Changes to

ISO 13485:2016

Presented by:

Mark Swanson
Owner/Lead Consultant, H&M Consulting Group & Associate
Director, Medical Technology Quality Graduate Program, St.
Cloud State University

In the following slides, the ISO 13485

Standard is paraphrased for
instructional purposes. Refer to the
standard for the actual text.
Comments on changes are based on
FDIS ISO 13485:2015. Be aware that
additional changes are likely to occur.

Todays Agenda
Introduction

2 min.

What is ISO 13485?

3 min.

Why is ISO 13485 changing? 15 min.

How is ISO 13485 changing? 45 min.
Questions

20 min.

About the Presenter

Mark Swanson (CMQ/OE, CQE, CBA)
is the President and lead consultant of
H&M Consulting Group; a group
focused on helping small to mid-sized
companies have the same regulatory
and quality systems knowledge as the
large medical device companies.

In addition to this, Mark is currently the Director of the Medical

Technology Quality Graduate program at St. Cloud State Universitys
Twin Cities Graduate Center in Maple Grove, Minnesota. This
innovative program was started in 2012 to provide quality
professionals with graduate level learning in the application of quality
management principles, particularly for those in the key Minnesota
industry of medical devices.
Mark has spent close to 4 years being an active member of ISO
Technical Committee 210 (TC210), Working Group 1 (WG1) working
on the revision of ISO 13485:2003 that is on track to be released in
February 2016 and has also participated with ISO TC176, WG24 on
ISO 9001:2015. This work includes discussions regarding the impact
of changes on the ISO quality management system standards, the
integration of different management standards and how to
effectively integrate the different ISO standards and other
regulations into a single quality management system.

Introduction

Questions we will cover today:

What is ISO 13485?
Why is ISO 13485 changing?
How is ISO 13485 changing?
What is the planned timeline for these changes?
Other considerations?

What is ISO 13485?

Who uses ISO 13485?

What is ISO 13485?

The world-wide sector Quality Management System (QMS)

standard for medical device organizations.

Takes general quality system requirements for all organizations

intending to provide products or services to customers and
modifies it for application within the highly regulated medical
device industry.

An internationally agreed way to implement common regulatory

concepts (presumption of conformity) that support maximizing
the potential benefits of making the strategic decision to
implement a quality management system.

Potential benefits of ISO 13485

Enhances the ability of the organization to meet customer

and regulatory requirements.

Helps the organizations capability to address product

safety and effectiveness.

Allows the organization to obtain external recognition of

conformity of the quality management system to
accepted requirements (certification).

What ISO 13485 is NOT.

It is not a required structure for your Quality

Management System.
It does not define requirements for the products
and services provided by the organization.

It does not define other business requirements or

initiatives (e.g. financial or environmental
requirements).

Why is ISO 13485 Changing?

Why is 13485 changing now and what are
the key perspectives for the change?

Why does ISO 13485 need to change?

The standard was due for revision based on the regular 5-year cycle (second edition
released in 2003)

First review (2008) determined no change needed.

This review (2012/13) there were a couple of drivers.

Requests from GHTF and AHWP

User surveygenerally pointed out the need for clarifications (implicit requirements)

European Union lost faith in ISO 13485 as a way to obtain presumption of conformity
with the EU Medical Device Directive (issuance of EN ISO 13485:2012)

User InputClarity

Enhance Clarity for Users Manufacturers voice

Survey of users found a desire for the standard to provide more clarity (implicit
requirement)

Guidance exists in ISO TR 14969 but few individuals know this document exists (auditor
interpretation)

Auditing (ambiguity) Certification bodys voice

Some clauses difficult to audit against

Nonconformities could be written against different clauses

MDSAPMedical Device Single Audit Program

User InputGlobal Harmonization

Further Harmonization Global voice

GHTF Study Group 3 had published several guidance documents with additional
concepts--can these be incorporated and used with changes to the standard?

More countries developing medical device regulations did not believe ISO 13485 could
meet their needs

Prevalence of importers & distributors in a few geographies

Outsourcing of both manufacturing (contract manufacturing) and design (contract design)

Organizations that only do part of the overall process

Enhance compatibility with latest regulations and expectations

User InputEU Challenges

Standard not Robust Enough EU Regulator Voice

Due to scandals in EU with breast and hip implants the entire regulatory framework was
being challenged

Determined that ISO 13485 alone and as written could NOT assure presumption of
conformity to the MDDs appropriate quality system requirement

More prescriptive requirements need to be included in the standard

How is ISO 13485 Changing?

