WIXLIB

www.fasttrack365.comLaboratory Quality Management SoftwareIntegrating ISO 9001:2015 with ISO 17025As it is the customer who pays the bill, it will be the customer who decides what standard he wants to refer, it is not uncommon that laboratories areunfortunately saddled with maintaining both ISO 17025 and ISO 9001 certification. Although it is simpler to create and implement two QMS, and to"merge" those activities that can be merged, it is arduous, inefficient, and prone to mistakes. To integrate both 9001 and 17025, lab activities should beconsidered processes (with specific requirements for the methods and the management), under the new “Operations” section of ISO 9001:2015.As this is a subjective view of a new standard, I welcome feedback on this cross reference. Please send feedback to: gcarroll@fasttrackaust.comISO 9001:20154.Context of the OrganizationA risk-based approach rather thanputting risk into a separate clause.Companies are not required to do aformal risk assessment as consideringrisk becomes integral to themanagement system as a whole.Just preparing separate risk assessment documents isnot only an overhead; it does not meet thisrequirement. More over risk assessment and reviewsneed to be incorporated into existing Workflows andprocess screens. As a single integrated tool, this can besimply configured into existing screens and workflows.The introduction of a requirement tounderstand the “Context of theOrganization” as well as the expectationsof interested parties and how it impactson the objective of the system, which isto achieve customer satisfaction.This is to remove the existing “silo” method of eachdepartment carrying out its own functions. Context isabout achieving the purpose of their existence not justtheir function. Include an “Involved” list on activityscreens and set up notification rules to improvecommunication and feedback. Include a review of“Related Items” to increase the Neural Network onrecords to allow easy identification of the effect of, andon, other areas of operation.Greater integration with strategicdirection and business processesSept 2015COMMENTSISO 17025

www.fasttrack365.comincludes a strengthening of therequirements to achieve strategicalignment behind the organizationalobjectives, as well as support of theadoption of the process approach.4.1Laboratory Quality Management SoftwareSet up a register of Objectives and Obligations linked toBusiness Plans (FT’s Strategic Management module).Against each Objective & Obligation specify thestrategic & tactical risks and rate, to effect on thoseobjectives. By listing the processes under the applicableBusiness Plan you now have an integrated processapproach to achieving strategic objectives.Understanding the organization andits context4.1Organization4.2Management system4.2Understanding the needs andexpectations of interested parties4.3Determining the scope of the qualitymanagement system4.2Management system4.4Quality management system and itsprocesses4.1Organization4.2Management system5.LeadershipThe focus is on leadership rather thanmanagement. Leadership includes mostof the existing “managementresponsibility” requirements.A management representative is nolonger a specific requirement althoughcertification bodies will require anominated contact.Sept 2015Leadership is about empowering staff (see WhyCorporate Governance is broken and how to fix it). Thismeans greater decentralisation of “owner”responsibilities with management taking a moremandatory review role. Delegate in workflows, whileensuring adequate quality gates.The Quality Manager’s role is now a facilitator not anenforcer. Use the auto escalation rules and publictraffic lights to have line management responsible forquality functions. The QM’s role is to identify

www.fasttrack365.comLaboratory Quality Management Softwareopportunities for improvement, and developmanagement capabilities initially in Risk Based Thinking.5.15.1.1Leadership and commitmentLeadership and commitment for thequality management system4.1Organization4.2Management system4.15Management reviews4.1Organization4.2Management system4.15Management reviews5.1.2Customer focus4.4Review of requests, tenders and contracts5.2Quality policy4.2Management system5.3Organizational roles, responsibilitiesand authorities4.1Organization4.2Management system4.2Management system6.Planning for the qualitymanagement systemGreater emphasis on “Planning”,focusing on the identification of risks andopportunities as they impact on thescope of the system. This removes theneed for preventive action as defined inthe 2008 version, but includesstrengthened requirements for themanagement of change and riskmanagement.6.1Sept 2015Actions to address risks andopportunitiesIncorporate a Business Plan function in your system(Governance module) down to operational departmentlevels. Under each Plan list risks, opportunities andcontrols (from template libraries) and rate their effecton the plan. Link KPIs to the plan to have Traffic Lightsdisplay when risks levels are threatened (upper andlower).

www.fasttrack365.comLaboratory Quality Management Software4.9Control of nonconforming testing and/orcalibration work4.11Corrective action6.2Quality objectives and planning toachieve them4.2Management system6.3Planning of changes4.2Management system7.Support5Technical requirements5.5Equipment4.2Management system4.3Document control4.4Review of requests, tenders and contracts4.7Service to the customer4.10Improvement5.4.2Selection of methods5.4.3Laboratory developed methods4.2Management system“Support” includes most of therequirements of the previous clause 6 –Resource Management and also includesa new requirement to manage“organizational knowledge”.7.1Resources7.1.1General7.1.2Sept 2015PeopleA much under-utilised component of FastTrack is theResources module. This is a graphic drag-drop calendartool for combined schedules of people, equipment andfacilities with tasks and activity. Also link workflow“close” steps to Lessons Learnt register. These can thenbe included as a lookup on any screen field configuringthe new Eye icon against that field. This provides“organizational knowledge” at the point of processing,empowering staff to action or troubleshootimmediately.

