ISO 13485:2016 Transition Are You Prepared - OMTEC 2017

Copyright © 2014 BSI. All rights reserved.
ISO 13485:2016
Johnathon Bis
VP Medical Devices Solutions Sales
BSI Group America

Copyright © 2014 BSI. All rights reserved. 3Copyright © 2014 BSI. All rights reserved.
1 - ISO 9001:2015
2 - Key additions for ISO 13485:2016
3 - Potential Timings

Copyright © 2014 BSI. All rights reserved. 4
ISO 9001:2015

6/19/2017

New ISO Management Systems High Level Structure
• New and revised ISO MS Standards now using
ISO Annex SL: A standard for standard writers
• Provides a 10 clause high-level structure and
common text
• Standardises terminology for fundamental
Management System requirements
• Follows the Plan → Do → Check → Act
(PDCA) principle

ISO 9001:2015
10 Clause
Structure

Today

ISO 13485:2016
Published February 26, 2016

• Many additions
• Some new requirements
• Some expansion & clarification
• Increased clarity of
interrelationship between
clauses and requirements
ISO 13485:2016 – What you will see?

Changes to Clause Numbering
• Due to the inclusion of several new clauses,
several sub-clauses have been re-numbered.
• This presentation covers changes to content,
not every sub-clause re-number.
• In order to work with Medical Device Single
Audit Program (MDSAP) levels of non-
conformance grading, the clauses and
sub-clauses required formatting
* See GHTF Document SG3 N19

Regulatory Requirements
ISO 13485:2003 FDIS ISO 13485:2016
“Regulatory requirements”
Appears 9 times* Appears 37 times*
* Within Normative Requirements, i.e. Clauses: 4 - 8

Objectives and scope
ISO 13485:2003 ISO 13485:2016
Objectives Facilitate harmonization Facilitate global alignment
Scope & Role Organizations provide Medical
devices and related services
Organizations can be involved in one or more
stages of the life-cycle including the design
and development, production, storage and
distribution, installation, or servicing of a
medical device and the 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.

Definitions
ISO 13485:2003 ISO 13485:2016
3.7 Definition
（8 19）
Active implantable medical device
Active medical device
Advisory notice
Customer complaint
Implantable medical device
Labelling
Medical Device
Sterile medical device
Advisory notice
Clinical evaluation
Complaint
Distributor
Implantable medical device
Importer
Labelling
Life cycle
Manufacturer
Medical device
Medical device family
Performance evaluation
Post market surveillance
Purchased product
Risk
Risk management
Sterile barrier system
Sterile medical device

4 – Quality Management System
4.1 - 2
General
Requirements
+ Document
role(s)
undertaken by
organization
under
regulatory
requirements
+ Risk based
approach to
control QMS
processes
4.1.3 - 5
General
Requirements
Records to
meet
regulatory
requirements,
Change control
For outsourced
processes
control based
on risk and
ability
4.1.6
General
Requirements
+ Requirement
to validate the
computer
software used
for QMS prior
to initial use &
after changes
4.2
Documentation
Requirements
Medical Device
File
+ Detailed list
of items (a-f)
that shall be
included to
meet
regulatory
requirements

5 – Management Responsibility
5
General
requirements
Increased
emphasis on
regulatory
requirements
5.5.1
Responsibility
& Authority
Top mgmt
shall
DOCUMENT
the
interrelation
of all
personnel
who....
5.5.2
Management
representative
Focus on
awareness of
quality
management
system and the
removal of
customer
requirements
from bullet c)
5.6
Management
review
Procedures
required,
document
planned
intervals
+ More bullet
points for
inputs, new
bullet for
outputs

6 – Resource Management
6.2
Human resources
Shall document the
processes for
establishing
competence,
providing training,
and ensuring
awareness
6.2
Human resources
+ Maintain
competency
+ NOTE
Methodology used
to check
effectiveness to be
proportionate to risk
associated with
work for which
training or other
action is provided.
6.3
Infrastructure
+ Prevent product
mix up, ensure
orderly handling;
Maintenance of
equipment applies to
production, control
of work env, monitor
and measurement.

6.4 – Work environment and contamination control
6.4.1
Work environment
Adds documentation
requirements, competence for
temporary work, NOTE refers
to ISO 14644 and ISO 14698
for further information
6.4.2
Contamination control
For sterile medical devices, the
organization shall document
requirements for control of
contamination with micro-
organisms or particulate matter
and maintain the required
cleanliness during assembly or
packaging processes.

7.1
Planning of product
realization
+ Documented
processes for risk
management
+ Required planning for
verification, validation,
monitoring,
measurement,
inspection, test
activities, handling,
storage, distribution, &
traceability
7.2.1
Determination
of product
requirements
+ Any user
training needed
to ensure
specified
performance
and safe use of
the medical
device
7.2.2
Review of
product
requirements
+ applicable
regulatory
requirements
are met
+ any user
training
identified in
accordance
with 7.2.1 is
available or
planned to be
available…
7.2.3
Communication
+ The
organization
shall
communicate
with regulatory
authorities in
accordance
with applicable
regulatory
requirements
7 – Product Realization

7.3.2
Design &
development
planning
+ List of items
to document:
+ Traceability
of outputs to
inputs
+ Resources
including
competence
7.3.3 - 5
D & D Inputs,
outputs, review
Inputs + Usability,
standards, ability
to verify/validate
Review + specific
record
requirements
7.3.6 & 7
Design &
development
V/V
Requirement to
document: the
V/V plan, the
methods of
V/V, criteria for
acceptance,
rationale for
sample sizes.
Connections
and interfaces
7.3.6 & 7
Design &
development
V/V
V/V of device
interfaces. All
validation
activity must
be conducted
on
representative
product or
documented
equivalent
devices
7 – Product Realization (continued)

