he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016). The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes). ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.” The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later. (You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning) In this webinar, you'll learn specifically: What your organization needs to be doing to prepare for the transition to ISO 13485:2016 Why the transition presents an opportunity for your organization to implement better processes An overview of the specific changes coming with ISO 13485:2016 The actions you should be taking now and how to plan for the implementation of the standard

1. 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.

2. Today’s 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.

3. 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 University’s
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.

4. 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?

5. What is ISO 13485?
Who uses ISO 13485?

6. 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.
?

7. Potential benefits of ISO 13485
• Enhances the ability of the organization to meet customer
and regulatory requirements.
• Helps the organization’s 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).
+

8. 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).
+

9. Why is ISO 13485 Changing?
Why is 13485 changing now and what are
the key perspectives for the change?

10. 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 survey—generally 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)

11. User Input—Clarity
• Enhance Clarity for Users – Manufacturer’s 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 body’s voice
• Some clauses difficult to audit against
• Nonconformities could be written against different clauses
• MDSAP—Medical Device Single Audit Program

12. User Input—Global 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

13. User Input—EU 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 MDD’s “appropriate quality system” requirement
• More prescriptive requirements need to be included in the standard

14. How is ISO 13485 Changing?
What are the main changes?

15. 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-­‐cycle—risk-­‐based decision-­‐
making

16. 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.)

17. 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

18. Impact of Annex SL—Problems
• 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

19. Additional Detail of Changes
What potential gaps exist?

20. What’s Changing?
• Introduction & scope statement clarifications
• New/modified Definitions
• General Requirements clarifications—risk

21. What’s Changing (cont.)
• Updates to Management Review
• Competency/Training effectiveness
• Work Environment (health & cleanliness)

22. What’s Changing (cont.)
• Product Realization
• Risk Management
• Resources and requirements
• Design stages—additional detail
• Verification
• Validation (use of pre-­‐clinical and clinical evaluations)

23. What’s Changing (cont.)
• Purchasing—risk-­‐based controls and define communication
• Production and Service—cleanliness/inclusion of service activities in feedback/
process and software validation
• Identification & traceability
• Preservation of product—storage conditions and packaging validation

24. What’s Changing (cont.)
• Feedback/Customer communication—new complaint handling & reporting sections
• Non-­‐conforming product
• Before delivery
• After delivery
• Improvement—Simplified and strengthened

25. Annexes & Bibliography
• Annex A—comparison between 2003 & 2016 versions
• Annex B—correspondence of sections between ISO 9001:2015 and ISO
13485:2016
• Bibliography—the information provided helps locate documents referenced in the
definitions and in the informational notes

26. Timeline, Other Considerations and Summary
What is the timeline and
things we should keep in mind?

27. 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 IAF—no new
certifications/re-­‐certifications after year 2
• Periodic review has been accelerated to March 2019

28. Summary—Why 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)

29. What to do now?
• Determine gaps
• Ask questions of experts
Free Detailed Deck of Specific Changes: http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer

30. Where to Get More Information
• ISO 13485
http://www.iso.org
• ISO web site for TC210
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
• IMDRF website (includes GHTF documents)
http://www.imdrf.org
• Notified Bodies/Certification Bodies
• Local experts
Free Detailed Deck of Specific Changes: http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer

31. 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 Detailed Deck of Specific Changes: http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer