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Quality management principles 5- improvement.

The owner of a small but very successful organization decided to implement an ISO 9001:2015-
based QMS. To ensure that the QMS was effectively implemented, the owner decided 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.
Select the correct application of the PDCA cycle in a management system.

- The whole cycle applies only to clause 0.3.2 of the standard.

- The whole cycle applies only to each clause of the standard.
- The whole cycle applies only to each subclause of the standard.
- The whole cycle applies to each process required by the standard.

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Which one of the following is not an ISO 9000:2015 quality management principle?

- Evidence-based decision-making
- Leadership
- Process approach
- Risk-based approach
- Customer focus
- Relationship management

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Which one of the following is not an ISO 9000:2015 quality management principle?

- Evidence-based decision-making
- Leadership
- Process approach
- Risk-based approach
- Customer focus
- Relationship management

Integrated management System awareness Eng. : Mohamed Fouad 32

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Below are four of the seven principles on which ISO 9000 series are based. Match each a related
potential benefit to each of quality management principles (QMP). Quality management principles:
- Customer focus
- Engagement of people
- Improvement
- Evidence-based decision-making
- ------------------------------------------------------------------
- Increased revenue and market share
- Enhanced drive for innovation
- Enhanced trust and collaboration throughout the organization
- Improved operational effectiveness and efficiency
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Below are four of the seven principles on which ISO 9000 series are based. Match each a related
potential benefit to each of quality management principles (QMP). Quality management principles:
- Customer focus: Increased revenue and market share
- Engagement of people: Enhanced trust and collaboration throughout the organisation
- Improvement: Enhanced drive for innovation
- Evidence-based decision-making: Improved operational effectiveness and efficiency

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Which two of the following are the key expected results of a quality management system that conforms to the
requirements of ISO 9001:2015?
• Consistently provide products that meet customers' requirements
• Decreased number of warranty claims
• Decreased number of management system nonconformities
• Increased profits
• Decreased number of nonconforming products in all stages of the manufacturing cycle
• Enhanced customer satisfaction

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As a third-party auditor, you must lead a Stage 1 certification audit to an organization ABC that manufactures steel
tubes of 10-70 cm diameter. They have implemented a quality management system (ISO 9001) for the whole plant.
However, for marketing purposes, they want to certify the management system for the manufacture of tubes of
only 10-25 cm diameter. They have two production lines with the same infrastructure and can manufacture all
tubes in both lines.
What would be an acceptable path forward? Select one.
- Do not accept to perform the audit; the scope of certification cannot be narrower than the scope of ABC's
management system.
- Accept to perform the audit only to the manufacture of tubes from 10-25 cm, as required by ABC.
- Accept to perform the audit if ABC commits to dedicate one production line only for tubes of 10-25 cm.
- Accept to perform the audit if ABC commits to extend the scope of certification to all tubes in 12 months' time.
- Accept to perform the audit if ABC agrees labelling the tubes manufactured within the scope of the
management system with the words ISO 9000.

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Select the words that best complete the sentence:

"When auditing the scope of a quality management system, it is important to review the organisation's [………………………]
 context including interested parties
 improvement , goals
 physical infrastructure
 competence requirements
 performance evaluation

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Select the words that best complete the sentence:

"When auditing the scope of a quality management system, it is important to review the organisation's [………………………]
 context including interested parties
 improvement , goals
 physical infrastructure
 competence requirements
 performance evaluation

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1. Which clause tells you to identify the processes needed for the quality management system?
a) 4.1 c) 5.1
b) 4.4 d) 6.1
2. Which clause describes the scope of the organization’s quality management system?
a) 4.1 c) 4.3
b) 4.2 d) 4.4
3. Which requirement needs to maintain or retain a "Documented Information" according to ISO 9001:2015 in context"
a) 4.1, 4.4.2 c) 4.2, 4.1
b) 4.1, 4.2 d) 4.3, 4.4.2

