LAB LOGO & NAME              Document No.:   Issue No.: 0.1                             WPMEL-LAB.QM    Issue Date: 5 May ...
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LAB LOGO & NAME               Document No.:   Issue No.: 0.1                              WPMEL-LAB.QM    Issue Date: 5 Ma...
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QM17025+Rev0.1-05May2011.doc

  1. 1. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 1 of 27 Water Pollution & Marine Environment Lab – Institute of Graduate Studies & Researches Manual of Quality Policies
  2. 2. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 2 of 27Table of ContentsSection Topic Page1. Introduction -------------------------------- 32. Controlled distribution of the QM -------------------------------- 33. Quality Policy Statement -------------------------------- 34. Management Requirements -------------------------------- 34.1 Organization -------------------------------- 34.2 Management System -------------------------------- 54.3 Document Control -------------------------------- 84.4 Review of Requests, Tenders and Contracts -------------------------------- 94.5 Subcontracting of Tests -------------------------------- 104.6 Purchasing Services and Supplies -------------------------------- 114.7 Service to the Customer -------------------------------- 114.8 Complaints -------------------------------- 124.9 Control of Non-conforming Work -------------------------------- 124.10 Improvement -------------------------------- 134.11 Corrective Action -------------------------------- 134.12 Preventive Action -------------------------------- 144.13 Control of Records -------------------------------- 144.14 Internal Audits -------------------------------- 154.15 Management Reviews -------------------------------- 165.0 Technical Requirements -------------------------------- 165.1 General -------------------------------- 165.2 Personnel -------------------------------- 175.3 Accommodation and Environmental Conditions -------------------------------- 185.4 Test Methods and Method Validation -------------------------------- 195.5 Equipment -------------------------------- 225.6 Measurement Traceability -------------------------------- 245.7 Sampling Operations -------------------------------- 265.8 Handling of Samples -------------------------------- 275.9 Assuring the Quality of Test Results -------------------------------- 285.10 Reporting the Results -------------------------------- 28
  3. 3. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 3 of 27Introduction.1This Water Pollution and Marine Environmental Laboratory Quality Manual has beenprepared to meet the requirements for laboratory accreditation of the InternationalOrganization for Standardization/International Electro-technical Commission (ISO/IEC)17025 (2005). It has been formatted using clause numbers from ISO/IEC 17025 to provideease in review. Controlled Distribution of the Quality Manual.2The Quality Manager (QM) is responsible for maintaining the official master soft and hardcopy of this quality manual.Quality Policy Statement .3Water Pollution and Marine Environmental Laboratory is committed to laboratoryaccreditation according to the requirements of ISO/IEC 17025. This commitment is evident .by the approval signatures for this manualThe quality policy statement is stated in this QM, Subsection 4.2.2Management Requirements .4Organization 4.1Water Pollution and Marine Environmental Laboratory is a government laboratory 4.1.1under Institute of Graduate Studies & Researches – Alexandria University. The laboratoryis required to follow the Ministerial Decree No. #. The laboratory provides its services as asecond party laboratory in the field of environmental testing, particularly chemical and.microbiological analysis of water and wastewaterThe intent of Water Pollution and Marine Environmental Laboratory Top 4.1.2:Management is to operate the laboratory according to the following requirements ;ISO/IEC 17025• Customer contracts; and• .Laws and Regulations•The management system outlined in this quality manual covers the work carried out 4.1.3in Water Pollution and Marine Environmental Laboratory permanent facilities at the:following addressWater Pollution and Marine Environmental Laboratory136 Hirreya Avenue,Alexandria,Egypt
  4. 4. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 4 of 27Water Pollution and Marine Environmental Laboratory organization chart is 4.1.4:indicated below Water Pollution and Marine Environmental Laboratory Organization Chart Laboratory Director (Dean of Institute) Laboratory Executive Manager Quality Manager Technical Manager Technical Manager Chemistry Laboratory Microbiology LaboratoryResponsibility of the Laboratory Director as the Dean of the Institute of Graduate Studiesand Researches – Alexandria University4.1.5a. The laboratory Top Management delegate full authorities to the lab Quality Manager,and Technical manager to discharge their duties as reflected in the prepared jobdescriptions. This authority delegation includes the implementation, maintenance, andimprovement of the management system. The resources needed to discharge these dutiesare identified in Section 5.2 through Section 5.6 in this manual.b. Management applies restrict arrangements to ensure that the laboratory personnel arefree from any undue internal and external pressure. Therefore, the laboratory pursues aneffective communication system between the laboratory management and the staff givingsufficient attention to internal complaints or concerns from employees aiming at avoidingany internal undue pressure. Also, precautions are taken to ensure that the lab staff is:always free from external undue pressure. These precautions include
  5. 5. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 5 of 27 The lab staff does not deal directly with the lab customers e.g. samples are.1 received and reports are delivered to the customers in specially designated .area .Sample information is hidden from the lab staff during testing processes.2c. The lab ensures the protection of customers’ confidential information and proprietary:rights at all times through Dealing with customers’ confidential information is restricted to the reports.1 .issuing and approval authorities Test results are submitted either manually or electronically to the customer.2 .according to the contact information identified within the test request form Lab computer facilities that contain customer related information are access-.3 .controlled for further protection The lab is not allowed to use the customers’ confidential information without.4 .prior consent of the customers to protect the customers’ proprietary rightsd. To avoid involvement in any activities that would diminish confidence in the labcompetence, impartiality, judgment or operational integrity employees are familiar withand observe