Both the 2003 and 2016 versions of the ISO
13485 standard cover fundamentally the same topics. However, there are some
There is a new requirement for
infrastructure, which should prevent product mix-ups and ensure orderly handling.
Moreover, information technology has been added as an infrastructure
requirement in supporting services. For more information, read: Managing
medical device infrastructure requirements according to ISO 13485:2016.
The new version of the standard includes
mandatory documents and procedures to ensure that the design and development
outputs have met the input requirements. Verification plans, which include
acceptance criteria and statistical techniques with rationale for sample size,
should be documented.
Requirements are the same in both versions of the standard.
There are no significant differences in the requirements between the two
versions of the standard.
In the new standard, the identity of the person authorizing the release
of product shall be recorded, and records of test equipment used for release
should be maintained.
Requirements of analysis of data are the same; however, in the new
version of the standard, analysis should also be performed on audits and
service reports. See the following sample document: Procedure
for data analysis.
Requirements are almost the same, except that in the new version of the
standard, medical device safety and performance must be taken into
consideration during improvement activities.
Both versions of the standard have the same requirements for corrective
Both versions of the standard have the same requirements for preventive
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