"When auditing the scope of a quality management system, it is important to review the organisation's [………………………]
a) context including interested parties
b) improvement, goals
c) competence requirements
d) performance evaluation

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From‫ت‬the‫ت‬activities‫ت‬below‫ت‬which‫ت‬one‫ت‬is‫ت‬an‫ت‬evidence‫ت‬of‫"ت‬Management‫ت‬commitment"‫ت‬
a) adjust or re-adjust measuring manager's as necessary.
b) take care of customer property
c) promoting the use of the process approach and risk-based thinking
d) provide training
A‫"ت‬Quality‫ت‬Policy"‫ت‬shall‫ت‬،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،
a) provides a framework for setting quality objectives.
b) be exactly the same as the purpose or goal of the organization.
c) be communicated and understand within the managers level.
d) be reviewed for continuing suitability every month.
Top‫ت‬Management‫ت‬shall‫ت‬assign‫ت‬the‫ت‬responsibility‫ت‬and‫ت‬authority‫ت‬for،
a) ensuring that the processes are delivering their intended outputs.
b) reporting on the performance of the quality management system and on opportunities for improvement in particular to top
management.
c) ensuring the promotion of customer focus throughout the organization.
d) All of the above.
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From‫ت‬the‫ت‬activities‫ت‬below‫ت‬which‫ت‬one‫ت‬is‫ت‬an‫ت‬evidence‫ت‬of‫"ت‬Management‫ت‬commitment"‫ت‬
a) adjust or re-adjust measuring devices as necessary.
b) take care of customer property
c‫ ا‬promoting‫ت‬the‫ت‬use‫ت‬of‫ت‬the‫ت‬process‫ت‬approach‫ت‬and‫ت‬risk-based‫ت‬thinking
d) provide training
A‫"ت‬Quality‫ت‬Policy"‫ت‬shall‫ت‬،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،،
a‫ ا‬provides‫ت‬a‫ت‬framework‫ت‬for‫ت‬setting‫ت‬quality‫ت‬objectives،
b) be exactly the same as the purpose or goal of the organization.
c) be communicated and understand within the managers level.
d) be reviewed for continuing suitability every month.
The‫ت‬Management‫ت‬shall‫ت‬assign‫ت‬the‫ت‬responsibility‫ت‬and‫ت‬authority‫ت‬for،
a) ensuring that the processes are delivering their intended outputs.
b) reporting on the performance of the quality management system and on opportunities for improvement in particular to top
management.
c) ensuring the promotion of customer focus throughout the organization.
d‫ ا‬All‫ت‬of‫ت‬the‫ت‬above،
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During an external audit, the auditor asks to see the quality policy and is shown an intranet web page headed "Our
Mission". The auditee states they do not have a stand-alone "quality policy" document.
The auditor is informed that copies of the "Our Mission" web page are displayed on notice boards throughout the
facility. The auditor verifies that this is the case, and notices that neither the web page nor the pages displayed on
notice boards is signed by Top Management.
How should the auditor respond? Select 3
- Raise a non-conformity because the organization has not established a quality policy
- Review the document to understand the strategic direction of the organization, then ask to see the quality policy
- Review the document to see if it covers the requirements of ISO 9001 5.2.
- Gave positive feedback that the policy is clearly communicated within the organization,
- Ask members of staff to explain their understanding of the policy and how it applies to their job role.
- Rase a non-conformity because there is no evidence that "top management, has established a quality policy",
- Discuss with Top Management their involvement in developing, implementing, and maintaining the quality policy.
- To avoid raising a non-conformity, ask the auditee if they can get Top Management to sign the document before
the end of the audit