Code of Ethics. The following core concepts are embodied in this code of :ethics ,Employees shall not use public office for private gain.1 Employees shall act impartially and not give preferential treatment to any.2 .private organization or individuale. The organization and the relationship among the laboratory staff is reflected in the .laboratory’s organizational chart described in section 4.1.4f. Lab personnel authorities and responsibilities are documented in the management systemprocedures and operating instructions. The roles and responsibilities of the lab quality andtechnical managers are defined in this quality manual section 4.2.6. Job descriptions of lab (staff are defined and maintained according to the procedure of personnel (QP-5.2-1g. The laboratory employees performing testing have access to consensus standards,instrument manufacturers’ manuals, and laboratory procedures for reference evidence ofdesired familiarity with laboratory methods. Supervisors are designated and trainees do notperform regulatory work until competent as per the laboratory training program.h. The lab defines Technical Managers who have the overall responsibility for the technicaloperations of the laboratory. Resources for training, laboratory methods, measurement .traceability, and purchasing are described in sections of this manual, and in proceduresi. The laboratory Quality Manager is responsible for the laboratory’s management systemand its implementation. The Quality Manager has direct access to the Laboratory Top .Management, who is responsible for decisions concerning policy and resourcesj. Qualified laboratory personnel are assigned to serve in the absence of key managerialpersonnel, such as Laboratory Top Management, Quality Manager, Technical Managers.and Senior Technical Personnel. Deputies are appointed in the Job Description records
  6. 6. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 6 of 27k. The lab ensures that its personnel are aware of the relevance and importance of theiractivities and how they contribute to the achievement of the objectives of the managementsystem through ensuring the availability of the minutes of the lab management review .meetings to all lab staff4.1.6 Effective communication from management occurs through the use of but not limitedto staff meetings, memos, newsletters, electronic presentations, emails, or verbally tolaboratory personnel regarding the effectiveness of the management system.Related Documents & Records Code of Ethics•Management System 4.2The laboratory quality management system (QMS) is outlined in the following 4.2.1 :documents ;Quality manual includes all lab policies• ;Quality procedures• Work Instructions; and• .Forms and records•This quality management system is established to address the requirements in ISO/IEC17025. A master list of all quality management system documents is maintained by the labas per document control procedure (QP 4.3-1). These documents are accessible to all.personnel and are included in the laboratory’s training programPolicies and Objectives 4.2.2 Quality Policy Statement•Water Pollution and Marine Environmental Laboratory is committed to anexcellent professional testing service, which meets the needs of the customers,statutory, and regulatory requirements and the requirements of ISO/IEC17025; and to continually improve the effectiveness of the management .systemThe purpose of Water Pollution and Marine Environmental Laboratorymanagement system is to assure the accuracy and precision of laboratory .results so that they will be reliable, interpretable, repeatable, and defensibleWater Pollution and Marine Environmental Laboratory personnel involvedin testing activities are required to become familiar with the lab qualitymanagement system documentation and implement its policies and procedures.at all times
  7. 7. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 7 of 27Water Pollution and Marine Environmental Laboratory Top Managementcommits to good professional practice, to offer high testing services quality tothe laboratory customers according to the requirements of internationalstandards ISO/IEC 17025:2005. Quality Objectives•Water Pollution and Marine Environmental Laboratory overall objectives areestablished on annual basis by the lab Top Management. These objectives are reviewed.during the management review meetingsEvidence of management’s commitment to the management system and its continual 4.2.3improvement in effectiveness is demonstrated by, but not limited to, conducting themanagement reviews, performance of internal audits, proficiency testing, and the analysis.of quality control samples4.2.4 The lab Top management communicates to the organization the importance ofmeeting customer requirements as well as statutory and regulatory requirements throughthe lab quality policy statement.Procedures and Outline of the Management System 4.2.5Management system procedures supporting quality policies are cited in the RelatedProcedures at the end of each section of this manual. The outline of the management.system is included in this manual, Subsection 4.2.1Roles and Responsibilities 4.2.6General roles and responsibilities for Water Pollution and Marine Environmental:Laboratory personnel are summarized as follows Quality Manager• Ensures that the management system is established, implemented,‐ and maintained in conformance with the requirements of ISO/IEC .17025 Technical Management• .Oversee technical functions‐ .Ensure compliance with the requirements of ISO/IEC 17025‐ Ensure management system procedures, applicable standards,‐ .specifications, and regulations are followed Ensure that qualified, skilled, and trained personnel and other‐ .resources are available .Ensure that products and services satisfy customer requirements‐Top management ensures that the integrity of the management system is maintained 4.2.7when changes to the management system are planned and implemented through applying.the document change procedure outlined in procedure QP 4.3
