Management Systems toManagement Systems toDrive LaboratoryDrive LaboratoryPerformance ImprovementPerformance ImprovementPeter T. MaynardPeter T. MaynardTom A. PedersenTom A. PedersenAugust 2005August 2005

Presentation OverviewPresentation Overview

Management SystemsManagement Systems Continual Improvement CycleContinual Improvement Cycle Common ThemesCommon Themes ISO/IEC 17025:1999ISO/IEC 17025:1999 Alignment of Management SystemsAlignment of Management Systems BenefitsBenefits

What is a Management System?What is a Management System?

A set of interrelated elements used to establishA set of interrelated elements used to establishpolicy and objectives and to achieve thosepolicy and objectives and to achieve thoseobjectives.objectives.

Elements includeElements include Organizational structureOrganizational structure Planning activitiesPlanning activities ResponsibilitiesResponsibilities PracticesPractices ProceduresProcedures ProcessesProcesses ResourcesResources

ANSI/ISO/ASQ E14001-2004, 3.8 Note 1 & 2

Management System ModelsManagement System Models

QualityEnvironment

Health and Safety

ISO 14001: 2004USEPA NEIC 2001

OSHAS 18001: 1999

ANSI/AIHA Z10: 2005

ISO 9001: 2000

ISO/IEC 17025: 1999

Process ApproachProcess Approach

Processes versus ProceduresProcesses versus Procedures Identify processes needed for the ManagementIdentify processes needed for the Management

SystemSystem Demonstrate the ability of processes to achieveDemonstrate the ability of processes to achieve

planned resultsplanned results Develop information on characteristics andDevelop information on characteristics and

trends of processestrends of processes Top management reviewTop management review

Why Use a Standard or a GuideWhy Use a Standard or a Guide

Minimize re-inventing the wheelMinimize re-inventing the wheel

Capitalize on shared experiencesCapitalize on shared experiences

Improved recognitionImproved recognition

PDCA Cycle in Management SystemsPDCA Cycle in Management Systems

Plan

Do

Check

Act

Makeimprovements

What to doHow to do it

Do what wasplanned

Did thingshappenaccordingto plan?

Common Management System ThemesCommon Management System Themes

ThemeTheme

PolicyPolicy

PlanPlan

ImplementationImplementation

CheckCheck

Management ReviewManagement Review

Critical Success FactorsCritical Success Factors

Management Impetus/ AlignmentManagement Impetus/ Alignmentwith Business Strategywith Business Strategy

Needs to be done/ ProcessNeeds to be done/ ProcessApproachApproach

Awareness and TrainingAwareness and Training

Evaluation and Corrective ActionsEvaluation and Corrective Actions

Multiple perspectivesMultiple perspectives

Improvement OpportunitiesImprovement Opportunities

Continual Improvement

Policy

Planning

Implementation &Operation

Checking &

CorrectiveAction

ManagementReview

PDCA Cycle with Emphasis onPDCA Cycle with Emphasis onContinual ImprovementContinual Improvement

ISO/IEC 17025:1999ISO/IEC 17025:1999General Requirements for the CompetenceGeneral Requirements for the Competenceof Testing and Calibration Laboratoriesof Testing and Calibration Laboratories

Grew out of and replaces ISO/IEC Guide 25 and ENGrew out of and replaces ISO/IEC Guide 25 and EN4500145001

Incorporates elements of ISO 9001 relevant toIncorporates elements of ISO 9001 relevant tolaboratorieslaboratories

Clause 4 specifies MANAGEMENT REQUIREMENTSClause 4 specifies MANAGEMENT REQUIREMENTS

Clause 5 specifies TECHNICAL REQUIREMENTSClause 5 specifies TECHNICAL REQUIREMENTS

ISO/IEC 17025 Management RequirementsISO/IEC 17025 Management Requirements

4.14.1 Organization and Management Organization and Management

4.24.2 Quality Policy Quality Policy

4.34.3 Document control Document control

4.44.4 Request and tender review Request and tender review

4.54.5 Sub-contracting of tests Sub-contracting of tests

4.64.6 Purchasing services and Purchasing services andsuppliessupplies

4.7 Service to Clients4.7 Service to Clients

4.8 Complaints4.8 Complaints

4.9 Control of nonconforming work4.9 Control of nonconforming work

4.10 Corrective action4.10 Corrective action

4.11 Preventive action4.11 Preventive action

4.12 Records4.12 Records

4.13 Internal audits4.13 Internal audits

4.14 Management reviews4.14 Management reviews

ISO/IEC 17025 Technical RequirementsISO/IEC 17025 Technical Requirements5.1 General5.1 General

5.2 Personnel5.2 Personnel

5.3 Accommodation and5.3 Accommodation andenvironmental conditionsenvironmental conditions

5.4 Test and calibration5.4 Test and calibrationmethods including samplingmethods including sampling

5.5 Equipment5.5 Equipment

5.6 Measurement Traceability

5.7 Sampling

5.8 Handling andtransportation of test samples

5.9 Assuring the quality of testresults

5.10 Reporting the results

ISO/IEC 17025; 4.3 Document ControlISO/IEC 17025; 4.3 Document Control

Maintain procedures to control allMaintain procedures to control alldocuments that form part of its qualitydocuments that form part of its qualitysystem. Includessystem. Includes Regulations and normative documents asRegulations and normative documents as

well as policy statements, procedures,well as policy statements, procedures,software, drawings and planssoftware, drawings and plans

Authorization and availability of documentsAuthorization and availability of documents Unique identificationUnique identification Change managementChange management

