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ISO 13485:2016VsISO 9001:2015Ms. Khwunsuda AnuanClient manager – Regulatory Services - APAC Assessment Delivery OperationsOct 07, 2021Copyright 2020 BSI. All rights reservedCopyright 2020 BSI. All rights reserved1
Relationship betweenISO13485 andISO90012
Relationship with ISO 9001ISO 13485ISO 9001Is for organizations structured inthe same way as ISO 9001:2008Is a quality management systemappropriate for all types of organizations3
Process Model: ISO 9001:2015Quality Management SystemContext oforganization ration(7,8)Leadership(5)ActNeeds andexpectationof interestedparties (4)DoPerformanceEvaluation(9)CheckImprovement pyright 2020 BSI. All rights reserved
Process model: ISO 13485:2016Maintain effectiveness of the QMSManagementresponsibilityClause 5RegulatorsandcustomersResourcemanagementClause 6RequirementsInputQMSClause 4ProductrealizationClause 7RegulatorsandcustomersMeasurement,analysis andimprovementClause 8ProductFeedbackOutput5Copyright 2020 BSI. All rights reserved
ISO 13485 andISO 9001in detail6
Clause 1.1: Scope: GeneralISO 13485 specifies requirements for:Organizations whodesigndevelopinstallorproduceservicemedical devices7
Clause 1.1: Scope: GeneralISO 9001 specifies requirements for allbusiness to:demonstrate its ability to consistently provideproducts and services that meet customerand applicable statutory and regulatoryrequirementsCustomer satisfaction8
ISO 9001 versus ISO 13485: SummaryISO 9001ISO 134856 Documents27 DocumentsAims for customer satisfactionthrough continual improvementCustomer satisfaction and continualimprovement are not objectivesCovers all products uniformlyDifferent requirements for differenttypes of productsBasis for voluntary certificationBasis for regulatory certification9
ISO 13485Clause 4 and 5Vs ISO 900110
ISO 13485:2016: Clause 44.1.1 Quality management system: Document a QMS Maintain effectiveness Document the role(s) undertaken bythe organization under the applicableregulatory requirements4.1.2 Determine processes needed Apply processes Risk based approach Determine sequence and interactionthe processesof11
ISO 13485:2016: Clause 44.1.3 and 4.1.4For each QMS process: Determine criteria and methods - effectiveprocesses Resources and information Implement actions Monitor, measure (as appropriate) and analyse Establish and maintain records Change management12
ISO 13485:2016: Clause 44.1.5 Outsourcing: Monitor and ensure control Retain responsibility of conformity Written quality agreements4.1.5 Software applications: Document procedures for validation of the applicationof computer software used in the QMS, plus validatebefore use and after changes Risk based Maintain recordsCorrespondence with ISO 9001 Clause 4.1, 4.,2, 4.413
Clause 4.2: Documentation4.2.1 General4.2.2 Qualitymanual4.2.3 MedicalDevice File**4.2.4 Control ofdocument**4.2.5 Control ofrecord**Correspondence with ISO 9001 Clause 7.514
Clause 5: Management responsibility5.1 Management commitment5.15.2 Customer focus5.1.25.3 Quality policy5.25.4 Planning5.5 Responsibility, authorityand communication5.6 Management Review65.39.3Correspondence with ISO 900115
ISO 13485Clause 6Vs ISO 900116
ISO 13485: Clauses 6.1 and 6.26.1: Provision of resources; determine and provideresources for quality management system6.2: Human resources: Ensure personnel are competent on the basis ofappropriate education, training, skills and experience Evaluate effectiveness of training (methodologyproportionate to risk) Maintain recordsCorrespondence with ISO 9001 clause 7.1-7.417
ISO 13485: Clause 6.3 Infrastructure Prevent product mix upof ISOhandling13485 ClauseEnsure6orderly Maintenance of equipment applies to production, control ofwork environment, monitor and measurement Document intervalsResourcesCorrespondence with ISO 9001 clause 7.1.318
ISO 13485: Clause 6.4 Work environmentand contamination control6.4.1 Work environment Document requirements Competence for temporary work Reference to cleanroom standards6.4.2 Contamination control Document requirements Sterile medical devicesCorrespondence with ISO 9001 Clause 7.1.419