  8. 8. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 8 of 27The management system process and procedures as defined in this manual maintain theintegrity of the management system when changes such as a change in the structure of the.organization or management, or a change is a policy or procedure are madeDocument Control 4.3 General 4.3.1The document control and management procedure in the laboratory describes the processfor controlling quality documents that form part of its management system. The qualitydocuments include those required for the generation of laboratory data. These documentsinclude those published by the laboratory and those used from external sources.Documents of external origin include regulations, standards, test methods, instructions and .manualsDocument Approval and Issue 4.3.2Documents issued to personnel in the laboratory as part of the management system 4.3.2.1are reviewed and approved for use prior to issue in accordance with the laboratory’sdocument control and management procedure. The laboratory’s master list identifies thecurrent revision status and distribution of documents in the management system. Throughthe use of the master list, quality documents are posted to personnel to preclude the use of .invalid or obsolete documents Procedure Content 4.3.2.2The laboratory’s master list and document control and record management procedure :provide for the followinga. Authorized management system documents and external documents are at locations .where operations essential to the effective functioning of the laboratory are performedb. Documents are reviewed according to a schedule and revised to ensure continuingsuitability and conformance with the management system and ISO/IEC 17025 .requirementsc. Invalid or obsolete documents are promptly removed from all points of issue or use, or .marked as Obsolete to assure against unintended used. Obsolete documents retained for either legal or knowledge preservation purposes are .marked as Archived Document Identification 4.3.2.3A document control header as described in the laboratory’s document control andmanagement procedure uniquely identifies management system documents generated bythe laboratory. Such identification includes the date of revision, identification number andinclusive pagination. The issuing authority is indicated by the name of the approving.official in the document history section at the end of each document Document Changes 4.3.3Changes to documents are reviewed and approved in accordance with the laboratory’sdocument control and management procedure. Unless designated otherwise, this procedureis followed by the same personnel or function as in the original review or approval. The
  9. 9. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 9 of 27use of reference documents and information is required upon which to base the review and .approvalThe altered or new text is identified in the history section at the end of each 4.3.3.1.documentThe laboratory’s document control and management procedure addresses the 4.3.3.2.handling of document amendments by hand pending reissueComputerized Systems 4.3.3.3The laboratory’s document control and management procedure addresses the control of.electronic management system documentsRelated Documents.WPMEL-LAB 4.3 – Document ControlReview of Requests, Tenders and Contracts 4.4 Review 4.4.1Water Pollution and Marine Environmental Laboratory Management puts accommodatingcustomers’ requests and satisfying their needs at priority. The laboratory designates certainpersonnel for dealing with the customers. These personnel have the required capabilities ofhandling the normal customer requests. However, in case of receiving a special customerrequest either for a new type of analysis and/or matrix or for an unusual number of samplesetc, the request is directed to the related Technical Manager to review. This review:includes, but is not limited to, the following Ensuring the capability of meeting the customer requested test(a method and/or the modifications required in an existing method and that these requirements are adequately defined, documented ;and understood Ensuring that the laboratory has the technical capability(b represented by sufficient number of personnel who have the ;skills and expertise to handle the special customer request Ensuring that the laboratory work schedule is able to(c ;accommodate the customer request Ensuring the accessibility to resources such as certified/reference(d materials, chemicals, calibration, etc to meet the contractual ;requirements Ensuring the capability of generating additional data that might(e be needed to support the test result such as measurement ;uncertainty, detection limit, confidence limits, etcThis review process should lead to a contract between the laboratory and the customer to.provide testing servicesThe results of this process are discussed and documented as part of the laboratory’s annual.management review
  10. 10. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 10 of 27 Records of Review 4.4.2Water Pollution and Marine Environmental Laboratory maintains records of requests.reviews, changes, and change requests. Records of discussions are also maintained Subcontracting Laboratories 4.4.3.The laboratory does not subcontract its services Contract Deviations 4.4.4In case of any deviation from the contract, the deviation is reported in the final test report .issued by the laboratory Amendments to Contracts 4.4.5If a contract needs to be amended after work has commenced, the same contract reviewprocess is repeated and any amendments are communicated to all affected personnel.named in the contractRelated DocumentsAnalysis request formSubcontracting of Tests 4.5Water Pollution and Marine Environmental Laboratory does not subcontract routine.analyses within its scope of accreditationPurchasing Services and Supplies 4.6Procedure 4.6.1Water Pollution and Marine Environmental Laboratory uses the related procedures for theprocurement of materials, supplies and services that critically affect the quality of the tests.These procedures describe the process for the selection, purchase, reception and storage ofequipment, services and supplies, including reagents and laboratory consumable materials,used in the performance of the tests. The laboratory has work instructions describing the.processing of requisitions Inspection and Verification 4.6.2The laboratory’s purchasing procedure describes how purchased equipment, supplies,services, reagents, and consumable materials that critically affect the quality of tests areinspected or verified prior to use. Inspection or verification criteria are used to establishconformance with requests made by the customer, included in standard specifications, or.defined in the methodsPurchasing Documents 4.6.3
  11. 11. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 11 of 27Purchasing documents for items affecting the quality of laboratory output describe theservices or supplies ordered. These purchasing documents are reviewed and approved for.technical content prior to submission Records and Registry 4.6.4Records of supplier evaluations and a list of approved suppliers are maintained by the.laboratoryRelated Documents.WPMEL-LAB 4.6 - Purchasing Services and SuppliesService to the Customer 4.7The laboratory clarifies the customers request within the framework of the contract 4.7.1review process described in this manual, section 4.4 - Review of Requests, Tenders andContracts. The laboratory maintains communications regarding deviations from contract .workThe opportunity for the customer to witness laboratory activity is given upon request,providing the laboratory is able to maintain confidentiality to other customers during such .casesThe laboratory seeks customer feedback on their services and general performance. 4.7.2Records of the comments, both positive and negative, are maintained and are taken intoaccount for identifying management system improvements during the reviews performed.by managementRelated DocumentsNone •Complaints 4.8The laboratory has a complaint procedure describing the process for the receipt andrecording of complaints received from any party. Records of all complaints received aremaintained according to the procedure. Complaints identified as nonconformities are.processed according to this manual, section 4.11 - Corrective ActionRelated Documents.WPMEL-LAB.4.8 ComplaintsControl of Non-conforming Work 4.9Procedure 4.9.1Water Pollution and Marine Environmental Laboratory has a control of non-conformingwork procedure that is implemented when any aspect of their testing work, or the results of
