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PECB ISO/IEC 17025 Foundation study materials
PECB ISO/IEC 17025 Foundation study resources

PECB ISO/IEC 17025 Foundation practice questions

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Question 1Fundamental principles and concepts of a Laboratory Management System (LMS)

In ISO/IEC 17025, which document type contains requirements that a laboratory must satisfy to demonstrate its competence?

  1. The main body of the standard itself Correct answer.
  2. A technical protocol issued by the customer
  3. A standard test method published by a sector body
  4. A normative annex of a calibration guideline

Explanation

ISO/IEC 17025 is structured so that the main clauses (resources, process requirements, management system requirements) carry the mandatory requirements; annexes and external documents are supplementary. Competence is demonstrated against those main-body requirements, not against customer protocols or sector methods.

Question 2Fundamental principles and concepts of a Laboratory Management System (LMS)

What is the primary purpose of a laboratory management system as described by ISO/IEC 17025?

  1. To replace the need for technical competence with documented procedures
  2. To consistently produce valid results and satisfy customer, regulatory and standard requirements Correct answer.
  3. To guarantee that every test result is scientifically novel
  4. To certify individual technicians as professionally registered

Explanation

The standard frames the management system as the means to consistently deliver valid results while meeting customer, statutory and regulatory requirements and the standard's own requirements. It does not substitute documentation for competence, nor does it certify individuals.

Question 3Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory's quality policy states that it will maintain impartiality. Which activity best demonstrates that this commitment is actually implemented?

  1. Displaying the policy on the reception wall
  2. Identifying risks to impartiality from its activities and managing them Correct answer.
  3. Requiring staff to sign the policy once at induction
  4. Recording the policy in the quality manual only

Explanation

Impartiality is a process requirement: the laboratory must identify risks to impartiality arising from its activities and eliminate or minimise them. Displaying, filing or signing a policy are documentation acts that do not by themselves manage risk.

Question 4Fundamental principles and concepts of a Laboratory Management System (LMS)

How does ISO/IEC 17025 treat confidentiality of customer information obtained during laboratory activity?

  1. It is a management system requirement, with information released only as the customer authorises Correct answer.
  2. It applies only to information marked confidential by the customer
  3. It applies only to test results, not to the samples themselves
  4. It is optional where the laboratory is publicly funded

Explanation

Confidentiality is a management system requirement: the laboratory manages information obtained or created during its activities and releases it only when authorised by the customer or required by law. It is not limited to information the customer has labelled or to results alone.

Question 5Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement correctly distinguishes a laboratory from an inspection body for the purpose of standards terminology?

  1. A laboratory only performs chemical analysis, while an inspection body performs all physical measurement
  2. A laboratory performs testing or calibration, while an inspection body examines products or installations against requirements Correct answer.
  3. A laboratory issues certificates of conformity, while an inspection body issues test reports
  4. A laboratory works only for internal customers, while an inspection body works only for external customers

Explanation

In conformity assessment terminology, a laboratory carries out testing, calibration or sampling, whereas an inspection body examines items or installations and exercises professional judgement against requirements. The other options wrongly narrow or misassign the activities.

Question 6Fundamental principles and concepts of a Laboratory Management System (LMS)

ISO/IEC 17025 is best described as which type of standard?

  1. A management system standard for laboratory competence, impartiality and consistent operation Correct answer.
  2. A product specification standard for laboratory equipment
  3. A personnel certification scheme for individual analysts
  4. A mandatory regulation adopted identically by every country

Explanation

The standard is a management system standard that specifies general requirements for the competence, impartiality and consistent operation of laboratories. It is not a product specification, not a regulation in itself, and not a personnel scheme.

Question 7Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory adopts a method that is not covered by an international, regional or national standard. Which principle governs its use under ISO/IEC 17025?

  1. It may be used if it is validated and appropriate for the intended use, with customer agreement where required Correct answer.
  2. It is prohibited because only published standards may be used
  3. It may be used only if the customer supplies the method in writing
  4. It may be used without validation provided results are reported as indicative

Explanation

The standard permits non-standard, laboratory-developed or modified methods provided they are validated as fit for intended use and documented, with customer agreement where relevant. Published standards are not the only permitted source.

Question 8Fundamental principles and concepts of a Laboratory Management System (LMS)

What does metrological traceability mean for a calibration result?