What are the main changes?

Overview

New Design Specification (ISO Guide 72)

Move toward harmonization with US CFR, Brazilian law (ANVISA), CMDR (Canada),
and other law (MDD, JPAL, TGA)MDSAP

Integrates risk throughout the QMS and product life-cyclerisk-based decision-

making

Overview (cont.)

Additional linkage to documentation required for regulatory purposes

Integration of QMS software

Emphasis on appropriate infrastructure

New references to other standards (usability, sterile barrier, etc.)

Overview (cont.)

New sections on complaint handling and reporting to regulatory authorities

Clarity for auditing

Planning and documenting corrective action (without undue delay) and preventive
action

Maintains current format (aligned with ISO 9001:2008, not 2015)see next slide

Impact of Annex SLProblems

The change in structure is not the concern but the primary issue is the text included
in the mandated TMB required format could lead to a more generic standard

Many regulators have the current ISO 13485 as their regulatory model (not enough
time to change)

Users want a standard that is more detailed and clear for regulatory purposes

Additional Detail of Changes

What potential gaps exist?

Whats Changing?

Introduction & scope statement clarifications

New/modified Definitions

General Requirements clarificationsrisk

Whats Changing (cont.)

Updates to Management Review

Competency/Training effectiveness

Work Environment (health & cleanliness)

Whats Changing (cont.)

Product Realization

Risk Management

Resources and requirements

Design stagesadditional detail

Verification

Validation (use of pre-clinical and clinical evaluations)

Whats Changing (cont.)

Purchasingrisk-based controls and define communication

Production and Servicecleanliness/inclusion of service activities in feedback/

process and software validation

Identification & traceability

Preservation of productstorage conditions and packaging validation

Whats Changing (cont.)

Feedback/Customer communicationnew complaint handling & reporting sections

Non-conforming product

Before delivery

After delivery

ImprovementSimplified and strengthened

Annexes & Bibliography

Annex Acomparison between 2003 & 2016 versions

Annex Bcorrespondence of sections between ISO 9001:2015 and ISO

13485:2016

Bibliographythe information provided helps locate documents referenced in the

definitions and in the informational notes

Timeline, Other Considerations and Summary

What is the timeline and
things we should keep in mind?

Current (probable) Timeline

The Working Group has completed the first stages (WD, CD, DIS, FDIS)

Document is currently in final review for publication (target date is March 1, 2016).

WG1 has started work on a guidance handbook (approx. 1 year)

The recommended 3 year transition accepted by TC 210 and IAFno new

certifications/re-certifications after year 2

Periodic review has been accelerated to March 2019

SummaryWhy did I come?

Focus of this change is clarifications for use of the standard (implicit is now explicit)

Basic changes to incorporate risk-based decision making

Set up to align documentation, clinical and other requirements with EU (MDD)

Expansion of supplier controls and post-market requirements in feedback

Drive to Medical Device Single Audit Program (MDSAP) (FDA set to implement in
2017)

What to do now?

Determine gaps

Ask questions of experts

Free Bonus: An Additional Detailed Deck of All the Specific Changes: http://
greenlight.guru/iso-13485-webinar-offer

Where to Get More Information

ISO 13485

http://www.iso.org

ISO web site for TC210

IMDRF website (includes GHTF documents)

http://www.imdrf.org

Notified Bodies/Certification Bodies

Local experts

http://isotc.iso.org/livelink/livelink/open/tc210

ISO web site for TC176/SC2 (ISO 9001)

http://www.iso.org/tc176/sc02/public

IMDRF website (includes GHTF documents)

http://www.imdrf.org

Free Bonus: An Additional Detailed Deck of All the Specific Changes: http://
greenlight.guru/iso-13485-webinar-offer

Thanks for Attending! - Questions?

Mark Swanson, President, H&M Consulting Group
https://www.linkedin.com/in/markswansoncmq/
mark@hmcg.biz
763-234-0727

Jon Speer, Founder & VP QA/RA, greenlight.guru

www.greenlight.guru
jon.speer@greenlight.guru
317-762-5311

Free Bonus: An Additional Detailed Deck of All the Specific Changes: http://
greenlight.guru/iso-13485-webinar-offer