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ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
ISO 15189:2007 Quality Manual
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ISO 15189:2007 Quality Manual

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A Quality Manual should not be a copy of the ISO Standards, however it shall reflects the processes implemented in your company

A Quality Manual should not be a copy of the ISO Standards, however it shall reflects the processes implemented in your company

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  • 1. QUALITY MANUALAuthor Name: Bilal Al-kadri Document Number: XXXXXXAuthor Title: QA Consultant Issue Date: Feb/2009 Name, Title Signature DateApproved By Name, Title Signature Date SOP Annual Review Version # Revision Date Description (notes) Revision [0.0] [dd/mm/yy] History Name (or location) # of copies Name (or location) # of copiesDistributedCopies to UNCONTROLLED DOCUMENT IF PRINTED
  • 2. TABLE OF CONTENTSSection Topic Page0.0 Introduction 31.0 Purpose & Scope 42.0 Quality Policy 53.0 Description of Laboratory 74.0 Terms & Definitions 85.0 Abbreviations 116.0 Management Requirements 127.0 Management Review 148.0 Staff Education & Training 159.0 Quality Assurance 1510.0 Document Control 1611.0 Records Maintenance & Archiving 1712.0 Accommodation and Environment 1713.0 Instruments 1814.0 Reagents and Consumables Management 1915.0 Selection and Validation of Examination Procedures 1916.0 Safety 2017.0 List of Examination Procedures 2118.0 Pre-Examination 2119.0 Validation of Results 2320.0 Quality Control 2321.0 Reporting of Results 2422.0 Remedial Actions & Complaints 2423.0 Communications 2524.0 Audits 2625.0 Laboratory Information Systems Management 2626.0 Ethics 2727.0 References 2728.0 Appendixes 27 UNCONTROLLED DOCUMENT IF PRINTED
  • 3. INTRODUCTIONThis Quality Manual specifies requirements and policy for Company XYZ used to addresscustomer satisfaction, to meet customer and applicable regulatory requirements and to meet ISO15189:2007 requirements.COMPANY XYZ has adopted a business process map based on quality management system andISO 9001:2000. The new process map is represented in the diagram below: ORGANISATION & MANAGEMENT RESPONSIBILITY 6.1 ORGANIZATION AND MANAGEMENT 6.2 RESPONSIBILITY & AUTHORITY 7.0 MANAGEMENT REVIEW QUALITY MANAGEMENT SYSTEM 2.0 QUALITY POLICYPLAN 8.0 STAFF EDUCATION & TRAINING ACT 10.0 DOCUMENT CONTROL 11.0 RECORDS MAINTAINING & ARCHIVINGRESOURCE MANAGEMENT EVALUATION & CONTINUAL IMPROVEMENT8.0 STAFF EDUCATION & TRAINING12.0 ACCOMMODATION AND WORK ENVIRONMENTAL 9.0 QUALITY ASSURANCE13.0 INSTRUMENTS 22.0 REMEDIAL ACTIONS & COMPLAINTS14.0 REAGENTS AND CONSUMABLE MANAGEMENTS 23.0 COMMUNICATIONS15.0 SELECTION & VALIDATION OF EXAMINATION PROCEDURES 24.0 AUDITS25.0 LABORATORY INFORMATION SYSTEMS MANAGEMENT26.0 ETHICS CHECK DO EXAMINATION PROCESSES 16.0 SAFETY USER 17.0 LIST OF EXAMINATION PROCEDURES USER 18.0 PRE EXAMINATION PROCESSES SATISFACTION 19.0 VALIDATION OF RESULTS REQUIREMENTS 20.0 QUALITY CONTROL OR 21.0 REPORTING RESULTS DISSATISFACTION INPUTS OUTPUTS = = REQUEST PROCESS REPORT UNCONTROLLED DOCUMENT IF PRINTED
  • 4. 1.0 PURPOSE & SCOPE1.1 Quality Manual:This manual describes Particular requirements for quality and competence of United Laboratories.It includes COMPANY XYZ‘s quality policy and describes how it is implemented and sustainedthroughout the organization.It is written to meet the requirements of our customers as well as applicable International andNational Standards ISO 15189:2007. The key elements of acquiring these standards aredescribed with references to key organizational policies and procedures.1.2 Purpose:To ensure product and service quality continue to meet the highest standards demanded by theorganization and expected by its customers.1.3 Scope:Provide a reliable and high quality comprehensive diagnostic solutions and laboratory services inthe field of clinical and dental laboratories. Research and development services are not applicableas supposed to the nature of services provided. This document applies to all COMPANY XYZsites including Quality System, Medical Laboratories (Central United Medical Laboratory (CUML)and International Clinic Laboratory (ICL)), Al Seef Hospital, Dental Laboratory (Central UnitedDental Laboratory (CUDL)) and any projected premises for COMPANY XYZ in the future. UNCONTROLLED DOCUMENT IF PRINTED
  • 5. 2.0 QUALITY POLICYOur company is dedicated to the Quality Policy that will ensure its products and services fullymeet and preferably exceed the requirements of its clients at all times. Our goal is to achieve thehighest level of client satisfaction. We achieve this goal by commitment to the implementation ofsupporting managerial and business operational systems.COMPANY XYZ believes in working together with clients and suppliers to achieve this policy, andin continually striving for improvements in all areas of its business.Our quality policy is based on four key principles: 1. Conformance with our clients‘ requirements at all times, ensuring that we fully identify and conform to the needs of our clients 2. Looking at our business processes, identifying the potential for errors and taking the necessary action to eliminate them 3. Ensuring that everyone in the organization understands how to do their job and does it right first time 4. All personnel are having responsibility for qualityTo ensure that the policy is successfully implemented: 1. Staff will be responsible for identifying customer requirements, and ensuring that the correct procedures are followed to meet those requirements 2. Objectives, needed to ensure that the requirements of this policy are met and continual improvement is maintained in line with the spirit of this policy, will be set, determined and monitored at Management Review. 