standards.

There are no statutory and regulatory requirements applicable to the manufacturing of products in
India. These Sterilizers (Autoclaves), Distillation Plants and Pure Steam Generators, Washer
Disinfectors Dryer&Lyophilizers. (Freeze Dryers) are subjected to periodic checks/certification
wherever applicable, by competent authorities, after they are put into use, which is the responsibility
of the user of these products. To ensure safety of the equipment, while in use, the organization has
included pressure testing methods in the process of production. The design of these products are as
per the standards, provided in ASME (Section-VIII)/PED, EN285, ASME BPE, wherever applicable,
which are followed by the organization.

For the purpose of managing various design, processes risk of the organization in a systematic &
visible manner & to establish customer oriented organization, the Management has defined Risk
management as a System, in accordance with requirements of criteria defined in subsequent clause
including ISO: 14971:2018 standards.

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3.0.A. Abbreviation and Definitions

Asst. Assistant MR Management Representative

BOM Bill Of Material IQA Internal Quality Auditor
CH Chart MNT Maintenance
CSD Customer Support Department NCR Non Conformity Report
CSP Customer Supplied Product NCD Next Calibration Date
DC Delivery Challan O/P Operator
DCRN Document Change Request Note OQ Operational Qualification
DGM Deputy General Manager PPC Production Planning And Control
DGN Design PUR Purchase
DQ Design Qualification PM Process Manual
DSP P.O. Purchase Order

Dispatch

Exe.
Executive PQ Performance Qualification

Exc.
Excise RM Raw Material

FAT Factory Acceptance Test QC Quality Control

FIN Finance Qty. Quantity
FR Format QMS Quality Management System
FQP Final Quality Plan QM Quality Manual
GM General Manager QP Quality Plan
HR Human Resource QPM Quality Procedure Manual
IQP Incoming Quality Plan SOP Standard Operating Procedure
IPQP In-Process Quality Plan Sr. Senior / Serial (Depending Upon Use)

LB
Label SUP Supervisor

LS
List ST Stamp

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M/c Machine STR Stores
Mat.
Materials Tech. Technical

MRM
Management Review Meeting WI Work Instruction

MGR Manager VP Vice President

MKT Marketing WM Works Manager

3.0.B. Scope and Exclusion

This Risk Manual is prepared based on the following elements of criteria

 ISO 14791:2018:-Application of risk management to medical devices

 ISO
 Applicable MEDDEV guidelines
 Machinfabrik Industries Pvt. Ltd. own requirements.
 Customer’s requirements

3.0.B.1 Scope of QMS

"Design, Manufacturing, Installation, Commissioning and Servicing of Steam Sterilizer (HPHV
Steam Sterilizer, Flash Steam Sterilizer, Table top Steam Sterilizer, Vertical Steam Sterilizer), Closure
Processor, Hot Water Spray Sterilizer, Ventilator, EO Sterilizer, Dry Heat Sterilizer, Washer-
Disinfector-Dryer, WFI Still, Pure Steam Generator, VHP Pass Box, Thermo Compression Distiller,
Plasma Sterilizer, Ultrasonic Cleaner Rinser Dryer, Drying Cabinet, Trolley Wash System, Control &
Packing Table, Packing Table with two shelves, Linen Fold Table, Linen Inspection Table, Linen
Distribution Trolley, Linen Storage Trolley, Magnifying Lamp, Work Table, Work Table for Wet &
Dry Goods, Storage Rack Floor Mounted, Storage Rack Wall Mounted, Basket, Instrument Tray, Free
Standing Basket Rack, Double Column Basket Rack, Mesh Rack, Panelling, Cladding, Storage
Cabinet, Storage Cupboard, Sterilizing Container, Stool, Shoe Rack, Wire Storage Shelf Module,
Waste Bin, Changing Room Locker, Table Trolley, Basket Distribution Trolley, Issue / Receiving
Counter, Basket Trolley, Closed Cart, Closed Transport Trolley, Wash Station with Spray Gun, Office
Table, Visitor Chair, Staff Chair, Multi Roll Paper Dispenser and Paper Dispensing Trolley"

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3.1.B.2 Exclusion of QMS

Clause Justification
6.4.2 All equipment/device mentioned in scope does not required contamination control.
Particular requirements for active implantable medical devices and implantable
7.5.5
medical devices.
Particular requirements for validation of process for sterilization and sterile barrier
7.5.7
system.

4.0 Quality Management System

All department heads, as a team, have established, implemented, maintained and continually improved a
Quality Management System including the processes needed and their interaction in accordance with
the requirements of Standard.

Employees at all levels within boundaries of Quality Management System have participated in various
meetings and shared their views related to their roles, processes, goals, targets and expected results,
during development of Quality Manual. Due respect is also paid to compliance with legal requirements.

While determining various processes needed for the Quality Management System and their application
throughout the organization, team of all department heads have also

a. Determined the inputs required and outputs expected from these processes
b. Determined the sequence and interaction of these processes
c. Determined the criteria and methods (including monitoring, measurement and related
performance indicators) needed to ensure the effective operation and control of these
processes
d. Determined the resources needed for these processes and ensure their availability
e. Assigned the responsibilities and authorities for these processes
f. Addressed the risks and the opportunities as determined in accordance with the
requirements
g. Evaluated these processes and implement applicable changes needed to ensure that these
processes achieve their intended results, and
h. Improved the processes and the Quality Management System

In order to maintain compliance with stated requirements, entire team of MACHINFABRIK

INDUSTRIES PVT.LTD has maintained documented information at necessary levels to support the

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operation of its processes and retained it in order to have confidence that the processes are being carried
out as planned.

