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ISO 13485MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS
REQUIREMENTS FOR REGULATORY PURPOSES
When Recognition Matters
WHITEPAPER
www.pecb.com
CONTENT____
Introduction
An Overview of ISO 13485:2003
Key Clauses of ISO 13485:2003 Link of ISO 13485 with other Standards
ISO 13485 opposed to ISO 9001
WhataretheBenefitsofQualityManagement?
WhyisPECBaWorthyChoice?
StepsforObtainingaPECBCertification
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ISO13485//MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS2
PRINCIPAL AUTHORSEric LACHAPELLE, PECBBesnik HUNDOZI, PECB
INTRODUCTION____
Anauditedandcertifiedmedicaldevicequalitymanagementsystemissuedbyathird-partyisoftenrequired,orstronglypreferred,byregulatoryauthoritiesinmostmajormarketssuchasEU,USA,Canada,JapanandTaiwan,formanufacturersthatwanttosellmedicaldevicesintheserespectivecountries.
ThisInternationalStandardissuitableforallsizesandtypesoforganizationsthatareinvolvedinthelifecycleofamedicaldeviceandareseekingforimprovementsonhowtheyareoperatedandmanaged.Itcanbeusedbyanorganizationforthedesignanddevelopment,production,installationandservicingofmedicaldevices,andthedesign,development,andprovisionofrelatedservices.
SincetheISO13485InternationalStandardisbasedonaprocessapproachtoqualitymanagement,apartfromestablishingaqualitymanagementsystemthatcomplieswith thestandard, it isalsoessential tocomplywithproductandservicetechnicalstandardsandregulations.
DespitethefactthatISO13485:2003isbasedontheISO9001:2000qualitymanagementstandard,itisstillastand-alonestandard.
According to the latest ISO Survey of Management System Standard Certifications, up to the end ofDecember2013,atleast25,666ISO13485:2003certificates,agrowthof15%(+3,349),hadbeenissuedin95countriesandeconomies,twolessthaninthepreviousyear.
ThetablebelowsummarizesthestatisticsoftheISO13485certificationsaroundtheworld.
Standard Number of certificates in 2013
Number of certificates in 2012 Evolution Evolution in %
ISO 13485 25,666 22,317 3,349 15%
Source:iso.org
Thus,ISO13485showsa15%incrementfromthepastyear.
ThetopthreecountriesforthetotalnumberofcertificatesissuedweretheUSA,GermanyandItaly,whilethetopthreeforgrowthinthenumberofcertificatesin2013weretheUSA,ChinaandGreece.
ISO13485MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS 3
ANOVERVIEWOFISO13485:2003____
ISO13485specifiesrequirementswhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicable to medical devices and related services.
All requirementsof ISO13485arespecifictoorganizationsprovidingmedicaldevices, regardlessofthetypeorsizeoftheorganization.
QualitystandardizationevolveswithISO13485byadding:• Greateremphasisonsettingtheobjectives,monitoringperformanceandmetrics;• Clearerexpectationsonmanagement;and• Morecarefulplanningforandpreparingtheresourcesneededforensuringquality.
What is a Quality Management System?Qualitymanagementsystemisdefinedasasetofinterrelatedorinteractingelementstoestablishpolicyandobjectivesforanorganizationandtoachievethoseobjectiveswithregardtoquality.
ISO13485APPLIESTOALLTYPESANDSIZESOFORGANIZATIONSTHATWISHTO:1.Establish,document,implement,maintainaQMSandmaintainitseffectiveness;2.Assureconformitywiththeorganization’sstatedqualitypolicy;3.Demonstrateconformitytoothers;4.Seekcertification/registrationofitsQMSbyanaccreditedthirdpartycertificationbody;or5.Makeaself-determinationandself-declarationofconformitywiththisInternationalStandard.
ISO13485//MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS4
KEYCLAUSESOFISO13485:2003____
ISO13485ISORGANIZEDINTOTHEFOLLOWINGMAINCLAUSES:Clause4:QualitymanagementsystemClause5:ManagementresponsibilityClause6:ResourcemanagementClause 7: Product realizationClause8:Measurement,analysisandimprovement
Each of these key activities is overviewed below.
CLAUSE4:QUALITYMANAGEMENTSYSTEMAnorganizationshallestablish and documenttheirqualitymanagementsystemformedicaldevices,basedontherequirementsofISO13485.