  12. 12. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 12 of 27this work, does not conform to requirements of the management system, testing methods, :or the requests of the customer. This procedure addresses the following elements responsibilities and authorities for the management of identified non-• conforming work and taking actions such as the halting of work, the ;withholding of test reports ;application of criteria to evaluate the significance of non-conforming work• remedial action taken, together with any decision about the acceptability of the• ;non-conforming work notification of the customer, and if necessary, recall of work; and• .responsibility for authorizing the resumption of work• Follow-Up 4.9.2If the non-conforming work could recur, or there are other significant problems identified,the corrective action procedures in this manual, section 4.11 - Corrective Action are.promptly followed Related DocumentsA procedure for handling control of non-conforming work. WPMEL-LAB.4.9 Control of •.Non-conforming WorkImprovement 4.10The effectiveness of the laboratory’s management system is improved by using the followingactivities: internal audits; management reviews; analysis of quality control data; corrective.actions; preventive actions; the quality policy; and the quality objectivesCorrective Action 4.11 General 4.11.1Water Pollution and Marine Environmental Laboratory has a corrective action procedurethat designates the authorities for implementing corrective action when one of the :following is identified ,non-conforming work• departures from the policies and procedures in the management system, and• .departures from required technical operations•Cause Analysis 4.11.2The procedure for corrective action includes investigating and determining the root cause.of the non-conformanceSelection and Implementation of Corrective Actions 4.11.3Potential corrective actions are identified. The action most likely to eliminate the problem.and to prevent recurrence is selectedThe corrective action chosen addresses the magnitude of the non-conformance and the risk.attributed to the non-conformance
  13. 13. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 13 of 27Corrective actions are documented, and any changes resulted from the corrective action.investigation are implementedMonitoring of Corrective Actions 4.11.4The corrective action procedure addresses the monitoring for the effectiveness of.corrective actions performed Additional Audits 4.11.5Where the identification of non-conformances may affect the laboratory’s conformancewith management system policies and procedures or conformance with ISO/IEC 17025,the areas of activity affected by the non-conformance are audited as soon as possible in.accordance with section 4.14 Internal Audits of this manualRelated Documents.Corrective action procedure. WPMEL-LAB.4.11 Corrective ActionPreventive Action 4.12 General 4.12.1Sources for needed improvements and potential sources of non-conformance are identifiedaccording to the process described in the laboratory’s preventive action procedure, and arepart of the management review process. Preventive actions plans are developed, .implemented, and monitored to address the identified opportunities for improvementProcedure 4.12.2The procedure includes the initiation of action. The management review process monitors.the effectiveness of such actions in providing improvement to the management system Related Documents .A preventive action procedure. WPMEL-LAB. 4.12 - Preventative Action •.A management review procedure. WPMEL-LAB. 4.15 - Management Review •Control of Records 4.13 General 4.13.1 Procedure 4.13.1.1Water Pollution and Marine Environmental Laboratory has a control of records procedurefor identifying, collecting, indexing, accessing, filing, storing, maintaining, and disposingof quality and technical records. Quality records include reports from internal audits,management reviews, corrective actions, and preventive actions. Technical records areaccumulation of data and include, but are not limited to, forms, worksheets, control charts,.calibration certificates and reportsLegibility, Storage, and Retention 4.13.1.2
  14. 14. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 14 of 27Records are to be legible. Laboratory records are archived in a way that can be easily.retrieved. A record retention period is identified in the control of records procedureSecurity and Confidentially 4.13.1.3Records are stored in secured areas and only authorized personnel are allowed to retrieve.them Electronic Records 4.13.1.4Water Pollution and Marine Environmental Laboratory has a procedure describing theprotection and back-up of electronic records. The procedure also describes the amendment .of electronic records Technical Records 4.13.2Retained Records, Audit Trail, and Identification 4.13.2.1Staff records, equipment calibration, and verification reports as well as other laboratory.records are retained in accordance with the laboratory’s control of records procedureLaboratory records contain sufficient information that, depending on the type of analysis,include calculations, standard preparation, instrument printouts, and results. Theseinformation are sufficient to enable establishing audit trails and to repeat the test under .conditions as close as possible to the originalRecording and Identification 4.13.2.2Observations, data, and calculations are recorded at the time they are made and areidentifiable to the activity performed. Method numbers and titles are used to provide.traceability of recordsCorrections 4.13.2.3When errors occur in records, each mistake is lined out, not erased, not made illegible, nor.deleted. The correct value is entered and initialedRelated Documents.Control of records procedure. WPMEL-LAB.4.13 Record and Data ManagementInternal Audits 4.14 General 4.14.1Internal audits are conducted according to a schedule included in the laboratory’s auditprocedure. Internal audits are conducted of activities to verify that operations continue to .conform to the requirements of the management system and ISO/IEC 17025The internal audit program addresses all elements of the management system, includingtesting activities. The laboratory’s Quality Management System Manager is responsible for .the coordination of internal audits as listed by the schedule and requested by managementTrained and qualified personnel are responsible for conducting internal audits. Audits are .performed by personnel other than those who performed the work being auditedCorrective Action 4.14.2
