LAB1604 Laboratory Quality Management System (ISO 17025:2005): SOP, Accreditation, Documentation and Auditing

Transcription

1 LAB1604 Labratry Quality Management System (ISO 17025:2005): SOP, Accreditatin, Dcumentatin and Auditing H.H. Sheikh Sultan Twer (0) Flr Crniche Street Abu Dhabi U.A.E

2 Curse Intrductin: Analytical chemistry is experiencing dramatic, turbulent change beynd cntrl f the labratry and labratry management. Technlgical innvatins, staffing demgraphics, new business mdels, autmatin, industry cnslidatin, sciety and regulatry expectatins, and ther factrs are transfrming nearly aspect f the business. This curse is cmprehensive lk at the latest revisin f the ISO and its dcumentatin and internal auditing requirements. Yu will gain critical insight n the interpretatin f the requirements f this labratry standard and yu will als receive a detailed review f the accreditatin prcess. Yu will learn hw t design and develp labratry dcuments and quality manuals. The quality manual will be examined as t its impact n labratry peratins and what purpse it serves. Yu will learn what infrmatin it shuld cntain, what writing style is mst effective and hw t keep yur dcuments and quality manual up t date. This curse als gives attendees the knwledge needed t establish an internal quality audit prgram as required by ISO 17025, and t initiate the sequence f activities invlved in scheduling, planning cnducting, reprting n and clsing ut internal quality audits. Participants will be able t emply effective techniques f auditing and the ability t develp the auditing prcedures, scheduling and recrding systems needed t sustain the prgram. Attendees will receive practical instructins n the develpment, implementatin and lng-term maintenance f an effective labratry quality system. This curse takes a strategic view f the labratry system in the cntext f current quality management philsphies t determine ptins fr achieving best practices. Experiences will be shared t prvide insight int the bstacles and expected utcmes fr the varius appraches. Further this wrkshp includes the missin and functin f the analytical enterprise alng with ways t imprve the quality, perfrmance and evaluatin f the labratry. Curse Objectives: Upn successful cmpletin f this curse, the delegates will be able t: Apply prper techniques in labratry quality management and its standard peratinal prcedures, accreditatin, dcumentatin and auditing in accrdance with the ISO Design and develp labratry dcuments (SOP) & quality manuals and recgnize the infrmatin they shuld cntain, emply an effective writing style as well as maintain dcuments and quality manuals up t date Emply effective techniques f auditing and develp auditing prcedures, scheduling and recrding systems needed t sustain and auditing prgram. LAB1604 REV. 001 PAGE 2 OF 6

3 Recgnize the requirements f an ISO accreditatin and review the accreditatin prcess Carryut an internal quality audit prgram in accrdance with ISO as well as initiate the sequence f activities invlved in scheduling, planning, cnducting, reprting n and clsing ut internal quality audits Develp, implement and maintain a lng term effective labratry quality system in the lng run in cmpliance with the requirements f ISO Learn hw labratries are applying current management philsphies t get clser t the business and t streamline peratins accrding t the ISO 17025:2005; SOP, accreditatin, dcumentatin and auditing. Practical details f labratry management such as cst cntrl, maintaining analysis quality, imprving labratry reputatin, effective staffing, capital budget justificatin, and s frth will be discussed but the emphasis will be n systems rather than daily peratinal issues. Participants are expected t share experiences and best practices. Wh Shuld Attend? This curse prvides an verview f all significant aspects and cnsideratins f labratry quality management in accrdance with the internatinal standards fr thse wh are invlved in the labratry accreditatin, dcumentatin and auditing. This includes labratry managers, superintendents, supervisrs, scientists, chemists, analysts and ther lab technical staff. Further, the curse will be f great value fr quality managers, quality engineers, quality auditrs and management representatives. Curse Outline: Day 1: Quality Management Scpe and Benefits Accreditatin Labratry Risk Management Labratry Waste Management Dealing with chemical Spillage Quality cntrl aim and definitin Types f errrs Labratry quality Management Technical requirements fr Gd lab Management reference t ISO Persnnel Accmmdatin And Envirnmental Cnditins Calibratin Methds And Methd Validatin LAB1604 REV. 001 PAGE 3 OF 6

4 Equipment Measurement Traceability Sampling Handling Of Test And Calibratin Items Assuring The Quality Of Calibratin Results Reprting The Results Day 2: Labratry Business activity Visin and Missin Management and Leadership, Team Building, Negtiatin and decisin making Develping emplyees Labratry Human resurce Management: rganizatin, hiring, training and persnnel appraisal Labratry Financial Management: capital and perating budget Labratry Prcurement Management Day 3: Labratry safety Management Labratry Safety check List Fume hd mnitring Day 4: Management Requirements fr Gd Labratry Management Reference ISO/EC 17025:2005 Organizatin Quality system Dcument cntrl Review f requests, tenders and cntracts Subcntracting f tests Purchasing services and supplies Service t the client Cmplaints Cntrl f nncnfrming testing wrk Crrective actin Preventive actin Cntrl f recrds Internal audits Management reviews Internal Quality auditing LAB1604 REV. 001 PAGE 4 OF 6

5 Day 5: Prficiency Test Definitin and Benefits Statistical Cncept Z- scre definitin and calculatin Statistical prcess Cntrl Dcumentatin Curse Requirement: Hand s n practical sessins, equipment and sftware will be applied during the curse if required and as per the client s request. Curse Certificate: Internatinal Center fr Training & Develpment (ICTD) will award an internatinally recgnized certificate(s) fr each delegate n cmpletin f training. Curse Fees: T be advised as per the curse lcatin. This rate includes participant s manual, hand-uts, buffet lunch, cffee/tea n arrival, mrning & afternn f each day. Curse Methdlgy: A variety f methdlgies will be used during the curse that includes: (30%) Based n Case Studies (30%) Techniques (30%) Rle Play (10%) Cncepts Pre-test and Pst-test Variety f Learning Methds Lectures Case Studies and Self Questinaires Grup Wrk Discussin Presentatin LAB1604 REV. 001 PAGE 5 OF 6

6 Curse Timings: Daily Curse Timings: 08:00-08:20 Mrning Cffee/Tea 08:20-10:00 First Sessin 10:00-10:20 Cffee/Tea/Snacks 10:20-12:20 Secnd Sessin 12:20-13:30 Prayer & Lunch 13:30-15:00 Last Sessin LAB1604 REV. 001 PAGE 6 OF 6