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Poll
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Activity 1 (Review Poll) What is the total number of Quality Management
principles for ISO 9001:2015?
10
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Poll
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Activity 1 (Review Poll) What is the total number of operative/auditable
clauses in ISO 9001:2015?
10
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Poll
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Activity 1 (Review Poll) Auditors usually inspect the product quality in an ISO
9001 Audit.
True
False
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Poll
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Activity 1 (Review Poll) - CQI IRCA Specimen Question The purpose of a management
system standard is to __________ the performance of an organization.
improve
monitor
dictate
manage
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Quiz
Activity 2 (PDCA)
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The owner of a small but very successful organization decided to implement an ISO
9001:2015-based QMS was effectively implemented, the owner decide to apply the
steps of the Plan-Do-Check-Act (PDCA) cycle. However, when reading the standard, he
does not clearly understand how to apply the PDCA cycle. Which would be the best
advice you would provide to the owner?
The whole cycle applies to each process required by the standard.
The whole cycle applies only to each clause of the standard
The whole cycle applies only to each sub-clause of the standard
The whole cycle applies only to each clause 0.3.2 of the standard
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Which of the following phrases would apply to ‘Plan’ in relation to the Plan-Do-Check-
Act cycle for a business process?
Training staff
Organisation change
Providing infrastructure
Identifying risks
Retaining documentation
Setting objectives
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Drag and Drop
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Poll
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Activity 4 Which of the following types of quality audits are used for follow-up of
supplier corrective actions?
Third-party audits
Second-party audits
First-party audits
Certification audits
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Activity 5 – Collaborate Board
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Quiz
Activity 7
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Which of the following are critical elements during the selection of the
auditor? (Select two)
Competence
Familiarity
Friendliness
Impartiality
Flexibility
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Which of the following could be considered audit objectives in a QMS third-party audit?
(Choose two)
To verify if the customer requirements have been fulfilled
To verify the financial status of the auditee
To verify if the auditee conducts a supplier audit every year
To verify if the statutory and regulatory requirements have been fulfilled
To verify if the auditee organization has a business development plan
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Quiz
Activity 8
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Which three statements describe the purpose of conducting an ISO 9001:2015
Stage 1 Audit?
Determine if the key documentation requirement of ISO 9001:2015 have been
met.
Determine if the organization's Quality Manual contains the required content.
Assist with developing an audit plan with a logical sequence of processes to
verify during the Stage 2 audit.
Evaluate the organization's readiness for the Stage 2 audit.
Determine if the organization fully conforms to ISO 19011:2018
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Which activities are NOT part of the Stage 2 audit execution?
Opening Meeting
Preparing Audit Plan
Verifying objective evidence
Preparing Audit Conclusion
Interviewing the customer
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All of the following are key reasons to perform Stage 1 Audit EXCEPT:
To review the documented information of the management system
To identify the competency required to perform the audit
To evaluate the conditions at the audit site
To compare the auditee organization with the industry leaders
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Quiz
Activity 9
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Who has the responsibility for assigning work to the audit team?
the audit team leader
the auditee organization
the audit team member
the certification body
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Which two of the following roles do not contribute to the audit outcomes?
Technical expert
Customer
Auditee
Observer
Guide
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Which of the following is the responsibility of the auditee organization?
Conduct documentation Review.
Select the Audit Team Leader.
Conduct audits according to the audit plan.
Provide resources, facilities, and guides.
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Activity 10 – Collaborate Board
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Open Ended Question
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FAA 1A Identify non-applicable clauses or opt-out clauses in the given cases. (In the
answer, please mention the clauses with proper justifications) Alpha Industries is a
small company that produces pharmaceutical products based on client specifications.
However, they are not approved to develop any new drugs by the local food and drug
authority. Which of the ISO 9001 clause is NOT applicable for this organization?
Please enter your answer here.
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Open Ended Question
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FAA 1B Identify nonapplicable clauses or opt-out clauses in the given cases. ( In the
answer, please mention the clauses with proper justifications) Scenario 2 Ostrich
Testing Services (OTS) is a large organization that provides inspection services to clients
who import commodities for food processing. OTS provides inspection services at the
entry point (Airport and Ports) by picking small samples of those commodities and
providing an instant report on conformity at the Customs Warehouse itself. Which of
the ISO 9001 clause is NOT applicable for this organization?
Please enter your answer here.
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Open Ended Question
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FAA 1C Identify nonapplicable clauses or opt-out clauses in the given cases. ( In the
answer, please mention the clauses with proper justifications) Web Reach LLC is
specialized in web design and online advertisements. They do not use any measuring
equipment or instruments in their line of business. Which of the ISO 9001 clause may
NOT be applicable for this organization?
Please enter your answer here.
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FAA 2 - Planning an Audit Programme
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https://docs.google.com/document/d/13AN06jadiFDvjMLxLMP_9BDPTPkwpH7m/edit?usp=sharing&ouid=111269580042510869998&rtpof=true&sd=true
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FAA 3 - Planning for Stage 1 Audit
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FAA 4 - Conducting Stage 1 Audit
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Quiz
Activity 11 - Domain 1 and 2 Comprehensive
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In the context of a third-party certification audit, it is very important to have effective
communication. Which is not the responsibility of the audit team leader?
