What’s changed in ISO 13485:2016?
Dr Arthur Brandwood
• Previous Director Devices Registration and Assessment at TGA and Director, TGA
Biomaterials and Engineering Laboratories
• Past Chair National Board and Regulatory Expert Panel – AusMedtech
• Adviser to AHWP SG1 and Leader of Combination Products Task group
• Adviser and trainer to multiple Asia Pacific regional regulators
• Australian Delegation Leader to ISO TC 194 – Biocompatibility and Clinical Trials and
ISO TC 150 – Implantable Devices
• Past President Australian Society for Biomaterials
• Visiting Professor in Biomedical Engineering, University of Sydney
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
What’s changed in ISO 13485:2016?
Dr Arthur Brandwood
• Previous Director Devices Registration and Assessment at TGA and Director, TGA
Biomaterials and Engineering Laboratories
• Past National Chair and Chair Regulatory Expert Panel AusMedtech
• Member of AHWP SG1 and Leader of Combination Products Task group
• Adviser and trainer to multiple Asia Pacific regional regulators
• Australian Delegation Leader to ISO TC 194 – Biocompatibility and Clinical Trials
and ISO TC 150 – Implantable Devices
• Past President Australian Society for Biomaterials
• Visiting Professor in Biomedical Engineering, University of Sydney
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
BRANDWOOD
securing your compliance
:BIOMEDICAL
Medical Devices and IVDs
Asia Pacific Focus
Global Perspective
Highly Networked
Highly Engaged
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
It’s Arrived!
Published 1 March 2016
3 Year Transition Period. Expect:
− all certifications after March 2018
to be to the new version
− ISO 13485:2003 Certificates not
valid after March 2019
(ISO/TC 210/WG 1 N 233)
Europe expected to harmonise
and follow ISO transition…
http://www.iso.org/iso/catalogue_detail?csnumber=59752 BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
ISO 9001:1994 EN 46001:1996 ISO 13485:1996
ISO 9001:2000 ISO 13485:2003
The
How to Family
separate
9001 and
ISO 9001:2008 Tree
13485?
ISO 9001:2015 ISO 13485:2016
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Key Changes
Complaints Departure
Emphasis on Sterile
Risk Software and from ISO
Regulations Devices
Postmarket 9001
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Three little words…
ISO 9001 And now 3 more…
Quality management
systems — Requirements Product Safety and Performance
ISO 13485
Medical devices —
Quality management
systems —Requirements
for regulatory purposes
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Emphasis on Regulatory Requirements
Regulatory Clause 8.5.1
Objectives Postmarket
Documents Improvement
Continued safety
product and performance
requirements (State of the
Technical File Art?)
Reporting to
Complaint Files
regulatory
Design History authorities
File Specific use of
regulatory
post market
requirements
surveillance.
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Risk
Apply risk management to all processes, including
outsourced processes
− Process Control
− Purchasing
− Software Validation
Use definition of Risk from ISO 14971
− This is different to the definition used in ISO 9001
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Risk
4.1.2 The organization shall:
a) determine the processes needed for the quality management
system and the application of these processes throughout the
organization taking into account the roles undertaken by the
organization
b) apply a risk based approach to the control of the appropriate
processes…
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Risk
7.4.1 Purchasing process
…
The organization shall establish criteria for the evaluation and selection of
suppliers. The criteria shall be:
…
d) proportionate to the risk associated with the medical device
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Software
Software for
Process control
QMS software monitoring and
software
measurement
Consistent requirements for software
validation
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Software
4.1.6
The organization shall document procedures for the validation of the
application of computer software used in the Quality
Management System.
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Sterile Devices
7.5.7 Particular Requirements for validation of processes
for sterilization and sterile barrier systems
The organization shall document procedures (see 4.2.4) for the
validation of processes for sterilization and
sterile barrier systems.
NOTE Further information can be found in ISO 11607-1 and ISO 11607-2.
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Sterile Devices
6.4.2 Contamination Control
For sterile medical devices, the organization shall
document requirements for control of contamination
with micro-organisms or particulate matter
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Complaints and Postmarket
8.2.2 Complaint handling
The organization shall document procedures for timely complaint handling in
accordance with applicable regulatory requirements
These procedures shall include at a minimum requirements and responsibilities for
a) receiving and recording information,
b) evaluating information to determine if the feedback constitutes a complaint,
c) investigating complaints,
d) determining the need to report the information to the appropriate regulatory
authorities,
e) handling of complaint-related product, and
f) determining the need to initiate corrections or corrective actions
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Complaints and Postmarket
Identify and implement
changes necessary to
Includes specific
maintain the system as Embodies concept of
requirements for post
well as ensure continued “state-of-the-art"
market surveillance
medical device safety
and performance
8.5.1 Improvement
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
A Fork in the Road…
ISO 9001:2015 ISO 13485:2016
1. Scope 1. Scope
2. Normative References 2. Normative References
3. Terms and definitions 3. Terms and definitions
4. Context of the organization 4. Quality Management System
5. Leadership 5. Management
6. Planning 6. Resource management
7. Support 7. Product realization
8. Operation 8. Measurement, analysis and improvement
9. Performance evaluation
10. Improvement This is unchanged from ISO 13485:2003
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
But Wait, There’s More…
More detail in Design
Application
Flexibility to exclude Emphasis on and Development:
throughout the
requirements in appropriate usability, use of
lifecycle and supply
Clauses 6, 7, or 8 infrastructure standards, planning,
chain
transfer, records
User Training:verify
Records: consider
Statistics: Rationale that regulatory
privacy regulations for
for sample size, requirements will be
protecting confidential
documented in plans met and user training
health information
will be available
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
And more…
Annex A
(Informative)
Comparison of Content between ISO 13485:2003 and ISO
13485:2016
Table A1 outlines the changes in this edition of this International Standard compared with
the previous edition (ISO 13485:2003)
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
MDSAP
Medical Device Single Audit Program
Uses ISO 13485
USA Brazil Australia Japan Canada
Replace CMDCAS
by 2019 (follow
From 2017 Ready Now Ready Now? Will take time… ISO Transition)
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
Full Day Training Seminar
9 May 2016
Adelaide, South Australia
http://brandwoodbiomedical.com/events/full-day-workshop-transition-to-iso-134852016
BRANDWOOD
BIOM EDICAL
www.brandwoodbiomedical.com securing your compliance