This manual is applicable throughout the organization. It defines the organization’s Management policies
with regard to the application of QMS in all areas of activities, which have influence on the quality of the
products supplied to our customers.
The manual has been prepared based on criteria mentioned in scope including requirements of ISO
13485:2016 and is designated to be used as a basic reference document which outlines in broad terms, the
controls operated to ensure that the requirements of Quality Management Standard can be met.

Implementation of the policies defined herein is by means of QMS, which defines specific responsibilities
and details the essential controls that must be exercised in carrying out the various activities during the
course of contract/activities.

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General Requirement:
This quality manual details the quality management system (QMS) established,
documented, implemented & maintained in the organization in accordance with the
requirements of criteria mentioned in scope under clause 5.0.

The processes needed for QMS and their application throughout the organization, its
sequence and interaction among each other, criteria and methods needed to ensure that
both the operation and control of these processes are effective, are documented in this
manual. Top Management ensures the availability of resources and information
necessary to support the operation and these processes. (Refer Annexure – 1)

The management processes include defining quality policy and objectives, resource
Provision, management review meetings, monitoring and measurement, internal audit,
4.1
analysis , corrective and preventive action. The core processes include marketing, design
and development, purchase, production, quality control, and, sales & service.

The support processes include human resource development and finance. Where
applicable, the processes are monitored, measured and analyzed. Machinfabrik takes
every effort to achieve planned objective & maintain the effectiveness of these processes.

These processes are monitored, measured and where appropriate analyzed w.r.t criteria
and necessary actions are implemented to achieve planned objectives and continual
improvement of these processes. These processes are managed in accordance with the
requirements of ISO 13485: 2016 Standards.

The internal audit process covers all the processes. Corrective and preventive action is
taken based on analysis of data from all processes. For the human resource development
process, requirements and competencies required for all processes are considered.

The control over the outsource process is ensured through any one or combination of
selection and Evaluation of Supplier and Incoming Inspection. Generally heavy
fabrication & machining of special parts are outsourced e.g. Shell, heat exchanger etc.

Note*
The methodology of ‘Plan-Do-Check-Act’ (PDCA) is applied to all process.

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4.2
Documentation Requirements:

General:
 Documented statements of Quality Policy & Quality Objectives
 Quality Manual
 Documented procedures and records.
 Documents & records necessary to ensure effective planning, operation & control of
its processes.
4.2.1
 Technical documentation.
 Associated Procedures and other documents for control of the business processes.
 Quality Records required by the ISO 13485:2016 International Standards and
Medical Device Directive - 93/42/EEC as amended by 2007/47/EC.
 Machinfabrik Industries Pvt. Ltd. ensures & assures that it will maintain all
documentation abiding to national & regional regulations.
Quality Manual :
 The scope of the Quality Management System, including details of /and justification
for any exclusions of the standard
 Reference to the documented procedures established for the Quality Management
4.2.2 System,
 A description of the interaction between the processes of the Quality Management
System.
 The quality manual outlines the structure of the documentation used in quality
management system.
Medical Device File :
For each medical device, establishes and maintains a Device Record file or Job File
that includes documents defining:
 Product specifications including work order,
 Approved design qualification
 Bill of material
4.2.3  Fabrication drawing and specification.
 In-process inspection plan & report.
 Manual/documentation & test certificates.
 Non-conformities within factory trail.
 Factory acceptance trail report.
 Packing clearance & packing list.
 Commissioning report.

4.2.4 Control Of Documents :

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Quality management system documents have been developed, reviewed, approved,
Implemented, maintained, changed and controlled:
 The reviewing & approving authority is clearly specified in the quality procedure.
 The approving, reapproving authority appointed by Machinfabrik is strictly based on
pertinent background, experience & merit of the personal.
 Documents of external origin are periodically reviewed to assure the most recent
Versions are in use.
 Document Written legibly and are readily identifiable.
 Prevent loss of document.
 Machinfabrik has clearly defined the period of retention of all “obsolete” documents.
The “obsolete” documents are retained for 3 years.
Reference QP no.-01
Control of records :
Quality management system records have been established, retained and controlled.
 The same records are stored in the medical device file. The same is evident in the
identification & traceability procedure.
 Controls are defined for the identification, storage, security, integrity, protection,
retrieval, and disposition of records
 Machinfabrik ensures that all the relevant records are maintained for the span of 8
years.
4.2.5
Reference QP no.-02
External documents like National / International Standards & customer specifications,
machine manuals, customer formats (if applicable) are also controlled through master list.
Data maintained in computer / electronic media is protected with password and virus
controlled system. Backup is maintained for its retrieval in case of deletion or system
corruption.