3. Our quality policy principles and objectives will be communicated and made available to staff at all times. 4. Training will be an integral part of the strategy to achieve our objectives. 5. COMPANY XYZ will operate under the disciplines and control of Quality Management System that conforms to international standards ISO 15189:2007 and College of American Pathologists. 6. We will constantly review and improve our services to ensure tasks are completed in the most cost-effective and timely manner for benefit of all our clients. 7. We will ensure that our personnel understand and fully implement our company‘s policies and objectives and are able to perform their duties effectively through an ongoing training and development programmers. UNCONTROLLED DOCUMENT IF PRINTED
  • 6. 2.1 MISSION:To offer reliable and high-quality laboratory services to all our customers while providing the bestworking environment to our staff and assuring the highest return on investment for ourshareholders  Aid in the diagnosis, treatment, and monitoring of the health status of our patients.  Developing, sharing, and implementing disease management strategies to reduce overall costs and improve patient care.  Lowering unit costs by sharing, standardizing and integrating laboratory services.  Increasing revenues through enhanced outreach services.  Successfully competing for managed care contracts for laboratory services.2.2 VISION:To serve as a wide-reference company for Kuwait and Gulf region that provides laboratory testingand consultation in the health care sector.  Diagnostic services leadership in the Private health care of Kuwait.  A single, influential, educational laboratory with an entrepreneurial approach  High quality patient care through effective and efficient use of laboratory resources  Maximal provision of specialized and reference clinical laboratory services for the country.  Responsive to changing clinical, service, education, technological and fiscal needs  Commercialized applied research and internationally recognized expertise  Balance between generalists and specialists  Serve as a Kuwait -wide reference company for laboratory testing and consultation UNCONTROLLED DOCUMENT IF PRINTED
  • 7. 3.0 DESCRIPTION OF LABORATORYCompany XYZ (COMPANY XYZ) is a specialized company established in January 2004 to providecomprehensive diagnostic solutions and laboratory services in the medical fields such as Clinical,Dental, Animal, Environmental and food testing.COMPANY XYZ is a subsidiary of ---------------------- which is one of the leading medical groupsproviding multi-specialty healthcare services to the population of Kuwait through its specializedmedical group of companies.COMPANY XYZ has established the largest private medical laboratory in the Gulf region capableof performing comprehensive lab tests in the field of Hematology, Biochemistry, Microbiology,Hispathology, Cytology, Molecular Biology and Immunology. It‘s a sister of a group of companiesunder the umbrella ofCOMPANY XYZ manages a number of clinical laboratories located geographically in differentareas in Kuwait. It also provides comprehensive and cost effective diagnostic services whichbalance the needs of clinical programs with the resources of laboratory medicine.As a result, COMPANY XYZ provides optimal patient care in the clinical and dental fields.COMPANY XYZ became accredited by the College American of Pathologists (CAP) in 2007 (Firstin Kuwait).COMPANY XYZ became accredited under ISO 15189:2007 in 2009. UNCONTROLLED DOCUMENT IF PRINTED
  • 8. 4.0 TERMS & DEFINITIONSFor the purposes of this document the following terms and definitions shall apply:4.1 accreditationProcedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks4.2 auditSystematic, independent and documented process for obtaining audit evidence and evaluating itobjectively to determine the extent to which audit criteria are fulfilled4.3 corrective actionAction to eliminate the cause of a detected nonconformity or other undesirable situationNOTECorrective action is taken to prevent reoccurrence whereas preventative action is takento prevent occurrence4.4 efficiencyRelationship between the result achieved and the resources used4.5 environmentSurroundings in which an organization operates, including air, water, land, natural resources, flora,fauna, humans and their interrelation.4.6 environmental aspectElement of an organization‘s activities or products or services that can interact with theenvironment.4.7 environmental impactAny change to the environment, whether adverse or beneficial, wholly or partiallyresulting from an organization‘s environmental aspects.4.8 examinationSet of operations having the object of determining the value or characteristics of a propertyNOTEIn some disciplines (e.g. microbiology) examination is the total activity of a number of tests,observations or measurements4.9 laboratory directorCompetent person(s) with responsibility for, and authority over, a laboratory4.10 laboratory managementPerson who manage the activities of the laboratory headed by the laboratory director4.11 multidisciplinary laboratory UNCONTROLLED DOCUMENT IF PRINTED
