ISO 13485 is an internationally recognized quality management system standard specifically designed for the medical device industry. It outlines the requirements for a comprehensive system that ensures the consistent design, development, production, installation, and servicing of medical devices that meet both customer and regulatory requirements. The standard focuses on risk management, process validation, product traceability, and maintaining effective documentation throughout the product lifecycle. Compliance with ISO 13485 demonstrates an organization's commitment to quality and patient safety, and it is often a prerequisite for market access in many countries.

1. Quality System
Regulations of Medical
Devices:
ISO 13485
Presented By: Khushi H. Gor
M.Pharm Sem-2 (Regulatory Affairs)
Regulatory Aspects of Medical Devices (MRA203T)

2. TABLE OF CONTENTS
ISO 13485 Medical device
Content of iso
13485
qms
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3. • ISO is an independent, non-governmental international
organization with a membership of 162* national standards
bodies.
• Through its members, it brings together experts to share knowledge
and develop voluntary, consensus-based, market-relevant
International Standards that support innovation and provide
solutions to global challenges.
• ISO has published more than 21000* International Standards and
related documents covering almost every industry, from technology
to food safety, to agriculture and healthcare
ISO (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION)

4. ISO 13485 Medical devices
Quality management systems Requirements for
regulatory purposes
• International Organization for Standardization
(ISO) 13485 represents the requirements for a
comprehensive quality management system for
the design and manufacture of medical
devices.
• ISO 13485 is an internationally-accepted model,
a medical device organization can implement to
help demonstrate compliance to laws and
regulations of the medical device industry.

5. • ISO 13485 helps an organization
design a quality management
system that establishes and
maintains the effectiveness of its
processes.
• It reflects a strong commitment
to continual improvement and
gives customers confidence in its
ability to bring safe and effective
products to market

6. • A medical device is an instrument, apparatus, implement, machine,
implant, in vitro reagent, or other similar article, that is intended for
use in the diagnosis, prevention and treatment of disease or other
medical conditions.
• There is a huge variety of medical devices, ranging from basic hand
tools to complex computer-controlled machines.
• These include simple devices like wound dressings and scalpels ;
durable devices like wheelchairs and dentist chairs; implantable
devices like cardiac pacemakers and monitors, prosthetic limbs and
prosthetic joints ; life-supporting devices like respirators and lung
ventilators ; sophisticated, software-controlled devices like CT
scanners and MRI machines; and in vitro diagnostic reagents and test
kits.
WHAT IS MEDICAL DEVICE ?

7. • A quality management system (QMS) is a set of policies, processes and
procedures that help an organization meet the requirements expected by
its stakeholders.
• It is based on the Plan-Do-Check-Act cycle, a four-step management method
used in business for the control and continual improvement of processes and
products.
• In the medical devices industry, a QMS is required by regulators in most
countries.
• ISO 13485 enables an organization to consistently provide safe and effective
medical devices and fulfil customer and regulatory requirements.
• It is also flexible enough to meet the individual needs of different types of
medical devices organizations.
WHAT IS A QUALITY MANAGEMENT SYSTEM?

8. ISO 13485 Structured
1. Scope
2. Normative References
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement

9. Content
Requirements for ISO 13485.
I. Quality Manual
II. Medical Device file
III. Control of Documents
IV. Control of Records
• Management responsibility
• Resource Management.
• Product Realization
• Methods of Measurement Analysis & Improvements.
I. Monitoring and measurement
II. Control of nonconforming product
III. Analysis of data
IV. Improvement

10. Requirements in Quality Management
System
General
Requirements
Documentation
Requirements

11. • Maintaining documents for implementing the procedures
• Segregations of duties among manufacturer, authorized representative,
importer or distributor.
• Determine the processes needed for the Quality Management System and the
application of these processes throughout the organization
• Maintaining the records needed to comply with regulatory requirements
• Applications a risk-based approach
• Controlled process & regulations shall be changed as per requirements
• Software should be validated & revalidated within a specified time period.
• Monitor and ensure control over outsourced processes.
• Controls & risk must be managed appropriately.
• Records shall be maintained & performed consequently in defined interval.
General requirements

12. Documentation requirements
Quality
Manual
Medical
Device file
Control of
Documents
Control of
Records

13. • SOP, Master Formula Record
• The scope of the quality management
system, including details of and
justification for any exclusion or non-
application;
• The documented procedures for the
quality management system, or
reference to them;
• A description of the interaction
between the processes of the quality
management system.
Quality manual