ISO/IEC 17025;ISO/IEC 17025;5.6.3 Reference Standards and Materials5.6.3 Reference Standards and Materials

Laboratory must have a program andLaboratory must have a program andprocedure for calibration of referenceprocedure for calibration of referencestandards and materialsstandards and materials Traceable to International System of UnitsTraceable to International System of Units

(SI) or to certified reference materials(SI) or to certified reference materialsthrough an unbroken chain of calibrations orthrough an unbroken chain of calibrations orcomparisonscomparisons

Use of intermediate checks to maintainUse of intermediate checks to maintainconfidence in calibrationsconfidence in calibrations

Handling and storage shall be sufficient toHandling and storage shall be sufficient tomaintain integrity of materialsmaintain integrity of materials

National Environmental LaboratoryNational Environmental LaboratoryAccreditation Committee (NELAC)Accreditation Committee (NELAC) Established (1995) as a standards setting body,Established (1995) as a standards setting body,

supported by EPA, to support a Nationalsupported by EPA, to support a NationalEnvironmental Laboratory Accreditation ProgramEnvironmental Laboratory Accreditation Program(NELAP)(NELAP)

Foster cooperation among accreditation activitiesFoster cooperation among accreditation activitiesof different states or governmental agenciesof different states or governmental agencies

Unify state and federal standards at minimum costsUnify state and federal standards at minimum costs 2002: amended constitution to become standards2002: amended constitution to become standards

adoption bodyadoption body Requirements organized according to ISO/IECRequirements organized according to ISO/IEC

1702517025

Alignment of Management SystemsAlignment of Management Systems

Systems with similar focus; for exampleSystems with similar focus; for examplequalityquality

–– Align technical operations with otherAlign technical operations with otherbusiness unitsbusiness units

–– Take advantage of processes to achieveTake advantage of processes to achievethe same objectivethe same objective

Systems Cross Walk:Systems Cross Walk:Similar Focus - QualitySimilar Focus - Quality

5.4.145.4.144.144.145.65.6

8.5.18.5.1Management ReviewsManagement Reviews

5.5.65.5.65.65.67.5.37.5.3

7.67.6MeasurementMeasurementTraceabilityTraceability

5.5.105.5.105.105.107.5.17.5.1

7.5.47.5.4

8.2.48.2.4

Reporting ResultsReporting Results(Product Delivery)(Product Delivery)

5.4.125.4.124.124.124.2.44.2.4Control of RecordsControl of Records

5.4.2.25.4.2.24.2.24.2.24.2.14.2.1PolicyPolicy

NELACNELAC2003 2003 11

ISO/IECISO/IEC17025: 199917025: 1999

ISOISO9001:9001:20002000

11 Effective July 2005

Alignment of Management SystemsAlignment of Management Systems

Systems with similar processes acrossSystems with similar processes acrossdiffering foci; for example documentdiffering foci; for example documentcontrol for quality and environmentalcontrol for quality and environmentalmanagementmanagement

–– Align processes across business unitsAlign processes across business units

–– Take advantage of processes to achieveTake advantage of processes to achievethe same objectivethe same objective

–– Organizational synergyOrganizational synergy

–– Maximized awarenessMaximized awareness

Systems Cross Walk:Systems Cross Walk:Similar ElementsSimilar Elements

QMSQMSEMSEMS

4.34.34.4.54.4.5Document ControlDocument Control

4.144.144.64.6Management ReviewsManagement Reviews

4.124.124.5.44.5.4Control of RecordsControl of Records

4.2.24.2.24.24.2PolicyPolicy

ISO/IEC 17025:ISO/IEC 17025:19991999

ISO 14001:ISO 14001:20042004

Systems Cross-walksSystems Cross-walks

OHSOHSEMSEMS

Feedback to PlanningFeedback to Planning

Management ReviewManagement Review

6.56.5

7.17.1

4.64.6Management ReviewManagement Review

Education, Training andEducation, Training andAwarenessAwareness

5.25.24.4.24.4.2Competence, TrainingCompetence, Trainingand Awarenessand Awareness

Initial ReviewInitial Review

AssessmentAssessment

4.1.14.1.1

4.24.2

4.3.14.3.1Environmental AspectsEnvironmental Aspects

PolicyPolicy3.1.23.1.24.24.2PolicyPolicy

ANSI/AIHA Z10 ANSI/AIHA Z10 11ISO 14001:2004ISO 14001:2004

11 Draft September 2004

Management Systems:Management Systems:Benefits to be RealizedBenefits to be Realized

Work within a Recognized FrameworkWork within a Recognized Framework Provides for Systematic DevelopmentProvides for Systematic Development

Beyond Compliance - SustainabilityBeyond Compliance - Sustainability Management SupportManagement Support Participation at All LevelsParticipation at All Levels Improved RecognitionImproved Recognition

(Certification/Accreditation)(Certification/Accreditation)

Management System AlignmentManagement System AlignmentBenefitsBenefits

Align Laboratory Operations amongAlign Laboratory Operations amongBusiness OperationsBusiness Operations

Take Advantage of Prior Efforts -Take Advantage of Prior Efforts -EfficiencyEfficiency

Improved CollaborationImproved Collaboration Alignment of Processes with OverallAlignment of Processes with Overall

Business StrategyBusiness Strategy

SummarySummary

Use of ManagementUse of ManagementSystemsSystems

Common ThemesCommon Themes Continual ImprovementContinual Improvement

CycleCycle ISO 17025:1999ISO 17025:1999 Alignment of ManagementAlignment of Management

SystemsSystems BenefitsBenefits