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ISO 17025 Culture SHOQ Quiz Introduction: A. True ISO 17025 provides all the requirements that labs have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results. A. True B. False © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.1 Organization: Management and technical personnel shall have the necessary: A. Personnel B. Authority and resources C. Instrumentation © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.1 Organization: A. Vice President What is the position title of the person who must have direct access to the highest level of management at which decisions are made on laboratory policies and resources? A. Vice President B. Technical Manager C. Quality Manager © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.2 Quality System: A. Quality Manual The laboratory’s quality system policies and objectives shall be defined in a: A. Quality Manual B. Quality Policy Statement C. Standard Operating Procedure © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.2 Quality System: A. Quality Manual Overall quality system objectives shall be documented in a: A. Quality Manual B. Quality Policy Statement C. Standard Operating Procedure © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.3 Document Control: Document control means: A. Ways to reduce paper B. You give all documentation to your supervisor to maintain C. Documents are identified, authorized, reviewed © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.4 Review of requests, tenders, and contracts: Requests, tenders, and contracts are reviewed for: A. Client requirements and lab capability B. Potential revenue C. Spelling and grammar © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.5 Subcontracting: A. True A laboratory is responsible to the client for the work of a subcontractor even when the client specifies which subcontractor to use: A. True B. False © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.6 Purchasing: A. Insured Supplies of critical consumables, supplies, and services which affect quality must be: A. Insured B. ISO 9001 registered C. Evaluated and approved by the lab © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.7 Service to client: The lab shall help clarify the client’s request and allow the client to: A. monitor the lab’s performance in relation to the work performed B. review other client’s samples and reports C. assist in testing their own samples © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.8 Complaints: Records shall be maintained of all client complaints and of: A. How angry the client is/was B. The investigations and corrective actions taken by the lab C. How loud the client complained © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.9 Control of Nonconforming work: Procedures for nonconforming test work that is halted (and test reports with held) includes: A. An evaluation of the significance of nonconforming work B. Repeating test conditions over until QC works C. C.Y.A © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.10 Corrective Action: A. Finger-pointing The procedure for corrective action must start with: A. Finger-pointing B. Risk management C. An investigation to determine the root cause(s) of the problem © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.11 Preventive Action: Preventive action plans are to be developed for: A. Nonconformances &/or opportunities for improvement B. Potential nonconformances &/or opportunities for improvement C. Nonconformances &/or potential nonconformances © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.12 Control of records: Records must be: A. Legible, readily retrievable, and in a suitable environment B. Designed for auditors C. Controlled by IT personnel © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.13 Internal Audits: Internal audits are conducted to verify: A. Compliance of operations with quality system B. Compliance of operations with quality system and ISO 17025 C. Compliance of operations with ISO 17025 © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 4.14 Management Reviews: Management reviews ensure: A. Continuing suitability and effectiveness of the quality system B. That there will always be another Dilbert cartoon C. Employee requirements are met through 365 degree feedback © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.2 Personnel: A. Writing Job Descriptions Training records are essential to: A. Writing Job Descriptions B. Accrediting the analyst C. Ensure competence and authorize personnel © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.3 Accommodation and environment: Effective separation of incompatible activities may be achieved through: A. Physical separation or different time B. Physical separation or SOPs C. SOPs or different time © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.4 Methods and validation: Methods must be sufficiently validated as well as: A. Maximize profits B. Meet the needs of the client and appropriate for the test C. Easily implemented by the lab © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.5 Equipment: Choose the most correct answer for the following statement. Before equipment is placed back in service, lab personnel must: A. Ensure that the function and calibration status are shown to be satisfactory B. Ensure the “Out-of-Service” label is removed C. Not start new work too close to coffee break © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.6 Measurement Traceability: Measurement standards and instruments must be traceable to the International System of Units by means of an unbroken chain of calibrations or comparisons linking them to: A. International Laboratory Accreditation Committee B. National measurement standards C. Check samples © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.7 Sampling: A. True Sampling generally happens prior to reception at a lab. Under these conditions, sampling has little affect on final results: A. True B. False © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.8 Handling of Test/Calibration Items: The lab shall have a system for identifying test &/or calibration items to ensure that items cannot be confused: A. Physically or when referred to in records B. With reference standards or reference materials C. With measurement uncertainty © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.9 Assuring Results: QC data shall be recorded in such a way that: A. Confidence limits are set at 17-25 B. Trends are detectable C. Technical staff are reminded of how much work it is to keep records © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

ISO 17025 Culture SHOQ Quiz 5.10 Report the Results: When it is necessary to issue a new test report: A. It shall be uniquely identified and reference to the original B. It shall retain the same identity as the original C. The original is returned to the lab © SHOQ Quality Assurance Manuals Inc. www.e-shoq.com

26 Question Scoring Perfect Score: Quality Manager 1-2 wrong: Very Good 3 or more wrong: Review ISO 17025 standard or complete our ISO 17025 Quality Manual Template and utilize as a training tool in your laboratory

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