ISO 13485 Certification in Kuwait
In today’s blog I will be taking you through ISO 13485 certification in
Kuwait; ISO 13485 standard deals with Medical Devices – Quality Management
System. I will explain you the details of this standard, benefits of it and its
implementation in The State of Kuwait. International Organization for
Standardization popularly known as ISO is an independent global organization
that is involved in the process of setting international standard for almost
everything right from finished products, technology, and food safety to medical
devices etc. It was founded in the year 1947 and has grown leaps and bounds from
then on; currently it has members from across 167 countries that meet annually
at the General Assembly to discuss future strategies and their implementations.
ISO 13485 standard deals with Medical Device –
Quality Management System; it is dedicated for those organizations who are
involved in the manufacturing and distribution of medical devices. This
standard is designed to check the quality of the medical devices at any stages
of the product life cycle. The latest version of this standard was published in
the year 2016 and it supersedes the previous edition which was published in the
year 2003. Since the latest version of the standard was published in the year
2016 it is also represented as ISO 13485:2016 which is the official name for
it. ISO 13485 standard is applicable to any organization irrespective of the
size of the organization, given the fact that the organization is involved in
the process of manufacturing and distribution of medical devices.
Benefits
of getting ISO 13485 certified
Getting ISO 13485 certified has multiple benefits; I
will try to lay down a few of them for you below.
·
It gives an international recognition to
your organization as the quality of medical devices manufactured by you is
complied with international standards.
·
Since, ISO 13485 is concerned with
medical devices manufacturing the safety of patients depend on the quality and
consistency of medical products so maintaining the QMS is critical to patients,
stakeholders, regulatory agencies etc.
·
It helps in increasing the efficiency of
internal process as the quality of the product needs to be top notch.
·
This certificate establishes the
credibility of your organization and hence the explanation of the product
features and its specification becomes more straightforward thus increasing the
sale and profit.
ISO
13485 in Kuwait
The State of Kuwait popularly known as Kuwait is a
country in the Middle East which is surrounded by the Persian Gulf on one side
and it shares its land borders with Saudi Arabia and Iraq. Kuwait is one of the
most flourished nations of the world hence it becomes important to discuss ISO certification in Kuwait.
The economy of Kuwait is mostly driven by its oil
export and has most affluent population living in this part of the world. The
medical standards of such affluent societies need to be top notch and ISO 13485
helps in achieving this feat.
About
Finecert
ISO 13485 has become one of the most important standard
for medical device manufacturing industries; this standard act as an added
advantage and helps improve the credibility of the organization. It serves as a
benchmark for the quality of products manufactured by the organization and
establishes a name for itself. Having explained everything related to ISO 13485
let me add one more thing that ISO only sets standard and is not involved in
the process of lending certificates this is done by external bodies.
Finecert is one such leading global organization
that has expertise in providing ISO certification and consultation. We employ a
cost effective model for our clients, check ISO
in Kuwait and build a long term relationship with them. We have a team of
highly trained consultants that can solve any of your queries related to ISO
certification. We at Finecert aspire to provide best client experience and help
their organization get ISO certified in the given or less than that time frame.
We have a global presence and we employ a very transparent approach in dealing
with our clients and integrity for us is of utmost virtue.
To know more about ISO 13485 certification and
consultation for your organization, you can write to us or request a quote at contact@finecert.com
or you can visit our website www.finecert.com
and take a look at the services we offer.
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