Question 1

Which of the following is NOT a requirement for the management system documentation according to ISO/IEC 17025:2017?

Accepted Answer

All documentation must be digitally stored andbacked up in at least three different geographical locations.

Answer

The laboratory must define and document itspolicies, systems, programs, procedures, and instructions.

Answer

The management system documentation must includethe roles and responsibilities of technical and management personnel.

Answer

The documentation must be communicated to,understood by, available to, and implemented by the relevant personnel.

Question 2

What does ISO/IEC 17025:2017 require regarding the control of management system documents under Option A?

Accepted Answer

Laboratories must establish a formal procedure for document control, including review, approval, and revision.

Answer

Management system documents must be in hard copy form to ensure integrity and confientiality.

Answer

External documents are not required to be controlled or reviewed for relevance to the management system.

Answer

All laboratory personnel must have unrestricted access to all management system documents at all times.

Question 3

What is required for the identification of nonconforming work in a laboratory as per ISO/IE 17025:2017?

Accepted Answer

Documentation and review of nonconforming work

Answer

Client notification within 24 hours

Answer

Immediate cessation of related activities

Answer

Mandatory external audit

Question 4

How does ISO/IEC 17025:2017 address confidentiality in laboratories?

Accepted Answer

Applies to all information obtained during laboratory activities.

Answer

Only applies to electronic data.

Answer

Requires written consent for all data sharing.

Answer

Optional for non-sensitive data.

Question 5

According to ISO/IEC 17025:2017, what is the role of management reviews?

Accepted Answer

To ensure the effectiveness of the management system and laboratory operations.

Answer

To review and approve all technical methods.

Answer

To review external and internal audits results, procedures and policies and financial performance.

Answer

To address financial performance only.

Question 6

What does ISO/IEC 17025:2017 require regarding the use of externally provided products and services?

Accepted Answer

Laboratories must evaluate and monitor the performance of external providers.

Answer

External products and services do not require evaluation.

Answer

Use of external products and services is notallowed when accredited activities is performed.

Answer

Laboratories must use only internally developed products and services.

Question 7

In the context of ISO/IEC 17025:2017, how should a laboratory approach the calibration of its equipment to ensure reliability in testing and calibration results?

Accepted Answer

Equipment calibration should be traceable to national or international standards.

Answer

Calibration is only required for new equipment.

Answer

In-house calibration methods are preferred regardless of their validation status.

Answer

Calibration frequency is at the discretion of laboratory clients.

Question 8

How does ISO/IEC 17025:2017 guide laboratories in the selection and use of reference materials?

Accepted Answer

Reference materials, when used, must be traceable to SI units or certified reference materials.

Answer

Laboratoriesare encouraged to develop their own reference materials as needed.

Answer

Reference materials must be used in every test and calibration.

Answer

Use of reference materials is optional.

Question 9

In terms of continual improvement, what specific approach is recommended by ISO/IEC 17025:2017 for laboratories to enhance their management system and technical competencies?

Accepted Answer

Use of feedback, audits, reviews, and corrective actions to drive improvements.

Answer

Implement only corrective actions without preventive measures.

Answer

Continual improvement is considered optional and left to the laboratory's discretion.

Answer

Focus solely on internal audits and management reviews.

Question 10

How does ISO/IEC 17025:2017 guide laboratories in ensuring personnel competence for specific tasks?

Accepted Answer

Periodic performance evaluations are recommendedto ensure ongoing competence.

Answer

Competence is based solely on academic qualifications.

Answer

External certification is required for all personnel performing accredited technical tasks.

Answer

Competence is assessed once at the time of hiring to achieve the final qualification.

Question 11

How does ISO/IEC 17025:2017 address the need for laboratory personnel to maintain confidentiality and impartiality in their work, considering potential conflicts of interest and pressures that could compromise testing and calibration integrity?

Accepted Answer

By establishing policies and procedures that ensure personnel act impartially and maintain confidentiality.

Answer

By requiring annual signed confidentiality agreements from all personnel.

Answer

Through mandatory external audits of personnel conduct.

Answer

Requiring that personnel have no direct financial interest in the outcome of the laboratory's work.

Question 12

Considering the principles of ISO/IEC17025:2017, which approach is recommended for laboratories to continuously validate their methods and ensure the reliability of results, especially when introducing new tests or adapting existing methods?

Accepted Answer

Using a combination of internal quality controls, external quality assessments, and comparison of results with other laboratories to evaluate method performance over time.

Answer

Relying solely on the initial validation conducted at the time of method development.

Answer

Limiting method validation to those instances where significant discrepancies in results are observed, to conserve resources.

Answer

Implementing a fixed schedule for revalidation that applies universally to all methods.

Question 13

How does ISO/IEC 17025:2017 specify the treatment of unexpected results or deviations from standard methods within a testing report?

Accepted Answer

By documenting and justifying any deviations or non-standard methods used.

Answer

By excluding them to maintain report clarity.

Answer

By requiring a separate report for any deviations from standard procedures.

Answer

By reporting only the standard method results, regardless of deviations.

Question 14

How does ISO/IEC 17025:2017 require laboratories to monitor and control environmental conditions to ensure the integrity of test results and calibrations?

Accepted Answer

Laboratories must define and document the range of acceptable environmental conditions that affect the validity of results.

Answer

Environmental monitoring equipment is recommended but not required for accreditation.

Answer

Environmental conditions should be recorded only when deviations from normal conditions occur.

Answer

Only temperature and humidity need to be monitored, regardless of the test or calibration.

Question 15

ISO/IEC 17025:2017 requires laboratories to handle test or calibration items in a way that ensures what?

Accepted Answer

The integrity and identification of the items are maintained.

Answer

The items are disposed of in an environmentally friendly manner.

Answer

The items are processed in the order they are received.

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