  1. That the result is linked to a reference through a documented unbroken chain of calibrations, each contributing to uncertainty Correct answer.
  2. That the result was produced by the most senior technician available
  3. That the result was compared with a second identical instrument in the same room
  4. That the result is traceable to the day it was recorded in the database

Explanation

Traceability requires an unbroken, documented chain of calibrations linking the result to a stated reference, with each step contributing to measurement uncertainty. It concerns the measurement reference chain, not staff seniority, record dates or informal side-by-side comparison.

Question 9Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory reports a result together with a statement of measurement uncertainty. Which statement best reflects the standard's expectation?

  1. Uncertainty is reported only when the result falls outside specification
  2. Uncertainty must be evaluated for all results and reported where relevant to the validity or application of the result, or as required Correct answer.
  3. Uncertainty statements are required only for calibration certificates
  4. Uncertainty may be omitted whenever the customer does not ask for it

Explanation

Measurement uncertainty must be evaluated for all results where the laboratory performs its own measurements, and reported where it affects validity or application, where the customer's instructions require it, or where it affects compliance with a specification. It is not limited to calibration.

Question 10Fundamental principles and concepts of a Laboratory Management System (LMS)

Which element is a process requirement rather than a resource requirement in ISO/IEC 17025?

  1. Review of requests, tenders and contracts Correct answer.
  2. Personnel competence and records
  3. Accommodation and environmental conditions
  4. Equipment maintenance and calibration

Explanation

Review of requests, tenders and contracts belongs to the process requirements, which describe how the laboratory handles work from request to reporting. Accommodation, equipment and personnel are resource requirements.

Question 11Fundamental principles and concepts of a Laboratory Management System (LMS)

Why does ISO/IEC 17025 place risk-based thinking at the centre of the management system?

  1. To focus effort on the areas where the risk of invalid results is greatest and to act on opportunities for improvement Correct answer.
  2. To replace internal audits with informal risk discussions
  3. To allow the laboratory to drop procedures when it judges them unnecessary
  4. To satisfy insurers who require a documented risk register

Explanation

Risk-based thinking directs attention and resources to where the risk of invalid or unreliable results is highest and encourages action on improvement opportunities. It does not permit abandoning required procedures or replacing audits.

Question 12Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory subcontracts a test to another laboratory. Under ISO/IEC 17025, what is the originating laboratory's responsibility?

  1. To hide the subcontractor's identity to protect confidentiality
  2. To re-perform the test in-house as a check
  3. To inform the customer in advance and ensure the subcontractor is competent and compliant Correct answer.
  4. None, because responsibility transfers entirely with the sample

Explanation

When work is subcontracted, the customer must be informed, preferably in advance and in writing, and the laboratory must ensure the subcontractor is competent and complies with relevant requirements. Responsibility does not simply transfer.

Question 13Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement best captures the relationship between ISO/IEC 17025 and the ISO 9001 quality management principles?

  1. ISO/IEC 17025 and ISO 9001 are mutually exclusive because one is technical and one is administrative
  2. ISO/IEC 17025 forbids laboratories from holding ISO 9001 certification
  3. ISO/IEC 17025 includes management system requirements written so that they generally align with ISO 9001 principles while adding technical competence requirements Correct answer.
  4. ISO/IEC 17025 replaces ISO 9001 entirely for laboratories

Explanation

The management system requirements of ISO/IEC 17025 are written to support operation in a manner generally consistent with ISO 9001 principles, while the standard adds the technical competence requirements that make it specific to laboratories. The two can coexist.

Question 14Fundamental principles and concepts of a Laboratory Management System (LMS)

What distinguishes a reference material from a certified reference material?

  1. A certified reference material is issued only by the laboratory that uses it
  2. A reference material must always be a pure chemical substance
  3. A certified reference material has one or more property values certified by a technically valid procedure, with an associated uncertainty and traceability Correct answer.
  4. A certified reference material is any material used more than once

Explanation

A certified reference material carries certified property values, each accompanied by an uncertainty and a statement of metrological traceability, established by a technically valid procedure. Ordinary reference materials lack that formal certification.

Question 15Fundamental principles and concepts of a Laboratory Management System (LMS)

A customer asks a laboratory to report a result as conforming to a specification. What must the laboratory consider before making the compliance statement?