Planning formal communication arrangements, so an auditee can
communicate with the auditor any time during the audit.
Confirming formal communication channels between the audit team and the
auditee during the opening meeting.
If audit objectives are unattainable, reporting the reasons to the accreditation
body.
Communicating the progress, any significant findings and any concerns to the
auditee and audit client, as appropriate.
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Identify the two activities which pertain to First-Party Audit (FPA))
An auditing firm is hired to audit an organization's different sites.
ABC organization outsourced their internal audits and sent their QMS Manager to evaluate the auditing
firm to verify if it will meet their requirements.
Certification body auditing an organization for its conformance to ISO 9001.
An organization was audited by its local authority for its ability to comply with statutory requirements for
its office extension.
An auditing firm was hired by ABC organization to audit a warehouse facility that will supply storage
services to ABC.
An organization was implementing a quality management system and decided to qualify their external
providers, so they audited them.
An organization audited its management system's implementation to verify the effectiveness of the organization's QMS
implementation.
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Which of the following determines the extent and boundaries of the audit?
Audit Objectives
Audit Criteria
Audit Scope
Audit Evidence
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Which of the following two principles are critical while gathering audit
evidence?
Objective and Verifiable
Hardcopy and Legible
Softcopy and Accessible
Video and Audio Recordings
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Which of the following are classified as Maintained documented
information? Choose two
Scope of the QMS
Competency Record
Communication Matrix
Quality Policy
Quality Records
Key Performance Results
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Read the below scenario to identify the type of audit. ABC corporation has
hired Quality Metrics Auditing firm to audit their suppliers to verify if they
can supply products and services per their Quality requirements.
First Party Audit
Second Party Audit
Third-Party Audit
Compliance Audit
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All of the following are benefits of third-party certification, EXCEPT:
Increased Sales and Profitability
Fulfilling standard requirements of ISO 9001:2015
Fulfilling statutory and regulatory requirements
An unbiased review of the organizational Quality Management System
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In which of the following stage an Audit Plan is prepared?
Conducting Stage 1 Audit
Preparing for Stage 2 Audit
Conducting Stage 2 Audit
Reporting after Stage 2 Audit
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Quality Metrics Auditing Firm is in preparation to conduct a third-party audit. However,
none of the team members has the required technical expertise in the specific industry.
Which of the following is a recommended action?
Cancel the audit
Hire an independent technical expert as part of the audit team
Request client to provide technical expert
Train the team members on the client's technical domain
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Who is responsible for preparing the audit plan?
Lead Auditor
Auditee
Observer
Guide
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Quiz
Domain 1 - Practice Quiz
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The adoption of a quality management system is a _________________ decision for
an organization that can help to improve its overall performance and provide
a sound basis for __________________ development initiatives.
management and quality
one-time and continuous
specific and definable
strategic and sustainable
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Risk‐based thinking enables an organization to ________________the factors that could
cause its processes and its quality management system to deviate from the planned
results, to put in place __________________ controls to minimize negative effects and to
make maximum use of opportunities as they arise.
enable and corrective
identify and accurate
determine and preventive
specify and proper
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Which of the following are quality management principles:
Material Focus, Management Approach, and Investment
Customer Focus, Process Approach, and Improvement
Friendship, Connection of People, and Relative Management
Fraternity, Continuance of People, and Professional management
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An audit is a:
systematic, independent, and documented process for obtaining objective
evidence
strict, keen, and neutral process for deciding management outcome
honest, friendly, and thorough process for getting conformities
applied, helpful and usual process for helping organisations
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Audit evidence should be ____________
versatile
venerable
verifiable
visible
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Choose four auditing principles listed below:
Incidence
Independence
Fair Presentation
Fraternity
Integrity
Applicability
Accessibility
Confidentiality
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Only a risk-based approach in planning, conducting and reporting of the audit can help
achieve the _________________________
Auditing Standard
Audit Plan
Audit Findings
Auditor Timelines
Audit Objectives
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Evidence-based auditing is a:
Optional means of performing an acceptable audit
Optimal method of asking questions and taking audit notes
Rational method to reach a reliable audit conclusion
Nominal means of meeting the auditee and handing over the audit report
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Impartiality helps in conducting an ___________________ auditing and an
_________________ reporting
impartial, objective
lateral, nominal
rational, acceptable
jovial, subjective
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Open Ended Question
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That's a wrap. We now completed Day 1 of the ISO 9001:2015 QMS Lead Auditor
Course. Would you please give us constructive feedback on our: Course Resource
(Day 1) Tutor (What improvements you seek from the tutor for the next session)
Support (What improvement you seek from 3FOLD to enrich your overall learning
experience) Your feedback could help improve the course, which will ultimately
benefit you for rest of the training sessions.
Please enter your answer here.
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