www.fasttrack365.com7.1.3InfrastructureLaboratory Quality Management Software4.3Document control4.7Service to the customer4.10Improvement5.4.2Selection of methods5.4.3Laboratory developed methods4.1Organization4.6Purchasing services and supplies4.12Preventive action5.3Accommodation and environmentalconditions5.5Equipment5.6Measurement traceability5.6.3Reference standards and referencematerials5.8Handling of test and calibration items5.10Reporting of results7.1.4Environment for the operation ofprocesses5.3Accommodation and environmentalconditions7.1.5Monitoring and measuring resources5.4Test and calibration methods and onnel7.2Sept 2015Competence

www.fasttrack365.com7.3AwarenessLaboratory Quality Management SoftwareSenior managers need to be able to demonstrate anunderstanding of the wider business environment,social, cultural and regulatory, and how that impacts orcould impact on the organization’s ability to meetcustomer el5.5Equipment4.1Organization4.2Management systemUsing the Obligations register, schedule reportingrequirements for managers to record reviews of social,cultural and regulatory impacts.7.4Communication7.5Documented informationShift from an explicit need for traditional documentssuch as a quality manual to a broader requirement for‘documented information’.This acknowledges that the electronic workflowsembodied in modern software are a more functionalexpression of an organization’s processes than traditiondescriptive paper documents. Utilising extensive userdefinable tooltips, the online tool doubles as theprocess documentation.7.5.1General4.2Management system7.5.2Creating and updating4.3Document control4.12Preventive action4.3Document control4.12Preventive action7.5.38.Sept 2015Control of documented informationOperationTo recap Product Realisation is about the processes forplanning, and verifying the production and delivery ofoperations. The main thing here is to ensure existing

www.fasttrack365.com“Operations” replaces the previousProduct Realisation clause 7, howevercontains most of the previousrequirements. The intention is to make itmore relevant to the service sector.8.18.28.2.18.2.2Sept 2015Operational planning and controlDetermination of requirements forproducts and servicesCustomer communicationDetermination of requirementsrelated to products and servicesLaboratory Quality Management Softwaredocuments and processes reflect online systemworkflows and review the Neural Network links toensure they are comprehensively networked to aspectsof your systems.4.1Organization4.2Management system5.1General5.4Test and calibration methods and methodvalidation5.9Assuring the quality of test and calibrationresults4.4Review of requests, tenders and contracts5.10Reporting of results5.4Test and calibration methods and methodvalidation5.9Assuring the quality of test and calibrationresults4.4Review of requests, tenders and contracts4.5Subcontracting of tests and calibrations4.7Service to the customer4.8Complaints4.4Review of requests, tenders and contracts

www.fasttrack365.com8.2.38.3Laboratory Quality Management SoftwareReview of requirements related toproducts and servicesDesign and development of productsand servicesOutsourcing and purchasing is now combined.5.4Test and calibration methods and methodvalidation5.9Assuring the quality of test and calibrationresults5.10Reporting of results4.4Review of requests, tenders and contracts5.4Test and calibration methods and methodvalidation5.9Assuring the quality of test and calibrationresults5.10Reporting of results5.4Test and calibration methods and methodvalidation5.9Assuring the quality of test and calibrationresults4.6Purchasing services and supplies8.4Control of externally providedproducts and services8.4.1General4.6Purchasing services and supplies8.4.2Type and extent of control ofexternal provision4.6Purchasing services and supplies8.4.3Information for external providers4.6Purchasing services and supplies8.5Production and service provision8.5.1Control of production and serviceprovision4.2Management systemSept 2015

www.fasttrack365.comLaboratory Quality Management Software4.5Subcontracting of tests and calibrations5.1General5.2Personnel5.4Test and calibration methods and methodvalidation5.4.2Selection of methods5.5Equipment5.6Measurement traceability5.7Sampling5.8Handling of test and calibration items5.9Assuring the quality of test and calibrationresults8.5.2Identification and traceability5.8Handling of test and calibration items8.5.3Property belonging to customers orexternal providers4.1Organization5.8Handling of test and calibration items4.6Purchasing services and supplies4.12Preventive action5.8Handling of test and calibration items5.10Reporting of results5.1General5.2Personnel8.5.48.5.5Sept 2015PreservationPost-delivery activities