  15. 15. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 15 of 27When audit findings cast doubt on the effectiveness of the operations or on the correctnessor validity of the laboratory’s test results, corrective action is undertaken according to the .laboratory’s corrective action procedureThe customer is notified if investigations show that non-conformances related to auditresults also have affected work performed for the customer. This notification is .documented Audit Records 4.14.3The area of activity audited, the audit findings, and corrective action that arise from them .are recorded according the laboratory’s audit procedure Follow-up Audit Activities 4.14.4Follow-up audit activities are conducted to verify and record the implementation andeffectiveness of the corrective action taken. This follow-up is included as part of the.management review processRelated Documents.WPMEL-LAB 4.14 – Internal AuditsManagement Reviews 4.15 General 4.15.1The laboratory’s management review procedure includes the schedule for conductingmanagement reviews. This review is conducted by the laboratory’s executive managementto ensure continuing fitness for use and effectiveness of the management system and to .introduce needed changes or improvementsThe management review addresses the elements of the management system and includes :but is not limited to the following elements Overall quality objectives• ;Suitability of policies and procedures• ;Reports from managerial and supervisory personnel• ;Outcome of recent internal audits• ;Corrective and preventive actions• ;Assessments by external bodies• ;Results of interlaboratory comparisons, proficiency test, and quality control• ;Changes in the volume and type of work• ;Customer feedback• Complaints; and• .Other factors, such as quality control activities, resources•Findings and actions that arise from the review are recorded according to the laboratory’s.management review procedure. Each action includes a due date for resolutionRelated Documents.WPMEL-LAB 4.15 – Management Reviews
  16. 16. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 16 of 27Technical Requirements 5.0General 5.1The sections following below address the factors affecting the correctness and 5.1.1.reliability of the tests performed by a laboratory:These factors include contributions from ,Personnel• ,Accommodation and environmental conditions• ,Test methods and method selection and validation• ,Equipment selection and calibration• Measurement uncertainty and traceability, and• .Handling of test items• Contribution to Total Uncertainty of Measurement 5.1.2These factors are considered in determining and updating total measurement uncertainty.Additionally, these factors are considered by the laboratory when developing testprocedures, in the training and qualification of personnel, and in the selection of the.equipment utilizedPersonnel 5.2 Personnel Competence 5.2.1Laboratory management ensures that laboratory personnel have the knowledge, skills, andabilities to perform their duties. Competence is based on education, experience,demonstrated skills, and training. Staff records contain the documentation of personnel.education, experience, skills, and training for the position heldTrainees undergo a training program in accordance with the laboratory’s trainingprocedure. For in-house training, a senior analyst serves as the trainer. Trainees performprocedures when training is completed and competency has been demonstrated. Thedocumented demonstration of competence is an exercise that the trainee performsindependent of supervision. The trainee is considered competent after the specified criteria.have been successfully met Education, Training and Skills 5.2.2.1The annual performance evaluation process can be used to discuss career advancement andtraining possibilities. By using this process, individuals have the opportunity to identify .areas of study and request trainingIn-house training is conducted according to laboratory’s training procedure. Theeffectiveness of personnel training is documented in but not limited to managementreviews, internal audits, external assessments, proficiency testing, and performance.evaluations
  17. 17. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 17 of 27Skills of personnel are based upon demonstration of competence. This demonstration is to.be completed successfully before analysts generate data independently Employees and Contracted Personnel 5.2.3Water Pollution and Marine Environmental Laboratory utilizes the skills and talent of bothfull-time employees. In case of hiring contracted personnel, the requirements of themanagement system are administered equally to both categories. No differentiation is madebetween the two categories of workers in the requirement of the management system.Supervision, training, and competence are documented for all technical and key support.personnelJob Descriptions 5.2.4The laboratory maintains active job descriptions for managerial, technical, and key support.personnel involved in testsManagement Authorization 5.2.5:The Laboratory Executive Manager authorizes identified personnel to ,perform testing and calibration• ,issue test reports• give opinions and interpretations, and• .operate particular types of equipment•Records of authorizations, demonstration of competence, education, training, and.experience are maintained by the laboratory and datedAccommodation and Environmental Conditions 5.3 Facilities and Environmental Conditions 5.3.1Water Pollution and Marine Environmental Laboratory maintains proper environmentalconditions that facilitate the correct performance of analytical testing and ensures the .quality of test resultsMonitoring 5.3.2Test methods used by the laboratory include instructions addressing applicableenvironmental conditions. The laboratory monitors and records critical environmentalconditions that are mainly temperature and humidity unless otherwise specified in themethod to ensure that results and the quality of the measurement are not adversely .affected .Where environmental controls are needed, the environmental conditions are recordedTesting activities are stopped when the environmental conditions invalidate the test results.or adversely affect quality controlCross-contamination 5.3.3Separate areas are maintained for incompatible activities. Measures taken to prevent cross-:contamination include but are not limited to ,Chemistry laboratories are separated from microbiology laboratories• ,Sample receiving and storage are conducted in designated areas•
