Key Changes in ISO 13485-2016

ISO 13485 3rd Edition
Copyright © 2015 BSI. All rights reserved. 1

Presenters
• Vicky Medley • Stewart Brain
• Head of QMS – • QMS Certification

Medical Devices Lead – Medical
Devices

1 - Current ISO 13485:2003 & EN ISO 13485:2012
2 - ISO 9001:2015
3 - ISO 13485:2016
4 - Key Changes in ISO 13485:2016
5 - Potential Timings

ISO 13485:2003 & EN ISO 13485:2012

What is the difference?
• The current • The previous • Changes within

ISO 13485:2003
EN ISO 13485:2003
EN ISO 13485:2012
International version of the Foreword &
Standard European Annex Zs only
Harmonised • No change to
Standard requirements
(Normative
Text)
• Obsolete as of
• Annex Z’s to
30 August provide greater
2012 clarity on
applicability &
alignment with
AIMDD, MDD &
IVDD

Example
EN ISO 13485:2012
Annex ZB
Relationship between
Annex II of 93/42/EEC and
clauses of ISO 13485

ISO 9001:2015

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

New
ISO 9001:2015
10 Clause
Structure

The Future

ISO 13485:2016
Based on the Final Draft International Standard (FDIS) of 29 October 2015

ISO 13485:2016 – What’s New?
• What’s been put in?
• What’s come out?
• What’s the same?

ISO 13485:2016 – What’s New?
• Many additions
• Some new requirements
• Some expansion & clarification
• Increased clarity of interrelationship

between clauses and requirements

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 Facilitate global alignment

harmonization
Scope & Role Organizations Organizations can be involved in one or more stages
provide Medical of the life-cycle including the design and
devices and development, production, storage and distribution,
related services 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 13485:2015
Active implantable medical Advisory notice

Clause 3 device Authorized representative
Active medical device Clinical evaluation
Advisory notice Complaint
Customer complaint Distributor
Implantable medical device Implantable medical device
Labelling Importer
Medical Device Labelling
Sterile medical device Life cycle
Manufacturer
Medical device
Medical device family
Performance evaluation
Post market surveillance
Purchased product
Risk
Risk management
Sterile barrier system
Copyright © 2015 BSI. All rights reserved. Sterile medical device 16
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

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

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

6 – Resource Management
6.2 6.2 6.3

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

6.4 – Work environment and contamination control
6.4.1 6.4.2
Work environment Contamination control
For sterile medical devices, the

organization shall document
Adds documentation
requirements for control of
requirements, competence for
contamination with micro-
temporary work, NOTE refers
organisms or particulate matter
to ISO 14644 and ISO 14698
and maintain the required
for further information
cleanliness during assembly or
packaging processes.

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

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

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

7.4.2 7.4.3
7.4.1
Purchasing Verification of
Purchasing
information purchased product
Criteria for evaluation

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

7.5.2
7.5.1 7.5.3
Cleanliness & 7.5.4
Control of production Installation
& service provision contamination activities Servicing activities
control
Production and service Servicing activity

provisions must be records must be
monitored and Similar to 2003 analyzed to
controlled as well as requirements, adds Similar to
2003 determine if the
planned and carried contamination issue is a complaint
out to ensure product control requirements
or must be utilized
conforms to as an improvement
specifications input

7.5.6 7.5.7
Validation of processes for 7.5.8 Validation of
production and service Identification sterilization and sterile
provision barriers
+ UDI where required

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

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

8 – Measurement, Analysis and Improvement
8.2.2 and 8.2.3
8.2
Complaint handling & Reporting
Monitoring and measurement
to regulatory authorities
New Clauses
+ Feedback procedures, input Requires procedures for timely

to risk management and complaint handling,
improvement process. Clause investigation, regulatory
strengthened. notification and more
Procedures for reporting to
regulatory authorities regarding
complaints are required

8 – Measurement, Analysis and Improvement
8.2.6
8.3 8.5.2 & 8.5.3
Monitoring and
Control of non Corrective & Preventive
measurement of
conforming product action
product
+ details in respect of Verifying that CAPA

+ Test equipment controls, concessions, does not have an
shall be identified as records. Clause adverse effect,
appropriate restructured actions to be taken
without undue delay

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

ISO 13485:2016 Annexes
Annex A
• Comparison of content between ISO 13485:2003 and ISO 13485:2016
Annex B
• Correspondence between ISO 13485:2016 and ISO 9001:2015
European Annexes ZA (AIMD), ZB (MDD) and ZC (IVD)

• Identifies relationship between the European Standard (EN ISO 13485:2016?)
and Conformity Assessment Requirements of the respective EU Medical
Device Directives via each conformity assessment route for each directive

Annex A
• Comparison of content
between ISO 13485:2003
and ISO 13485:2016
• List of ‘Comments on
change compared with
ISO 13485:2003’