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5.0
Management Responsibility

Management Commitment :
Top Management of Machinfabrik, is fully committed to the development, up
gradation and implementation of QMS (w.r.t. criteria mentioned under scope) and
maintain its effectiveness.
 To achieve this goal, top management communicated importance of meeting
customer requirements as well as statutory and regulatory requirements throughout
the organization by arranging training programs.
 The top management has established ‘Quality Policy’.
 Measurable ‘Quality Objectives’ and communicated the same to all.
 The top management has implemented practice of conducting management review
 Ensured that necessary resources are available to deliver service to the customer.
 Taking accountability for the effectiveness of Quality Management System.
5.1  Ensuring that the quality management system achieves its intended results
 promoting improvement
 supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility

Director reviews overall performance of Quality Management System at periodic

intervals (during every Management Review Meeting as per clause no. 5.6 and
appropriate actions are initiated and implemented. Every aspect of business is carefully
studied at the beginning stage itself and has been integrated into Quality Management
System documentation. Process approach and risk based thinking are integral parts of
every management decision that is concluded and implemented to achieve intended
results for organization’s improved performance at all levels. Director leads from the
front and provides direction to all task force

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Customer Focus :
Director has demonstrated leadership and commitment w.r.t. to customer focus by
ensuring that
5.2 customer and applicable statutory and regulatory requirements are determined,
understood and consistently met
Ensure the risk and opportunities that can affect conformity of product or service and the
ability to enhance customer satisfaction are determined and addressed
and on-time delivery are measured and that appropriate actions are taken if planned
results are not or will not be, achieved.
The focus on enhancing customer satisfaction is maintained
Quality Policy :
The quality policy is developed/ revised periodically by top Management or stakeholder.
The policy is circulated to the senior management for review and the comments, if any
shall be addressed. The review includes the following to ensure that the policy;
Includes consideration to the complete range of products, safety and
Performance features of the medical devices.
This quality policy is available and maintained as documented information in Quality
Manual.
5.3 Top management’s commitment to comply with and maintain its effectiveness.
Quality objectives shall be established and reviewed periodically
Process for communicating to the employees in English/ vernacular languages and to the
stakeholders.
Management review for its suitability and effectiveness.

Chairman is responsible for final review and approval of quality policy.

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Quality Policy
 The leadership of Machinfabrik Industries Private Limited pledges to achieve
customer satisfaction by honest & fair business practices & actions & also
complying with all applicable norms & regulations.

 We assure customized solutions to our customers by factually analyzing process /

product requirements, re-engineering, continual improvement, abiding regulations,
& developing systems to meet their most exacting needs.

 We ensure total team involvement by appreciating the unique ability of every

individual to provide every opportunity to improve competencies & abilities. This
will be achieved by practicing a sound process & system approach.

 We act with thoughtfulness & empathy by establishing a mutually beneficial

relationship with all our stake holders &by generating harmonious & healthy work
environment.

A.B. Kotwal
Chairman
Machinfabrik
Industries Pvt Ltd

This Quality Policy is …

a. Is appropriate to the purpose and context of the organization and support its strategic direction
b. Provides a framework for setting Quality Objectives
c. Includes a commitment to satisfy applicable requirements (customer’s as well as legal)
d. Includes a commitment to continual improvement of Quality Management System

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5.4
Planning :

Quality Objectives :
Quality objectives for relevant functions / processes (e.g. MR, Design, Production, Marketing, Customer
5.4.1 Support, QC, Purchase, and Stores) have been identified, established and documented and circulated to
respective functional heads. These objectives / performance indicators are monitored by MR, on half
yearly basis.
Targets for Quality Objectives are decided at the beginning of financial year and reviewed in every MRM.

Quality Management System Planning :

Quality Management System planning is carried out as to meet the requirements of the ISO Standard
13485:2016 in clause : 4.1 and to define quality objectives.
5.4.2
The Integrity of the Quality Management System is maintained when changes to the QMS are planned and
implemented through management review and approval.

5.5 Responsibilities, Authority and Communication

Responsibility and Authority:

 The responsibilities and authorities of those who manage perform and verify work
affecting the quality management system is defined, documented and communicated
within the organization.
 The responsibilities and authorities for key areas affecting the quality management
system are established and defined in the relevant job description
 It also ensures independency & impartiality for specific task & important processes
like internal audit, quality control, external audit & management review meeting.
 Machinfabrik has appointed “Head Regulatory” to critically monitor & upgrade any
5.5.1 national, regional or international regulations affecting product or system.

Each employee of MACHINFABRIK is responsible for ensuring:

a) Applicable policies and procedures are followed within their work area,
b) Any process creating non-conforming product is stopped until corrective action is
taken,
c) Procedures, which are undefined or fail to satisfy customer requirements, are
identified for corrective action,
d) Principles and methods of continual improvement are regularly applied to
processes
5.5.2 Management Representative:
Machinfabrik has appointed a Management Representative. In Addition to other
responsibilities, he is also
 Responsible for quality management system are documented
 Responsible for ensuring that processes needed for the Quality System are
established, implemented and maintained in accordance with International Standard

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ISO 9001: 2015 and ISO 13485: 2016.
 Responsible for reporting the performance of the Quality Management System &
need for the improvement to the top management.
 Responsible for ensuring the promotion of awareness of customer requirements
throughout the organization
 Responsible for liaison with external bodies / organization on the matters relating to
Quality Management System.
 Responsible for promotion/ awareness of regulatory and customer requirements
 Throughout the organization and to ensure that the same have been understood.

