files. The other sub-clauses on Planning, Inputs, Outputs, Review, Verification, and
Changes remain, but have been renumbered because of the additions.
4. The sub-clauses under 7.5.1, Control of production and service provision, have
been elevated in the clause hierarchy, e.g., Installation activities at 7.5.1.2.2 is now
7.5.3. As a result, other sub-clauses have been renumbered, e.g., Customer property
at 7.5.4 is now 7.5.10. A new sub-clause 7.5.7 has been added on Particular
requirements for validation of processes for sterilization and sterile barrier systems.
5. New clauses 8.2.2 on Complaints handling and 8.2.3 on Reporting to regulatory
authorities have been added. These additions shifted the old clause entries to new
numbers, e.g., Internal audit is now 8.2.4.
6. Clause 8.3 on Control of nonconforming product has four new sub-clauses: 8.3.1
for General; 8.3.2 for Actions in response to nonconforming product detected
before delivery; 8.3.3 for Actions in response to nonconforming product detected
after delivery; and 8.3.4 for Rework.
Annex A and Annex B
Annex A of ISO 13485:2016 provides a comparison of the content between ISO
13495:2003 and ISO 13485:2016, while Annex B describes the correspondence
between ISO 13485:2016 and ISO 9001:2015.
Requirements Applicability
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 organizations quality management system (QMS) 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 QMS. These
regulatory requirements can provide alternative approaches that are to be addressed
in the QMS. 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 Clause 6 (Resource management), 7 (Product realization), or 8
(Measurement, analysis, and improvement) 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 QMS is applied, the organization does not need to include such a
requirement in its QMS. For any clause that is determined to be not applicable, the
organization must record the justification as described in 4.2.2 (Quality manual).
Transition Timing
During the transition period, ISO 13485:2016 will co-exist with ISO 13485:2003. Due to
the requirement changes, users will have three years in which to update their quality
management systems to meet the requirements of ISO 13485:2016. It is
recommended that the users of ISO 13485:2003 work with their certification bodies or
registrars to schedule an upgrade audit at a convenient time within the transition
period.