| |
ISO 13485 Consultants In Pune India
ISO 13485:2003 -
Medical devices -- Quality management systems
ISO 13485:2003 - Medical
devices -- Quality management systems -- Requirements
for regulatory purposes specifies requirements
for a quality management system where an organization
needs to demonstrate its ability to provide medical
devices and related services that consistently
meet customer requirements and regulatory requirements
applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to
facilitate harmonized medical device regulatory
requirements for quality management systems. As
a result, it includes some particular requirements
for medical devices and excludes some of the requirements
of ISO 9001 that are not appropriate as regulatory
requirements. Because of these exclusions, organizations
whose quality management systems conform to this
International Standard cannot claim conformity
to ISO 9001 unless their quality management systems
conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific
to organizations providing medical devices, regardless
of the type or size of the organization.
If regulatory requirements permit exclusions of
design and development controls, this can be used
as a justification for their exclusion from the
quality management system. These regulations can
provide alternative arrangements that are to be
addressed in the quality management system. It
is the responsibility of the organization to ensure
that claims of conformity with ISO 13485:2003
reflect exclusion of design and development controls.
|
|
| |
If any requirement(s) in
Clause 7 of ISO 13485:2003 is(are) not applicable
due to the nature of the medical device(s) for
which the quality management system is applied,
the organization does not need to include such
a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which
are applicable to the medical device(s), but which
are not performed by the organization, are the
responsibility of the organization and are accounted
for in the organization's quality management system.
Who
is certified to these standards?
? Companies, who design, manufacture, distribute,
install and service medical devices for the European
and World markets.
? Companies who manufacture OEM products, which
are sold under other, company names.
? Companies who design and/or manufacture medical
device components or raw materials for the medical
device market.
? Companies selling, installing or servicing medical
devices.
? Consultants providing design services to the
medical device market.
? Companies providing services to the medical
device market such as sterilisation, cleaning,
testing, etc.
What does each standard mean?
ISO 9001 is a
quality system standard applicable to many industries.
ISO 13485 is a standard specific to medical device
quality systems that supplement the ISO 9001 standard.
Some of the additional requirements relate to
design controls, risk management, environmental
controls, special processes (e.g. software validation),
traceability, record retention, and regulatory
actions (such as vigilance), which are more critical
for the medical device industry.
Formal certification
of your quality management system, specifically
for medical devices, to ISO 13485:2003 proves
advantageous, and in many cases essential, for
medical companies which export their products
to the global market.
In the European Union, the fulfilment of EU Directives
(e.g. Active Implantable Medical Devices Directive,
Medical Devices Directive and In Vitro Diagnostic
Directive) allows the free trade of medical devices.
A significant portion of demonstrating compliance
with the EU Directive requirements is the establishment
and independent assessment of the quality system
meeting the requirements of ISO13485.
ISO 13485: 2003 has been harmonised against the
three medical device directives. This means that
compliance with this standard automatically demonstrates
compliance with the specific parts of the directives
that require a quality management system.
When manufacturers are active in the world market,
the focus on global or international standards
such as ISO13485:2003, is not only advantageous
- it may be stipulated by certain countries. For
example, Canada requires that medical device manufacturers
marketing their products in Canada must have a
quality system certified to ISO 13485 by an SCC
accredited certification body.
In the U.S., the revised Quality System Regulation
(21 CFR 820, Oct. 7, 1996) was based on the ISO
9001 and ISO 13485 quality system standards. US
manufacturers in compliance with the FDA Quality
System Regulations can assume that their quality
system is close to meeting the requirements of
the ISO 9001/ISO 13485 standards.
|
