Specific Changes

ISO 13485:2016
Section by section details of changes
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.
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
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 organizations role
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
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 organizations role

Establish risk-based approach within processesproportionate to the risk

Maintain control of outsourced processes

QMS software validation

Changes to QMS Documentation (4.2)

Reorganized paragraphs

Added new section to listing of device master record file content

Security of documents/recordsprevention of loss

Control of recordsChanges shall be identifiable & protection of confidential

health information
Changes to Management Responsibility

Customer focus includes regulatory requirements

Quality objectives include meeting appropriate regulatory requirements

Management representativeremoves customer requirement and note on liaison

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
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)
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
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 devicesdocument requirements to prevent contamination and maintain
cleanliness including microorganisms during assembly and packaging
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
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.

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)
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

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
Changes to Product Realization - Design & Development (cont.)

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.)

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.)

Purchasing (expanded)

Purchasing process controlsrisk 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 productrisk based

Changes to Product Realization - Design & Development (cont.)

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.)

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 recordscomplaint determination and source for improvement
Changes to Product Realization - Design & Development (cont.)

Production & Service (cont.)

Sterilizationbatch 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

Traceabilityreference to regulatory requirements

Changes to Product Realization - Design & Development (cont.)

Production & Service (cont.)

Customer Propertyremoved note on confidential health information

(added to control of records)

Preservation of productpackaging validation, record of conditions if it

impacts product, can include raw component or other assemblies.
Changes to Product Realization - Design & Development (cont.)

Monitoring & Measurement Equipment

Reference to 10012

Record adjustments

Calibration performed in accordance with planned arrangements and

documented procedures.

Validation of softwareproportionate to risk

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

Changes to Measurement, Analysis & Improvement (cont.)

Auditcalls 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
Changes to Measurement, Analysis & Improvement (cont.)

Analysis of Data
Added audits and service reports as input
Statistical techniquesapplicable methods

Improvement
GeneralEvaluate 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 Actionmatch with corrective action with add of potential (except
no review of nonconformity or undue delay)