The document outlines the detailed section-by-section changes made to ISO 13485:2016, focusing on improving quality management systems for medical device organizations. Key modifications include clarifications on regulatory requirements, risk management integration, and documentation processes, emphasizing compliance and effectiveness across design, production, and service stages. The author, Mark Swanson, leverages his expertise to support small to mid-sized companies in achieving equivalent quality standards as larger firms.

1. Specific Changes
ISO 13485:2016
Section by section details of changes

2. 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.

3. Changes to Introduction
• Explicit addition of storage and distribution, final decommissioning and disposal or
provision of “associated activities” including that it ‘may’ be used by suppliers
• Clarification of concepts
• Information on the influences on the design of the quality management system
• Relationship to ISO 9001 (both 2008 & 2015)
• Clarification that it does not include environmental, occupational, health & safety,
or financial management

4. Changes to Scope
• Scope includes organizations that have a role in one or more stages of the ‘life-­‐
cycle’
• Identification of ‘outsourced’ processes
• Maintain exclusion for design control if permitted by regulatory requirements with
new option to “not apply” requirements of clauses 6, 7, and 8 (with justification)
depending on organization’s role

5. Changes in References & Definitions
• Updated to ISO 9000:2015
• Removed: Supply Chain explanation, Active Implantable Medical Device, Active
Medical Device
• Modified: Complaint, Labelling, Implantable Medical Device, Medical Device and
Sterile Medical Device
• Added: Authorized Representative, Clinical Evaluation, Distributor, Importer, Life-­‐
cycle, Manufacturer, Medical Device Family, Performance Evaluation, Post Market
Surveillance, Product(from 9000:2005), Purchased Product, Risk, Risk Management,
Sterile Barrier System and Sterile Medical Device

6. Changes to QMS – General (Section 4/4.1)
• Re-­‐organized this entire clause
• Redefined ‘document’ to mean: Establish, implement and maintain (as well as
documenting)
• Must document organization’s role
• Establish risk-­‐based approach within processes—proportionate to the risk
• Maintain control of outsourced processes
• QMS software validation

7. Changes to QMS – Documentation (4.2)
• Reorganized paragraphs
• Added new section to listing of device master record file content
• Security of documents/records—prevention of loss
• Control of records—Changes shall be identifiable & protection of confidential
health information

8. Changes to Management Responsibility
• Customer focus includes regulatory requirements
• Quality objectives include meeting appropriate regulatory requirements
• Management representative—removes customer requirement and note on liaison

9. Changes to Management Review
• Management Review -­‐ documented procedure with documented planned interval.
• Inputs: reorganized to match changes in section 8. Removed ‘results’ and ‘status’
with intent to include more information.
• Output: Documentation of review must include the input reviewed and changes
needed to respond to new/revised regulatory requirements in addition to any
other action

10. Changes to Resource Management
• Document processes for
• Establishing competence
• Providing needed training or other actions to ‘maintain’ competency
• Ensuring awareness for personnel
• Methodology for checking effectiveness of training or other actions is
proportionate to the risk of associated work (in note)

11. Changes to Resource Management (cont.)
Infrastructure
• Document requirements when needed to achieve product requirements, prevent
mix-­‐up and ensure orderly handling of product
• Specified requirement for documenting maintenance of equipment used:
• in production
• for the control of the work environment
• monitoring and measurement

12. Changes to Resource Management (cont.)
Work Environment and contamination control
• Health, Cleanliness and clothing of personnel (Ref. to 14644 & 14698)
• Added “contamination control” to this as a new sub-­‐clause
• Provide arrangements to prevent cross-­‐contamination
• Sterile devices—document requirements to prevent contamination and maintain
cleanliness including microorganisms during assembly and packaging

13. Changes to Product Realization -­‐ Planning
• Paragraph on risk management moved up (Ref. to 14971 in note)
• Added infrastructure and work environment to item on planning of provided
resources
• Added determination of requirements related to measurement, handling, storage,
distribution and traceability to the required items

14. Changes to Product Realization -­‐ Customer Related Processes
• Applicable regulatory requirements are met.
• User training needed to ensure performance and safety of the device.
• Paragraph added on communication to regulatory authorities (planned and
documented)
• Note on inability to do formal review removed.

