ISO 13485:2016 & ISO 9001:2015 - BSI Group

ISO 13485:2016 & ISO 9001:2015Webinar 23rd March 2016Copyright 2016 BSI. All rights reserved.1

Presenters Stewart Brain Linda Moon QMS CertificationLead – MedicalDevices QMS CertificationSpecialist – MedicalDevices2

1 - ISO 13485:2003 & EN ISO 13485:20122 - ISO 9001:20153 - ISO 13485:20164 - Key Changes in High Level Structure, ISO 9001 & ISO 134855 - TimingsCopyright 2016 BSI. All rights reserved.3

ISO 13485:2003 & EN ISO 13485:2012Copyright 2016 BSI. All rights reserved.4

The previousversion of theEuropeanHarmonisedStandard Obsolete as of30 August2012EN ISO 13485:2012 InternationalStandardEN 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 &IVDD5

ExampleEN ISO 13485:2012Annex ZBRelationship between Annex IIof 93/42/EEC and clauses ofISO 134856

ISO 9001:2015Copyright 2016 BSI. All rights reserved.7

New ISO Management Systems High Level Structure New and revised ISO MS Standards now using ISOAnnex 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)principle8

NewISO 9001:201510 ClauseStructure9

Now10

ISO 13485:2016Published 26 February 2016Copyright 2016 BSI. All rights reserved.11

Areas of Increased tion,Verification &DesignTransferOutsourcedProcesses &SupplierControlFeedbackImprovedlinkage ofclauses12

ISO 13485:2016 AnnexesAnnex B Comparison of contentbetween ISO13485:2016 and ISO9001:2015 Top level clause mapping13

High level structureKey points14

High Level StructureMajor clause numbers and titlesIdentical core text and numberingschemesOrganizations implementing an integrated system (e.g. QMS,EMS, ISMS etc.) should achieve optimum benefits.The high level structure and common text is public information and can be found atwww.iso.org/directives15

Identical core text and numbering schemes1) Scope2) Normativereferences3) Terms anddefinitions4) Context of theorganization 4.1 Understanding the organization and itscontext 4.2 Understanding the needs andexpectations of interested parties 4.3 Determining the scope of the XXX MS 4.4 XXX management system16

Identical core text and numbering schemes5) Leadership6) Planning 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities andauthorities 6.1 Actions to address risks and opportunities 6.2 XXX objectives and planning to achievethem17

Identical core text and numbering schemes7) Support 7.1 Resources7.2 Competence7.3 Awareness7.4 Communication7.5 Documented information 8) Operation7.5.1 General7.5.2 Creating and updating7.5.3 Control of documented information 8.1 Operational planning and control18

Identical core text and numbering schemes9) Performanceevaluation 9.1 Monitoring, measurement, analysis andevaluation 9.2 Internal audit 9.2.1 [Internal Audits]9.2.2 [Programmes(s)] 9.3 Management review10) Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement19

ISO 9001:2015Key changes20

Representation of the structure of ISO 9001:2015 in the PDCA cycleQuality Management System (4)Organization andits context (4)Support andOperation( 7,8)DoPlanCustomerrequirementsNeeds andexpectationsof relevantinterestedparties (4)Planning (6)Leadership(5)ActPerformanceevaluation (9)CheckImprovement(10)CustomersatisfactionResults ofthe QMSProducts andservices21

ISO 9001:2015 – Key changes from 2008Some changesSpecific Greater integration with strategic direction and business processesRisk based thinkingContext of the organization must be understoodOutsourcing and purchasing is combinedA quality manual is no longer a requirement22

4 Context of the organization4.14.24.34.4Understanding the organization and its contextUnderstanding the needs and expectations of interested partiesDetermining the scope of the XXX management systemXXX management system23

5 LeadershipLeadership and commitmentPolicyOrganizational roles, responsibilitiesand authorities24

6 Planning6.1 Actions to address risks andopportunities25

6 Planning6.2 Objectives and plans to achieve them26

7 Support7.1 Resources7.2 Competence7.3 Awareness7.4 Communication27

7 Support7.5 Documented information28

8 OperationClause 8, Operation is the replacement forclause 7 from ISO 9001:2008. There aremany similarities in the 2015 version, butthere are also some important changes.Most of the clause titles have changed, butthe fundamental requirements of manyclauses have not changed29