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During an external audit, the auditor asks to see the quality policy and is shown an intranet web page headed "Our
Mission". The auditee states they do not have a stand-alone "quality policy" document.
The auditor is informed that copies of the "Our Mission" web page are displayed on notice boards throughout the
facility. The auditor verifies that this is the case, and notices that neither the web page nor the pages displayed on
notice boards is signed by Top Management.
How should the auditor respond? Select 3
- Raise a non-conformity because the organization has not established a quality policy
- Review the document to understand the strategic direction of the organization, then ask to see the quality policy
- Review the document to see if it covers the requirements of ISO 9001 5.2. ✔
- Gave positive feedback that the policy is clearly communicated within the organization,
- Ask members of staff to explain their understanding of the policy and how it applies to their job role. ✔
- Rase a non-conformity because there is no evidence that "top management, has established a quality policy",
- Discuss with Top Management their involvement in developing, implementing, and maintaining the quality
policy. ✔
- To avoid raising a non-conformity, ask the auditee if they can get Top Management to sign the document before
the end of the audit
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•You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time and safety training to
customers.
You are interviewing the Quality Systems Manager (QSM).
You: "What risks and opportunities have the business identified?"
QSM: "I'll show you. This was discussed with the Managing Director at the latest management review."
Narrative: The QSM shows you the latest management review record and points to the following table:

Reference Risks and Opportunities

1 Nine of the 10 employed trainers are retiring within next 12 months.

2 Changes to health and safety legislation imminent.

3 Market information indicates increasing preference for technology-driven, self-paced training.

4 Customer feedback highlights need for multi-language heath and safety training.

You: "How is the business planning to address these risks and opportunities?"
QSM: The MD said that they already knew about them, so it was not necessary."
You decide to raise a nonconformity.

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Nonconformity report

ISO 9001 Clause Number:

Nature of problem:

ISO 9001 requirement that has not been fulfilled:

To complete the nonconformity report, click on the blank section you want to complete so it is
highlighted in red and then click on the applicable text from the options below. Alternatively, you may
drag and drop the options to the appropriate blank section.

•"The organization shall plan Actions to address risks and opportunities

•Actions to address risks and opportunities not planned
•6.1.2a

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Nonconformity report

ISO 9001 Clause Number: 6.1.2a

Nature of problem: Actions to address risks and opportunities not planned

ISO 9001 requirement that has not been fulfilled: "The organization shall plan Actions to address risks and opportunities

To complete the nonconformity report, click on the blank section you want to complete so it is
highlighted in red and then click on the applicable text from the options below. Alternatively, you may
drag and drop the options to the appropriate blank section.

•The organization shall plan Actions to address risks and opportunities

•Actions to address risks and opportunities not planned
•6.1.2a

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ABC is an organization that employs 150 people. As audit team leader, you are conducting a certification audit
at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality
objectives have been set for every employee in the organization except top management. The Quality
Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking
questions about how much it will cost. He asks for your opinion on whether this is the correct method of
setting objectives.
Select the two best options of how the auditor should best respond to his question.
- The auditor should advise the organization to budget for its quality objectives.
- The organization should re-evaluate its own process for setting quality objectives.
- The auditor should evaluate the process for setting quality objectives.
- The organization should always include top management in setting quality objectives.
- The auditor should refuse to be drawn into giving his opinion.
- The organization should revise its quality objectives every year.
- The auditor should advise the organization to engage a quality consultant

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ABC is an organization that employs 150 people. As audit team leader, you are conducting a certification audit
at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality
objectives have been set for every employee in the organization except top management. The Quality
Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking
questions about how much it will cost. He asks for your opinion on whether this is the correct method of
setting objectives.
Select the two best options of how the auditor should best respond to his question.
- The auditor should advise the organization to budget for its quality objectives.
- The organization should re-evaluate its own process for setting quality objectives.
- The auditor should evaluate the process for setting quality objectives.
- The organization should always include top management in setting quality objectives.
- The auditor should refuse to be drawn into giving his opinion.
- The organization should revise its quality objectives every year.
- The auditor should advise the organization to engage a quality consultant

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Which three of the following phrases would apply to 'Plan' in relation to the Plan-Do-Check-Act cycle
for a business process?
- Identifying risks
- Releasing products
- Evaluating suppliers
- Setting objectives
- determining process steps and interactions
- Retaining documentation