14. • Technical File, Clinical Evaluation Report, Post
Marketing Surveillance, Risk Management File,
Biological Evaluation Report, Essential
Requirements, Instruction For Use, Packaging &
Labelling.
• General description of the medical device, intended
use/purpose, and labelling, including any
instructions for use
• Specifications for product or procedures for
manufacturing, packaging, storage, handling and
distribution;
• Procedures for measuring and monitoring;
• Requirements for installation;
• Procedures for servicing
Medical
Device File

15. A documented procedure shall define the controls needed to:
• Review and approve documents for adequacy prior to issue;
• Review, update as necessary and re-approve documents;
• Ensure that the current revision status of and changes to documents are
identified;
• Ensure that relevant versions of applicable documents are available at
points of use;
• Ensure that documents remain legible and readily identifiable;
• Ensure that documents of external origin, determined by the
organization to be necessary for the planning and operation of the quality
management system, are identified and their distribution controlled;
• Prevent deterioration or loss of documents;
• Prevent the unintended use of obsolete documents and apply suitable
identification to them.
Control of documents

16. Control of records
• Records shall be maintained to provide evidence of conformity to
requirements and of the effective operation of the quality
management system.
• The organization shall document procedures to define the controls
needed for the identification, storage, security and integrity, retrieval,
retention time and disposition of records.
• The organization shall retain the records for at least the lifetime of the
medical device as defined by the organization, or as specified by
applicable regulatory requirements, but not less than two years from the
medical device release by the organization.

17. • Top management shall provide evidence of its commitment to the
development and implementation of the quality management system
and maintenance of its effectiveness by:
• Establishing the quality policy;
• Customer requirements
• Planning of the quality management system is carried out in order to
meet the requirements for product, are established at relevant
functions and levels within the organization.
• Ensure that responsibilities and authorities are defined, documented
and communicated within the organization.
Management responsibility

18. • Top management shall review the organization’s quality management
system at documented planned intervals to ensure its continuing
suitability, adequacy and effectiveness)
• Feedback;
• Complaint handling;
• Reporting to regulatory authorities;
• Audits;
• Monitoring and measurement of processes;
• Monitoring and measurement of product;
• Corrective action;
• Preventive action;
Management Review

19. Product Realization
1. Product realization
2. Customer-related processes
3. Design and development
4. Purchasing
5. Production and service provision
6. Control of monitoring and measuring
equipment

20. • Monitoring and measurement
• Control of nonconforming product
• Analysis of data
• Improvement
Methods of Measurement Analysis and
improvement

21. • The organizations has to monitor on
the records gather the information
from the customers & post
productions activities of the products
whether its cover the customers
requirements, shall serve as potential
input into risk management for
monitoring and maintaining the
product requirements as well as the
product realization or improvement
processes.
• Complaint Handling
• Evaluating, Handling receiving and
recording of complaints information
related to the products,
• Determining the need to initiate
corrections or corrective actions. If any
complaint is not investigated,
justification shall be documented
• The organization shall ensure that product
which does not conform to product
requirements is identified and controlled to
prevent its unintended use or delivery.
• Records of the nature of the nonconformities
and any subsequent action taken, including the
evaluation, any investigation and the rationale
for decisions shall be maintained
• The organization shall deal with
nonconforming product by one or more of
the following ways:
• Taking action to eliminate the detected
nonconformity;
• Taking action to preclude its original intended
use or application;
• Authorizing its use, release or acceptance under
concession
• When nonconforming product is detected after
delivery or use has started, the organization
shall take action appropriate to the effects, or
potential effects, of the nonconformity.
Monitoring
& Measurement
Control of Non-Conforming
Product

22. • The organization shall document procedures to determine, collect and
analyse appropriate data to demonstrate the suitability, adequacy and
effectiveness of the quality management system.
• The analysis of data shall include data generated as a result of monitoring
and measurement
• Feedback;
• Conformity to product requirements;
• Characteristics and trends of processes and product, including
opportunities for improvement; Suppliers;
• Audits;
• Service reports,
Analysis of Data

23. • A significant focus is placed on strengthening the Corrective and
Preventive Action (CAPA) process by ensuring that root cause
analysis is thorough, actions are based on data trends, and
effectiveness checks are documented and monitored. CAPA is now
more integrated with post-market surveillance, allowing feedback
from customer complaints and field data to drive continuous
improvement.
Improvements

24. • https://www.iso.org/files/live/sites/isoorg/
files/archive/pdf/en/iso13485_medical_d
evices_2016.pdf
https://www.iso.org/iso-13485-medical-devi
ces.html
• https://www.iso.org/news/ref2318.html
• https://www.mastercontrol.com/
• https://isotc.iso.org/livelink/livelink ?
func=ll&objId=18808772&objAction=browse
&viewType=1
LIST OF REFERENCES

25. THANK YOU