  • 9. Laboratory in which two or more pathology disciplines work in an integrated manner4.12 nonconformityNonfulfilment of a requirement4.13 organisationGroup of people and facilities with an arrangement of responsibilities, authorities and relationships4.14 organisational structureArrangement of responsibilities, authorities and relationships between people4.15 post examination processPost analytical phase Processes following the examination including systematic review, formattingand interpretation, authorization for release, reporting and transmission of results and storage ofsamples of the examinations4.16 pre examination processPre analytical phase steps starting in chronological order from the clinician‘s request, includingexamination requisition, preparation of the patient, collection of the primary sample, transportationto and within the laboratory and ending when the examination procedure starts4.17 premisesPhysical environment in which an organisation carries out particular functions4.18 preventive actionsAction to eliminate cause of a potential nonconformity or other undesirable potentialsituationNOTEPreventive action is taken to prevent occurrence whereas corrective action is taken toprevent reoccurrence4.19 procedureSpecified way to carry out an activity or processNOTEWhen the term ‗procedure‘ is used in this document a written procedure is required which issubject to document control, regular review and revision.4.20 quality improvementPart of quality management focused on continually increasing effectiveness and efficiencyNOTEThe term ‗continual quality improvement‘ is used when quality improvement is progressiveand the organisation actively seeks and pursues improvement opportunities4.21 quality management systemManagement system to direct and control an organisation with regard to quality4.22 quality manualA document specifying the quality management system of an organization. UNCONTROLLED DOCUMENT IF PRINTED
  • 10. 4.23 quality objectiveSomething sought, or aimed for, related to qualityNOTEQuality objectives are generally based on the organisation‘s quality policy4.24 quality planningPart of quality management focused on setting quality objectives and specifying necessaryoperational processes and related resources to fulfill quality objectives4.25 quality policyOverall intentions and direction of an organisation related to the fulfillment of qualityrequirements as specified by laboratory managementNOTEThe quality policy should be consistent with the overall policy of the organisation andshould provide a framework for the setting of quality objectives4.26 recordDocument stating results achieved or providing evidence of activities performed4.27 referral laboratoryExternal laboratory to which a sample is submitted for supplementary or confirmatoryexamination procedure and report4.28 requirementNeed or expectation that is stated, generally implied or obligatory4.29 revisionIntroduction of all necessary changes to the substance and presentation of a document toensure its continuing suitability, adequacy, effectiveness to achieve established objectives4.30 reviewActivity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of thesubject matter to achieve established objectives4.31 userPatient, Medical doctor (Physician), clinic, or medical laboratory using the services of thelaboratory UNCONTROLLED DOCUMENT IF PRINTED
  • 11. 5.0 ABBREVIATIONSUsers of this Quality Manual shall be familiar of abbreviations found in the contents of themanual. Quality Assurance is responsible for maintaining those abbreviations.CA: Corrective actionCAP: College of American PathologistsCEO: Chief Executive OfficerDCC: Document Control CentreEQA: External Quality AssessmentHR: Human resourcesISO: International Organization for StandardizationLIMS: Laboratory Information & Management SystemMD: Medical DirectorMR: Management RepresentativeMRM: Management Review MeetingNCR: Non Conformance ReportPA: Preventive ActionPLM: Production Lab Manager (Dental)PTP: Proficiency Testing ProgramQA: Quality AssuranceQAD: Quality Assurance DepartmentQAM: Quality Assurance ManagerQC: Quality ControlQMS: Quality Management SystemSOP: Standard Operating ProcedureCOMPANY XYZ: Company XYZ UNCONTROLLED DOCUMENT IF PRINTED
  • 12. 6.0 MANAGEMENT REQUIREMENTS6.1 Organization and ManagementLaboratory Director or CEO has the responsibility and authority to ensure that all medicalservices offered in COMPANY XYZ shall meet the needs of patients and all lab staffresponsible for patient care.Laboratory Director or CEO and top management has the responsibility to ensure that thelab is designed to meet ISO 15189:2007 standards and the College of AmericanPathologists CAP requirements during testing and other routinely activities.CEO is responsible for ensuring that the Quality Policy is appropriate for the goals of thecorporation, that it promotes the continuing improvement of the effectiveness of the qualitymanagement system and that it is reviewed for continuing suitability.Laboratory management is responsible for maintaining the effectiveness, adequacy andimprovement of the QMS. This shall include the following: a. management support of all laboratory personnel by providing them with the appropriate authority and resources to carry out their duties; b. arrangements to ensure that management and personnel are free from any undue internal and external commercial, financial or other pressures and influences that may adversely affect the quality of their work; c. policies and procedures for ensuring the protection of confidential information (see Appendix A); d. policies and procedures for avoiding involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity; e. the organizational and management structure of the laboratory and its relationship to any other