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Remote Audit forMedical Devices QMS AuditKhwunsuda AnuanClient manager – Regulatory Services - APAC Assessment Delivery OperationsSeptember 24, 2021Copyright 2020 BSI. All rights reservedCopyright 2020 BSI. All rights reserved
Agenda: Remote audit under accredited rule and relevant requirement. Risk assessment to determine feasibility of remote audit Preparation for remote audit. Remote audit practicing on audit date. 2Copyright 2020 BSI. All rights reserved
Type of Audit and Remote AuditOn-site:Remote audit:An audit where all auditors are at theauditee premisesThe facilitation of assessment of aConformity Assessment Body from alocation other than that being physicallypresent. An audit performed off-site using ICT, such asmeeting platforms or limited video streaming Desktop audit: Remote audit usingdocumentation only, eg a audit of a file sent byemail Partial remote: An audit performed with amixture of remote audit and on-site.3Copyright 2020 BSI. All rights reserved
Remote audit under accredited rule and relevant requirement.IAF Informative DocumentUKAS Accredited document: IAF ID 12:2015Principles on Remote Assessment TPS 62 IAF ID 12:2015Extraordinary Events or CircumstancesAffecting ABs, CABs and CertifiedOrganizations IAF MD 4:2018Management of Extraordinary Events orCircumstances Affecting UKAS AccreditedCertification Bodies and their CertifiedOrganisations, Edition 2 August 2016) TPS 73UKAS Policy on Accreditation andConformity Assessment During the COVID19 Outbreak. Edition 1; April 2020Mandatory Document for the use ofinformation and communication technologyfor auditing/assessment purposes4Copyright 2020 BSI. All rights reserved
Remote audit under accredited rule and relevant requirement.MDR MDCG 2020-4Guidance on temporary extraordinary measures related to medical deviceNotified Body audits during COVID-19 quarantine orders and travelrestrictions MDCG 2020-17Questions and Answers related to MDCG 2020-4. Dec 20205Copyright 2020 BSI. All rights reserved
Risk assessment to determine feasibility of remote auditConsideration of risk Certification required i.e.: ISO and EN ISO 13485, MDR, MDSAP Product under certification scope and risk classification of device Audit objective i.e.: IAV, CAV, RAV, Scope extension Ability to be audited via an electronic platform and internet connection6Copyright 2020 BSI. All rights reserved
Risk assessment to determine feasibility of remote auditRisk Assessment (BSI):MediumLow Manufacturer with100% subcontractedprocessesSoftware onlymanufacturerLow risk processes e.g.Assembly of low riskdevices, Warehousingprocesses etc Site has somemanufacturingA good record ofconformity (no majorsor MDSAP gr 4-5)Devices are lowerrisk, e.g., CE Class I,Iia, IIb nonimplantable, non ClassDHigh Site has no technologybased solutions for remoteSite has noisy/challengingenvironments effect toremoteSite performs on-sitesterilization (Micro and QMSaudits) Legal manufacturer forhigh-risk device type7Copyright 2020 BSI. All rights reserved
Risk assessment to determine feasibility of remote auditExample 13485 Audit can be (BSI):LowMediumHighStage AVRemotePartialPartial8Copyright 2020 BSI. All rights reserved
Preparation for remote audit.Audit dateconfirmedAudit dateconfirmationAuditor sendaudit planConduct ICTTest ht 2020 BSI. All rights reserved
Preparation for remote audit.Audit planandplatformconfirmAudit dateconfirmationAuditor sendaudit plan MS TeamsWebExZoomLineSkypeGoogle meetOtherConduct ICTTest ght 2020 BSI. All rights reserved
Preparation for remote audit.11Copyright 2020 BSI. All rights reserved
Preparation for remote audit.Is there aneed?ConfidentialityandRegulators12Copyright 2020 BSI. All rights reserved
Preparation for remote audit.TestconnectionDocumentsharingVDO LivestreamingAudit dateconfirmationAuditor sendaudit planConduct ICTTest ght 2020 BSI. All rights reserved
Preparation for remote audit.Audit dateconfirmationAuditor sendaudit planGood connectionfor both desktop& VDO livestreaming &method ofdocumentsharingConduct ICTTest ght 2020 BSI. All rights reserved
Preparation for remote audit.Audit dateconfirmationAuditor sendaudit planConduct ICTTest ght 2020 BSI. All rights reserved
Remote audit practicing on audit date. Opening meeting via confirmed platform Audit as per audit plano Separate invitation / meeting by auditoro In case audit in operation area, may need to have earpiece. Auditor meeting Closing meeting via confirmed platformAudit step nodifference fromon-site audit16Copyright 2020 BSI. All rights reserved
Reflective quiz?Copyright 2020 BSI. All rights reserved
Remote audit: The facilitation of assessment of a Conformity Assessment Body from a location other than that being physically present. An audit performed off-site using ICT, such as meeting platforms or limited video streaming Desktop audit: Remote audit using documentation only, eg a audit of a file sent by email