9 Performance evaluation9 Performance and Evaluation9.1 Monitoring, measurement, analysisand evaluation9.1.1 General9.1.2 Customer satisfaction9.1.3 Analysis and evaluation9.2 Internal audit9.3 Management review30

10 Improvement10.1 Nonconformity andcorrective action10.2 Continual improvement31

Summary - Key changes ISO 9001:2015 Determining the organizational context (HLS)Greater emphasis on processesGreater alignment with strategic direction (HLS)Integration of the QMS into organization’s business processes (HLS)Determining risks/opportunities within the context (HLS)Change managementKnowledge managementCommunication expanded (HLS)Explicit performance evaluation requirements (HLS)Improvement expanded (HLS)32

Summary of Key Differences and SimilaritiesISO 9001:2015ISO 13485:2016SimilaritiesImprovementMaintain effectivenessProcess approachCustomer satisfactionMeet regulatory requirementsNo exclusions – applicabilitymanaged through scopeCan exclude from clause 7.3.Risk based thinkingQuality PolicyNo quality manual requiredNo management representativespecified – leadershipStrategic planningDocumented informationPreventive action not specificallyreferenced – risk based thinkingusedCopyright 2016 BSI. All rights reserved.Non-applicability needs to bedocumented and justified.Quality manual requiredManagement representativerequiredDocumented procedures andrecordsQuality objectivesResourcesStatutory and regulatoryrequirementsMeasurement traceabilityCompetence and awarenessPreventive action as a separateclause33

How do we manage both standards in a QMS? The higher requirement takes precedence No need to re-structure your QualityManagement System around the clausenumbers ISO 13485:2016 is meant to becompatible with the High Level Structure34

TimingsCopyright 2016 BSI. All rights reserved.35

ISO 9001:2015 Certification Transition Timeline2015September 2015ISO Publication201620172018September 2015 start of 3 years transitionperiod to September 201836

3 yeartransitionperiod nowstartedCease issue ofISO13485:2003CertificatesNOTE: Draftguidance - Nonew ISO13485:2003certificatesissued in finalyear oftransition28 February 2019BS EN ISO13485:2016publishedEuropeanHarmonization?28 February 2018ISO13485:2016publishedMarch – June 201625 February 2016ISO 13485:2016 – TimingsEnd of 3 yeartransition37

ISO 13485:2016 Transition ProcessEarly or Late Transition? Additional assessment time will be needed Early transition by reassessment limited additional assessmenttimeGradual Transition Over Assessment Cycle Transition over at least 2 visits Limited additional assessment time is required Probably 0.5 - 2 days additional assessment per site: Dependanton employee numbers, products, processes, activities, scope andcomplexityNote: The above is subject to confirmation of acceptance by relevant Accreditation Bodies38

ISO 9001:2015 Transition ProcessTimings ISO 9001:2015 was published 15 September 2015 Transition period ends 14 September 2018Transition IAF ID 9:2015 applies Where transition audits are carried out in conjunction withscheduled surveillance or recertification additional time is likely tobe required to ensure that all activities are covered for theexisting and new standards39

Global Picture ISO 13485 & ISO 9001 Revisions Europe - New MDR / IVDR MDSAP Pilot - US, Canada, Brazil,Australia Japan with Europewatching carefully Japanese Requirement (JPMD Act)40

What can you do now?1.2.3.4.5.6.7.8.Study the standardsConsider gap analysis of current QMS Vs. new requirementsPrepare initial transition plan, with timescalesFactor any additional resources & costs into budgetsReview staff awareness / knowledge and determine trainingrequiredCompile project / implementation planDiscuss top–level plan and timescales with BSI ClientManagerLook out for additional help, information and resources41

BSI Resources e-UpdatesWebinars & RecordingsWhite PapersFrequently Asked Questions- Coming /iso-9001-qualitymanagement/42

Questions43

Thank youNames:Stewart BrainLinda MoonTitles:QMS Certification LeadQMS Certification SpecialistMedical DevicesAddress:Links:BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton KeynesMK5 8PP, United e Join our New Global Medical Device LinkedIn ical-Devices44

38 ISO 13485:2016 Transition Process 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 Probab