organization with which it may be associated; f. specified responsibilities, authority and interrelationships of all personnel; g. adequate training of all staff and supervision appropriate to their experience and level of responsibility by competent persons conversant with the purpose, procedures and assessment of results of the relevant examination procedures; h. technical management which has overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory procedures; i. appointment of a quality manager (however named) with delegated responsibility and authority to oversee compliance with the requirements of the quality management system, who shall report directly to the level of laboratory management at which decisions are made on laboratory policy and resources; j. appoint deputies for key managerial personnel (could be impractical in smaller labs) UNCONTROLLED DOCUMENT IF PRINTED
  • 13. 6.2 Responsibility & AuthorityThe CEO is appointed as the Laboratory Director.Medical Director and Technical Director each reports to the Laboratory Director.Lab Supervisor reports to both Medical & Technical Directors as necessary.The CEO has appointed the Quality Manager as the management representative who,irrespective of other responsibilities, has the responsibility and authority for: a. ensuring that processes of the quality management system are established, implemented and maintained; b. reporting to top management on the performance of the quality management system, including needs for improvement; c. acting as liaison with external customers on matters relating to the quality management system and CAP requirements.The responsibilities of personnel in the laboratory with an involvement or influence on theexamination of primary samples shall be defined in order to identify conflicts of interest.UCL had developed detailed responsibilities of all employees in the form of jobdescriptions, which are maintained by the Human Resources Department and theDocument Control Center.Supporting Procedure of this section: COMPANY XYZ Organization Chart OG01 Employee Job Descriptions Manual UNCONTROLLED DOCUMENT IF PRINTED
  • 14. 7.0 MANAGEMENT REVIEWThe CEO, Laboratory Management and Quality Manager review the lab‘s QMS and all itsmedical services by conducting management reviews meetings (MRMs) periodically inorder to ensure the effectiveness and adequacy of the QMS in support of patient care andfor continual improvement.Management review meetings shall take account of, but not be limited to: a. follow-up of previous management reviews; b. status of corrective actions taken and required preventive action; c. reports from managerial and supervisory personnel; d. the outcome of recent internal audits; e. assessment by external bodies; f. the outcome of external quality assessment and other forms of inter-laboratory comparison; g. any changes in the volume and type of work undertaken; h. feedback, including complaints and other relevant factors, from clinicians, patients and other parties; i. quality indicators for monitoring the laboratory‘s contribution to patient care; j. nonconformities; k. monitoring of turnaround time; l. results of continuous improvement processes; m. evaluation of suppliers.Findings from MRMs and the actions that arise from them shall be recorded. The Qualitymanagement shall ensure that those actions are carried out within an appropriate andagreed timescale.Supporting Procedure of this section: Management Review COMPANY XYZ/ORG001 UNCONTROLLED DOCUMENT IF PRINTED
  • 15. 8.0 STAFF EDUCATION AND TRAININGTo provide excellence in medical, dental and administration services, COMPANY XYZhave established ―United Training and Continuing Education Center‖ whose objective isprimarily promoting continuing education and new technologies to COMPANY XYZ staffand other medical and dental technologists in Kuwait and the Gulf region.It is the responsibility of the Head of the United Training and Continuing Education Centerto ensure that training plan is always in place for future development and growth atCOMPANY XYZ. Moreover department managers should:  identify competency needs for personnel performing testing activities  assign specific tasks and duties to personnel‘s experience, education, training and/or demonstrated skills and ability.  provide training or taking other actions (e.g., coaching, communication, reading) to satisfy these needs when training is required;  ensure that staff are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;  assess the effectiveness of training and take actions accordingly;  maintain appropriate records of education, training, skills and experience.Supporting Procedure of this section: Training and Competency Program Training and Development COMPANY XYZ/HR-219.0 QUALITY ASSURANCEQA represents all those planned and systematic activities implemented to provideadequate confidence that an entity will fulfill requirements for quality (ISO definition). QAhas been a key component of the QMS implemented at COMPANY XYZ‘s. The QAprogram has been established through documentation (quality manual, procedures,policies, records, etc …), training of staff, corrective actions, internal audits, control ofrecords and process control. QA is defined as a program that guarantees quality patientcare by tracking outcomes through scheduled reviews. The QA process at COMPANYXYZ can be divided into three phases; Pre-analytical (Pre-examination Procedures),analytical (examination Procedures) and post-analytical (Post-examination Procedures).Supporting Procedure of this section: Management Review COMPANY XYZ/ORG001 Error Management COMPANY XYZ/EROR001 Internal Auditing COMPANY XYZ/ASS001 UNCONTROLLED DOCUMENT IF PRINTED
