ISO 13485 Medical devices-Quality
management systems-Requirements for regulatory purposes is an International
Organization for Standardization (ISO) standard published for the first time in
1996, it represents the requirements for a comprehensive quality management system
for the design and manufacture of medical devices. ISO 13485:2016 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 and applicable regulatory requirements. Such
organizations can be involved in one or more stages of the life-cycle,
including design and development, production, storage and distribution,
installation, or servicing of a medical device and design and development or
provision of associated activities (e.g. technical support). ISO 13485 was
written to support medical device manufacturers in designing quality management
systems that establish and maintain the effectiveness of their processes. It
ensures the consistent design, development, production, installation, and
delivery of medical devices that are safe for their intended purpose. Companies
are using compliance to this standard to obtain the certification of their Quality
Management System. The primary purpose of the ISO 13485 standard is the
Harmonization of the Medical Device regulatory requirements for Quality
Management Systems. All ISO standards are reviewed and revised regularly to
make sure they remain relevant to the marketplace. ISO 13485:2016 responds to
the latest QMS practices, reflecting the evolution in medical device technology
and changes in regulatory requirements and expectations. This ensures that the
standard remains compatible with other management system standards, including
the new edition of ISO 9001. The Quality Management System, which is often
referred to as a QMS, is a collection of policies, processes, documented
procedures, and records. This collection of documentation defines the set of
internal rules that will govern how your company creates and delivers your
product or service to your customers. The QMS must be tailored to the needs of
your company and to the product or service you provide, but the ISO 13485
standard provides a set of guidelines to help make sure that you do not miss
any crucial elements that a QMS needs to be successful. ISO 13485:2016
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 and applicable regulatory
requirements.
Conclusion: ISO 13485:2016 can also be used by
suppliers or e xternal parties that
provide product, including quality management system-related services to such
organizations. Ensures the consistent design, development, production,
installation, and delivery of medical devices that are safe for their intended
purpose. Requirements of ISO 13485:2016
are applicable to organizations regardless of their size and regardless of
their type except where explicitly stated. Because you are auditing your
processes, as well as having a certification body audit them, your customers
themselves do not need to audit your company. It is because of this that ISO
13485 has become a necessity for many companies to compete in the market.
Contact Us: If you plan to go for ISO 13485:2016 Certification, you may ask for Quotation by providing your organization’s information in application form & Details addressed in the websites - http://isoindia.org available at the website or submit your inquiry through feedback. Alternatively you may send your inquiry through details: mail id : info@isoindia.org ; call us a +91-522-2756327; Mobile no: +91-8604043344
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