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ISO 13485 3rd EditionStewart BrainQMS Certification Lead, MedicalDevicesCopyright 2015 BSI. All rights reserved.1

1 - Current ISO 13485:2003 & EN ISO 13485:20122 - ISO 9001:20153 - ISO 13485:20164 - Key Changes in ISO 13485:20165 - Potential TimingsCopyright 2015 BSI. All rights reserved.2

ISO 13485:2003 & EN ISO 13485:2012Copyright 2015 BSI. All rights reserved.3

Copyright 2015 BSI. All rights reserved. The previousversion of theEuropeanHarmonisedStandard Obsolete as of30 August2012EN ISO 13485:2012 The currentInternationalStandardEN ISO 13485:2003ISO 13485:2003What is the difference? Changes withinForeword &Annex Zs only No change torequirements(NormativeText) Annex Z’s toprovide greaterclarity onapplicability &alignment withAIMDD, MDD &IVDD4

ExampleEN ISO 13485:2012Annex ZBRelationship betweenAnnex II of 93/42/EEC andclauses of ISO 13485Copyright 2015 BSI. All rights reserved.5

ISO 9001:2015Copyright 2015 BSI. All rights reserved.6

New ISO Management Systems High Level Structure New and revised ISO MS Standards now usingISO Annex SL: A standard for standard writers Provides a 10 clause high-level structure andcommon text Standardises terminology for fundamentalManagement System requirements Follows the Plan Do Check Act (PDCA)principleCopyright 2015 BSI. All rights reserved.7

NewISO 9001:201510 ClauseStructureCopyright 2015 BSI. All rights reserved.8

The FutureCopyright 2015 BSI. All rights reserved.9

ISO 13485:2016Based on the Final Draft International Standard (FDIS) of 29 October 2015Copyright 2015 BSI. All rights reserved.10

ISO 13485:2016 – What’s New?Copyright 2015 BSI. All rights reserved. What’s been put in? What’s come out? What’s the same?11

ISO 13485:2016 – What’s New?Copyright 2015 BSI. All rights reserved. Many additions Some new requirements Some expansion & clarification Increased clarity of interrelationshipbetween clauses and requirements12

Regulatory RequirementsISO 13485:2003FDIS ISO 13485:2016“Regulatory requirements”Appears 9 timesCopyright 2015 BSI. All rights reserved.Appears 37 times13

Objectives and ScopeISO 13485:2003ISO ate global alignmentScope & RoleOrganizationsprovide Medicaldevices andrelated servicesOrganizations can be involved in one or more stagesof the life-cycle including the design anddevelopment, production, storage and distribution,installation, or servicing of a medical device and thedesign and development or provision of associatedactivities (e.g. technical support). This InternationalStandard can also be used by suppliers or externalparties that provide product including qualitymanagement system-related services to suchorganizations.Copyright 2015 BSI. All rights reserved.14

DefinitionsClause 3Copyright 2015 BSI. All rights reserved.ISO 13485:2003ISO 13485:2015Active implantable medicaldeviceActive medical deviceAdvisory noticeCustomer complaintImplantable medical deviceLabellingMedical DeviceSterile medical deviceAdvisory noticeAuthorized representativeClinical evaluationComplaintDistributorImplantable medical deviceImporterLabellingLife cycleManufacturerMedical deviceMedical device familyPerformance evaluationPost market surveillancePurchased productRiskRisk managementSterile barrier systemSterile medical device15

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 the MDSAP program ofdetermining levels of non-conformancegrading, the clauses and sub-clauses requiredformatting* See GHTF Document SG3 N19Copyright 2015 BSI. All rights reserved.16

4 – Quality Management System4.1 - 24.1.3 - eralRequirementsDocumentationRequirements Documentrole(s)undertaken byorganizationunderregulatoryrequirements Risk basedapproach tocontrol QMSprocessesCopyright 2015 BSI. All rights reserved.Records tomeetregulatoryrequirements.Change controlFor outsourcedprocessescontrol basedon risk andability Requirementto validate thecomputersoftware usedfor QMS priorto initial use &after changesMedical DeviceFile Detailed listof items (a-f)that shall beincluded tomeetregulatoryrequirements17

