Specific Detailed Changes to the New ISO 13485:2016

Specific Changes ISO 13485:2016Section 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 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.

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 organization’s 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 organization’s role

• Establish risk-‐based approach within processes—proportionate 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/records—prevention of loss

• Control of records—Changes 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 representative—removes 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 devices—document 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’


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

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.


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


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


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.


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



• 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



• 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.


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 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.)

• 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

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’)

Date post:	16-Apr-2017
Category:	Health & Medicine
Upload:	greenlightguru
View:	1,140 times
Download:	2 times

Specific Detailed Changes to the New ISO 13485:2016

Health & Medicine