15. Changes to Product Realization -­‐ Design & Development
Document procedures for design and development
Planning
• Maintain (update) planning documents
• Reviews separated from verification/validation
• Add method to assure traceability (inputs/outputs) and resource planning (including
competencies)

16. Changes to Product Realization -­‐ Design & Development (cont.)
Inputs
• Add usability (ref. to IEC 62366)
• Add ‘standards’ as an input
• Risk management moved up in list
• Added processes to other requirements
• Added ‘able to be verified or validated’

17. Changes to Product Realization -­‐ Design & Development (cont.)
Outputs
• In a form suitable for verification against design & development input
• Approved prior to product release
Design and development review
• Additional detail of information required in the records

18. Verification
• Planned & documented arrangements
• Plan includes: Method, acceptance criteria and statistical technique with rationale for
sample size
• Connection to other devices
• Report includes: Results (same) and conclusions (new)
Validation
• See above
• Clinical/performance evaluation not released for use (from notes in the 2003 version).
• Use of production units (representative product)/document equivalency (rationale for
choice of product)
• Clinical evaluation or performance evaluation in accordance with regulatory
requirements.
Changes to Product Realization -­‐ Design & Development (cont.)

19. Design and Development Transfer -­‐ New section
• Document procedures
• Verify design outputs are suitable for manufacturing
• Verify production specifications can meet product requirements
Change Control
• Document procedures
• Determine significance of change to function, performance, usability, safety &
regulatory requirements
Design and Development file -­‐ New section
Changes to Product Realization -­‐ Design & Development (cont.)

20. Purchasing (expanded)
• Purchasing process controls—risk based
• Supplier evaluation & selection
• Supplier monitoring & re-­‐evaluation
• Supplier documentation
• Communication
• Purchasing information
• Addition of “requirements for qualification of supplier personnel”
• Notification of changes (written agreement)
• Verification of purchased product—risk based
Changes to Product Realization -­‐ Design & Development (cont.)

21. Production & Service
• Reworded general requirements and separated/ elevated sections to
provide for clarity and structure for auditing (MDSAP).
• Requirements for cleanliness and contamination control (separate section)
—added to list if the product cannot be cleaned.
Changes to Product Realization -­‐ Design & Development (cont.)

22. Production & Service (cont.)
• Installation
• Documented requirements for installation and verification of installation
• Servicing activities
• Providing documented procedures, materials and required measurement/
equipment for servicing
• Analysis of records—complaint determination and source for improvement
Changes to Product Realization -­‐ Design & Development (cont.)

23. Production & Service (cont.)
• Sterilization—batch records
• Validation
• Both production and service
• Proportionate to risk
• Sterile barrier systems/sterilization validation (ref. to 11607
• Identification
• Status throughout product realization
• If regulatory requirements require unique device ID
• Traceability—reference to regulatory requirements
Changes to Product Realization -­‐ Design & Development (cont.)

24. Production & Service (cont.)
• Customer Property—removed note on confidential health information
(added to control of records)
• Preservation of product—packaging validation, record of conditions if it
impacts product, can include raw component or other assemblies.
Changes to Product Realization -­‐ Design & Development (cont.)

25. Monitoring & Measurement Equipment
• Reference to 10012
• Record adjustments
• Calibration performed in accordance with planned arrangements and
documented procedures.
• Validation of software—proportionate to risk
Changes to Product Realization -­‐ Design & Development (cont.)

26. Changes to Measurement, Analysis & Improvement
Feedback
• Production & Post-­‐production
• Input to risk management with application of statistical methodology
• New section on complaint handling
• Procedure required for requirements and responsibilities
• Maintain complaint records
• Information exchange to external party
• New section on reporting to regulatory authorities

27. Changes to Measurement, Analysis & Improvement (cont.)
• Audit—calls out correction and corrective action and still includes
reference to 19011
• Control of Nonconforming Product
• Determine need for investigation
• Actions if Discovered Before Delivery
• Actions if Discovered After Delivery
• Rework
• Separate section
• Procedure required

28. Changes to Measurement, Analysis & Improvement (cont.)
• Analysis of Data
• Added audits and service reports as input
• Statistical techniques—applicable methods
• Improvement
• General—Evaluate product safety and effectiveness and use of post market
surveillance added
• Corrective Action
• ”without undue delay”
• Update of documentation
• Verify ability to meet requirements is not adversely affected
• Preventive Action—match with corrective action with add of “potential” (except
no review of nonconformity or ‘undue delay’)