international std in blood banking

Overview of Roles & Functions of Quality Control Section in CTM

International Standardization in Blood BankingMs Sally LamLaboratory DirectorBlood Services GroupHealth Sciences Authority

#All Rights Reserved 2008 Health Sciences AuthorityInternational Standardization ? Products or services in a particular business or industry sector conform to an agreed standards achieved through consensus agreements between national delegations (suppliers, users and, often, governments.)agreed on specifications and criteria to be applied consistently in the classification of materials, the manufacture of products and the provision of services. International Standards provide a reference framework, or a common technological language, between suppliers and their customers

#All Rights Reserved 2008 Health Sciences AuthorityInternational Standardization : Benefits A set of standards commonly recognized & accepted world-wide World-class quality systemsIncreased business opportunities globallyIncreased productivityReduced inefficienciesQuality services and productsGained confidence from suppliers, customers & consumers

#All Rights Reserved 2008 Health Sciences AuthorityBackgroundISO ~ International Organization for Standardization Greek word isos, referred to as equal or uniformFounded in 23 Feb 1947Based in Geneva, SwitzerlandA Non-Government Organization, international standards-setting agency a network of the national standards institutes from 163 member countries

#All Rights Reserved 2008 Health Sciences AuthorityRole of ISOWorlds leading developer of international standardsSet, publish & maintain international standards for business, government & societyISO does not audit or issue certifications.a network of the national standards institutes of some 163 countries that coordinates the system and publishes the finished standards.18,000 standards produced as of Nov 2010Consist of Guidance and Conformance standards

#All Rights Reserved 2008 Health Sciences Authority

ISO member countries ~ 163/203Extracted from ISO online (Nov 2010)3 categories of membership : member bodies (green) correspondent members (black) subscriber members (red)Indonesia Badan Standardization Nasional (BSN)Singapore SPRING Singapore#All Rights Reserved 2008 Health Sciences AuthorityISO Standards : ClassificationsReference number - consists of a prefix, a serial number and the year of publication. The prefix will usually be "ISO" to indicate that the publication is an ISO International Standard.

ISO 1ISO 999 ISO 1000ISO 9999 ISO 9000 : Quality ManagementISO 10000ISO 19999 ISO 14000 : Environmental ManagementISO 15189 : Medical laboratories (Particular requirements for quality and competence)ISO 17025 : Test and calibration laboratories (General requirements for competence)ISO 2000ISO 29999 ISO 3000ISO 39999 ISO 80000#All Rights Reserved 2008 Health Sciences AuthorityISO Standards : ISO 9000International standards for good quality management practicesFirst published in 1987, developed for war industry Renamed as ISO 9000 for the civil versionIt is organization / process oriented Focus on quality management & quality assurance :Management ResponsibilitiesResource ManagementProduct RealizationMeasurement, Analysis & Improvement

#All Rights Reserved 2008 Health Sciences AuthorityISO 9000 SeriesStandardTitleEditionISO 9000:2005Quality management systems - Fundamentals and vocabulary3rdISO 9001:2008Quality management systems Requirements 4thISO 9004:2000Quality management systems Guidelines for performance improvements2nd#All Rights Reserved 2008 Health Sciences AuthorityISO 9001 : 2008a set of standardized requirements for a quality management systemIt is the only standard in the family against which organizations can be certified certification is not a compulsory requirement of the standard.a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.


Extracted from : http://www.iso.org#All Rights Reserved 2008 Health Sciences Authority

ISO Standards : ISO/IEC 17025Previously know as ISO/IEC guide 25International standards for Testing & Calibration Laboratories e.g. Standards Reference Laboratories, Chemical Metrology Laboratory, Forensic Science LaboratoryCommonalities to ISO 9000Focus on the concept of competence ~ aimed at improving the ability to consistently produce valid results Management Requirements : operation and effectiveness of the quality management system within the laboratoryTechnical Requirements : factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.

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ISO 15189 Medical LaboratoryBased on ISO 9001Quality management systems for organizationsBased on ISO/IEC 17025 Testing & calibration laboratoriesEmphasis is on technical notes relevant to medical laboratories with focus on :Pre-Analytical :provision of advice to users of the laboratory service, the collection of patient samples,Analytical :Quality controls & assurance, accuracy & reproducibility, traceabilityProvision of testing in medical emergencyTraining & competency of staffPost-Analytical :interpretation of test results, results reportingacceptable turnaround times,


ISO in Blood Banking ? #All Rights Reserved 2008 Health Sciences AuthorityBlood Transfusion Chain

Vein to - VeinSupply ChainGMPGLPGMP

ISO 9001 Integrated Quality Management System#All Rights Reserved 2008 Health Sciences Authority

