SA HB 13485:2020

This Standard adopts ISO 13485:2016 – Medical devices – A practical guide which provides additional insight and understanding of the requirements in AS ISO 13485:2017, Medical devices – Quality management systems – Requirements for regulatory processes (from here on referred to as “The Standard”). It is divided into sections outlined in the Contents in line with the clause structure of the Standard. The Handbook provides advice to guide understanding of the Standard and its application by including the text of the clauses of the Standard, followed by the intent of those clauses, and with the relevant guidance. Examples have been used wherever possible as an aid to understanding the intent and interpretation of the requirements.

Scope

This International Standard 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). This International Standard can also be used by
suppliers or external parties that provide product including quality management
system-related services to such organizations.
Requirements of this International Standard 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 this International Standard 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 with this International Standard reflect any exclusion of design
and development controls.
If any requirement in Clauses 6, 7 or 8 of this International Standard 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.