  1. The seniority of the person who signed the report
  2. Only the customer's preferred wording
  3. The measurement uncertainty and the decision rule applied Correct answer.
  4. Whether the sample was delivered in a branded container

Explanation

Statements of conformity must account for the measurement uncertainty and the decision rule used to decide conformity. Wording preference, packaging or signatory seniority do not substitute for that technical basis.

Question 16Fundamental principles and concepts of a Laboratory Management System (LMS)

Why must a laboratory control environmental conditions where testing or calibration takes place?

  1. Because comfortable staff work faster
  2. Because it removes the need to calibrate equipment
  3. Because conditions can influence results and must be monitored, controlled and recorded where relevant Correct answer.
  4. Because regulators require a fixed room temperature in all laboratories

Explanation

Accommodation and environmental conditions are controlled because factors such as temperature, humidity or contamination can influence measurement validity; where they matter, they must be monitored, controlled and recorded. The requirement is about result validity, not comfort or a universal temperature value.

Question 17Fundamental principles and concepts of a Laboratory Management System (LMS)

Which activity is a management review rather than an internal audit?

  1. Evaluating the suitability and effectiveness of the management system and deciding on changes and resources Correct answer.
  2. Verifying that a corrective action was implemented
  3. Examining whether a procedure is being followed in the test hall
  4. Checking a sample of records against a checklist

Explanation

Management review is a top-level evaluation of the system's continuing suitability, adequacy and effectiveness, leading to decisions on improvement, resources and change. Audits verify conformity of activities and are inputs to that review.

Question 18Fundamental principles and concepts of a Laboratory Management System (LMS)

What is the purpose of a corrective action in a laboratory management system?

  1. To record the nonconformity for the file
  2. To discipline the person who made the error
  3. To eliminate the cause of a nonconformity so that it does not recur Correct answer.
  4. To close the audit finding quickly

Explanation

Corrective action addresses the root cause of a detected nonconformity to prevent recurrence, which is distinct from simply recording the problem or containing its immediate effect. It is not a disciplinary tool nor a fast route to closing a finding.

Question 19Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory wants to demonstrate that a newly introduced in-house method is fit for its intended use. Which activity is required?

  1. Approval of the method by the laboratory's parent company
  2. A single successful test on a customer sample
  3. Comparison of the method's cost with the previous method
  4. Validation of the method using appropriate techniques for the intended use Correct answer.

Explanation

Non-standard, in-house or modified methods must be validated to show they are fit for the intended use, using techniques appropriate to the measurement. A single test or a commercial approval does not establish validation.

Question 20Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement reflects the standard's treatment of sampling as part of laboratory activity?

  1. Sampling is outside the scope of ISO/IEC 17025 because it happens in the field
  2. Sampling results need not be traceable because samples are consumed
  3. Sampling plans and methods must be documented and, where sampling is performed, the sampling process must be controlled and recorded Correct answer.
  4. Sampling is controlled only when the customer pays for it separately

Explanation

Where the laboratory carries out sampling, it must have a documented sampling plan and method, and the sampling process and any deviations must be recorded so that results remain interpretable. Location or commercial arrangements do not remove this requirement.

Question 21Fundamental principles and concepts of a Laboratory Management System (LMS)

What does the requirement for a documented decision rule in reporting signify?

  1. That all results must be rounded to two decimal places
  2. That conformity is declared whenever the measured value lies anywhere near the limit
  3. That the laboratory has agreed and applied a defined basis for deciding conformity, including how uncertainty is handled Correct answer.
  4. That the customer chooses the rule after seeing the result

Explanation

A decision rule defines how conformity or nonconformity is decided, including how measurement uncertainty is treated, and it is communicated and applied consistently. It is not chosen after the fact and does not reduce to rounding conventions.

Question 22Fundamental principles and concepts of a Laboratory Management System (LMS)

Which pair correctly matches a management system element with its purpose?

  1. Document control - selecting which customers to accept
  2. Complaints process - resolving customer dissatisfaction and using feedback to improve Correct answer.
  3. Management review - calibrating reference standards
  4. Internal audit - approving the laboratory's annual budget

Explanation

The complaints process handles customer dissatisfaction and provides feedback for improvement. Internal audit evaluates conformity, management review evaluates the system, and document control manages document versions and availability.