ISO 13485Clause 7Vs ISO 900120
ISO 13485 Clause 7 Vs ISO 9001 Clause 87.1 Planning productrealization7.2 Customer relatedprocesses7.3 Design anddevelopment8.17.4 Purchasing8.47.5 Production andservice provision8.58.28.37.6 Control of measuringand monitoring equipment 7.1.5Correspondence with ISO 900121
ISO 13485:Clause 7.1 Planning of product realization Plan processesRisk management throughout product realizationISO 14971Document process and keep recordsCorrespondence with ISO 9001 Clause 8.122
ISO 13485:Clause 7.2.1 Determination of requirements related to product Items not specified by the customer butneeded for intended use Consider user training Customer requirements (orders) includingdelivery and post-delivery activities Regulatory requirementsCorrespondence with ISO 9001 Clause 8.2.223
ISO 13485:Clause 7.2.2 Review of requirements related to the productContract review; this is to be done prior tocommitment to supply the productCorrespondence with ISO 9001 Clause 8.2.3 and 8.2.424
ISO 13485:Clause 7.2.3 CommunicationPlan and document arrangements forcommunicating with customersCorrespondence with ISO 9001 Clause 8.2.125
ISO 13485 Clause 7.3 Vs ISO 9001 Clause 8.4Design and development26
ISO 13485 Clause 7.4 Vs ISO 9001 Clause 8.47.4.1 Purchasing processCriteria for evaluation and selection of suppliers;Performance and risk; Plan monitoring and re-evaluationprocess; Additional record requirements8.4.18.4.27.4.2 Purchasing informationPurchasing specifications; Written agreements withsuppliers; Notification of changes8.4.37.4.3 Verification of purchased product8.4.18.4.28.6Verification based on risk/supplier evaluation; ChangecontrolCorrespondence with ISO 900127
ISO 13485 Clause 7.5 Vs ISO 9001 Clause 8.5Key clause for the ‘making’ of theproduct or delivery of the service28
ISO 13485 Clause 7.5 Vs ISO 9001 Clause 8.5Requirements – ISO 13485:20167.5 Production and service provision7.5.1 Control of production and serviceprovision7.5.2 Cleanliness of product.Requirements – ISO 9001:20158.5 Production and service provision8.5.1 Control of production and service provisionNo equivalent clause7.5.3 Installation activitiesNo equivalent clause7.5.4 Servicing activities7.5.5 Particular requirements for sterilemedical devices.7.5.6 Validation of processes forproduction and service provision7.5.7 Particular requirements forvalidation of processes forsterilization and sterile barriersystems.7.5.8 IdentificationNo equivalent clause7.5.9 Traceability.8.5.2 Identification and traceability7.5.10 Customer property.7.5.11 Preservation of product.No equivalent clause8.5.1 Control of production and service provisionNo equivalent clause8.5.2 Identification and traceability8.5.3 Property belonging to customers or externalproviders8.5.4 Preservation29
ISO 13485 Clause 7.6 Vs ISO 9001 Clause 7.1.5‘The organization shall determine themonitoring and measurement to be undertakenand the monitoring and measuring equipmentneeded to provide evidence of conformity ofproduct to determined requirements’.30
ISO 13485Clause 8Vs ISO 900131
ISO 13485Clause 8: Monitoring and measurementCorrespondence with ISO 9001 Clause 9 and 10.32
Additional Coursefor ISO 900133
ISO 9001: Clause 44.1Understandingtheorganizationand its contextClause 4Context of theorganization34
ISO 9001: Clause 6 Planning35
ISO 9001: Clause 6 Planning36
ISO 9001: Clause 8.5.5Property belonging to customers or external providers1549748 37
Reflective quiz? ?38
And finally.Thank you for participating.39Copyright 2020 BSI. All rights reserved
ISO 13485 Clause 7.5 Vs ISO 9001 Clause 8.5 Requirements -ISO 13485:2016 Requirements -ISO 9001:2015 7.5 Production and service provision 8.5 Production and service provision 7.5.1 Control of production and service provision 8.5.1 Control of production and service provision 7.5.2 Cleanliness of product. No equivalent clause