7.3.8
Design &
development transfer
New sub-clause
Procedures required
7.3.9
Design and
development
changes
Was 7.3.7 – more
detail added. Link to
risk management
and product
realization added.
Detail regarding
determining
significance of
change added.
7.3.10
Design and
development files
New sub-clause
+ Shall maintain a D&D
file for each medical
device type or family.
This file shall include or
reference records
generated to
demonstrate conformity
to the requirements for
D&D and records for
D&D changes

7.4.1
Purchasing
Criteria for evaluation
and selection of
suppliers includes
performance and risk.
Supplier performance
monitoring as part of
re-evaluation process,
additional record
requirements
7.4.2
Purchasing
information
+ Purchasing
information to
include, as
applicable product
specifications.
Suppliers to agree to
prior notification of
changes
7.4.3
Verification of
purchased product
+ Extent of
verification based on
risk/supplier
evaluation and link
to change control

7.5.1
Control of production
& service provision
Production and service
provisions must be
monitored and
controlled as well as
planned and carried
out to ensure product
conforms to
specifications
7.5.2
Cleanliness &
contamination
control
Similar to 2003
requirements, adds
contamination
control
7.5.4
Servicing activities
Servicing activity
records must be
analyzed to
determine if the
issue is a complaint
or must be utilized
as an improvement
input
7.5.3
Installation
activities
Similar to
2003
requirements

7.5.6
Validation of processes for
production and service
provision
+ Validate processes where
output cannot be or IS NOT
verified, + need for procedures,
+ Use appropriate statistical
techniques, rationale for
sample sizes, approval of
changes, and validation of
software after any changes,
risk based
7.5.8
Identification
+ UDI where required
by national or regional
regulations
+ Requirement for
procedures for
separation of returned
products from
conforming product
7.5.7
Validation of
sterilization and sterile
barriers
+ Added sterile
barriers
+ Validation required
prior to
implementation,
changes
+ Document results,
conclusions, actions

7.5.9
Traceability
Similar to 2003
version
7.5.10
Customer
property
Consistent with
7.5.4 of current
document
7.5.11
Preservation of
product
Specific reference
to packaging and
shipping
containers, other
measures
+ Distribution is
specified
7.6 Control of
monitoring and
measuring
equipment
Requirements for
the validation of
the application of
computer
software used for
monitoring and
measurement of
requirements
added to this
clause. Risk
based approach
required.

8 – Measurement, Analysis and Improvement
8.2
Monitoring and measurement
+ Feedback procedures, input
to risk management and
improvement process. Clause
strengthened.
8.2.2 and 8.2.3
Complaint handling & Reporting
to regulatory authorities
New Clauses
Requires procedures for timely
complaint handling,
investigation, regulatory
notification and more
Procedures for reporting to
regulatory authorities regarding
complaints are required

8 – Measurement, Analysis and Improvement
8.2.6
Monitoring and
measurement of
product
+ Test equipment
shall be identified as
appropriate
8.3
Control of non
conforming product
+ details in respect of
controls, concessions,
records. Clause
restructured
8.5.2 & 8.5.3
Corrective &
Preventive Action
Verifying that CAPA
does not have an
adverse effect,
actions to be taken
without undue delay

Regulatory
Requirements
Risk
Management
Validation,
Verification &
Design
Transfer
Outsourced
Processes &
Supplier
Control
Feedback
Areas of Increased Emphasis ISO
13485
3rd
Edition
Improved
linkage of
clauses

Timings

Timelines - QMS
2014 2015 2016 2017 2018 2019
ISO 9001:2015
ISO 13485:2016
CMDCAS
MDSAP
ISO 13485: 2003 => 2016
ISO 13485:2016
3-year implementation
New certificate issuances
ISO 13485: 2003 & 2016Will continue to accept Only MDSAP
Accept both ISO 13485 and MDSAP
MDSAP Pilot Program MDSAP Formal Program -->
ISO 13485: 2003
Only2016
ISO 9001: 2008 => 20153-year implementation Only 2015
ISO 9001: 2008New certificate issuances Only ISO 9001:2015

Is additional assessment time required?
Early or Late Transition?
• Additional assessment time will be needed
• Early transition by reassessment +
limited additional assessment time
Gradual Transition Over Assessment Cycle
• Transition over;
• 1 Surveillance (+full time)
• 2 Audits
• 1 Recertification Audit
• Limited additional assessment time is required
• Probably 1 – 2+ days additional assessment per site:
Dependent on employee numbers, products, processes,
activities, scope and complexity

Global Picture
• ISO 13485 & ISO 9001 Revisions
• Europe - New MDR / IVDR
• MDSAP Pilot - US, Canada, Brazil,
Australia + Japan from 1 February
2016 & Europe watching carefully
• Japanese Requirement (JPMD Act)

1. Study the standard (Do you have a copy?)
2. Consider gap analysis of current QMS vs. new requirements
3. Prepare initial transition plan, with timescales
4. Factor any additional resources & costs into budgets
5. Review staff awareness / knowledge and
determine training required
6. Compile project / implementation plan
7. Discuss top–level plan and timescales with
BSI Client Manager
8. Look out for additional help, information and resources
What can you do now?

• e-Updates
• Webinars & Recordings
• White Papers
• Frequently Asked Questions
BSI Resources
bsigroup.com/ISO13485
revision

Questions

Thank you
Name: Johnathon Bis
Title: VP Medical Devices Solutions Sales, BSI Group America
Address:
BSI America, 12950 Worldgate Drive, Suite 800, Herndon VA
20170
Telephone: 571-393-4337
Email: johnathon.bis@bsigroup.com
Links: www.bsigroup.com

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