This month the factory in Dezhou of PMA Group already got ISO13485 approval. There is a big progress for the whole company. Let us take a look at what is meaning of it.
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
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.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
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