1. • ISO 13485:2016 / ISO 9001:2015 Standards Comparison
• Major Differences between ISO 13485:2016 & ISO 9001:2015
• ISO 13485:2016 Critical Terminology
• ISO 13485:2016 – by Clause / Elements
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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

3. Changes -Planned &
Controlled
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Use a Risk-Based approach to control processes of QMS, in accordance with
requirements of ISO 13485:2016 and applicable regulatory requirements
Establish -
Document – roles of
organization (manufacturer,
distributor, etc.)
Determine -
-processes necessary for QMS
-criteria & methods needed t o
ensure operation & control of
processes
- availability of resources to
support operation & monitoring
of processes
Implement – actions needed to
achieve planned results ,
including:
-control outsourced processes
affecting product conformity to
requirements via written
agreement (proportionate to
risk involved & ability of
external party)
-validation of computer
software application used in
the QMS (retain records)
-
Maintain – effectiveness of
processes & QMS by:
-monitoring, measuring, &
analyzing processes
- maintain records
demonstrating conformance to
ISO 13485:2016 and applicable
regulatory requirements

4. QMS Objectives
Planned &
Communicated
Customer &
Regulatory
Requirements
Management
Commitment
(Top Mgmt &
Mgmt Rep)
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5. *Follow-up Actions from
previous Management
Reviews
*Applicable New or Revised
Regulatory Requirements
*Changes that could affect
the QMS
*Complaint Handling
*Reporting to Regulatory
Authorities
*Audits
*Monitoring &
Measurement of Processes
*Monitoring &
Measurement of Product
*Corrective Action
*Preventive Action
*Recommendations for
Improvement
Inputs
*Improvement needed to
maintain suitability,
adequacy, & effectiveness of
QMS / Processes
*Improvement of Product
Related to Customer
Requirements
*Changes Needed to
Respond to Applicable New
/ Revised Regulatory
Requirements
*Resource Needs
Outputs
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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
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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
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Rework
Maintain
records of
Rework

9. Feedback
(determine if
organization
met customer
requirements)
Complaint
Handling
(investigate
cause /
determine
action)
Reporting to
Regulatory
Authorities
(If adverse event
or advisory notice
warranted
Analysis of
Data
(demonstrate
suitability,
adequacy, &
effectiveness of
QMS)
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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
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