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Which three of the following phrases would apply to 'Plan' in relation to the Plan-Do-Check-Act cycle
for a business process?
- Identifying risks
- Releasing products
- Evaluating suppliers
- Setting objectives
- determining process steps and interactions
- Retaining documentation

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Which one of the following options is the definition of the context of an organisation?
- Complexity of internal and external issues that can take an effect on an organisation's approach to developing and
achieving its purpose.
- Consideration of internal and external issues that can have a positive or negative effect on an organisation's success.
- Combination of internal and external issues can have an effect on an organisation's approach to developing and achieving
its objectives.
- Control of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.

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Which one of the following options is the definition of the context of an organisation?
- Complexity of internal and external issues that can take an effect on an organisation's approach to developing and
achieving its purpose.
- Consideration of internal and external issues that can have a positive or negative effect on an organisation's success.
- Combination of internal and external issues can have an effect on an organisation's approach to developing and
achieving its objectives.
- Control of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.

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7.1.5 Monitoring and measuring resources

7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results when
monitoring or measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
‫ج‬The organization shall retain appropriate documented information as evidence of fitness for purpose of
monitoring and measurement resources.

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7.1.5 Monitoring and measuring resources

7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results when
monitoring or measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
‫ج‬The organization shall retain appropriate documented information as evidence of fitness for purpose of
monitoring and measurement resources.

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7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part
of providing confidence in the validity of measurement results, measuring equipment shall be:
a) Calibrated or verified, or both at specified intervals, or prior to use against measurement standards
traceable to international or national measurement standards. Where no such standards exist, the basis
used for calibration or verification shall be retained as documented information;
b) identified in order to determine their calibration status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
and subsequent measurement results.
The organization shall determine if the validity of previous measurement results has been adversely affected
when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as
necessary
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You are conducting a Stage 2 audit to ISO 9001 of an engineering organization, and you found that the 12V power
supply for a product test had not been recalibrated since it was purchased five years before. The test procedure
stated that the power supply should be standardized at 12V during the test, but the test report did not reflect this.
You raised the following nonconformity against clause 7.1.5 of ISO 9001.
“The 12V power supply unit ref. PS02 is not capable of producing the required constant voltage for conduct of the
galvanic efficiency test. Test report GETR0321 for Project DK confirmed that the voltage varied between 10.5V and
12V.”
Which of the following options would provide part of the acceptable corrective actions to close out the
nonconformity at the follow-up audit?
- Retest all anodes awaiting despatch with the proper equipment.
- Replace the power supply unit PS02 with a newly calibrated unit.
- Assign a test operator to stand by the power supply during the test and reset the unit if it starts to drift.
- Replace the power supply with a standardized 12V battery.
- Revise the test procedure to allow some drift in voltage during the test.
- Maintain PS02 to ensure that it is capable of supplying 12V constantly during the test.

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You are conducting a Stage 2 audit to ISO 9001 of an engineering organization, and you found that the 12V power
supply for a product test had not been recalibrated since it was purchased five years before. The test procedure
stated that the power supply should be standardized at 12V during the test, but the test report did not reflect this.
You raised the following nonconformity against clause 7.1.5 of ISO 9001.
“The 12V power supply unit ref. PS02 is not capable of producing the required constant voltage for conduct of the
galvanic efficiency test. Test report GETR0321 for Project DK confirmed that the voltage varied between 10.5V and
12V.”
Which of the following options would provide part of the acceptable corrective actions to close out the
nonconformity at the follow-up audit?
- Retest all anodes awaiting despatch with the proper equipment.
- Replace the power supply unit PS02 with a newly calibrated unit.
- Assign a test operator to stand by the power supply during the test and reset the unit if it starts to drift.
- Replace the power supply with a standardized 12V battery.
- Revise the test procedure to allow some drift in voltage during the test.
- Maintain PS02 to ensure that it is capable of supplying 12V constantly during the test. ✔