Internal Communication:
 MR & Head Regulatory are responsible for establishing the internal communication
processes appropriate to the quality management System.
 Certifying body / Regulatory authorities are informed in case of any change in
quality management system, product or any product processes, communication or
concern from any regulatory authorities.
5.5.3

5.6 Management Review

General :
 Top management shall review the quality management system at once in six months,
5.6.1 to ensure its continuing suitability, adequacy and effectiveness.
 MR shall be responsible to coordinate the meeting and maintain the records of the
management review.
5.6.2 Review Input:
Chairman, Directors & MR jointly reviews the continuing suitability & effectiveness of
QMS in Management Review meeting held every six months. This meeting is presided
over by Chairman or Directors. MR & all other department authority attend this meeting.
During review Chairman, Directors & MR jointly assesses opportunity for improvement
& need for the changes to the QMS including Quality Policy & Objectives.
 The agenda for management review meeting is to review
 Minutes of Previous Management Review Meeting
 Quality Policy and Quality Objectives
 Results of Audits, Nonconformities in System and Related Corrective Action
 Customer Feedback (Satisfaction Survey Index, Customer Complaints)
 Trend of QMS Process Performance
 Status of Product Conformity
 Status of Preventive and Corrective Action
 Changes That Could Affect the QMS
 Recommendations for Improvement
 Internal Failures (Service/Process Non Conformities) & Necessary Corrective
Actions

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 Review of Resources Necessary in QMS
 Any Other Quality Related Issues
 New or revised regulatory requirements (input will be given by Head Regulatory)
Review Output:
The output from management review includes any decisions and actions related to
maintenance and improvement of effectiveness of the quality management system and its
processes, improvement of product related to customer requirements, and resource needs.
MR prepares the Minutes of Meeting as review output that includes any actions or
decisions related to
5.6.3  Improvement of the effectiveness of the Quality Management System & its processes
 Improvement of the product related to the customer requirements, and
 Resources needed in QMS
 Chairman or Directors approves minutes & MR issues one copy each to Chairman,
Directors & circulates one copy among all process owners.

6.0 Resources Management

Provision of resources:
Machinfabrik, is committed to enhance customer satisfaction & abide to national, regional
& international regulations in terms of product compliance. It assures to implement,
maintain & continual improvement & effectiveness of QMS& also meet regulatory &
6.1
customer requirements.
To achieve this aim, top management has provided necessary resources like qualified &
experienced man power, machinery, testing equipment, material handling system,
technology that includes software & hardware.
6.2 Human Resources:
All personnel at Machinfabrik have adequate experience; training and education to ensure
that they can fulfill their responsibilities as it affects product quality.
Appropriate process is implemented to
 Determine the necessary competence for personnel performing work affecting
conformity to product requirement.
 Provide training or take other action to achieve the necessary competence. Training is
also provided in case of change in product processes or change in regulatory
requirements. Also special training will be given by Head Regulatory if a particular
regulations call for.
 Evaluate the effectiveness of the action taken,
 Ensure that personnel are aware about relevance & importance of their activities and
how they contribute to the achievement of the Quality Objective.
 Ensure that appropriate records of education, training, skill and experience in Training

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are maintained.
The necessary competence of personnel performing work effecting quality of product will
be determined. Machinfabrik will provide training, and evaluate the effectiveness of the
training, or the effectiveness of other actions taken, to ensure personnel performing work
effecting quality of product meet the required competence. Appropriate records of
specialized certifications, education, training, skills and experience are maintained.
Refer QP no.3
Infrastructure:
Machinfabrik is committed to provide necessary infrastructure required for improvement
in the QMS & to achieve product conformity. Office, shop floor and associated utilities
are provided as required along with services such as transport, communication &
information systems.
Production machines & associated accessories used for testing are sophisticated. These are
maintained & protected from damage during use. Adequate training is also imparted to
6.3
new comers before regular use. If need for any new infrastructure facility is identified, it is
evaluated by the management for its adequacy
Maintenance activity requirements which specify the frequency and activity required be
developed and established as per the Standard Maintenance Procedures. Records of
maintenance work done are maintained. Preventive maintenance activity is implemented
to maintain machines in healthy conditions and prevent unusual breakdown during
production process.

6.4 Work Environment and Contamination Control

Work Environment:
Work environment with adequate illumination & ventilation, noise, temperature,
humidity, or weather for normal working, needed to achieve conformity to product
requirements have been determined and provided.
Production manager shall ensure that employees who are required to work temporarily
under special environmental conditions within work environment are trained or supervised
by trained personnel.
Protective gloves, shoes & welding shield are used while performing production activities
6.4.1
at appropriate locations.
First Aid box and fire extinguisher are provided as per requirement.
Suitable actions are identified & implemented subsequently depending upon work
environment that includes factors such as noise, temperature, humidity, lighting or
weather.
For work environment, statutory & regulatory requirements are also considered and
monitored at factory.

6.4.2 Contamination Control:

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All equipment/device mentioned in scope does not required contamination control.

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7.0
Product Realization:

Planning of product realization:

The processes needed for product realization have been established and shown in
Annexure-1 of Process Interaction Matrix; The structure of the quality management
system reflects the quality planning to ensure that the product requirements are met.
Various services provided, various operations performed to get the final result & achieve
quality objectives are studied with respect to QMS requirement.
Following requirements are considered during the planning:
 Quality objectives and requirement for the product
 The need to establish processes and documents & to provide resources specific to the
product
 Necessary verification, validation, monitoring, measurement, inspection & test
7.1 activities specific to the product & criteria for product acceptance & responsibility
for test to be conducted
 Records to provide evidence that the realization processes & resulting product meet
requirements
 Action in case of non-conformity
The output of above activity is documented as Quality Procedures and Quality Plans.
Quality Plans are established for Incoming, In-process and Final stage activities. Quality
plans are controlled as per documented procedure.
Machinfabrik has established & documented the procedure for risk management
throughout the product realization.
we need to modified risk management according ISO14971
Refer QP no.04

