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 has become the
worldwide accepted standard in medical manufacturing industry and certifies the
conformity to regulatory requirements. Organizations in the industry are
expected to provide proof for quality management system implementation
throughout the entire production cycle. This is why getting ISO 13485 certified
is so important. ISO 13485 certification guarantees the conformity to international
standards throughout all phases of medical devices' life cycle: design,
manufacturing, installing, technical assistance and sales. This QMS standard
also covers other post production aspects like storage, distribution, provision
of associated services. Furthermore, disposal and decommission of used/damaged
medical devices is regulated by this ISO. This standard is based on the ISO
9001 QMS standard, adapted for the medical device manufacturing environment.
Being certified for both standards ensures competitiveness, transparency,
effectiveness and will only bring more trust to potential business partners. For
manufactures, the certification means expanded market access. Being able to
work with a worldwide network of potential customers and business partners is
one of the top reasons why any company should require certification. National
and international regulatory authorities prefer manufactures with a third-party
audited and certified quality management system in. Investing in such a system
speeds access into those countries that require it. Expanding production or
sales operation to a new country with this QMS is difficult and in some cases,
impossible.
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