Question 23Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory receives a complaint about a reported result. What does the standard require the laboratory to do?

  1. Publish the complaint and the customer's identity internally as a lesson
  2. Forward it to the accreditation body for resolution
  3. Dismiss it if the result was technically correct
  4. Record the complaint, evaluate it, investigate as appropriate and respond, retaining records of the investigation and actions Correct answer.

Explanation

Complaints must be received, recorded and evaluated, with investigation and response as appropriate and records of the investigation and actions retained. Dismissing, escalating by default or exposing the customer's identity is inconsistent with the requirement.

Question 24Fundamental principles and concepts of a Laboratory Management System (LMS)

Why does ISO/IEC 17025 require the laboratory to have a procedure for reviewing requests, tenders and contracts?

  1. To increase the volume of paperwork for accreditation purposes
  2. To fix the price of every test in advance
  3. To allow the laboratory to change the customer's requirements without discussion
  4. To ensure requirements are adequately defined, understood and within the laboratory's capability before work is accepted Correct answer.

Explanation

Contract review ensures that the customer's requirements, including the method and acceptance criteria, are adequately defined, documented and understood, and that the laboratory has the capability and resources to meet them. It is not a paperwork exercise or a price-setting mechanism.

Question 25Fundamental principles and concepts of a Laboratory Management System (LMS)

What is the role of the laboratory's quality policy within the management system?

  1. It is a confidential document that staff must not see
  2. It replaces the need for documented procedures
  3. It states the laboratory's commitment to good professional practice, quality of results and continual improvement Correct answer.
  4. It lists the names of all approved suppliers

Explanation

The quality policy is a top-level statement of the laboratory's commitment to good professional practice, the quality of its results and continual improvement, and it is communicated and understood within the organisation. It does not replace procedures or list suppliers.

Question 26Fundamental principles and concepts of a Laboratory Management System (LMS)

Which document type does ISO/IEC 17025 require a laboratory to establish for its management system, and what must it contain?

  1. A business plan describing marketing strategy and revenue targets
  2. A quality policy and objectives, documented in a quality manual or equivalent documentation Correct answer.
  3. A quality manual containing only the organization chart and job descriptions
  4. A list of all customers and their contractual payment terms

Explanation

The standard requires top management to establish, implement and maintain a quality policy and objectives, and to provide evidence of commitment; these are documented in a quality manual or equivalent documentation. The management system documentation must be communicated, understood and available, but it is not limited to an organization chart or a list of customers.

Question 27Fundamental principles and concepts of a Laboratory Management System (LMS)

In ISO/IEC 17025, what is the primary function of the laboratory's impartiality requirement?

  1. To require that all staff hold the same technical qualifications
  2. To guarantee that every test result is numerically accurate
  3. To prevent laboratories from accepting work from more than one customer
  4. To ensure that laboratory activities are undertaken without bias from commercial, financial or other pressures Correct answer.

Explanation

Impartiality concerns freedom from pressures that could compromise the objectivity of laboratory activities, and the laboratory must identify risks to impartiality on an ongoing basis. It does not guarantee numerical accuracy, which depends on method validation, traceability and quality control.

Question 28Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory identifies a risk to the validity of its results arising from a new supplier of reagents. According to ISO/IEC 17025, how should this risk be handled?

  1. It should be addressed through actions proportionate to its potential impact on the validity of results Correct answer.
  2. It should be recorded only in the internal audit report at the end of the year
  3. It should be transferred to the customer because suppliers are outside laboratory control
  4. It should be ignored until a nonconformity actually occurs in routine testing

Explanation

The standard requires the laboratory to consider risks and opportunities associated with laboratory activities and to take action proportionate to the potential impact on the validity of results. Risk handling is proactive and integrated into processes, not deferred until failure occurs.

Question 29Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement correctly describes the status of ISO/IEC 17025 in relation to ISO 9001?

  1. ISO/IEC 17025 incorporates the ISO 9001 requirements by reference and adds laboratory-specific clauses
  2. ISO/IEC 17025 is a standalone standard for laboratory competence that includes management system requirements written for laboratory use Correct answer.
  3. ISO/IEC 17025 is a certification scheme administered by accreditation bodies rather than a standard
  4. ISO/IEC 17025 replaces ISO 9001 for any organization that performs testing

Explanation

ISO/IEC 17025 is a standalone document covering both competence and management system requirements tailored to laboratories; it does not incorporate ISO 9001 by reference. Laboratories operating to ISO 9001 alone do not thereby demonstrate technical competence.