#All Rights Reserved 2008 Health Sciences AuthorityCountries Quality SystemAustraliaNATA accreditationHong KongISO 9001, ISO 14001, ISO 15189IndonesiaNational systemJapanNational systemKoreaISO 9001MalaysiaNATA accreditation New ZealandNATA accreditation SingaporeAABB accreditationThailandISO 9001, ISO 15189#All Rights Reserved 2008 Health Sciences AuthorityISO 9000 GMPAABBManagement ResponsibilitiesQuality ManagementOrganizationDocumentationDocuments & RecordsResource ManagementPersonnelPersonnelPremises & EquipmentEquipmentFacilities & SafetyProduct RealizationContract Supplier IssuesProductionProcess ControlQuality ControlAssessmentsMeasurement, Analysis & ImprovementComplaints Procedure & Product Recall Incidents, Errors, AccidentsSelf-InspectionProcess Improvement#All Rights Reserved 2008 Health Sciences Authority18QUALITY MANAGEMENT SYSTEMLEADER-SHIPPERSONNELPOLICIESSTRATEGIESRESOURCESPROCESSES&SERVICESMANAGEMENTQuality Management SystemProcesses and Products/Services defined

#All Rights Reserved 2008 Health Sciences AuthorityWrite what you doDo what is written Record what you didRevise what you will doCorrective loopDocumentation Corrective Loop#All Rights Reserved 2008 Health Sciences AuthorityDocumentation provides the tools for continuous improvement.Standard operating procedures are written to identify what must be done.Perform the activity as per approved SOP (Do what is written).Once the activity has been done the activity must be recorded. Records ensure traceability of the activity.Records can be reviewed to make sure things are done correctly.If there is a need to change part of the process or activity, procedures can be revised.Thereafter do what is written according to the revised procedure.This is a corrective loop which leads to continuous improvement. ISO 9001: 2008Layers of DocumentationLevel 4 ~ Records, forms, labelsLevel 3 SOPs, EOPs, JDsLevel 2 ~ Quality processesLevel 1 ~ Quality Manual (policies)#All Rights Reserved 2008 Health Sciences AuthorityQuality system documentation is made up of four levels.These four levels are defined in the ISO standards. (These levels can be called Level 1, 2, 3, 4 ISO 9000 (1994) or Level A, B, C. ISO 10013 (1995))Discuss the levels according to ISO9000:1994.Level 1. Describes the organizations quality system making reference to the applicable standard; policies for all elements of the quality system. These policies must be in line with the quality policy, to ensure quality objectives are met.Level 2. Describes the quality activities needed to implement the quality system elements I.e. One quality activity that applies to the entire organization e.g.. how to control documentation, how to write SOPs.Level 3. SOPs or working instructions that cover various activities in various divisions (Departmental procedures). e.g.. SOP on how to perform a cross match in the blood bank.Level 4. The working documents that complement the SOP e.g. datasheets, forms, labels, reports. These types of documents are usually found as annexes to the related SOP.

Continuous Improvement

Deming CyclePlan Do Check - Act

#All Rights Reserved 2008 Health Sciences AuthorityQuality system documentation is made up of four levels.These four levels are defined in the ISO standards. (These levels can be called Level 1, 2, 3, 4 ISO 9000 (1994) or Level A, B, C. ISO 10013 (1995))Discuss the levels according to ISO9000:1994.Level 1. Describes the organizations quality system making reference to the applicable standard; policies for all elements of the quality system. These policies must be in line with the quality policy, to ensure quality objectives are met.Level 2. Describes the quality activities needed to implement the quality system elements I.e. One quality activity that applies to the entire organization e.g.. how to control documentation, how to write SOPs.Level 3. SOPs or working instructions that cover various activities in various divisions (Departmental procedures). e.g.. SOP on how to perform a cross match in the blood bank.Level 4. The working documents that complement the SOP e.g. datasheets, forms, labels, reports. These types of documents are usually found as annexes to the related SOP.

Why Go For Accreditation ?

International RecognitionBenchmarking ; A defined and systematic quality system in placedBuilding Trust Assure public, patients, hospitals and the Ministry of Health of the standard of quality of blood supply and serviceQuality Culture & ProcessesReduced wastage, Increased productivity & efficiencySafe environment for donors and staffCompetent staff & Improve morale of staff and pride in their work


Accreditation Process

#All Rights Reserved 2008 Health Sciences AuthorityWhat Next ?Get familiarized with the accreditation processInitiate application processShare plans and objectives with blood centre staff Acquire knowledge and information about accreditation requirements Conduct Gap Analysis current processes against requirementsInitiate documentation (SOPs, records, checklists)Develop schedule and timelinesGuidance from consultants

Just do it!#All Rights Reserved 2008 Health Sciences AuthorityProvide training in quality system essentials and principlesConduct audit and baseline assessmentsIdentify gaps & advise on improvements and timelinesHelp stimulate quality consciousness

External Consultation and Audit#All Rights Reserved 2008 Health Sciences AuthorityTop management supportBuy-in of all staffStaff knowledgeable and aware of quality concepts, principles and practiceReduce the fear factorBe patient it always takes longer than you expectQuality is a journey, not a destination aim for accreditation for the right reasons The Most Important Factors


#All Rights Reserved 2008 Health Sciences Authority Staff Buy-In

The Q journey begins for BSG

2006 ~ 1st AABB Accreditation Assessment


2008 ~ 2nd AABB Re-Assessment


2010 ~ 3rd AABB Re-assessment


Thank You !Extracts from ISO in Brief


international std in blood banking

Documents

iso online

iso international standard

agreed standards

set of standards

conformance standards

finished standards

national standards institutes

international organization