  • 16. 10.0 DOCUMENT & RECORDS CONTROLThe quality manual, organizational policies, subordinate procedures, work instructions,and references are controlled documents. Changes to the quality manual require theapproval of CEO or designate. Printed copies of any documents are considereduncontrolled and shall be destroyed once retrieved.COMPANY XYZ/DOC001 had been established to illustrate how to: a. approve documents for adequacy prior to issue; b. review, update as necessary and re-approve documents; c. ensure that the changes and the current revision status of documents are identified; d. ensure that relevant versions of applicable documents are available at points of use; e. ensure that documents remain legible and readily identifiable; f. ensure that documents of external origin are identified and their distribution controlled; g. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose;The quality document pyramid at COMPANY XYZ is defined as follows: Level 1 Defines Approach & Responsibilities Quality Manual Level 2 Answers Policies How Level 3 Defines Who, What & When Departmental Procedures Level 4 Records Evidence& Proof UNCONTROLLED DOCUMENT IF PRINTED
  • 17. Records reveal that all aspects of a documented quality system are in place andadequately applied. Records are an integral part of the documented system and provideevidence to demonstrate conformance to international standards and the effectiveoperation of the quality system.Supporting Procedure of this section: Document and Record Control COMPANY XYZ/DOC00111.0 RECORDS MAINTENANCE & ARCHIVINGQA department is responsible for the implementation, the follow-up and the upkeep of thequality manual, quality procedures, working Instructions, and quality plans, etc…Documents are reviewed periodically, revised as necessary and approved by themanagement representative prior to distribution and use, have provisions forreview/approval signatures, and have a means for indicating the document revision level.Documents are numbered and assigned to an individual or area of use, and currentversions are available at locations where related activities are performed.A register is kept with DCC to indicate the document/copy number, locations of allcontrolled documents, and the current revision status of the document.The DCC alone has the authority to distribute a new version of the Quality Manual.Manager(s) or designate(s) have the responsibility of supporting quality assuranceprocedures in their respective services. Records are stored and maintained in a mannerthat is readily accessible and minimizes deterioration, damage, or loss.Supporting Procedure of this section: Document and Record Control COMPANY XYZ/DOC00112.0 ACCOMMODATION AND WORK ENVIRONMENT12.1 InfrastructureThe laboratory management determines, provides and maintains the infrastructure neededto achieve the conformity of service/product to requirements, including, as applicable: a. buildings, workspace and associated utilities; b. testing equipment, (both hardware and software); c. supporting services (such as transport and communication). d. work environment 12.2 Work EnvironmentThe Laboratory management determines and manages the work environment (e.g.,facilities and supporting items/services) and conducts audits to achieve service/product UNCONTROLLED DOCUMENT IF PRINTED
  • 18. conformity to requirements. This audit includes: (a) infrastructure, (b) health & safety, (c)housekeeping and recycling, (d) work ethics, and (e) ergonomics.Supporting Procedure of this section: Error Management COMPANY XYZ/EROR001 Document and Record Control COMPANY XYZ/DOC001 Internal Auditing COMPANY XYZ/ASS0011 3 . 0 I NSTRUMENTSCOMPANY XYZ uses the state of art equipments to meet the user‘s requirements and forpatients and staffs safety during testing activities. ―Equipment Policy‖ COMPANYXYZ/EQP001 has been established for the management and control of new and existingequipments at COMPANY XYZ. This policy and other related policies cover thefollowings: a. selection and defining intended use b. acceptance criteria, validation c. Staff training d. maintenance, service and repair e. transfer and troubleshooting f. record of instrument failure and subsequent corrective action g. planned replacement and disposal h. reporting major breakdownLab management assures that any equipment related records and forms shall bemaintained and available upon request.Note: For the purpose of ISO15189:2007, instruments, reference materials, consumables,reagents and analytical systems are included as laboratory equipment, as applicable.Supporting Procedure of this section: Equipment Policy COMPANY XYZ/EQP001 Equipment Validation Protocol COMPANY XYZ/EQP002 Equipment Trouble Shooting COMPANY XYZ/EQP003 Validation of New Storage Equipment COMPANY XYZ/EQP004 Equipment Transfer Policy COMPANY XYZ/EQP007 Change Control Policy UCL/PCN001 UNCONTROLLED DOCUMENT IF PRINTED
