2. Table of Content
◦ Introduction to ISO 13485
◦ ISO 13485 Structured
◦ The types of organizations covered by ISO 13485:2016 and the life-cycle
stages covered
◦ Revised ISO 13485
◦ benefits of ISO 13485
◦ Medical Device File
◦ Certification process and benefits
◦ Relationship with ISO 9001
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3. 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.
3
7. 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
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8. ISO 13485:2016 requires the organization to:
Identify its role under
applicable regulatory
requirements;
1
Identify the regulatory
requirements that apply to its
activities under these roles;
2
Incorporate these applicable
regulatory requirements
within its quality
management system.
3
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9. The types of organizations covered by ISO 13485:2016 and the
life-cycle stages covered:-
design and
development,
production,
storage and
distribution,
installation,
servicing,
final
decommissioning
and
disposal of medical
devices and design,
development and
provision of
associated activities.
9
10. CONT…
◦Types of organizations:
◦can be applied to suppliers or external parties providing
product (e.g., raw materials, components, subassemblies,
medical devices, sterilization services, calibration services,
distribution services and maintenance services) to such
organizations.
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11. Why was ISO 13485 revised and what are the main
improvements?
All ISO standards are reviewed every five years to establish if a revision is required in order
to keep it current and relevant for the marketplace.
ISO 13485:2016 is designed to respond to the latest quality management system practices,
including changes in technology and regulatory requirements and expectations.
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12. CONT…
The new version has a greater emphasis on risk management
and risk-based decision making, as well as changes related
to the increased regulatory requirements for organizations in
the supply chain.
This standard was last reviewed and confirmed in 2020.
Therefore, this version remains current.
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13. It specifies a greater consideration of risk as it
applies to a variety of critical areas
• Supplier and outsourcing controls.
• Training of personnel commensurate with the risks inherent in the processes
they perform.
• Software validation.
• Monitoring, testing and traceability.
• Management of corrective and preventive actions (CAPA).
• Documentation of risk management in product realization.
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14. Potential benefits of ISO 13485
Enhances the ability of the organization to meet customer and
regulatory requirements.
Helps the organization’s capability to address product safety and
effectiveness.
Allows the organization to obtain external recognition of
conformity of the quality management system to accepted
requirements. (certification)
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15. CONT…
Establishes an effective quality management system
Increases the efficiency of its processes and reduce waste
Improves staff morale
Enhances focus on risk management
15
16. CONT…
Gains awareness of improvement opportunities
Increases responsiveness to issues and nonconformities
Ensures safe, quality medical devices
Helps secure an organization's economic growth and corporate
reputation
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17. Medical Device File:-
◦ For each medical device (family), organization shall establish and
maintain files containing documents required by 13485 or
applicable regulatory requirements.
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18. File contents:-
◦ General description of device, intended use/purpose, labelling, instructions
for use
1) Specifications for product;
2) Specifications or procedures for manufacturing, packaging, storage,
handling and distribution;
3) Procedures for measuring and monitoring;
4) Requirements for installation (as appropriate);
5) Requirements for servicing (as appropriate).
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19. USES OF MEDICAL DEVICE
Minimally invasive surgery
High precision robotic surgery
Telemedicine
Targeted drug delivery systems
Lab-on-a chip
Regenerative Medicine
In-vivo nano-imaging
Cell therapies
& Artificial Organs
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20. The basic
regulatory
requirements that
manufacturers of
medical devices
must comply with
are:-
Document and record controls
Internal auditing procedures
Controls for non-conformance
Corrective and preventative actions
Process and design controls
Record retention
Accountability and traceability
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21. Certification process
Phase 1
• An initial discussion about existing practice to evaluate.
Phase 2
• A complete gap analysis of your company with respect to your certification requirements
Phase 3
• A custom written mandatory certification documentation, training and complete pre-assessment
Phase 4
• Certification audit by certification body – guaranteed success
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23. Benefits of ISO 13485 Certification
◦ ISO 13485 is intended to maintain an organization's effectiveness of
processes and to ensure safe medical devices.
◦ Certification to the standard clearly demonstrates an organization's
commitment to ensuring the design, development, and production of
medical devices that perform safely and effectively.
◦ Gaining certification through BSI provides the highest level of
confidence in a quality assurance system and informs the world that a
manufacturer is committed to quality.
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25. Number of certificates and sites Total - 2020
ISO 13485:2016 CERTIFICATES SITES
TOTAL 25656 34954
ISO 13485:2016 CERTIFICATES SITES
INDIA 567 686
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26. Who Enforces ISO 13485?
◦ ISO establishes and maintains standards, but it is not an enforcement agency.
◦ Certification to the standard is evaluated by third party agencies. Once an
organization has established a QMS it believes is in alignment with the
standard, an independent certification body or registrar audits the performance
of the QMS against the latest version of the ISO 13485 requirements.
◦ The certification body must be a member of the International Accreditation
Forum (IAF) in order to grant valid certification and should employ the
relevant certification standards established by ISO’s Committee on Conformity
Assessment (CASCO)
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27. CONT…
◦ When an organization passes an ISO 13485 audit, the authorized
certification body issues a certificate demonstrating that the organization
is registered to the standard for a three-year period.
◦ Manufacturers must be recertified every three years to maintain
certification status.
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28. Relationship with ISO 9001
◦ While ISO 13485 is a stand-alone standard, it is similar in scope and intent to
ISO 9001, Quality management systems.
◦ It contains additional requirements specific to organizations involved in the life
cycle of medical devices, while other elements of ISO 9001 have been
removed that are not relevant as regulatory requirements.
◦ Like all ISO management system standards, it is designed to be integrated into
an organization’s existing management systems.
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29. FDA PLANS TO USE ISO 13485
◦ The announcement by the FDA that it will use ISO 13485 in replacing
its current quality system regulation, is an important next step in the
recognition this standard has already gained globally.
◦ This bold step by the FDA seems logical, considering the role of ISO 13485 as
the foundation for the Medical Devices Single Audit Program (MDSAP),
currently operated by Australia, Brazil, Canada, Japan and the USA
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