  18. 18. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 18 of 27 Separate storage for standards and reference materials and cultures, and• Microbiology media preparation and sterilization are separated from work• .areasAccess 5.3.4Water Pollution and Marine Environmental Laboratory controls access to areas of criticalimpact on the quality of test results. Visitors are not allowed in the laboratory unless .escorted by laboratory staff Housekeeping 5.3.5Laboratory areas are maintained clean and orderly to prevent contamination of samples andto facilitate the efficiency of laboratory operations. The laboratory maintains procedure .that specifies minimum housekeeping measuresRelated DocumentsFacilities and Environmental Conditions. WPMEL-LAB.5.3Test Methods and Method Validation 5.4 General 5.4.1Water Pollution and Marine Environmental Laboratory uses methods and procedures forall tests within its scope identified in the laboratory’s accreditation programdocumentation.The laboratory instructions for the use and operation of equipment specified by thelaboratory methods is either a laboratory procedure identified on the master list or as .equipment manualsDeviations from test methods are documented, technically justified, authorized, andaccepted by the customer according to the procedure, WPMEL-LAB.5.10 Reporting.Laboratory DataSelection of Methods 5.4.2 Laboratory methods are selected to meet the customer’s need as addressed in• .this manual, section 4.4 Review of Requests, Tenders and Contracts The laboratory methods are controlled as external documents according to this• .manual, section 4.3 Document Control When the customer does not specify the method to be used, a standard method• is preferred and is verified for use in the laboratory. Those methods specified by .the manufacturer of the equipment are considered as standard methods The laboratory informs the customer when the method proposed by the• customer is considered to be the incorrect choice or the incorrect revision for the intended purpose. This is done as part of contract review addressed in this .manual, Section 4.4 Review of Requests, Tenders and ContractsLaboratory Developed Methods 5.4.3
  19. 19. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 19 of 27Water Pollution and Marine Environmental Laboratory does not have any developed.methodsNon-standard Methods 5.4.4.Water Pollution and Marine Environmental Laboratory uses standard methods onlyValidation of Methods 5.4.5Definition 5.4.5.1Validation is the confirmation by examination and the provision of objective evidence that.the particular specifications for an intended use are fulfilled Methods Requiring Validation 5.4.5.2The laboratory validates modified standard methods including use outside the intendedscope and applications, if any. Moreover, the laboratory confirms its proper .implementation of standard methods. All records are maintained Process 5.4.5.3The validation process addresses the needs of the given application or field of application.The laboratory analyst records the results obtained according to the procedure, WPMEL-LAB.5.4.5 Methods, Method Verification and Validation. The validation results include astatement as to whether the method is fit for the intended use. The needs of the customerdefine the intended use of the method. The attributes and data quality objectives include :but are not limited to ,accuracy• ,precision• ,specificity• ,detection limit• ,limit of quantitation• linearity, and• • range.If all the data quality objectives are met as indicated by the data collected, the method is.considered as validatedEstimation of Uncertainty of Measurement 5.4.6Procedure for Calibration Activities 5.4.6.1Water Pollution and Marine Environmental Laboratory is a testing laboratory and does not.perform its own calibrations Procedure for Testing Activities 5.4.6.2The laboratory has a procedure, WPMEL-LAB.5.4.6, Estimation of Uncertainty of .Measurement, to estimate the uncertainty of measurement for testing activitiesAn attempt is made to identify all the components of uncertainty and make a reasonableestimation of the measurement uncertainty. This estimation is based on knowledge,experience, and validation data of the performance of the method and on the measurementscope. If needed as a part of the laboratory data, the uncertainty estimation is reported.according to the same procedure
  20. 20. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 20 of 27 Uncertainty Components 5.4.6.3When estimating the uncertainty of measurement, all important uncertainty componentsare recorded in the uncertainty records for each determination as addressed in the .procedure, WPMEL-LAB.5.4.6, Estimation of Uncertainty of MeasurementControl of Data 5.4.7Data Transfers 5.4.7.1Calculations and data transfers are reviewed before the data is reported. All changes areidentified and verified where they occur. This process is detailed in the procedure forlaboratory quality control identified in this manual, Section 5.9 Assuring the Quality of .Test Results Computer Use 5.4.7.2Computers are used for the acquisition and storage of automated equipment test resultssuch as calibration curves, chromatograms, etc. They are also used for the processing,recording and reporting of test data. Excel spreadsheets are developed to facilitatecalculations of validation data, uncertainty and quality control data. Computers are used asthe means to produce laboratory records, but the laboratory does not keep softcopies of .records and considers the hard copies as the only official and controlled type of record Excel spreadsheets developed by the laboratory are documented in detail and(a .validated before use The laboratory ensures the protection of test data stored on automated(b equipment computers by applying strict data protection procedure that ensures data integrity and data confidentiality during entry, collection, storage, .transmission and processing Computers and automated equipment are maintained to ensure proper(c functioning and are provided with the environmental and operating conditions .to maintain the integrity of test and dataEquipment 5.5 Laboratory Equipment 5.5.1The laboratory has sample preparation, measurement and test equipment for the correctperformance of its tests. The laboratory also has ancillary equipment for processing .samples and for processing dataThe laboratory purchases the used equipment and establishes maintenance contracts as .neededWater Pollution and Marine Environmental Laboratory maintains an equipment inventory.of all laboratory equipment used to perform regulatory testingEquipment Capability 5.5.2