Question 30Fundamental principles and concepts of a Laboratory Management System (LMS)

What does the term 'competence' mean when applied to laboratory personnel under ISO/IEC 17025?

  1. Having the demonstrated ability to apply knowledge and skills to perform activities according to defined requirements Correct answer.
  2. Holding a university degree in a scientific discipline
  3. Being named in the organization chart as a supervisor
  4. Having the longest service record in the laboratory

Explanation

Competence is the demonstrated ability to apply knowledge and skills, established through education, training, experience and ongoing monitoring of performance. Qualifications alone, seniority or a job title do not by themselves demonstrate competence.

Question 31Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory is preparing to introduce a new analytical method. Which sequence best reflects the ISO/IEC 17025 principle of method validation before use?

  1. Report results immediately and validate retrospectively if a customer complains
  2. Skip validation when the method was published in a peer-reviewed journal
  3. Validate the method to confirm it is fit for purpose, then authorize its use and monitor performance Correct answer.
  4. Validate the method only after accreditation has been granted for it

Explanation

The laboratory must validate non-standard, in-house developed or modified methods to confirm fitness for intended use before using them, and must subsequently monitor performance. Publication in a journal does not remove the laboratory's obligation to demonstrate fitness in its own environment.

Question 32Fundamental principles and concepts of a Laboratory Management System (LMS)

Which of the following best describes the role of measurement uncertainty in ISO/IEC 17025?

  1. It is a commercial estimate provided by the customer
  2. It replaces the need for metrological traceability
  3. It must be evaluated for all calibrations and for testing where it affects compliance with specification limits Correct answer.
  4. It only applies to research and development work performed outside the scope of accreditation

Explanation

The laboratory must identify contributions to uncertainty and evaluate it, with identification applying to all calibrations and testing where the uncertainty affects conformity to a specification. Uncertainty evaluation complements, and never replaces, traceability.

Question 33Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory uses an external provider to calibrate its reference balance. What does ISO/IEC 17025 require regarding that provider?

  1. The provider must be the lowest-cost bidder in a tendering process
  2. The provider must be a public-sector body
  3. The provider must be located in the same country as the laboratory
  4. The provider must be competent and, where relevant, accredited for the calibration concerned Correct answer.

Explanation

Externally provided products and services must conform to requirements, and the laboratory must evaluate and select providers based on their competence and, where applicable, their accreditation status for the specific calibration. Cost, ownership or geography are not the governing criteria.

Question 34Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement captures the standard's expectation for handling deviations from documented procedures?

  1. Deviations must be reported to the accreditation body before work continues
  2. Deviations may be handled informally provided the final result looks reasonable
  3. Deviations from documented methods must be authorized, documented and accepted by the customer where relevant Correct answer.
  4. Deviations are prohibited in all circumstances

Explanation

Where a deviation from a method is necessary, it must be authorized, technically justified, recorded and, where the deviation affects the result, accepted by the customer. Informal handling or blanket prohibition does not reflect the requirement.

Question 35Fundamental principles and concepts of a Laboratory Management System (LMS)

What is the purpose of the laboratory's document control process under ISO/IEC 17025?

  1. To ensure that only current, approved documents are available at points of use and that obsolete documents are prevented from unintended use Correct answer.
  2. To limit the number of documents the laboratory may hold
  3. To transfer document ownership to the accreditation body
  4. To archive every email exchanged by laboratory staff

Explanation

Documents must be approved before issue, reviewed and updated as necessary, and uniquely identified, with controlled distribution so that current versions are available where work is performed. Obsolete documents must be protected against unintended use.

Question 36Fundamental principles and concepts of a Laboratory Management System (LMS)

How does ISO/IEC 17025 treat records of original observations?

  1. They may be discarded once a report has been issued
  2. They must be retained for a defined period and kept legible, retrievable and protected against alteration Correct answer.
  3. They may be kept only in the analyst's personal notebook
  4. They must be sent to the customer with every report

Explanation

Records must be retained for a defined period, kept in a form that is legible and retrievable, and protected against loss or alteration; the retention period is defined by the laboratory considering contractual and legal obligations. Records are not released to customers by default.

