ISO 13485:2016

Johnathon Bis
VP Medical Devices Solutions Sales
BSI Group America

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1 - ISO 9001:2015
2 - Key additions for ISO 13485:2016
3 - Potential Timings

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ISO 9001:2015

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3/20/2017
ISO 9001:2015

10 Clause
Structure

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Today

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ISO 13485:2016
Published February 26, 2016

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ISO 13485:2016 – What you will see?

• Many additions

• Some new requirements

• Some expansion & clarification

• Increased clarity of
interrelationship between clauses
and requirements

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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

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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

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Objectives and scope

ISO 13485:2003 ISO 13485:2016

Objectives Facilitate harmonization Facilitate global alignment

Scope & Role Organizations provide Medical
devices and related services
Organizations can be involved in one or more
stages of the life-cycle including the design
and development, production, storage and
distribution, 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.

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Definitions
ISO 13485:2003 ISO 13485:2016

3.7 Definition Active implantable medical device Advisory notice

（8 19） Active medical device Clinical evaluation
Complaint
Advisory notice
Distributor
Customer complaint Implantable medical device
Implantable medical device Importer
Labelling Labelling
Medical Device Life cycle
Sterile medical device Manufacturer
Medical device
Medical device family
Performance evaluation
Post market surveillance
Purchased product
Risk
Risk management
Sterile barrier system
Sterile medical device

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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

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Timings

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 Timelines - QMS
2014 2015 2016 2017 2018 2019

3-year implementation ISO 9001: 2008 => 2015 Only 2015

ISO 9001:2015
New certificate issuances ISO 9001: 2008 Only ISO 9001:2015

3-year implementation ISO 13485: 2003 => 2016 Only 2016

ISO 13485:2016 New certificate issuances ISO 13485: 2003 ISO 13485:2016

Will continue to accept ISO 13485: 2003 & 2016 Only MDSAP
CMDCAS
Accept both ISO 13485 and MDSAP

MDSAP MDSAP Pilot Program MDSAP Formal Program -->

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Is additional assessment time required?
Early or Late Transition?
• Additional assessment time will be needed
• Early transition by reassessment + limited additional assessment
time
Gradual Transition Over Assessment Cycle
• Transition over at least 2 visits
• Limited additional assessment time is required
• Probably 1 – 2+ days additional assessment per site: Dependant on
employee numbers, products, processes, activities, scope and
complexity

Note: The above is subject to confirmation of acceptance by

relevant Accreditation Bodies
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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)

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What can you do now?
1. Study the standard (Do you have a copy?)
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

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 BSI Resources

• e-Updates
• Webinars & Recordings
• White Papers
• Frequently Asked Questions
• Training

bsigroup.com/ISO13485
revision

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Questions

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Thank you

Name: Johnathon Bis

Title: VP Medical Devices Solutions Sales, BSI Group America
BSI America, 12950 Worldgate Drive, Suite 800, Herndon VA
Address: 20170
Telephone: 571-393-4337
Email: johnathon.bis@bsigroup.com
Links: www.bsigroup.com

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