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7.2
Customer Related Processes

Determine requirement related to product

Machinfabrik will determine what requirements are to be complied to fulfill the
customer’s needs during the order processes include delivery and post-delivery activities.
These requirements will include:
 Requirements for specified intended use but not stated by the customer, where known
7.2.1  Requirements specified by the customer for delivery and post-delivery activities
 Statutory, Regulatory and legal requirements as identified.
 Customer specific requirements such as component traceability and workmanship
standards.
 Material and manufacturing process requirements.
 Any additional requirements determined by Machinfabrik.
Review of requirement related to product
Following requirements related to the product are reviewed by Marketing Manager prior
to our commitment to deliver a product to the customer & at order acceptance stage it is
ensured that
 product requirements mentioned by the customer have been clearly defined and
documented & there are no ambiguities
7.2.2
 contract or order requirements differing from those previously expressed are resolved
 Record of the result of the review and action arising from the review
 Machinfabrik has the ability to meet the defined requirements
When product or contract requirements are changed, amendments are made to the
relevant documents and are transferred to the concerned functions within the
organization
Communication
Machinfabrik establishes effective methods of communication with our customers,
including :
Enquiry and orders are reviewed for the technical details of product as well as other
aspects like delivery and organization’s capacity to meet the requirements. All
ambiguities and doubts are resolved before acceptance of order. It is ensured that all
verbal instructions received from the customers are agreed prior to the execution of the
7.2.3
order & recorded as appropriate.
Amendment to the order received from customer is reviewed prior to acceptance.
Whenever any order is amended, its original order is reviewed and relationship is
established. Status of order execution is reviewed in accordance with amended order.
Quality records of order processing are maintained.
Refer QP no.5
Records of advisory notices are maintained.

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Design and development review
At suitable stages, systematic reviews of design and development is performed by
7.3.5 Design Manager, Sr. Executive and Officer in accordance with planned arrangements,
 The design and development reviews are carried out periodically as defined in the
planning, to evaluate whether the design and development activities meet the
requirements, and, to identify any problems, and, to propose necessary actions.
 Design & development team in such reviews include representatives of functions
concerned with the design and development stages, and specialist personnel for the
product involved.
 Records of the reviews shall be maintained.
Refer QP no.6
Design and development verification
Design & development verification is performed by Design Manager in accordance with
planned arrangements to ensure that the design and development output have met the
7.3.6 design and development input requirements. Records of the results of the verification
and any necessary actions are maintained by Design Manager.The Design qualification
& performance qualification are treated as Design Verification Records.
Refer QP no.6
Design and development validation
 Design and development validation performed by Design Manager in accordance
with planned arrangements to ensure that the resulting product is capable of meeting
the requirements for the specified application or intended use, where known.
 Wherever practicable, validation is completed prior to delivery of the product thru
7.3.7
trial at factory level (FAT).
 Records of the results of validation and any necessary actions are maintained by
Design Manager.
Machinfabrik has considered the clinical evaluation through the clinical literature route
as a part of Design & Development validation for medical device.
7.3.8 Design and development transfer
After completion of Design validation manager design approved the changes and ensures
it is suitable for manufacturing and then transfer drawing to the production department.
Refer QP. No. 7

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7.3.9 Control of design and development changes
 The design and development changes shall be identified and records are maintained. The changes are
reviewed, verified and validated as in 7.3.5, 7.3.7, and 7.3.8 above. Department head approves the
changes before implementation.
 The review also includes, effect of changes on specifications, documented procedures, operating
manuals, drawings etc., and it is revised before implementation, where required.
 The review also includes the evaluation of the changes on constituent parts and product already
delivered.
Refer QP. No. 7
7.3.1 Design and development files
0 Technical file of each type of medical device is available in Design department. All references, design
data, record of design and development change and validation record available in this file.

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7.4
Purchasing

Purchasing process
 Material Manager of Machinfabrik ensures that purchased products conform to
specified requirements.
Refer QP no.-8
 The procedure also defines system for the evaluation of suppliers including selection,
7.4.1
and re-evaluation.
Refer QP no.-9
 Records of the evaluations and necessary actions arising from the evaluation are
identified in the said procedure.

Purchasing Information
Materials Manager ensures that purchasing information describes the product to be
purchased / service to be hired, including where appropriate,

 Requirements for approval of product, procedures, processes and equipment

7.4.2
 Requirements for qualification of personnel, and
 Quality management system requirements

Purchase orders are reviewed and approved by Manager before release.

Verification of purchased product

Method of product release and inspection details is specified in Purchase Order. Based
on need, material verification is done at the supplier’s place & supplier make necessary
arrangement. Our customer does not verify raw materials or spares at our supplier's
place, but when customer specifies this requirement, it will be addressed in P.O.
7.4.3
Received material is verified by QC Manager. The record of verification of purchased
product is maintained &evident.
Refer QP no.-10 & QP no.-11

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7.5
Production and service provision

Control of production and service provision:

 The production process is planned and carried out under controlled conditions.
Manufacturing process is carried out in accordance with work instructions for
respective product.
 Product specifications are defined for all products, which form the basis for the
output requirements of the production process. The relevant documented
procedures, documented requirements, work instruction, reference material &
reference measurement procedure are available at work site.
 Production planning is based on committed dates by marketing, pending orders at
given time, and, availability of raw materials. Ref. QP no.12
 Suitable measuring and monitoring devices have been provided to check product
characteristics.
7.5.1
 The monitoring and measurement is performed as required at various stages of
production, and, after the product realization. Product is released after testing and
inspection.
 Customer order execution and post-delivery activities are undertaken as per the
works order instructions.
 Records of production and inspection activities are as per the WI & QPs, and are
maintained. The records provide for traceability and, identify the quantity
manufactured and quantity approved for distribution.
Machinfabrik has established & maintained job history file record for each single unit
manufactured to demonstrate traceability against dispatch. Relevant dispatch records
are also available to demonstrate traceability.

