ISO 9001 Lead Auditor Training Course

1.

Module 1 – Introduction to ISO 9001 and quality management systems

The degree to which a set of inherent characteristics of an object fulfills requirements” is known as:

2.

The Plan phase includes activities such as understanding the context of the organization, defining the scope, and defining the quality policy:

3.

In accordance with ISO 9001:2015, which of the following requires documented information to be retained by the organization?

4.

What does the application of the process approach in a quality management system enable?

5.

ISO 9001:2015 requires that the quality policy:

6.

Which of the following is not one of the seven Quality Management Principles?

7.

The following roles are common in the QMS implementation process:

8.

According to ISO 9001:2015, organizational knowledge shall be

9.

What is the benefit of an organization adopting a quality management system?

10.

ISO 9001:2015 requires organizations to prepare a Quality Manual?

11.

Improvement of customer satisfaction is one of the main benefits of implementing ISO 9001:

12.

ISO 9001:2015 requires organizations to assign a Management Representative to promote customer satisfaction?

13.

 In ISO 9001:2015 records and documents are now called documented information?

14.

Which of these documents are mandatory according to ISO 9001?

15.

In ISO 9001:2015 there is no requirement related to Preventive Actions?

16.

Which ISO standard provides guidelines for codes of conduct for organizations, including guidance to an organization in determining that its customer satisfaction provisions meet customer needs and expectations?

17.

ISO 9001:2015 has introduced the concept of risk-based thinking in quality management?

18.

The management strategy is known as the ‘Process Approach’ is a new requirement under ISO 9001:2015?

19.

The QMS consists of which of the following elements?

20.

Under the new Leadership section, top management can delegate a certain portion of the responsibility for ensuring the effective running of the QMS so long as they remain engaged and supportive?

21.

Within ISO 9001:2015, what does “shall” indicate?

22.

There’s still plenty of time to upgrade to ISO 9001:2015 as it doesn’t come into effect until September 2018?

23.

Module 2 – The planning phase

ISO 9001 requires the identification of interested parties significant for the Quality Management System, and for such parties to be documented.

24.

When planning the quality management system, organizations shall consider the issues and requirements referred to in 4.1 and 4.2 and determine the risks and opportunities that need to be addressed to;

25.

In order to define the QMS scope, the company should consider:

26.

How does ISO 9000 define “Management Systems”?

27.

 Who is responsible for reviewing the quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?

28.

Regarding competencies, ISO 9001 requires the company to

29.

Within clause 10.1 of the ISO 9001:2015 standard, what examples of improvement are provided in relation to improving and implementing any necessary actions to meet customer requirements and enhance customer satisfaction?

30.

When defining the quality objectives, the following aspects should be taken into consideration:

31.

How does ISO 9000:2015 define a process?

32.

What is the purpose of addressing risks and opportunities?

33.

Module 3 – Quality management operation

The purpose of implementing process controls is to:

34.

Defining criteria for processes means prescribing how the processes are executed.

35.

All the requirements regarding the product and service must be confirmed by the customer before the organization accepts the order or contract.

36.

Controlled conditions for production and service provision include:

37.

Which of the below is not one of the seven quality management principles?

38.

After production, the organization must determine post-delivery activities, and the following must be considered:

39.

What does Clause 6 of ISO 9001:2015 provide details of?

40.

Module 4 – The Check and Act phases

As part of the process for evaluating the quality, performance, and effectiveness of the QMS, ISO 9001 requires companies to:

41.

What does PDCA stand for?

42.

The internal audit clause from ISO 9001 defines the activities that companies should perform as part of the internal audit, such as:

43.

How does ISO 9001 define Quality Assurance?

44.

ISO 9001 requires the top management to conduct management review meetings for reviewing the QMS of the company.

45.

In order for top management to review the suitability, adequacy, and effectiveness of the QMS of the company, the following information should be taken into account:

46.

ISO 9001 requires companies to keep documented information related to corrective actions so that companies can provide evidence of:

47.

Module 5 – Auditing basics

The following outcomes represent audit findings:

48.

A nonconformity is considered to be a major one if it satisfies at least one of the following criteria:

49.

The audit program should contain the following items:

50.

What is the purpose of ISO 9000:2015?

51.

The information to be included in the internal audit checklist should be the following:

52.

The internal audit report must contain the following information:

53.

The main purpose of the corrective action follow-up is to check whether the corrective action forms are filled in properly.

54.

What is the appropriate approach when doing the interviews with employees?

55.

Who should be choosing the record samples?

56.

Module 6 – Understanding auditing standards

Certification against an ISO management system standard is available to any organization; however, accreditation to ISO 17021-1 is only required for certification bodies that want to issue certificates.

57.

All the competency requirements for a lead auditor are contained in the ISO 17021-1 document.

58.

Auditors should apply the principles of auditing at all times during audits.

59.

Module 7 – Understanding audit roles and responsibilities

If there is only one auditor carrying out the audit, this auditor will perform the duties of the lead auditor and auditor.

60.

Management does not need to be involved in the audit if they are too busy.

61.

It is the lead auditor who makes the final decision about whether or not to issue a certificate to an audit client.

62.

Module 8 – Planning the audit

What three aspects of the audit need to be defined before you can plan the audit?

63.

In a well-planned audit, the lead auditor makes contact with the audit team and the audit client to discuss the audit plans.

64.

Sampling just a limited few records to audit is lazy and should not be encouraged.

65.

Module 9 – Managing the audit process

Opening and closing meetings are an important part of the audit activities. Ideally, the management team should be invited to attend both meetings, but for shorter-duration audits, they should at least be invited to the closing meeting.

66.

Conflicts between auditor and audit should

67.

The debriefing sessions should be used to discuss the audit progress with the audit client, and not to discuss audit findings between auditors.

68.

Module 10 – Managing your audit team

Who is responsible for writing the audit plan?

69.

If one member of your audit team falls ill during the audit and is unable to participate in any more work, you should:

70.

Photographic copies of documents are not official audit documents and cannot be used to replace hard paper copies.

71.

You’re a good Lead Auditor when:

72.

Module 11 – Completing a successful audit

The difference between a major non-conformity and a minor non-conformity is the severity of the consequences to the business, for example compliance implications or cost.

73.

The audit report should include recommendations on how to fix the non-conformities so that the organization knows how to fix the issue.

74.

The closing meeting can be skipped if the audit has run out of time.