Annex B
• Comparison of content
between ISO 13485:2016
and ISO 9001:2015
• Top level clause mapping

European Annexes ZA (AIMD), ZB (MDD) and ZC (IVD)
• Identifies relationship between the European Standard (EN ISO 13485:2016?)
and Conformity Assessment Requirements of the respective EU Medical
Device Directives via each conformity assessment route for each directive

Potential Timings

EN ISO 13485:2016 – Possible Timings
FDIS Published End of 2 ISO European End of 3 year

29 October 2015
29 December 2015
March 2016
March – June 2016
March – June 2019

for 2 month month vote 13485:2016 Harmonization? transition
vote under the period published with EN ISO
Vienna If positive vote 3 year 13485:2016??
Agreement outcome transition
Straight Yes / proceeds to period
No Vote with publication No new ISO
no technical 13485:2003
comments certificates in
permitted final year of
transition

Is additional assessment time required?
Early or Late Transition?

• Yes additional assessment time will be needed
Gradual Transition Over Assessment Cycle

• Limited additional assessment time is likely in majority of
cases
• Time required will be determined based on certificate(s),
scopes, processes and activities

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)

What can you do now?
1. Study the standard (FDIS or when published)
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

BSI Resources
• e-Updates
• Webinars & Recordings
• White Papers
• Frequently Asked
Questions – Coming Soon
http://medicaldevices.bsig
roup.com/en-GB/our-
services/ISO-13485-
Revision/

Questions

Thank you
Names: Vicky Medley Stewart Brain
Titles: Head of QMS QMS Certification Lead

Medical Devices
Address: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes
MK5 8PP, United Kingdom
Links: http://medicaldevices.bsigroup.com/
LinkedIn: Please Join our New Global Medical Device LinkedIn Group
http://www.linkedin.com/groups/BSI-Global-Medical-Devices

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ISO 13485 3rd Edition

Copyright © 2015 BSI. All rights reserved. 1

• Vicky Medley • Stewart Brain

• Head of QMS – • QMS Certification

Copyright © 2015 BSI. All rights reserved. 2

4 - Key Changes in ISO 13485:2016

Copyright © 2015 BSI. All rights reserved. 3

Copyright © 2015 BSI. All rights reserved. 4

• The current • The previous • Changes within

Copyright © 2015 BSI. All rights reserved. 5

Copyright © 2015 BSI. All rights reserved. 6

Copyright © 2015 BSI. All rights reserved. 7

• Provides a 10 clause high-level structure and

• Standardises terminology for fundamental

• Follows the Plan → Do → Check → Act (PDCA)

Copyright © 2015 BSI. All rights reserved. 8

Copyright © 2015 BSI. All rights reserved. 9

Copyright © 2015 BSI. All rights reserved. 10

Copyright © 2015 BSI. All rights reserved. 11

• What’s been put in?

• What’s come out?

• What’s the same?

Copyright © 2015 BSI. All rights reserved. 12

• Some new requirements

• Some expansion & clarification

• Increased clarity of interrelationship

Copyright © 2015 BSI. All rights reserved. 13

ISO 13485:2003 FDIS ISO 13485:2016

Appears 9 times* Appears 37 times*

* Within Normative Requirements, i.e. Clauses: 4 - 8

Copyright © 2015 BSI. All rights reserved. 14

Objectives Facilitate Facilitate global alignment

Copyright © 2015 BSI. All rights reserved. 15

Active implantable medical Advisory notice

• Due to the inclusion of several new clauses,

• This presentation covers changes to content,

• In order to work with Medical Device Single

Copyright © 2015 BSI. All rights reserved. 17

Copyright © 2015 BSI. All rights reserved. 18

Copyright © 2015 BSI. All rights reserved. 19

6.2 6.2 6.3

Copyright © 2015 BSI. All rights reserved. 20

For sterile medical devices, the

Copyright © 2015 BSI. All rights reserved. 21

Copyright © 2015 BSI. All rights reserved. 22

Copyright © 2015 BSI. All rights reserved. 23

Copyright © 2015 BSI. All rights reserved. 24

Criteria for evaluation

Copyright © 2015 BSI. All rights reserved. 25

Production and service Servicing activity

Copyright © 2015 BSI. All rights reserved. 26

+ UDI where required

Copyright © 2015 BSI. All rights reserved. 27

Copyright © 2015 BSI. All rights reserved. 28

+ Feedback procedures, input Requires procedures for timely

Copyright © 2015 BSI. All rights reserved. 29

+ details in respect of Verifying that CAPA

Copyright © 2015 BSI. All rights reserved. 30

Copyright © 2015 BSI. All rights reserved. 31

European Annexes ZA (AIMD), ZB (MDD) and ZC (IVD)

Copyright © 2015 BSI. All rights reserved. 32

Copyright © 2015 BSI. All rights reserved. 33

• Top level clause mapping

Copyright © 2015 BSI. All rights reserved. 34