Control of product and service provision

Production Manager is primarily responsible for control of production and customer
support manager is primarily responsible control of service provision. Operational
guidelines of the machines and associated utilities are communicated to the operators &
they are trained accordingly. Suitable machines are used for production under
controlled conditions. These controlled conditions includes, as applicable
 The availability of information that describes the product characteristics (acceptance
criteria),
 The availability of work instructions, as necessary (machine manual or guidelines
7.5.1 etc.
 The use of suitable tools, machines & test equipments,
 The availability and use of monitoring and measuring equipments,
 The implementation of monitoring and measurement (use of quality plans & related
records), &
 The implementation of service release i.e. final testing, delivery and post-delivery
activities.
Evidence of planning & execution is maintained and periodically reviewed by
Production Manager.Refer QP no.-13

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7.5.2 Cleanliness of product
.
Cleanliness of product and contamination control. The operating manuals specify
requirements for the cleanliness of product, wherever the cleanliness is of significance.

Installation activities

7.5.3 Machinfabrik has established & documented procedure for installation activities.

Refer QP no.-14
Servicing activities

7.5.4 Machinfabrik has established & documented procedure for servicing activities.

Refer QP no.-15

Particular requirements for active implantable medical devices and implantable medical
7.5.5
devices.

Validation Of Processes For Production And Service Provision

Production Manager & QC Manager is primarily responsible for validation of processes
for production and service provision.

At the moment welding is the process where results cannot be verified by subsequent
monitoring or measurement and as a consequence, deficiencies become apparent only
after the product is in use or the service has been delivered. Validation is carried out in
such a way that it demonstrates the ability of these processes to achieve planned results.
7.5.6
Arrangements for these processes have been established including, as applicable
 defined criteria for review and approval of the processes,
 approval of equipment and qualification of personnel,
 use of specific methods and procedures,
 requirements for records, and
 revalidation

Refer QP no.-16

Particular requirements for validation of process for sterilization and sterile barrier
7.5.7
system.

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Identification
7.5.8 QC Manager, Materials Executive and Production Manager are primarily responsible
for identification and traceability.
The methodology for identifying the product by suitable name and means at receiving,
in-process, storage & final delivery stage is defined. Traceability is specified
requirement and records of raw materials, spare parts and finished products are
maintained suitably.
Machinfabrik has established & documented procedure for identification.
The evidence of identification is available in job history file.
Refer QP no.-17
Traceability
 Machinfabrik has established & documented procedure for traceability.
 The evidence of traceability is available in medical device file/job history file.
7.5.9
Particular requirements for active implantable medical devices and implantable
 medical devices: Not Applicable
Refer QP no.-17
Status Identification
 Product status is identified with respect to monitoring and measurements
requirements, where applicable. The products are marked as, ‘Under Testing’,
‘Tested/OK’, or ‘Rejected/NC’ depending on the test status. It also ensures clarity
of products released under an authorized concession.
 The identification of the product status is maintained throughout product realization.

Machinfabrik has established & documented procedure for status identification.

Refer QP no.-18
Customer Property :
Marketing Manager & Manager Customer Support are jointly responsible for contract
review for customer property.
7.5.10
At present none of our customer provides us material for incorporation in final product.
Actual site (plant) is also handed over to our team at the time of machine installation. In
case of loss or damage to the customer property, customer is informed suitably and
communications records are maintained.

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Preservation of product
Machinfabrik has established & documented procedure for preservation of products & relevant
7.5.11 accessories accompanying the product. It has a clear instruction to understand the identification,
handling, packaging, storage & protection. Production Manager & Manager Customer Support
are primarily responsible for preservation of product.
When finished products are transferred from production department for packing, appropriate
records are maintained.
Suitable methods for product handling, storage, and preservation are implemented & maintained.
Designated storage areas are used to store various raw materials, spare parts and finished
products to prevent it from damage.

Refer QP no.-19

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Control of monitoring and measuring equipment
QC Manager is primarily responsible for this function. Monitoring and measurement of the
product to be undertaken is determined & equipment are identified necessary for monitoring
and measurement to provide evidence of conformity of product to determined requirements.
The process is established to ensure that monitoring and measurement can be carried out and
are carried out in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment are
 calibrated or verified at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards
exist, the basis used for calibration or verification is recorded;
7.6  adjusted or re-adjusted as necessary;
 identified to determine calibration status;
 safeguarded from adjustments that would invalidate the measurement result; &
 protected from damage and deterioration during handling, maintenance and storage
During calibration if equipment found not confirming to requirements, validity of previous
measuring results is assessed and records are maintained. In such cases, calibrated equipment
with accepted and valid results are used for re-verification of the product. During re-
verification if any product found affected from quality point of view, it is identified &
appropriate actions are implemented. Records of actions are maintained to provide necessary
evidence.
A list of equipment that affects the product quality is prepared & used during calibration. These
equipment are identified with calibration status & due date. Calibration certificates are verified
for ID number, calibration result, master’s validity & its traceability to National / International
Std.
At present we do not use any computer software for product inspection.