5 – Management ity& Authority Regulatoryrequirements(throughout)Copyright 2015 BSI. All rights reserved.Top mgmtshallDOCUMENTtheinterrelationof nagementreviewFocus ondocumentationof the qualitymanagementsystem and theremoval ofcustomerrequirementsfrom bullet c)Proceduresrequired,documentplannedintervals More bulletpoints forinputs, newbullet foroutputs18

6 – Resource Management6.26.26.3Human resourcesHuman resourcesInfrastructure Maintaincompetency Prevent productmix up, ensureorderly handling;Maintenance ofequipment applies toproduction, controlof work env, monitorand measurement.Shall document theprocesses forestablishingcompetence,providing training,and ensuringawarenessCopyright 2015 BSI. All rights reserved. NOTEeffectivenessmethodology link torisk of work forwhich trainingprovided19

6.4 – Work environment and contamination control6.4.16.4.2Work environmentContamination controlAdditional reference - NOTEFor information see forexample ISO 14644 and ISO14698 series.For sterile medical devices, theorganization shall documentrequirements for control ofcontamination with microorganisms or particulate matterand maintain the requiredcleanliness during assembly orpackaging processes.Copyright 2015 BSI. All rights reserved.20

7 – Product Realization7.1Planning of productrealization7.2.17.2.2Determinationof productrequirementsReview ofproductrequirements Documentedprocesses for riskmanagement Required planning forverification, validation,monitoring,measurement,inspection, testactivities, handling,storage, distribution, &traceabilityCopyright 2015 BSI. All rights reserved. Any usertraining neededto ensurespecifiedperformanceand safe use ofthe product applicableregulatoryrequirementsare met any usertrainingidentified inaccordancewith 7.2.1 isavailable orplanned to beavailable ith regulatoryauthorities inaccordancewith applicableregulatoryrequirements21

7 – Product Realization (continued)7.3.2Design &developmentplanningList of items todocument: Traceabilityof outputs toinputs Competence7.3.3 - 5D & D Inputs,outputs, reviewInputs Usabilityand the ability toverify/validateOutputs Shallbe in a formsuitable forverification againstinputsCopyright 2015 BSI. All rights reserved.Review Recordrequirements7.3.6 & 77.3.6 & 7Design &developmentV/VDesign &developmentV/VRequirement todocument: theV/V plan, themethods ofV/V, criteria foracceptance,rationale forsample sizes.Connectionsand interfacesV/V of deviceinterfaces. Allvalidationactivity mustbe conductedonrepresentativeproduct ordocumentedequivalentdevices22

7 – Product Realization (continued)7.3.8Design &development transfer7.3.9Design anddevelopmentchanges7.3.10Design anddevelopment filesNew ClauseNew ClauseProcedures requiredCopyright 2015 BSI. All rights reserved.Was 7.3.7 – Includesgreater detailregarding the controlof changes, riskmanagement Shall maintain a D&Dfile for each medicaldevice type or family.This file shall include orreference recordsgenerated todemonstrate conformityto the requirements forD&D and records forD&D changes23

7 – Product Realization onVerification ofpurchased productCriteria for evaluationand selection ofsuppliers includesperformance and risk.Supplier performancemonitoring as part ofre-evaluation process Purchasinginformation toinclude, asapplicable productspecifications.Suppliers to agree toprior notification ofchanges Extent ofverification based onrisk/supplierevaluation and linkto change control7.4.1Copyright 2015 BSI. All rights reserved.24

7 – Product Realization (continued)7.5.1Control of production& service provisionProduction and serviceprovisions must bemonitored andcontrolled as well asplanned and carriedout to ensure productconforms tospecificationsCopyright 2015 BSI. All rights reserved.7.5.2Cleanliness &contaminationcontrolSimilar to 2003requirements7.5.3InstallationactivitiesSimilar to2003requirements7.5.4Servicing activitiesServicing activityrecords must beanalyzed todetermine of theissue is a complaintor must be utilizedas an improvementinput25

