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Achieving ISO 17025 ComplianceUsing LIMSArun ApteChief Executive Officer, CloudLIMS.com
Key Talking Points Why ISO 17025 accreditation? ISO 17025: 2017 standards and regulatoryrequirements for environmental testing laboratories Role of LIMS in ISO 17025 compliance How LIMS helps to achieve IS0 17025 compliance? Advantages gained by laboratories by using LIMS toachieve ISO 17025 Q&A
Why ISO 17025 Accreditation?It determines the technical competence of laboratoriesto perform specific types of testing, measurement andcalibrationISO 17025 Accreditation proves a laboratory has: An acceptable quality management system in place Ability and competence to provide testing andcalibration results Assures that tests are performed against theinternational standards (ISO 17025:2017) andresults are mutually acceptable between differentgovernmental and regulatory organizations
Why ISO 17025:2017 Accreditation?How does this benefit your customers? Your customers have assurance that they arechoosing a technically competent lab Your customers have more confidence in testingresults provided by your lab Your customers can avoid expensive retesting
New Edition of ISO/IEC 17025New Edition of ISO/IEC 17025:2017: Latest ChangesIn order to reflect the latest changes in marketconditions and technology, the new edition ofthe standard encompasses the activities andnew ways of working of laboratories today. Itcovers technical changes, vocabulary anddevelopments in IT techniques and takes intoconsideration the latest version of ISO 9001 onquality management.https://www.iso.org/news/ref2250.html
New Edition Changes Introduced a new chapter on risk-based thinking. Laboratorymust: consider risks associated with lab activities; plan howto address them; and evaluate the effectiveness of theseactions. Greater flexibility in the guidelines for processes, procedures,documented information, and organizational responsibilities.ISO 17025:2017 section 7.10 Non-conforming Work(previously 4.9) has been made more general. Terminology has been updated. For example, a definition for“laboratory” has been added. The scope has been revised to cover all laboratory activities.This includes testing, calibration, and the sampling associatedwith subsequent calibration and testing.
ISO 17025 Standards and Regulatory RequirementsManagement and Technical Requirements forLaboratories Performing Environmental Analysis Management RequirementsPertain to the operation and effectiveness of thequality management system within the laboratory Technical RequirementsAddress the competence of staff, sampling andtesting methodology, equipment, and the qualityand reporting of test and calibration resultsReference: ISO/IEC 17025 - General requirements for the competence of testing and calibration 424.html
Management RequirementsOrganizationWell-defined organizational structure, well-definedresponsibilities of the laboratory, the management, and keypersonnel.Document ControlEnsure that all documents related to the management systemare uniquely identified created, approved, and issued. Changesto documents should follow the same review process.Management SystemDefined policies, standard organization procedures and workinstructions to ensure the quality of test results, quality manualwith policy statements.
Management RequirementsReview of Requests, Tenders, and ContractsReview of requirements of requests, tenders and contracts toensure that the laboratory has the technical capability andresources to meet the customer request.Purchasing Services and SuppliesEnsure that services and supplies delivered by third parties donot adversely impact the quality and effectiveness of laboratoryoperations.Subcontracting of Tests and CalibrationsEnsure that tests and calibrations subcontracted to third partiesare performed according to the same quality standards.
Management RequirementsComplaintsResolution of complaints received from customers. Records ofcomplaints and all steps taken when resolving the complaintshould be maintained.Service to the CustomerClarify requests and get customer input for the request theyplaced. Collect customer feedback.Continuous ImprovementSuggestions for improvements should be taken from auditreports, analysis of data, customer complaints and suggestions,corrective and preventive actions, and management reviews.
Management RequirementsControl of Nonconforming Testing and/or Calibration WorkEnsure that nonconforming test and calibration results are adequatelyfollowed up and that corrections are initiated.Corrective and Preventive ActionCorrective actions can be triggered through nonconforming tests or otherwork, customer complaints, internal or external audits, managementreviews, and observations by staff.Procedure to identify potential sources of nonconformities and definepreventive actions to prevent occurrence of these nonconformities.
Management RequirementsControl of RecordsProcedures for identification, collection, indexing, storage, retrieval, anddisposal of records.Records should be stored such that their security, confidentiality, qualityand integrity are ensured.Management ReviewsSchedule and procedure for periodic management reviews.Internal AuditsProcedure and a schedule for internal audits. Internal audits can eithercover the whole laboratory and all elements of the quality system atone specific period of time or can be divided into several subsections.