CLAUSE5:MANAGEMENTRESPONSIBILITY• Topmanagementshallsupportqualityby:• Promotingtheimportanceofquality;• Developingaqualitymanagementsystem;and• Implementingandmaintainingthequalitymanagementsystem
// There shall be focused attention on customersbyexpectingpeopleandtheorganizationtoidentifyandmeettheserequirements.
// A qualitypolicyshall be definedandmanagedbytopmanagementthrough:• Ensuringthatthequalitypolicyservestheorganization’spurposeandmeetsrequirements;and• Communicating the policy throughout the organization, and reviewing it to ensure its continued
suitability.
//Topmanagementshallperformqualityplanning by:• Formulatingqualityobjectivestoensure that theyareset forall functionalareasandorganizational
levels;and• Planning,developing,implementing,improvingandmodifyingthequalitymanagementsystem.
//Topmanagementshallcontrolthequalitymanagement system by:• Definingresponsibilitiesandauthorities;• Appointingamanagementrepresentative;and• Supportinginternalcommunications.
//Topmanagementshallcarryoutmanagementreviews by:• Reviewingthequalitymanagementsystem;• Examiningmanagementreviewinputs;and• Generatingmanagementreviewoutputs.
CLAUSE6:RESOURCEMANAGEMENTTheactionsthatshouldbetakentoassureeffectiveresourcemanagementinanorganizationareto:• Providequalityresources;• Providequalitypersonnel;• Providequalityinfrastructure;and• Providequalityenvironment.
ISO13485MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS 5
CLAUSE7:PRODUCTREALIZATIONTheprocessesinvolvedintheorganization’sproductrealizationare:• Controlrealizationplanning;• Controlcustomerprocesses;• Controlproductdesignanddevelopment;• Controlthepurchasingfunction;• Manageproductionandserviceprovision;and• Controlmonitoringdevices.
CLAUSE8:MEASUREMENT,ANALYSISANDIMPROVEMENTTheprocessesthatensuretheeffectivenessofthemeasurement,analysisandimprovementrequirementsare:• Performingimprovementprocesses;• Monitoringandmeasuringquality;• Controllingnonconformingproducts;• Analyzingqualityinformation;and• Takingrequiredimprovementactions.
LINKOFISO13485WITHOTHERSTANDARDS
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ISO 13485 is linked with several other medical device standards:
• ISO/TR14969:2004,MedicalDevices–QualityManagementSystems–Guidanceontheapplicationof ISO 13485.
Thisstandardservesasguidancefortheapplicationoftherequirementsforqualitymanagementsystemscontainedin ISO13485. Itprovidesguidanceonhowtounderstandtherequirementsof ISO13485andexplainsdifferentmethodsthatareavailableformeetingtherequirementsofISO13485.
• ISO14971:2007,MedicalDevices–Applicationofriskmanagementtomedicaldevices.
Thisstandardspecifiestherequirementsforapplicationofariskmanagementsystemformedicaldevices.Itspecifiesaprocessforamanufacturertoidentifythehazardassociatedwithmedicaldevices,includinginvitrodiagnostic(IVD)medicaldevices,toestimateandevaluatetheassociatedrisks,tocontroltheserisks,and to monitor the effectiveness of the controls.
ISO13485OPPOSEDTOISO9001____
Asmentionedabove, ISO13485 isbasedon thestructureof ISO9001,even though it isastand-alonestandard.
Despitethatbothstandardsareorganizedinthesameway,ISO13485excludesISO9001requirementsrelated to continual improvement and customer satisfaction. The reasons for this exclusion are that most medicaldeviceregulationsrequireorganizationstomaintaintheirqualitymanagementsystemsinsteadof improving them;andcommitteemembers thought that customer satisfactionwas toosubjective toindicate in ISO 13485.
ISO13485//MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS6
WHATARETHEBUSINESSBENEFITSOFQUALITYMANAGEMENT?
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Aswithallthemajorundertakingswithinanorganization,itisessentialtogainthebackingandsponsorshipoftheexecutivemanagement.Byfar,thebestwaytoachievethisistoillustratethepositivegainsofhavinganeffectivequalitymanagementprocessinplace,ratherthanhighlightthenegativeaspectsofthecontrary.
Todayaneffectivequalitymanagementsystem isnotaboutbeing forced into takingaction toaddressexternalpressures,butitsimportancereliesonrecognizingthepositivevalueofqualitymanagementwhengoodpracticeisembeddedthroughoutyourorganization.