  • 19. 14.0 REAGENTS AND CONSUMABLES MANAGEMENTExisting policy COMPANY XYZ/SUP002 illustrate how to manage reagents and otherconsumables used during storing and testing activities. It is very crucial for labmanagement to ensure the availability of reagents, calibration and quality control materialrequired to provide and carry on services. It is the primary responsibility of purchasingdepartment to ensure that received consumables are identified, checked and storedaccording to manufacturer‘s requirements. COMPANY XYZ has a supplier managementprocess where assessment and selection of suppliers are based on in-house criteria andevaluation of suppliers and services are conducted periodically and as necessary.COMPANY XYZ/SAF explains how to dispose of consumables when required. All recordspertinent to supplies management are maintained and archived as per Document ControlCOMPANY XYZ/DOC001. Consumables in use shall be correctly identified with the dateof receipt, lot numbers, first use and expiry.Supporting Procedure of this section: Supplier Issues COMPANY XYZ/SUP001 Receipt, Inspection and Testing of Incoming Supplies COMPANY XYZ/SUP002 COMPANY XYZ Laboratory Bio-safety Manual COMPANY XYZ/SAF15.0 SELECTION AND VALIDATION OF EXAMINATION PROCEDURESThe CEO and laboratory management select and choose a new examination procedurewhich fulfill the needs and requirements for the user and the market. The selected method(s) or procedure (s) shall be within COMPANY XYZ‘s scope and method of applications.The new examination procedures shall be validated for its intended use and prior tointroduction. All pertinent records of method validation and other data as necessary (i.e.training of staff, equipment, etc…) shall be maintained for any justification in the future. AtCOMPANY XYZ, every existing examination procedure is validated and for everyexamination there should be a relevant SOP and related forms. All current examinationprocedures at COMPANY XYZ are maintained and available in English in relevantsections of the laboratory.Supporting Procedure of this section: Analytical Factors Important in Clinical laboratory COMPANY XYZ/MED012POL Change Control Policy COMPANY XYZ/PCN001 UNCONTROLLED DOCUMENT IF PRINTED
  • 20. 16.0 SAFETYThe CEO and Management Representative at COMPANY XYZ have issued and approveda safety policy to provide and maintain a safe work environment for patients, staff and/orany personnel available on the premises of COMPANY XYZ. Safety Policy statement isas follows:Company XYZ COMPANY XYZ is committed to providing safe and healthy workplaces.The WHO Guidelines and National Regulations define the essential standards for healthand safety performance for employers, employees and contractors; these standards maybe complemented by other legislation and may be exceeded by specific COMPANY XYZSafety Policies and departmental procedures for risk management and due diligence.COMPANY XYZ is committed to preventing occupational injuries and expects managersat all levels to be responsible and accountable for injury prevention. Management iscommitted to solving health and safety problems in a co-operative approach withemployees, to performing workplace inspections, monitoring on the-job safetyperformance, auditing for health and safety program success, and is committed to theprocess of continuous improvement in health and safety performance.COMPANY XYZ is committed to training and motivating employees for safety performanceand to sustaining and updating their safety knowledge. COMPANY XYZ strives tointegrate safety knowledge and/or safety performance expectations into its operations.Personal safety and responsibility shall be promoted for employees both on and off-the-joband for those who live, learn and pursue recreational activities at COMPANY XYZ.COMPANY XYZ expects that all employees shall work safely and that they shall regardsafety as a priority in all employment-related activities. Employees are expected to befamiliar with prescribed safety requirements and institutional policies pertinent to their jobs,to anticipate safety needs for every task, to report safety hazards or contravention ofprescribed requirements to their supervisors, and to constructively support employee andmanagement initiatives for improving workplace health and safety conditions.Supporting Procedure of this section: COMPANY XYZ Laboratory Bio-safety Manual COMPANY XYZ/SAF UNCONTROLLED DOCUMENT IF PRINTED
  • 21. 17.0 LIST OF EXAMINATION PROCEDURESAt COMPANY XYZ there are written and approved SOPs for the conduct of allexaminations that include and/or refer to, as applicable, the following:  purpose of examination  principle of procedure used for examinations  specimen requirements and means of identification  equipment and special supplies  reagents, standards or calibrators and internal quality control materials  relevant work instructions  limitations of the examination  recording and calculation of results  reporting reference limits  responsibilities of personnel in authorizing, reporting, and monitoring reports  hazards and safety precautions  uncertainty of measurementLaboratory management is accountable and responsible for ensuring that the contents ofexamination procedure are complete, current and have been thoroughly reviewed. AllSOPs are reviewed annually and verified by lab management.Supporting Procedure of this section: Change Control Policy COMPANY XYZ/PCN001 Analytical Factors Important in Clinical laboratory COMPANY XYZ/MED012POL Refer to Appendix E18.0 PRE-EXAMINATION 18.1 Requisition formThe request form used at COMPANY XYZ contains enough information to identify thepatient and the requestor as well as pertinent clinical data. The request form shall allowthe inclusion of the following items but not limited to: a. sufficient information to allow unique identity of the patient (ID, DOB, Sex, etc…) b. identification(s) and the location of the requesting individual c. date and time of specimen collection d. type of specimen and, where appropriate, anatomical site of origin e. date and time of receipt of samples by the laboratory f. relevant clinical information g. identification of priority status h. laboratory accession number. UNCONTROLLED DOCUMENT IF PRINTED