Machinfabrik has established & documented procedure for Control Of Monitoring &
Measuring devices.
Refer QP no.-20

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8.0
Measurement, analysis and improvement:

General:
The Top Management has implemented the monitoring, measurement, analysis and improvement
processes needed
1. To demonstrate conformity to the product requirements
2. To ensure conformity of the QMS
3. To maintain the effectiveness of QMS

8.1 MR, in presence of respective process owners reviews various data collected from various QMS
processes and identifies area where improvement can be achieved. Collected data is also
analyzed using suitable Statistical Techniques such as,
1. Histograms
2. Pie Chart
3. Line Graph
4. 7 QC Tool
5. PDCA
8.2
Monitoring and Measurement :

Feedback:
Manager Customer Support is primarily responsible for monitoring feedback.

Suitable process is implemented to monitor information related to the customer perception and to
ensure that Machinfabrik has met customer requirements. The methodology for obtaining and
8.2.1 using this information is determined in the process. This information is also reviewed in
subsequent MRM.

Machinfabrik has established & documented procedure for Monitoring feedback to provide early
warning of quality problems & for input to corrective & preventive actions.
Refer QP no.-21
Complaint handling :
Suitable process is implemented for Customer complaint (CCR) handling to provide immediate
solution for smooth function of equipment. Based on nature of complaint CCR analysis is being
8.2.2 done for CAPA. This is to ensure that Machinfabrik has met customer requirements. The
methodology for obtaining and closing the complaint is determined in the process. This
information is also reviewed in subsequent MRM.
Refer QP-15
Reporting to regulatory Authorities:
Machinfabrik Industries Pvt. Ltd. maintains a documented procedure for the issuance of advisory
8.2.3 notices.
Records of the issuance of advisory notices are maintained. As an organization,
Refer QP no.-30

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Internal Quality Audit:
Management Representative is primarily responsible for this activity.
Internal Audits are conducted once in a 6 months to determine whether the QMS :
a. Conforms to the planned arrangements to the requirements of this international
standard and to the quality management system requirements established by the
organization &
b. Is effectively implemented and maintained.

Internal Audits are scheduled to cover all areas of operations. Audit is carried out by
professional consultant or by internal auditors, trained by professional consultant for
conducting audit.
8.2.4 Annual Audit Plan is released at the beginning of commercial year considering the status
and the importance of the processes and the areas to be audited as well as the results of
previous audit so that it provides time frame for respective audit schedule.

The audit criteria, scope, frequency and method are defined in procedure for conducting
internal audit. This procedure also defines responsibilities and requirements for planning,
conducting audits, establishing records and reporting results. The records of audits &
results are also maintained.

Non-conforming results of the audit are reported on non-conformity report and are
brought to the notice of the department authority. Auditee gives the details of root cause,
necessary correction and corrective action with target date of completion.

Management Representative ensures that necessary corrections and corrective actions are
taken without undue delay to eliminate detected non conformity and its root causes.
Where necessary, follow up action also includes verification of the action taken and
reporting of results. A summary of Audit Reports is one of the inputs for Management
Review Meeting.
Refer QP no.-22
Monitoring And Measurement Of Processes:
MR is primarily responsible for monitoring and measurement of the process.

Functional level objectives for all the major processes identified are established. These
8.2.5
objectives are communicated to concerned persons. Data for these objectives is
monitored and reviewed. When planned results are not achieved, appropriate correction
or corrective actions are implemented.
Refer QP no.-23

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Monitoring And Measurement Of Product

QC Manager is primarily responsible for monitoring and measurement of the product at

incoming, in-process and final stage whereas Manager Customer Support is primary
8.2.6
responsible for monitoring and measurement of the product at installation and
commissioning stage.
Characteristics of the raw material are verified w.r.t. specification, whereas
characteristics of the product are verified w.r.t. drawing and quality plan suitably.
Evidence of the conformity with the acceptance criteria is maintained in the form of
appropriate records. These records also indicate the person authorized to release the
product for delivery to the customer.
The release of the product and delivery to the customer does not proceed until the
planned arrangements have been satisfactorily completed.

Refer QP no.-23

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8.3
Control of Non-conforming products:

Control of Non-conforming products:

a) Nonconforming product is detected during receiving, in-process, final inspection and
testing, or at the customer's end.
b) The procedure for identification and control of the nonconforming product has been
established. The Procedure specifies controls to prevent unintended use or delivery of
nonconforming product, the responsibilities and authorities to deal with it, and records
maintained.
c) The methods of disposition adopted are:
 Reprocessed, repaired to meet specified requirements, wherever feasible
8.3  Re-grade for alternative applications
 Acceptance in present condition if deviations are not significant in terms of
specification required, if authorized by Director Technical , in due consultation with
the head regulatory and manager QC.
 Rejected and scrapped
 Advisory notices-communicate to Certifying Body & Notified Body.
d) Reprocessed product is retested and conforming product is transferred to stores. There
is no release of product under concession if it is violating the regulatory guidelines.
e) When nonconformity of the product is detected after delivery or use has started, the
appropriate action taken is specified in the said procedure.
Action in response to nonconforming product detected before delivery :
Machinfabrik has established & documented procedure for Control Of Nonconforming
8.3.2 Product
Refer QP no.24.
Action in response to nonconforming product detected after delivery :
Machinfabrik has established & documented procedure for Control Of Nonconforming
8.3.3 Product
Refer QP no.24.
Rework:
In case, where product needs to be reworked, the operating manual documents the rework
process, with a provision to determine any adverse effect of reworking upon product. These
procedure shall undergo the same review and approval as original procedure.
8.3.4 The clearance is given by authorized person only.
Records of rework shall be maintain as per clause 4.2.5
Refer QP no.-23

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8.4
Analysis Of Data

MR & all Process owners are primarily responsible for this activity.

