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. 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. This standard
supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the
previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The
current ISO 13485 edition was published on 1 March 2016. One of the medical
device industry’s most widely used international standards for quality
management, ISO 13485, is evolving with the publication of a new version of the
standard by the International Organization for Standardization (ISO). The ISO
13485 standard is an effective solution to meet the comprehensive requirements
for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers
to address the Medical Device Directives, regulations, and responsibilities as
well as demonstrating a commitment to the safety and quality of medical
devices. A survey of ISO 13485 certification at the end of 2015 shows that
despite the global recession, the number of companies that have implemented an
ISO 13485 Quality Management System still shows a general positive trend
worldwide. 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. Such organizations can be involved in
one or more stages of the lifecycle, including design and development,
production, storage and distribution, installation, or servicing of a medical
device; or design and development or provision of associated activities (e.g.,
technical support). ISO 13485:2016 can also be used by suppliers or external
parties that provide product, including Quality Management System-related
services to such organizations.
Conclusion: Requirements of ISO 13485:2016 are applicable
to organizations regardless of their size and regardless of their type, except
where explicitly stated. Wherever requirements are specified as applying to
medical devices, the requirements apply equally to associated services as
supplied by the organization. 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.
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