  • 22. Lab staffs are instructed to encourage the requestor for proper completion of the requestform to facilitate for the benefits of the patient and satisfaction of requestor.18.2 Specimen Collection and HandlingLab management at COMPANY XYZ has established specific procedure for collecting aspecimen from the patient or from the requestor. Proper preparation of the patient,specimen collection and handling are essential for the production of valid results by alaboratory.Prior to, during and after executing the medical testing of the specimen collected the labstaff shall: a. Check the completion of the request form and confirming the identity of the patient b. Verify that the specimen container is labeled correctly c. Ensure that the patient is appropriately prepared d. Ensure that the specimen is collected correctly e. Exercise precautions and awareness of risk of interchange of samples f. Ensure that environmental and storage conditions are fulfilled g. Ensure the safe disposal of all materials used in specimen collection h. Ensure that all spillages and breakages are dealt with correctlyThese procedures for specimen collection are available for the phlebotomist and all otherstaff in the hematology departments. Other policies which focus on the transportation ofspecimen with a minimum risk on the safety of courier and the receiver are available.These policies cover the followings; a) Ensuring the safety of the courier, the general public and receiving laboratory b) packaging, labeling and dispatch c) Protection of the specimens from deterioration d) Reporting incidents during transportation that may affect the quality of the specimen or the safety of personnel.At the receiving area, laboratory staff shall accept and or refuse the collected specimen asper in house procedure and criteria.Note: Phlebotomist cannot label any specimen they did not personally collect.Supporting Procedure of this section: Receiving Samples and Releasing Results Lab to Lab COMPANY XYZ/MED001POL Receiving Samples and Releasing Results COMPANY XYZ/MED003 POL Specimen Labeling Requirement COMPANY XYZ/MED004 POL Requisition Requirements COMPANY XYZ/MED005 POL UNCONTROLLED DOCUMENT IF PRINTED
  • 23. Phlebotomy Manual Rejection of Specimens COMPANY XYZ/MED008POL Transporting Specimens COMPANY XYZ/MED009POL19.0 VALIDATION OF RESULTSAll healthcare equipments at COMPANY XYZ undergo a preventive maintenance programto produce valid test results for safety and care of the patient. There are established andapproved policies which instruct lab personnel on how to report and deal with invalid testresults. In addition COMPANY XYZ All test report results shall be reviewed andvalidated by Medical director at COMPANY XYZ. Laboratory staff shall first review theresults and ensure no discrepancies or deficiencies are observed. In addition a LIMS isavailable at COMPANY XYZ to provide more sophisticated services, to reduce downtimeduring testing activities and to provide valid test results.Supporting Procedure of this section: Report Contents COMPANY XYZ/MED006POL Invalidation Test Results COMPANY XYZ/PCN00320.0 QUALITY CONTROLQC is defined as a process where known samples are tested routinely, in a systematicway, in order to confirm the reliability and precision of analytical procedures. QC can beconsidered part of the operational control of processes, being extremely useful fordetecting and correcting real and potential deviations. Areas of phlebotomy subject to QCare: Patient preparation procedures, Specimen collection procedures (Identification,puncture device, evacuated tubes, Labeling and etc…). COMPANY XYZ currentlyparticipates in inter-laboratory comparison ―proficiency testing program‖ provided by theCollege of American Pathologists in order to monitor the validity of tests and tests results.Laboratory management at COMPANY XYZ is responsible for monitoring the results ofEQA and implementing corrective actions when control criteria are not fulfilled.Supporting Procedure of this section: Proficiency Testing Program COMPANY XYZ/PCN002 Response To Unsatisfactory Proficiency Testing Program COMPANY XYZ/PCN004 Review PT Evaluation COMPANY XYZ/PCN005 Investigating PT Failure COMPANY XYZ/PCN006 Analytical Factors Important in Clinical laboratory COMPANY XYZ/MED012POL UNCONTROLLED DOCUMENT IF PRINTED
  • 24. 21.0 REPORTING OF RESULTSThe main method of communicating the results of examinations to the user of thelaboratory is through a report. The report is electronic and could be written.COMPANY XYZ have developed a typical report format which comply with the needs ofusers, clear and unambiguous and enables the user to interpret the results. The reportshall be as follows:  the laboratory name  the unique identity of the patient  requester and/or address for delivery  type of specimen, date and time of collection  Clear identification of the examination.  time and date of report  results, including reasons if no examination is performed  comments as appropriate  status of report as appropriate, eg, copy, interim or corrected  identification of the person authorizing the release of the report;  signature or authorization of the person checking or releasing the report, where possible.Authorized lab staff may release the results by telephone or email as advised by themedical director or designee. Communicating report results to the user are furtherdiscussed in relevant medical policies.Supporting Procedure of this section: Report Contents COMPANY XYZ/MED006POL Notification of Critical Values COMPANY XYZ/MED010POL Corrected Reports Corrected Report COMPANY XYZ/MED041POL Verbal Requests For Medical Testing COMPANY XYZ/MED042POL22.0 REMEDIAL ACTIONS & COMPLAINTSLaboratory management and QAD are highly committed to resolve any complaint or aproblem whether the complaint is internal or external. Once a problem occurs, labmanagement takes into consideration first to document the problem, and assign adesignate for problem solving. Problem solving will involve root cause analysis, correctiveactions and preventive actions.COMPANY XYZ/EROR001 – Error Management policy defines requirements for:  reviewing nonconformities (including customer complaints);  evaluating the need for actions to ensure that nonconformities do not recur; UNCONTROLLED DOCUMENT IF PRINTED