Better understanding of the organization Regulatory compliance Cost reduction
Confidenceofclient Contract compliance Competitiveadvantage
Increasedefficiency Legalcompliance Respect of the interested parties
The adoption of an effective quality management process within an organization will have many benefits in a number of areas:• Extendedmarketaccessthroughmeetingregulatoryrequirements;• Increasedrevenuethroughmeetingcustomerrequirements;• Increasedefficiency;• Reducedcostofsales;• Improvedperformance;• Staffmotivation;• Betterdefinitionofrolesandresponsibilities;etc.
ISO13485MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS 7
WHYISPECBAWORTHYCHOICE?ImplementationofQMSwithIMS2methodology
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ConsideringthewelldocumentedbenefitsofimplementingaQualityManagementSystembasedonISO13485,makestheproposaleasiertodecideon.
Mostcompaniesnowrealizethatitisnotsufficienttoimplementageneric,“onesizefitsall”qualityplan.Foraneffectiveresponse,withrespecttomaintainingthequalitymanagementsystem,suchaplanmustbecustomizedtofittoacompany.Amoredifficulttaskisthecompilationofanimplementationplanthatbalancestherequirementsofthestandard,thebusinessneedsandthecertificationdeadline.
There isnosingleblueprintfor implementingISO13485thatwillworkforeverycompany,buttherearesomecommonstepsthatwillallowyoutobalancethefrequentconflictingrequirementsandprepareyouforasuccessfulcertificationaudit.
PECBhasdevelopedamethodology(pleaseseeexamplebelow)forimplementingamanagementsystem;the“IntegratedImplementationMethodologyforManagementSystemsandStandards(IMS2)”,andit isbasedonapplicablebestpractices.ThismethodologyisbasedontheguidelinesofISOstandardsandalsomeetstherequirementsofISO13485.
IMS2isbasedonthePDCAcycledividedintofourphases:Plan,Do,CheckandAct.Eachphasehasbetween2and8stepsforatotalof18steps. In turn, thesestepsaredivided into101activitiesandtasks.This‘PracticalGuide’considersthekeyphasesinyourimplementationprojectfromstarttofinishandsuggeststheappropriate‘bestpractice’foreachone,whiledirectingyourtofurtherhelpfulresourcesasyouembarkonyourISO13485journey.
1.1InitiatingtheQMS
1.2UnderstandingtheOrganization
4. PLAN 3. DO 2. CHECK 1. ACT
2.2DocumentManagement
3.2 Internal Audit
3.1Monitoring,Measurement,Analysis and
Evaluation
3.3ManagementReview
2.3DesignofControlsand Procedures
2.4 Communication
2.5 Awareness and Training
2.6 Product Realization
2.7 Operations Management
2.1OrganizationalStructure 4.1 Treatment of
non-conformities
4.2 Improvement
1.3 Analyze the ExistingSystem
1.4 Leadership and ProjectApproval
1.5 Scope
1.6QualityPolicy
ISO13485//MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS8
QMS Projects
Plan
Do
Check
Act
4 Phases
21 Steps
101 Activities
Undefined tasks
ISO13485MEDICALDEVICESQUALITYMANAGEMENTSYSTEMS 9
The sequence of steps can be changed (inversion, merge). For example, the implementation of themanagement procedure for documented information can be done before the understanding of theorganization.Manyprocessesareiterativebecauseoftheneedforprogressivedevelopmentthroughouttheimplementationproject;forexample,communicationandtraining.
Byfollowingastructuredandeffectivemethodology,anorganizationcanbesure itcoversallminimumrequirements for the implementation of a management system. Whatever methodology used, theorganizationmustadaptittoitsparticularcontext(requirements,sizeoftheorganization,scope,objectives, etc...)andnotapplyitlikeacookbook.
STEPSFOROBTAININGAPECBCERTIFICATION
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For organizations: For individuals:
1.Implementthemanagementsystem 1.Participateinthetrainingcourse
2. Perform internal audit and reviews 2.Registerforthecertificationexam
3.Selectpreferredcertificationbody 3.Sitforthecertificationexam
4.Performapre-assessmentaudit(optional) 4.Applyforthecertificationschemeuponsuccessful completion
5.Performthestage1audit 5.Obtaincertification
6.Performthestage2audit(on-site)
7.Performafollow-upaudit(optional)
8.Registerthecertification
9.Assurecontinualimprovementbyconductingsurveillance audits
ForfurtherdetailsrelatingthetypesoftrainingsandcertificationsthatPECBoffers,pleasevisitourwebsite:www.pecb.com