  21. 21. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 21 of 27 Equipment and its software used for testing are ensured to• achieve the accuracy expected and comply with specifications of .the testing concerned Laboratory equipment that has a significant effect on the results• follow a calibration schedule. The equipment performance is .verified and verification records are maintained Equipment is to meet the laboratorys testing parameters and• conform to standard specifications before being placed into .service Authorized Operation 5.5.3Personnel are authorized to operate equipment according to this manual, subsection 5.2.5Management Authorization. Authorization is based on work assignment, training,experience and demonstrated proficiency. Equipment manuals and maintenance proceduresare maintained and supplied to laboratory personnel as described in this manual, subsection4.3.1 General and procedure, WPMEL-LAB.5.5.1 Instrument and Equipment .Documentation and RecordsEquipment Identification 5.5.4Each item of equipment used for testing has an identification number that is unique to each.instrument Equipment Records 5.5.5Records are maintained of each item of equipment and its software significant to the testsor calibrations performed according to the procedure, WPMEL-LAB.5.5.1 Instrument and .Equipment Documentation and Records:Records include at least the following items ;identity of the item of equipment and its software• manufacturer’s name, type identification, and serial number or other unique• ;identification performance checks that equipment conforms to testing parameters and• ;acceptance criteria ;location of the equipment• ;manufacturer’s instructions• dates, results and copies of reports and certificates of calibrations, adjustments,• ;acceptance criteria, and the due date of next calibration maintenance plan and maintenance carried out to date; and• .any damage, malfunction, modification or repair to the equipment• Management of Equipment 5.5.6The laboratory implements a procedure, WPMEL-LAB.5.5 Equipment, for the safehandling, transport, storage, use and planned maintenance of measuring equipment to .ensure proper functioning and to prevent contamination or deterioration Out of Service 5.5.7Equipment that has been subjected to overloading or mishandling, gives suspect results, orhas been shown to be defective or outside specified limits, is taken out of service. It is
  22. 22. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 22 of 27isolated to prevent its use and clearly labeled as being “Out of Service” to prevent its use .until it has been repaired and shown to perform correctlyLaboratory personnel examine the effect of the defect or departure from specified limits onprevious tests and report on a non-conforming work according to the laboratory procedure .WPMEL-LAB 4.9 Control of Non-conforming Work Calibration Status 5.5.8Equipment under the control of the laboratory and requiring calibration is labeled or codedto indicate the calibration status, including the date of last calibration and the date due forrecalibration. Alternatively, equipment calibration status may be identified in an associated .record to indicate the status of calibration Equipment Leaving the Laboratory 5.5.9Equipment are not allowed to leave the laboratory. However, if for any unforeseen reason,equipment leaves the direct control of the laboratory, the function and calibration status ofthe equipment is checked upon return and shown to be satisfactory before the equipment is.returned to serviceCalibration Confirmation 5.5.10Intermediate calibration confirmation checks are performed to maintain confidence in thecalibration status of the equipment. These checks are conducted according to the procedure .in this manual, Section 5.9 Assuring the Quality of Test ResultsCorrection Factors 5.5.11Where calibrations give rise to a set of correction factors, these factors are communicated.to users Safeguards 5.5.12Test equipment, including both hardware and software, are safeguarded from adjustmentsthat would invalidate the test results. Safeguards are provided using access control to the.laboratory, as practicableMeasurement Traceability 5.6 General 5.6.1The laboratory equipment is calibrated before being placed into service, as scheduled andfollowing repairs. Procedures for equipment calibration are provided in procedure, .WPMEL-LAB.5.5 EquipmentSpecific Requirements 5.6.2Calibration 5.6.2.1As a testing laboratory, details about measurement traceability are found in section 5.6.2.2.of this quality manual
  23. 23. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 23 of 27 Testing 5.6.2.2Water Pollution and Marine Environmental Laboratory ensures its measurement 5.6.2.2.1traceability to the International System of Units (SI) through conducting its externalcalibrations in calibration laboratories that are accredited to ISO/IEC 17025 in therequested scope. In case of the unavailability of an accredited laboratory in the requiredparameter, Water Pollution and Marine Environmental Laboratory seeks this calibration .(from the National Institute for Standardization (NISThe laboratory uses Certified Reference Material (CRM) as another means of 5.6.2.2.2.achieving measurement traceability to SI unitsReference Standards and Reference Materials 5.6.3Reference Standards 5.6.3.1The laboratory implements a calibration program for its reference standards. Details are.included in procedure, WPMEL-LAB.5.5 EquipmentThe reference standards are calibrated by an accredited laboratory and are used only for.calibration purposes Reference Materials 5.6.3.2A reference material is a homogenous and well characterized substance used forstandardization of equipment used in the testing process. Reference materials are, wherepossible, traceable to SI units, or certified reference materials (CRMs) from competent.suppliers of reference materials and are checked, as practicableIntermediate Confirmation of Calibration Status 5.6.3.3Metrological confirmation for reference standards and reference materials included in thecalibration program is conducted according to a schedule addressed in the procedure in theprocedure, WPMEL-LAB.5.5 Equipment. The confirmation is conducted to maintain .confidence in the calibration status of reference standards and reference materialsTransport and Storage 5.6.3.4The procedure, WPMEL-LAB.5.6 Measurement Traceability, addresses the safe handling,transport, storage and use of reference standards and reference materials. These activitiesare established in order to prevent contamination, deterioration, and to protect the integrity.of reference standards and reference materialsSampling Operations 5.7Procedure 5.7.1Water Pollution and Marine Environmental Laboratory does not routinely performsampling in the sense of collecting a representative sample from a product lot to represent .the whole