  • 25.  determining and implementing the corrective & preventive action(s) needed;  reviewing of corrective and preventive actions taken.  evaluating the need for action to prevent occurrence of nonconformities;Supporting Procedure of this section: Error Management COMPANY XYZ/EROR001 Internal Auditing COMPANY XYZ/ASS00123.0 COMMUNICATIONS23.1 StaffThe CEO has identified communication processes (e.g., memos, e-mail, fixed and cellphones, and employee meetings) to ensure communication is taking place regarding theeffectiveness of the quality management system. Weekly management/employeecommunication meetings cover the QMS and customer operating issues as well asimprovement opportunities. Management review meeting conducted periodically as perISO requirements and in house policies.23.2 Patients & Health ProfessionalsLab staffs at COMPANY XYZ communicate to patients face to face (verbally), customerfeedback, test reports (electronic or written), by the phone, emails, etc….23.3 SuppliersCOMPANY XYZ maintains a list of registered suppliers that supply our company withreagents, washing solution, test tubes, dental supplies, etc…Communication with thesupplier is by phone, emails, self evaluation survey, supplier evaluation, etc…23.4 Referral LaboratoriesCOMPANY XYZ maintains a list of approved referral lab (accredited), customer careservices at COMPANY XYZ communicate with referral labs through email, phone, fax, andairway services.Supporting Procedure of this section: Supplier Issues COMPANY XYZ/SUP001 Outsourcing Policy COMPANY XYZ/CC002 Report Contents COMPANY XYZ/MED006POL UNCONTROLLED DOCUMENT IF PRINTED
  • 26. 24.0 AUDITSUCL conducts internal audits to determine whether the QMS conforms to the requirementsof ISO 15189:2007 and CAP and has been effectively implemented and maintained. QAManager develops the audit plan annually, taking into consideration the status andimportance of the activities and areas to be audited as well as the results of previousaudits. The audit plan is revised after each audit and updated if needed. The audit criteria,scope, frequency and methods are defined.Audits are conducted by personnel other than those who perform the activity beingaudited. Internal Auditing Policy COMPANY XYZ/ASS001 identifies the responsibilitiesand requirements for conducting audits, recording results and reporting to management.Responsible managers take timely corrective action on deficiencies found during the audit.Follow-up actions include the verification of the implementation of corrective action, andthe reporting of verification results.Supporting Procedure of this section: Internal Auditing COMPANY XYZ/ASS00125.0 LABORATORY INFORMATION SYSTEMS MANAGEMENTLike other sophisticated medical labs, COMPANY XYZ currently uses a LIMS in allapplications in the laboratory. LIMS is very crucial to the lab where it serves as a tool fortracking all tasks related to primary samples from receiving, collecting, testing, retesting,and reporting test results. Hence COMPANY XYZ have developed a manual whichenables all lab staff to be familiar with and to ensure consistency in all tasks and validity oftest results in the lab.Supporting Procedure of this section: Laboratory Information and Management Systems Manual COMPANY XYZ/LIS26.0 ETHICSLaboratory management at COMPANY XYZ has set principles and standards by which labstaffs practice their duties and daily activities. Medical Lab and dental staff at COMPANYXYZ shall:  Maintain strict confidentiality of patient information and test results.  Be accountable for the quality and integrity of the services and tests they provide.  Exercise sound judgment in conducting, and evaluating laboratory testing.  Maintain a reputation of honesty, integrity and reliability with respect to profession. UNCONTROLLED DOCUMENT IF PRINTED
  • 27.  Establish a sound respectful relationship with health professional and colleagues.  Contribute to the general well being of the community. Administration staff shall also comply with supporting procedure of this section.Supporting Procedure of this section: Business Integrity and Ethics COMPANY XYZ/HR-2427.0 REFERENCES  College Of American Pathologists, Lab Accreditation manual, 2010 Edition  Medical laboratories — Particular requirements for quality and competence ISO 15189:2007(E)  NCCLS A Quality System Model for Health Care; Approved Guideline Vol. 19 No. 20  Quality Management Systems -- Requirements ISO 9001 Fourth edition  General requirements for the competence of testing and calibration laboratories ISO/IEC 17025:2005(E)28.0 APPENDIXES  Licensing from MOH, refer to A  Certificates & Accreditations, refer to B  COMPANY XYZ Business Process Interaction, refer to C  Confidentiality Agreement. refer to D  List of Examination Procedures, refer to E UNCONTROLLED DOCUMENT IF PRINTED

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