Appropriate data is collected & analyzed to demonstrate the suitability and effectiveness of
the quality management system and to evaluate where continual improvement in quality
management system can be made. This includes data generated as a result of monitoring
and measurement and from other relevant sources.
Analysis of data provides information related to
a. customer satisfaction (for ISO 9001 : 2015) and feedback for ISO 13485 : 2016
8.4
b. conformity to product requirements
c. characteristics & trends of processes & products including opportunities for
preventive action
d. Suppliers’ performance.
Necessary record result of analysis of data has been maintained by Machinfabrik.

Machinfabrik has established & documented procedure forAnalysis Of Data.

Refer QP no.-25

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8.5
Improvement

General

Every active position within organization having freedom to share their views and thoughts
related to improvement in QMS participate in improvement.

Continual improvement is achieved through the use of Quality Policy, quality objectives,
audit results, analysis of data, corrective & preventive action and management review.

Machinfabrik has established & documented procedure for issue and implementation of
advisory notices which are capable of being implemented at any point of time.
Refer QP no.-26
8.5.1
Machinfabrik maintains all the necessary records for investigation of customer complaints.
If observed that activities outside the organization contributed to customer complaint
relevant information shall be exchanged between the organization involved. Also ensures
that if any customer complaint does not have CAPA the reasons are authorized and
recorded.
Machinfabrik has established a documented procedure to report adverse events as
mentioned in Vigilance System
QP no.-30

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Corrective Action
Non-conformities regarding customer complaints, product, process are analyzed and
investigated to find causes of non-conformities. The corrective action is identified &
implemented to eliminate the causes of nonconformities in order to prevent recurrence.
Responsibility to determine and implement corrective action lies with department
superiors where non-conformity is detected.
8.5.2
A documented procedure is established to define requirements for
a. reviewing nonconformities (including customer complaints)
b. determining the causes of non conformities
c. evaluating the need for action to ensure that nonconformities do not recur
d. determining and implementing actions needed
e. records of the results of the action taken &
f. reviewing the effectiveness of corrective action taken

MR handles non-conformities in the systems as per documented procedure. Records of

corrective actions are maintained suitably.

Refer QP no.-27
Preventive Action
Every active position within organization having freedom to share their views and
thoughts related to Preventive Action initiate Preventive Action. When any preventive
action is identified/ recommended, MR reviews its suitability.

The preventive action is identified and implemented to eliminate the causes of potential
nonconformities in order to prevent their occurrence. MR ensures that preventive actions
are appropriate to the effects of the potential problems.
8.5.3
A documented procedure is established to define requirements for
a. determining potential nonconformities and their causes
b. evaluating the need for action to prevent occurrence of nonconformities
c. determining and implementing actions needed
d. records of the results of the action taken &
e. reviewing the effectiveness of preventive action taken

Refer QP no. 28

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A. Post Market Surveillance
Machinfabrik has established procedure for Post Market Surveillance. This includes
9.0
collection of data through customer feedback/ complaints, analysis of data and deciding /
implementing action plan where ever quality problems are reported.

The collection of data also include information about compotators products and the data
access from public domain i.e. website of Regulatory Authorities.
Manager Q.C ensures that the action plan is implemented and reports the progress to the
management.
Refer QP no.-29

B. Medical Device Vigilance System

Machinfabrik has established procedure for market vigilance as per the requirements of
MEDDEV guideline.

9.0 The manager Quality Control and MR are responsible for implementing and reviewing
this system within the organization.The company authorized EU representative is also
responsible to report incident. Based on the nature of incident suitable action is initiated.
Refer QP no.- 30

C. Product Recall
Machinfabrik has established procedure for Product Recall as per the requirements of
MEDDEV guideline.
9.0
The medical Devices which are in use the market are recalled in case of the incident of
malfunction or potential danger to the operator is observed.
Refer QP no.-31

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Change Notification
9.0D
MR is responsible for notifying changes in Product requirements, Product process within
organization to all concern individual. MR is also responsible for sending notification to
the certifying body when significant changes occur to product / process or the organization
itself.
Refer QP no.-32

Regulatory Compliance/ Monitoring

MR and Head Regulatory are responsible to ensure that all regulatory requirements of regulatory
bodies are always complied fully. Head regulatory will ensure that updated requirements of
regulatory bodies are available and suitable changes are implemented. Management reviews the
9.0E
compliance in MRM.
Refer QP no.-33

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Annexure 2 – Organogram Chart

Yellow Marked Position Vacant

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Annexure 3- QMS Review:

Internal Audit - Management Review

QMS Meeting

Customer Production As Per Product Delivery To Customer

Requirements Annexure A The Customer Feedback

Resource Infrastructure Employee

Provision Provision Training

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