2. Copyright 2016, QMS Consulting LLC
•High Level Structure (HLS) remains at 8 clauses
•Primary focus on safety / performance of medical
devices in conformance with customer and
regulatory requirements
•Applicable to manufacturers and servicers in one
or more stages of the medical device life-cycle
•Term “Risk” pertains to safety or performance
requirements of device or meeting applicable
regulatory requirements
•Standard still requires
Documented Procedures, Quality Manual, and role
of Management Representative
•High Level Structure (HLS) increased to 10 clauses
•Primary focus on customer satisfaction and
continual improvement in consideration of the QMS
as a risk-based business model
•Applicable to wide range of manufacturers and
servicers
•Term “Risk” pertains to effect of uncertainty,
positive or negative, on organization’s QMS
•Standard no longer requires Documented
Procedures, Quality Manual; nor requirement for a
Management Representative
ISO 13485:2016 ISO 9001:2015
6. Copyright 2016, QMS Consulting LLC
Validation of Computer
Software
•validate software applications
prior to initial use & after
changes to software or
application
•specific approach & activities
for V&V proportionate to risk
associated with software use
•consider effect on ability of
product to conform to
specifications
Identification &
Traceability
•maintain ID of product status
thru production, storage,
installation, & servicing
•ensure only product passing
required inspections / tests or
released under authorized
concession is dispatched,
used, or installed
•if regulatory requirements
apply – document system to
assign unique device
identification number
•ensure returned devices are
ID’d & distinguished from
conforming product
•traceability in accordance w-
applicable regulatory req’s
Preservation of
Product
•Protect product from
alteration, contamination, or
damage when exposed to
expected conditions & hazards
during processing, storage,
handling, & distribution
•Design & construct suitable
packaging and shipping
containers
•Document req’s for special
conditions needed if
packaging alone cannot
provide preservation
Document procedures for
validation of application of
computer software used in
Production and Service
Provision
Document procedures for
preserving product conformity
to requirements
7. •take action,
appropriate to
effects or potential
effects of NC
•Issue advisory
notices in accordance
with applicable
regulatory req’s
•take action to
eliminate NC
•preclude original
intended use /
application
•authorize use,
release, or accept
under concession
Before Delivery
After Delivery
Copyright 2016, QMS Consulting LLC
Documented procedure to define controls & related
responsibilities / authorities for identification,
documentation, segregation, evaluation, &
disposition of NC product.
Records of nature of NC’s and any subsequent
action, including investigation and notification of
any investigation & rationale for decisions must be
maintained
8. Documented procedures – must
undergo same review / approval as
original
Rework – must consider potential
adverse effect of rework on
product
Completion of rework – must verify
product / ensure meets acceptance
criteria & regulatory requirements
Copyright 2016, QMS Consulting LLC
Rework
Maintain
records of
Rework
10. If Regulatory
Requirements stipulate
Feedback Gathered
Feedback Procedures
•organization must obtain specific
experience from Post-Production
activities
•review of experience must form
part of Feedback process
•potential input to Risk
Management
•applicable to monitoring &
maintaining product
requirements, realization, or
improvement
•documented methods for
obtaining & using info
•provisions to gather data from
Production & Post-Production
Copyright 2016, QMS Consulting LLC
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