Technical RequirementsPersonnelOnly competent personnel should perform testing and calibrationsManagement should define and maintain tasks, job descriptions, andrequired skills for each job.Accommodation and Environmental ConditionsEnvironmental conditions should not adversely affect the requiredquality of tests. Equipment should operate within the manufacturer’sspecifications for humidity and temperature.Test and Calibration Methods & Method ValidationTest methods and procedures should be used within their scope. Thelaboratory should have up-to-date instructions on the use of methodsand equipment.
Technical RequirementsEquipmentEquipment that is performing well and properly maintained is aprerequisite for the ongoing accuracy of test and calibration results.Measurement TraceabilityTraceability of equipment to the same standard is a prerequisite forcomparability of test and calibration results.SamplingEnsure that statistically relevant representative samples are taken andthat all information on the sample and the sampling procedure isrecorded and documented.
Technical RequirementsReporting of ResultsTest/calibration results should be reported in such a way that it hasclarity and accuracy, but it also has very detailed requirements on thecontents.Assuring the Quality of Test and Calibration ResultsEnsure the quality of results on an ongoing basis through, for example,regular analysis of quality control samples or participation ofproficiency-testing programs.
Role of LIMS in ISO 17025 ComplianceThere are many areas in which a LIMS supports andpromotes ISO 17025 compliance Sample handling Managing and maintaining SOPs (standard operating procedures) Managing all test methods, and all documents pertaining to quality Equipment maintenance and calibration Quality assurance of test results COAs (Certificate of Analysis), and CoCs Data integrity audits
How LIMS Helps to Achieve IS0 17025 Compliance?REVIEW OF REQUEST & CONTRACTS Review of client request Agreed statement of work to be performed Attachments as a evidence of requestTest Request
How LIMS Helps to Achieve IS0 17025 Compliance?PURCHASING SERVICES & SUPPLIES Track your inventory stocks such as standards, reagents Track your vendorsLab Supplies
How LIMS Helps to Achieve IS0 17025 Compliance?EQUIPMENT MAINTENANCE AND CALIBRATION PROGRAM Track your equipment Track equipment history Track calibration details and link to Test via equipment
How LIMS Helps to Achieve IS0 17025 Compliance?TEST DATA & COC Manage test results Manage the test COC to track the analyst performing test Validate test resultsTest Data
How LIMS Helps to Achieve IS0 17025 Compliance?INSTRUMENT INTEGRATIONIntegrate LIMS with Analytical Instruments for Seamless Data Transferand Data Integrity
How LIMS Helps to Achieve IS0 17025 Compliance?RECORDS MANAGEMENTMaintain SOP Documents Electronically
A2LA Environmental Testing AccreditationA2LA Environmental Testing Accreditation Programserves following testing bodies to meet the needs offederal and state government agencies Air Drinking water Non-potable water Solids Tissue Asbestos RadiochemistryEnvironmental Testing Environmental lead Microbiology
A2LA Environmental Testing Accreditation Program Requirements ISO/IEC 17025 general requirements for the accreditationof testing and calibration laboratories Specific program requirements for all environmentaltesting laboratories, which include industry-specificrequirements from the National EnvironmentalLaboratory Accreditation Program (NELAC) standard Optional requirements for the accreditation of field work A2LA also offers additional requirements for laboratoriesperforming tests in the field (i.e., at other than apermanent laboratory site)Reference: esting
Benefits of using LIMS to Support ISO 17025Enhance reputation, gain a competitive advantage Increased technical competency over other testing labs Enhanced the reliability and credibility of the measurement results Increased trust of customers in your labBefore LIMSAfter LIMS
Benefits of using LIMS to Support ISO 17025Improved quality and productivity Reduction in paper and manual process Management of all documents electronicallyBefore LIMSAfter LIMS
Benefits of using LIMS to Support ISO 17025Reduce operational costs Improve operational performance of the laboratory withstandardized processes using LIMS Speed up the reporting and auditing of quality controlBefore LIMSAfter LIMS
Benefits of using LIMS to Support ISO 17025Assuring strong commitment to quality, operational efficiencyand management practices, to their prospective clients ISO 17025 Certification eliminates the need for independent supplieraudits, because the quality, capability and expertise of the laboratoryhave been verified by external auditors.Before LIMSAfter LIMS
Thank Youwww.cloudlims.com 1-302-789-0447support@cloudlims.com
ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Before LIMS After LIMS Benefits of using LIMS to Support ISO 17025. Thank You www.cloudlims.com 1-302-789-0447 support@cloudlims.com. Title : PowerPoint Presentation Author: Admin Created Date: 8/10/2018 4:47 .