7 – Product Realization (continued)7.5.6Validation of processes forproduction and serviceprovision7.5.8Identification Validate processes forproduction & service provisionwhere output cannot be or isnot verified UDI where requiredby national or regionalregulations Use appropriate statisticaltechniques and rationale forsample sizes, approval ofchanges, and validation ofsoftware after any changes,risk basedCopyright 2015 BSI. All rights reserved. Requirement forprocedures forseparation of returnedproducts fromconforming product7.5.7Validation ofsterilization and sterilebarriers Documentedprocedures requiredfor validation ofsterilization andsterile barriers Validation requiredprior toimplementation Document resultsand conclusion26

7 – Product Realization (continued)7.5.9TraceabilitySimilar to n ofproductConsistent with7.5.4 of currentdocumentSpecific referenceto packaging andshippingcontainers Distribution isspecifiedCopyright 2015 BSI. All rights reserved.7.6 Control ofmonitoring andmeasuringequipmentRequirements forthe validation ofthe application ofcomputersoftware used formonitoring andmeasurementrequirements arenow within thisclause. Riskbased approachrequired.27

8 – Measurement, Analysis and Improvement8.2Monitoring and measurement8.2.2 and 8.2.3Complaint handling & Reportingto regulatory authoritiesNew Clauses Feedback procedures, inputto risk management andimprovement process. Clausestrengthened.Copyright 2015 BSI. All rights reserved.Requires procedures for timelycomplaint handling,investigation, regulatorynotification and moreProcedures for reporting toregulatory authorities regardingcomplaints are required28

8 – Measurement, Analysis and Improvement8.2.6Monitoring andmeasurement ofproduct Test equipmentshall be identifiedas appropriateCopyright 2015 BSI. All rights reserved.8.3Control of nonconforming product8.5.2 & 8.5.3Corrective & Preventiveaction NC product shall beconsidered for correctiveaction followinginvestigation (ordocumented justificationfor lack of investigation)Verifying that thecorrective orpreventive actiondoes not adverselyaffect the ability tomeet applicableregulatoryrequirements orthe safety andperformance ofproduct 8.3.1 - 4 New clausesfor nonconforming productbefore delivery, afterdelivery and rework29

Areas of Increased tsCopyright 2015 BSI. All rights reserved.Validation,Verification &DesignTransferOutsourcedProcesses &SupplierControlISO134853rdEditionImprovedlinkage ofclauses30

ISO 13485:2016 AnnexesAnnex A Comparison of content between ISO 13485:2003 and ISO 13485:2016Annex B Comparison of content between ISO 13485:2016 and ISO 9001 9001:2015European Annexes ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European Standard (EN ISO 13485:2016?)and Conformity Assessment Requirements of the respective EU MedicalDevice Directives via each conformity assessment route for each directiveCopyright 2015 BSI. All rights reserved.31

Potential TimingsCopyright 2015 BSI. All rights reserved.32

Copyright 2015 BSI. All rights reserved.No new ISO13485:2003certificates infinal year oftransitionEuropeanHarmonization?EN ISO13485:2016?Compiled Paul Sim - Issue 1 - January 2015March – June 2019If positive voteoutcomeproceeds topublicationISO13485:2016published with3 yeartransitionperiodMarch – June 2016Straight Yes /No Vote withno technicalcommentspermittedEnd of 2month voteperiodMarch 2016FDIS Publishedfor 2 monthvote under theViennaAgreement29 December 201529 October 2015EN ISO 13485:2016 – Possible TimingsEnd of 3 yeartransition33

Global Picture ISO 9001 and ISO 13485Revisions MDSAP Pilot - US, Canada, Brazil,Australia (& in 2016 Japan withEurope watching carefully) Japanese Requirement (JPMD Act) New MDR / IVDRCopyright 2015 BSI. All rights reserved.34