1.
What is the role of top management in a laboratory according to ISO 17025?
2.
The principles of auditing are only applicable to auditors who work for third-party firms.
3.
The audit programme should be updated to address risks and opportunities identified during its implementation.
4.
An auditor's competence should be evaluated against:
5.
ISO 17025 requires laboratories to document their organizational structure.
6.
The maintenance of an auditor's competence can be demonstrated through participating in audits, even without formal training
7.
What must laboratories ensure about their preventive actions?
8.
ISO 17025 requires laboratories to have a customer feedback system.
9.
Which of the following is NOT a requirement for equipment in ISO 17025?
10.
Which of the following is NOT a process requirement in ISO 17025?
11.
Which of the following is a structural requirement of ISO 17025?
12.
Which of the following is NOT a requirement for test and calibration methods in ISO 17025?
13.
ISO 17025 requires laboratories to have a marketing strategy.
14.
ISO 17025 requires laboratories to have a documented quality objective.
15.
A closing meeting is always required at the conclusion of an audit
16.
ISO 17025 requires laboratories to have a documented management system.
17.
The improvement of the audit programme should be based on:
18.
The auditor must always conduct the audit on-site
19.
What must laboratories ensure about their test and calibration records?
20.
A key part of the risk-based approach is focusing on:
21.
The audit team leader is primarily responsible for:
22.
The audit programme must include the criteria for selecting auditors.
23.
The audit programme manager should monitor the programme to ensure:
24.
What must laboratories ensure about their test and calibration methods?
25.
Which clause of ISO 17025 addresses impartiality and confidentiality?
26.
Laboratories must ensure that their personnel are technically competent.
27.
During the opening meeting, the audit team leader should:
28.
The principle of confidentiality requires auditors to:
29.
What must laboratories ensure about their test and calibration reports?
30.
Which of the following is NOT a general requirement of ISO 17025?
31.
Which clause of ISO 17025 specifies the requirements for the validation of methods?
32.
ISO 17025 requires laboratories to have a documented quality policy.
33.
The principle of independence can be compromised if an auditor has a personal relationship with the person being interviewed
34.
Laboratories must ensure that their test and calibration results are accurate and reliable.
35.
What is the purpose of validating test and calibration methods in ISO 17025?
36.
Which clause of ISO 17025 specifies the requirements for management reviews?
37.
What is the purpose of maintaining accurate and complete test and calibration records in ISO 17025?
38.
The principle of fair presentation requires auditors to report:
39.
What is a key management system requirement in ISO 17025?
40.
The criteria for competence should be established by the audit programme manager
41.
ISO 17025 requires laboratories to have a customer satisfaction survey.
42.
What is a key resource requirement in ISO 17025?
43.
The audit programme manager is responsible for defining the audit programme's scope
44.
Which of the following is a key aspect of laboratory competence according to ISO 17025?
45.
Laboratories must validate their test and calibration methods.
46.
Which of the following is NOT a resource requirement in ISO 17025?
47.
Which principle is primarily concerned with an auditor's professional conduct and judgment?
48.
During the audit, the audit team should gather evidence through:
49.
What must laboratories ensure about their test and calibration methods?
50.
Which clause of ISO 17025 specifies the requirements for internal audits?
51.
The principle of evidence-based approach is directly linked to the concept of:
52.
The overall responsibility for managing an audit programme rests with top management
53.
Which clause of ISO 17025 specifies the requirements for handling test and calibration items?
54.
The methods for evaluating an auditor's competence include:
55.
Which of the following is NOT a requirement for corrective actions in ISO 17025?
56.
What is the primary objective of ISO 17025?
57.
The competence of a technical expert who assists an audit team is the responsibility of the audit programme manager
58.
ISO 17025 requires laboratories to have a financial report.
59.
The competence of a technical expert should be evaluated to ensure they can:
60.
What is required for the documentation of the quality management system in ISO 17025?
61.
The establishment of an audit programme should involve consideration of:
62.
An audit programme can be managed by a team instead of a single person
63.
What is the purpose of conducting management reviews in ISO 17025?
64.
If a nonconformity is found, the audit team must investigate its root cause
65.
Which clause of ISO 17025 specifies the requirements for corrective actions?
66.
The audit programme manager should review the programme to ensure:
67.
Which of the following is NOT a requirement for laboratories under ISO 17025?
68.
ISO 17025 requires laboratories to have a financial plan.
69.
The laboratory director is responsible for the overall management of the laboratory.
70.
Which of the following is NOT a requirement for test and calibration reports in ISO 17025?
71.
During the audit, the team must communicate with the auditee to:
72.
What does ISO 17025 require laboratories to demonstrate regarding their operations?
73.
Which of the following is NOT a structural requirement in ISO 17025?
74.
Who is responsible for ensuring the impartiality of laboratory activities?
75.
Which of the following is a step in preparing for an audit?
76.
What must laboratories ensure about their corrective actions?
77.
Which clause of ISO 17025 specifies the requirements for the quality management system?
78.
Which clause of ISO 17025 deals with the requirements for test and calibration methods?
79.
Which of the following is NOT a requirement for internal audits in ISO 17025?
80.
The audit plan should contain:
81.
Laboratories must ensure that their equipment is validated and maintained
82.
Impartiality and Confidentiality is one of General requirements
83.
A key part of maintaining competence is an auditor's ongoing professional development
84.
The principle of integrity requires auditors to be honest and responsible in their work.
85.
What must laboratories ensure about their management reviews?
86.
The principle of due professional care means auditors should always seek to find as many nonconformities as possible
87.
ISO 17025 requires laboratories to have a financial investment plan.
88.
An auditor must be completely independent from the process they are auditing to be objective.
89.
The competence of an auditor is based on their personal attributes and experience, but not their formal education
90.
Auditors who work for a third-party audit firm are assumed to be competent and do not need to maintain their competence
91.
The competence of an audit team is determined by the competence of the lead auditor alone
92.
When establishing the audit programme, the audit programme manager must consider the risks and opportunities associated with:
93.
The audit programme should be designed to focus only on a specific department, like sales or marketing
94.
An auditor must be completely independent from the process they are auditing to be objective.
95.
What is the purpose of equipment calibration in ISO 17025?
96.
ISO 17025 requires laboratories to have a documented quality management system.
97.
The lead auditor should possess additional skills, such as the ability to:
98.
ISO 17025 requires laboratories to have a customer database.
99.
The lead auditor is responsible for deciding when the audit activities are completed
100.
What is required for the validation of methods in ISO 17025?
