This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.

1. ISO 13485:2016
ISO 13485 is an international
standard that specifies the quality
management system requirements
for organizations involved with
medical devices at any stage of
the product lifecycle. This would
include the design, development,
production, storage, distribution,
installation, service and technical
support of the device.

2. Why ISO
13485:2016
• The importance of maintaining the
highest quality achievable in the
manufacture, distribution, use and
maintenance of medical devices is
more vital than with other products
and services.
• Product quality issues in the majority
of industries may result in
widespread recalls, substantial
financial impact, and loss of brand
equity. Quality problems with medical
devices can result in class action
lawsuits, physical harm to patients,
and potential loss of life.

3. How to implement
ISO 13485
• The organization must develop and
implement a robust Quality
Management System (QMS) in order to
comply with the standard.
• A robust QMS should consist of business
policies, procedures, forms, work
instructions, and other supporting
documents. The QMS should also
indicate the quality records to be
generated, their storage location, and the
period of time for which they are retained.

4. Quality
• The standard of something as
measured against other things of a
similar kind or The degree of
excellence of something.

6. Quality Policy and the Quality
Manual
The ISO 13485 standard requires that leadership
establish and maintain a Quality Policy and a Quality
Manual.
The quality objectives should be documented,
preferably measurable, consistently monitored,
maintained, updated, and properly communicated.

7. Medical Device File
This is one of the requirements that sets ISO 13485 apart from most of the
ISO standards. Per the ISO 13485 standard and legal requirements
organizations must maintain a file for each medical device or family of
medical devices that they manufacture. Some of the information required to
be in the file is as follows:
• A general description of the medical device including intended purpose,
labeling and instructions for use.
• Specifications of the device / product
• Procedures for the manufacture, packaging, handling, storage and
distribution of the device.
• Documented procedures for measuring and monitoring
• Installation requirements and service of the device, if applicable

8. QMS Documentation
Quality Objectives
Measuring
Performance
Work Environment
and
Contamination
Control
Product
Realization
Measurement,
Data Analysis and
Improvement
Control of Non-
Conforming
Product
Continual
Improvement
Corrective and
Preventive Actions

9. Conclusion
• ISO 13485 provides organizations with guidance for improving the
quality of their products and services, with the ultimate goal of
achieving customer satisfaction and adherence to all legal and
regulatory requirements.