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 13485:2016 can also be used by suppliers or external parties that
provide product, including quality management system-related services to such
organizations. 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. The processes required by ISO 13485:2016 that are applicable to
the organization, but are not performed by the organization, are the
responsibility of the organization and are accounted for in the organization's
quality management system by monitoring, maintaining, and controlling the
processes. If applicable 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 regulatory requirements can
provide alternative approaches that are to be addressed in the quality
management system. It is the responsibility of the organization to ensure that
claims of conformity to ISO 13485:2016 reflect any exclusion of design and
development controls. 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. 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.
Conclusion: ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. 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.
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 - https://iso-india.org available at the website or submit your inquiry through feedback. Alternatively you may send your inquiry through details
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