Question 37Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory's equipment is found to be out of tolerance during calibration. What does ISO/IEC 17025 require the laboratory to consider?

  1. Replacing the instrument regardless of the cause
  2. Removing the affected results from the laboratory's records
  3. The effect of the out-of-tolerance condition on previous results and the need to notify affected customers Correct answer.
  4. Only recalibrating the instrument and taking no further action

Explanation

The laboratory must investigate the effect of the defect on previous results and, where results were affected, take appropriate action such as notifying customers and recalling work. Deletion of records would destroy the evidence needed for that investigation.

Question 38Fundamental principles and concepts of a Laboratory Management System (LMS)

Which requirement applies to the laboratory's accommodation and environmental conditions?

  1. All laboratory rooms must be windowless
  2. Conditions must be monitored, controlled and recorded where they influence the validity of results Correct answer.
  3. Temperature must always be maintained at exactly 20 degrees Celsius
  4. Environmental monitoring is required only for microbiological testing

Explanation

Where environmental conditions influence results, the laboratory must monitor and control them, and record the relevant conditions. The specific limits are set by the method or specification, not by a universal fixed temperature.

Question 39Fundamental principles and concepts of a Laboratory Management System (LMS)

What does ISO/IEC 17025 mean by 'metrological traceability' of a measurement result?

  1. The result is related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty Correct answer.
  2. The result has been reviewed and signed by a supervisor
  3. The result is stored in a traceable database
  4. The result has been repeated three times by the same analyst

Explanation

Traceability is a property of a measurement result whereby it is related to a reference through a documented unbroken chain of calibrations, each contributing to uncertainty. Repetition, storage or signature review does not establish that chain.

Question 40Fundamental principles and concepts of a Laboratory Management System (LMS)

A customer requests a test that the laboratory has never performed and for which it has no validated method. What is the most appropriate response under ISO/IEC 17025?

  1. Accept the work and subcontract it without informing the customer
  2. Perform the test with whatever method is available and label the result as indicative
  3. Review the request against capability and resources, and only accept it after ensuring a suitable validated method and competent staff are in place Correct answer.
  4. Decline all requests for new tests permanently

Explanation

The review of requests, tenders and contracts must confirm that requirements are adequately defined and that the laboratory has the capability and resources to meet them. Accepting work without a validated method or competent staff would compromise the validity of results.

Question 41Fundamental principles and concepts of a Laboratory Management System (LMS)

Which of the following is a resource requirement in ISO/IEC 17025?

  1. Handling of test or calibration items
  2. Control of records
  3. Evaluation of measurement uncertainty
  4. Provision of adequate facilities and environmental conditions Correct answer.

Explanation

Facilities and environmental conditions belong to the resource requirements, alongside personnel, equipment and metrological traceability. Handling of items, uncertainty evaluation and records control are process requirements.

Question 42Fundamental principles and concepts of a Laboratory Management System (LMS)

What is the purpose of an internal audit in a laboratory management system?

  1. To confirm that all customers are satisfied with turnaround times
  2. To verify that the management system conforms to the laboratory's own arrangements and to ISO/IEC 17025, and that it is effectively implemented Correct answer.
  3. To appraise individual staff performance for salary decisions
  4. To replace external accreditation assessment

Explanation

Internal audits determine whether the management system conforms to the standard and to the laboratory's own requirements and is effectively implemented and maintained. They are system-focused and planned with defined criteria, scope and auditors.

Question 43Fundamental principles and concepts of a Laboratory Management System (LMS)

A nonconformity is detected during internal audit. What does ISO/IEC 17025 require the laboratory to do?

  1. Reissue the audit report with the finding removed
  2. Record the nonconformity, evaluate the need for corrective action to eliminate the cause, and implement action proportionate to the risk Correct answer.
  3. Wait for the next accreditation cycle before acting
  4. Discipline the individual who performed the activity

Explanation

The laboratory must react to the nonconformity, evaluate the need for action to eliminate the root cause so it does not recur, implement the action, and review its effectiveness. Removing findings or deferring action defeats the corrective action process.

Question 44Fundamental principles and concepts of a Laboratory Management System (LMS)

What must a laboratory do before reporting a result that falls outside the scope of its accreditation, if it chooses to report it at all?

