ISO 13485 Quality management for

medical devices: relationship to other

quality management systems and its
future

By:

Anette Sjgren, MSc.

PREVENTIA AB

April 2016 1 of 13
 Presentation

Background to ISO 13485

Future of ISO 13485
ISO 13485 its relation to the EU GMP, US
21 CFR 820 and other regulatory quality
management systems for medical devices
ISO 13485 interfaces with other ISO standards

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 Background ISO 13485

MDD 93/42/EEC
EN 46001
ISO 13485:1996
ISO 13485:2003
EN ISO 13485:2012
ISO 13485:2016

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 TC210 WG1

Status today
Five years work
Design Specification ISO 9001:2008
ISO 13485:2016 three years implementation
time
Handbook guidance replacing TR14969

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 TC210 WG1

Future
ISO 9001:2015
New MD EU regulation
Industry feedback
Authority feedback

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 Main revisions 13485:2016
Risk starts in the introduction
Organization and lifecycle
Outsourcing
Software validation

Check list part of the standard

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 Implementation ISO 13485:2016

GAP analysis QMS

Plan
Education needs
Process updates
Documentation updates
Organization including outsourcing
Software validation
Certification established latest Feb 2019
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ISO 13485 relations to other QMS

Although ISO means international there are local

national regulations for medical device QMS.
21CFR820 QSR cGMP (US)
JPAL JGMP (Japan)
CMDR (Canada)
BR GMP (Brasil)
AU GMP (Australia)

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 ISO 13485 and EU GMP

There are some differences of course the 13485

is moving closer to EU GMP and vice versa.
Vigilance
Labelling
QP role
Processes in general ans well as risk and
design
Quality Manual
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 MDSAP

Medical Device Single Audit Program

Based on the ISO 13485
The overall objective of the Medical Device Single
Audit Program is to develop, manage, and oversee a
single audit program that will allow a single regulatory
audit of a medical device manufacturer conducted by
an MDSAP recognized auditing organization to satisfy
the needs of multiple regulatory jurisdictions

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 MDSAP

Current participating regulators

Australia (TGA)
Brazil (ANVISA)
Canada (HC)
Japan (MHLW/PMDA)
U.S. (FDA)
The European Commission is an observer of the
program.
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 13485 interface

ISO 14971:2007 risk management

IEC 62366-1:2015 usability engineering
IEC 62304:2006 software lifecycle
ISO 19011:2012 quality audit
ISO 14644 clean rooms

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 Thank you!

Contact information

Anette Sjgren
www.preventia.se
anette.sjogren@preventia.se
+46 709 299779

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