Name: Mohamed Fouad

1. Difference between audit criteria and audit findings

audit criteria audit findings

Set of policies, procedures or requirements Results of the evaluation of the collected audit
used as a reference against which audit evidence against audit criteria. (+ve or –ve)
evidence

2. Difference between audit conclusion and audit finding

audit conclusion audit finding

outcome of an audit after consideration of the Results of the evaluation of the collected audit
audit objectives and all audit finding “Decision” evidence against audit criteria. (+ve or –ve)

3. Difference between audit scope, audit criteria and audit objectives

audit scope audit objectives

 Extent and boundaries of an audit
 Evaluating conformity of
documentation to ISO 9001
 Judging conformity of implementation
to documentation
 Determining effectiveness in meeting
requirements
 Meeting any contractual or regulatory
requirements for auditing providing an
opportunity to improve the QMS

4. Difference between audit plan and audit program

audit plan audit program

Description of the activities and Arrangement for a set of one or more
arrangements for an audit audits planned for a specific
timeframe and directed for a specific
purpose

5. Mention four reasons for conducting documentation review

To review whether the organization comply with QMS or not
Review action taken for non-conformity
Review of any change
Review the effectiveness of the management system

6. What is the purpose of closing meeting?

 Determine the interval between stage 1 and stage 2
 Communicate the organization any further rearrangements for stage 2
 Confirm the readiness of organization to proceed stage 2 audit
 Revise its arrangement for stage 2 audit
7. Mention the difference between correction, corrective action and preventive action
 correction Corrective
Action to eliminate a detected Action to eliminate the cause
non-conformity of a non-conformity and
prevent the recurrence
preventive
Action to eliminate the cause
of a potential non-conformity
or other potential undesired
situation

8. Mention the purpose of opening meeting then mention items to be considered in the opening
meeting
 Establishing good audit environment between auditors and auditees
 Facilitate the smooth running of an audit
 Ease and clear up any misconception
Items: a) introduce the audit team
b) determine the guide
c) review the audit plan with the auditee
d) review visit arrangements
e) confirm confidentiality
f) answer auditee questions
g) restate audit objectives, scope and criteria
h) identifying methods of communication during the audit
i) record attendance
j) describe methods of gathering objective evidence
k) clarify sampling methods
9. Outline five items of audit plan that should be included
 Audit scope
 Audit criteria
 Audit language
 Audit resources
 Audit objectives
 Responsibilities of audit team
 Expected durations
 Key personnel
10. Mention why it is important to contact the auditor prior to an audit then list topics you want to
discuss to contact the auditee prior to the audit

11. Mention meaning of using evidence based approach auditing and mention two reasons for using
it

It is the rational method for reaching reliable and reproductible audit conclusion based on
evidence in a systematic audit
Reasons: to check whether the organization comply with QMS or not
Knowing the area of concerns and non-conformity and opportunity for improvement
12. Identify methods auditor use to gather the data
Interviewing – checklist – documentation and procedures to review
13. Mention the agenda of closing meeting and briefly describe the purpose of each
1. List of Attendees 
The team leader or the second auditor passes around an attendance list with name and position 
to be entered by each attendee. 
2. Thanks 
The team leader should thank the company on behalf of the team for their help, time, etc.
Thank  the guides for their assistance. 
3. Objectives, Scope, and Criteria 
As a formality,the objectives, scope, and criteria should be restated to reset the context of the 
audit. 
4. Report 
The audit conclusions on system effectiveness will be formally reported and the results to be 
given to the auditee should be described.  
5. Limitations 
It bears repetition that the audit was a sample of activities and is, therefore, subject to the risks 
associated with sampling.  
6. Confidentiality 
The lead auditor should reassure the auditee that everything seen or heard during the audit is 
kept in strict confidence. 
6. Audit Summary 
• The audit results should be summarized for presentation to management. • Start by
presenting the positive. 
• Provide sincere and factual feedback on the: 
★ QMS strengths 
★ Departments 
★ Processes 
★ Resources 
★ Controls 
★ documentation, etc.  
• Nonconformity findings may be grouped by functional area (department), clause of the 
standard, and severity level (major, minor, or concern).  
• Findings could also be categorized by type of failure, for example, intent (defined  processes
and documentation), implementation (practices), or effectiveness (results).  
8. Presentation of Nonconformities 
• The nonconformities to be read out one after the other until they have all been presented, 
although it might be necessary to give a summary. 
• Nonconformities may be agreed with the Management Representative or authorized  person.
Signature usually designates acceptance, however, there will be times when the  auditee may
disagree with a particular nonconformity and not accept it. In this case, the  signature may
simply denote acknowledgment of receipt of the nonconformity. 
9. Agreement 
• Although agreement was reached earlier by a departmental representative at that time, the 
wording of the nonconformity is unlikely to have been at its most complete and concise.  •
These nonconformities are signed by the auditee to acknowledge receipt and understanding  of
the content.
  
 10. Recommendation 
• The team leader is responsible for presenting the conclusion reached by the team based on 
the audit results.  
• This is the “informed judgement” of the auditors. It must consider the seriousness of any 
nonconformities and whether they indicate a departmental or company wide breakdown of  the
system.  
• The conclusion must be balanced with positive findings made during the audit. • The
recommendation must reflect what effect the results of the audit will have on the future 
relationship between the two organizations. Thus, if it is a second party audit, the auditors  will
have to make recommendations audit client about business with the auditee. The  auditors
should leave the auditee with a clear idea where they stand. 
• If it is a third party audit, the team leader has to state whether registration is recommended 
or not. A copy of the audit report including any nonconformities is left with the auditee. 
11. Clarification 
• This is the auditee’s opportunity to ask questions about the nonconformities or the summary 
• The team leader should, state that a proposed plan of corrective action is necessary within a 
number of days or weeks after receipt of the report.  
• If the recommendation is for a full re-audit, then it will not be necessary to submit a 
corrective action plan. 
The closing meeting is not the place to discuss actual corrective action. That should  be given
very careful consideration by the auditee.  
12. Departure 
Having presented the findings and discussed them to the auditee's satisfaction, the audit  team
can depart, once again thanking the auditee for time, etc.

14. List four typical phases that is involved in QMS stage 2 audit and briefly describe the role
of lead auditor in each phase

Plan : the auditor confirms audit objective, scope and criteria – select audit team

Do: opening meeting – gather information and evidence

Check : NC’s – opportunity for improvement

Act : closing meeting – final audit report

15. In your words mention the meaning of open minded auditor with example

Open minded auditor : accept all opinions and implementations during audit ( auditor accept to
switch in audit plan ( perform audit on R&D before QC as the QC guide is not available in the
specific time frame)
16. In your words mention the meaning of closed minded auditor with example
Doesn’t accept any opinions during audit ( auditor doesn’t accept to switch in audit plan
(perform R&D audit before QC as the QC guide is not available)
17. In your words mention the meaning of diplomatic auditor with example
 Can conduct the audit and hear from auditee ( auditor hear justifications from auditee)
18. Give examples of working documents that auditor prepare before the audit, then mention how
to use it “benefits of using it”
Audit plan : mention the audit scope – audit criteria – audit objectives – duration and time
frame of audit – audit resources and mentioning the auditors responsibility and names and
posts
Check list : define a formal audit – helps maintain the pace of audit – provide space for audit
notes
Iso 9001: provide requirements that the auditor check on
19. Mention the principles of audit.
Ethical conduct – fair presentation – independence – evidence approach
20. Describe the objective of stage 2 audit
To evaluate the implementation and effectiveness of the organization MS