  1. Omit the result from the report entirely
  2. Report it only after the accreditation body grants retrospective approval
  3. Clearly identify the result as not covered by the accreditation Correct answer.
  4. Present it as accredited to avoid confusing the customer

Explanation

Where results are reported and the laboratory holds accreditation, the report must clearly identify results that are not covered by the accreditation so the customer is not misled. Misrepresenting scope is a breach of both impartiality and reporting integrity.

Question 45Fundamental principles and concepts of a Laboratory Management System (LMS)

How does ISO/IEC 17025 address the laboratory's responsibility when it provides opinions and interpretations in a report?

  1. Opinions may be included only if they are identical to the numerical result
  2. Opinions and interpretations may be included and must be clearly identified as such, with the basis on which they are made Correct answer.
  3. Opinions and interpretations are prohibited in accredited reports
  4. Opinions must be approved by the customer before issue

Explanation

When opinions and interpretations are included, the laboratory must ensure they are clearly identified and that the basis on which they are made is documented. They must not be presented as if they were the measurement result itself.

Question 46Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement best explains why ISO/IEC 17025 requires the laboratory to plan and structure its work to manage risk?

  1. To increase the likelihood of achieving the intended purpose of the management system and prevent adverse effects on the validity of results Correct answer.
  2. To remove the requirement for corrective action
  3. To guarantee that no equipment will ever fail
  4. To eliminate the need for internal audits

Explanation

Risk-based thinking increases the likelihood of achieving intended objectives and prevents adverse effects on the validity of results. It complements, rather than replaces, internal audit and corrective action.

Question 47Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory's quality manager proposes to demonstrate conformity with ISO/IEC 17025 by showing an ISO 9001 certificate. How should this be assessed?

  1. It is not sufficient because ISO 9001 does not address the technical competence requirements specific to laboratories Correct answer.
  2. It is sufficient only if the certificate was issued by the same accreditation body
  3. It is sufficient if the certificate is more than three years old
  4. It is sufficient because ISO 9001 covers all laboratory requirements

Explanation

ISO 9001 certification addresses general quality management but does not demonstrate the technical competence, method validation, traceability and uncertainty requirements that ISO/IEC 17025 imposes on laboratories. Conformity with ISO/IEC 17025 must be demonstrated against that standard itself.

Question 48Fundamental principles and concepts of a Laboratory Management System (LMS)

Why does ISO/IEC 17025 require the laboratory to review its management system at planned intervals through management review?

  1. To satisfy customer requests for copies of internal reports
  2. To determine the annual salary budget for technical staff
  3. To ensure continuing suitability, adequacy and effectiveness, and to decide on improvement and resource needs Correct answer.
  4. To replace the need for internal audits and corrective actions

Explanation

Management review evaluates the continuing suitability, adequacy and effectiveness of the management system and considers inputs such as audit results, corrective actions, complaints and risks, producing decisions on improvement and resources. It is a strategic review, not a substitute for audit or a personnel budgeting exercise.

Question 49Fundamental principles and concepts of a Laboratory Management System (LMS)

A laboratory receives a complaint alleging that a reported result was affected by a sample mix-up. What does ISO/IEC 17025 require?

  1. Acknowledge the complaint and resolve it by offering a discount on future work only
  2. Have a documented process to receive, evaluate and decide on complaints, investigate the allegation and take action where justified Correct answer.
  3. Discard the complaint record once the customer is informed
  4. Refer the complaint directly to the accreditation body without internal review

Explanation

The laboratory must have a documented process for receiving, evaluating and making decisions on complaints, and must investigate and take appropriate action, including corrective action where a nonconformity is confirmed. Records of complaints and investigations must be retained.

Question 50Fundamental principles and concepts of a Laboratory Management System (LMS)

Which statement best describes how ISO/IEC 17025 handles sampling as part of laboratory activity?

  1. Sampling is outside the scope because it occurs before the sample reaches the laboratory
  2. When the laboratory performs sampling, it must have a sampling plan and method, and record relevant data Correct answer.
  3. Sampling results need not be considered when evaluating measurement uncertainty
  4. Sampling requires no documentation if it is performed by the customer

Explanation

Where the laboratory performs sampling, it must have a documented sampling plan and method, and must record sampling data and operations so that each result can be linked to the sample taken. Sampling is treated as part of the laboratory activity and its uncertainty contribution is considered where relevant.