  24. 24. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 24 of 27Sample Collection Conducted by the Customer; but occasionally, laboratory personnel areconsulted about sampling parameters such as sample type or size or guidance for aparticular sampling or analytical need. However, Water Pollution and MarineEnvironmental Laboratory, exert no direct control over such sampling and do not have.responsibility for samplingSampling conducted by Water Pollution and Marine Environmental Laboratory involvesfor the most part those analyses that call for a portion or aliquot of the total samplereceived by the laboratory to be analyzed. Generally, this calls for mixing or preparing ofsamples to assure homogeneity before portions are taken for analysis. Sample preparationand subsampling protocols are found in the analytical methods, compliance programs, and.assignmentsHandling of Samples 5.8 Protection of Samples 5.8.1The laboratory procedure, WPMEL-LAB.5.8 Sample Management, describes the receipt,processing, protection, storage, retention and disposal of samples. This procedure .addresses the laboratory activities conducted to protect sample integrity Identification of Samples 5.8.2The laboratory has a system for uniquely identifying samples. The sample number is usedto track its progress from the time the sample is received into the lab until the analysis iscompleted and the sample is disposed. The sample number is also used to providetraceability between the sample and the data. The numbering system also providestraceability during transfer of samples within the laboratory. The identification system is .described in procedure, WPMEL-LAB.5.8 Sample Management Departures, Additions or Exclusions 5.8.3Upon receipt of the sample, abnormalities or departures from normal or specifiedconditions are recorded according to the procedure, WPMEL-LAB.5.8 Sample .ManagementWhen samples received do not meet established acceptance criteria, laboratory personnelconsult the customer for further instructions before proceeding. Communication with the .customer is documented Protection of Samples during Processing and Storage 5.8.4The procedure, WPMEL-LAB.5.8 Sample Management, provides the details for protectingtest items from deterioration, loss or damage during storage and processing. The laboratory has .arrangements for storage and security that protect the condition and integrity of samplesProcessing Instructions 5.8.4.1Handling instructions provided with the sample are followed, as well as the instructions in the.procedure, WPMEL-LAB.5.8 Sample Management
  25. 25. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 25 of 27 Monitoring of Environmental Conditions 5.8.4.2When samples are held under environmental conditions specified in the test method, thoseconditions are maintained, monitored and recorded. Monitoring records are collected accordingto established procedures. These activities are conducted according to the policies stated in this.manual, Section 5.3 Laboratory EnvironmentAssuring the Quality of Test Results 5.9 Quality Control Procedures 5.9.1The laboratory has quality control procedures to validate the results of tests undertaken .according to procedure, WPMEL-LAB.5.9 Assuring the Quality of Test ResultsThe monitoring data is recorded in control charts. Monitoring activities are planned andevaluated according to the same procedure. Depending on the type of test, one or more of:the following monitoring techniques may be used ;Scheduled use of certified reference materials(a ;Scheduled participation in interlaboratory comparison or proficiency-testing(b ;Replicate tests using the same or different methods(c Retesting of reference materials and retained customer samples; and(d Correlation of results from tests conducted for different characteristics of a(e .sampleWhen data is found to be outside the established limits of the control charts or when 5.9.2there is a violation of the quality control program requirements, action is taken in.accordance with the laboratory’s control of non-conforming work procedureReporting the Results 5.10General .5.10.1Test reporting is addressed in the procedure, WPMEL-LAB.5.10 Reporting LaboratoryData. This procedure gives the details for reporting data using consistent reporting formats..Reports are reviewed against acceptance criteria that address accuracy Reporting Results 5.10.2Data entered onto the worksheets includes all the information specified by Water Pollutionand Marine Environmental Laboratory as described in the procedure WPMEL-LAB.5.10Reporting Laboratory Data. Other government agency-specified data is recorded by the.laboratory on sample forms that accompany the samplesSpecific Requirements .5.10.3The following information is included in test reports for the interpretation of the test:results, where necessary for the interpretation of test results Deviations from, additions to, or exclusions from the test method, and(f ;information on test conditions, such as environmental conditions ;A statement of conformance or non-conformance with specifications(g
  26. 26. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 26 of 27 A statement of the estimated uncertainty of measurement upon customer(h ;request ,Opinions and interpretations as detailed in this manual, Section 5.10.5; and(i .Additional information that may be requested by methods or customers(j Calibration Certificates 5.10.4Water Pollution and Marine Environmental Laboratory is a testing laboratory and does not.perform calibration activitiesOpinions and Interpretations 5.10.5Laboratory management expresses its opinion and interpretation of the compliance or non-.compliance of the results through the laboratory classification assigned to each sampleTesting Results Obtained from Subcontractors 5.10.6Subcontracting laboratories are not utilized by Water Pollution and Marine EnvironmentalLaboratory, therefore, there is no such data found for incorporation in the analysis report to.the customerElectronic Transmission of Results 5.10.7Water Pollution and Marine Environmental Laboratory submits hard copies only to the.laboratory representative and does not submit the results electronicallyFormat of report 5.10.8The format of laboratory reports is designed to accommodate the type of test conducted tominimize the possibility of misunderstanding or misuse. The report format is described in.the procedure, WPMEL-LAB.5.10 Reporting Laboratory Data Amendments to report 5.10.9Material amendments to analytical findings after issue are made only in the form of anadditional document. They are flagged “Supplement to Test Report #” in accordance withprocedure WPMEL-LAB.5.10 Reporting Laboratory Data. Amendments are to meet the.same reporting criteria
  27. 27. LAB LOGO & NAME Document No.: Issue No.: 0.1 WPMEL-LAB.QM Issue Date: 5 May 11Title: Issued By: MANUAL OF QUALITY POLICIES Page 27 of 27Document/Change HistoryIssue # Issue date Issued By Approved By

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