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You are carrying out an audit at an organization seeking certification to 1S0 9001 I for the first time. The organization offers
regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.
You are auditing the organization’s laboratory where trials are performed to determine the microbiological stability of customers'
products over the life of the product. You are interviewing the Laboratory Supervisor (LS).
You: "I would like to review your calibration arrangements. What equipment do you calibrate!"
LS: "We calibrate two weigh scales, four temperature measuring probes and one pH meter"
You: "How often do you calibrate these?"
LS: "The weigh scales are calibrated once each day. The temperature measuring probes are also calibrated once each day. The ph
meter is set up using standard pH solutions prior to use."
You need to determine the extent to which ISO 9001 requirements are fulfilled with respect to the control of this equipment.
Which of the following statements is false?
- You would verify a selection of appropriate calibration records for each item of equipment
- You would determine how the suitability of the equipment was confined.
- You would confirm a documented procedure for calibration is available and in use.
- You would confirm those responsible for calibration are competent.
- You would determine how other equipment is calibrated.
- You would determine the extent of traceability of measurement standards.
- You would determine the action taken should calibration results exceed defined tolerances.

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You are carrying out an audit at an organization seeking certification to 150 9001 I for the first time. The organization offers
regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.
You are auditing the organization’s laboratory where trials are performed to determine the microbiological stability of customers'
products over the life of the product. You are interviewing the Laboratory Supervisor (LS).
You: "I would like to review your calibration arrangements. What equipment do you calibrate!"
LS: "We calibrate two weigh scales, four temperature measuring probes and one pH meter"
You: "How often do you calibrate these?"
LS: "The weigh scales are calibrated once each day. The temperature measuring probes are also calibrated once each day. The pit
meter is set up using standard pH solutions prior to use."
You need to determine the extent to which ISO 9001 requirements are fulfilled with respect to the control of this equipment.
Which of the following statements is false?
- You would verify a selection of appropriate calibration records for each item of equipment
- You would determine how the suitability of the equipment was confined.
- You would confirm a documented procedure for calibration is available and in use. ✔
- You would confirm those responsible for calibration are competent.
- You would determine how other equipment is calibrated.
- You would determine the extent of traceability of measurement standards.
- You would determine the action taken should calibration results exceed defined tolerances.

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Match the process descriptions below to the process names:

- The process by which the accuracy of test equipment is checked against a known standard.:

- The process by which a product or service is visually examined to determine conformity to requirements.:

- The process by which data is examined in detail to reach a specific answer or answers.:

- The process by which a parameter of a product or service is examined to determine a specific value.:

Measurement - Analysis - Calibration – Monitoring

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Match the process descriptions below to the process names:

- The process by which the accuracy of test equipment is checked against a known standard.: Calibration

- The process by which a product or service is visually examined to determine conformity to requirements.: Monitoring

- The process by which data is examined in detail to reach a specific answer or answers.: Analysis

- The process by which a parameter of a product or service is examined to determine a specific value.: Measurement

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7.1.6 Organizational Knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of
products and services.
This knowledge shall be maintained and made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to
acquire or access the necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information
that is used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on::
a)internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful
projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes,
products and services)
b)external sources (e.g. standards, academia, conferences, gathering knowledge from customers or external providers).

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You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of
cosmetics. You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for
providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"
TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry.
" You: "How is their regulatory competence maintained?"
TD: "They are dedicated individuals with lots of contacts in the sector."
You: "How does the business enable them to maintain their understanding of current regulatory requirements?"
TD: "We leave that up to them."
You decide to raise a nonconformity.

Nonconformity report

ISO 9001 Clause Number:

Nature of problem:

ISO 9001 requirement that has not been fulfilled:

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 38
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You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of
cosmetics. You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for
providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"
TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry.
" You: "How is their regulatory competence maintained?"
TD: "They are dedicated individuals with lots of contacts in the sector."
You: "How does the business enable them to maintain their understanding of current regulatory requirements?"
TD: "We leave that up to them."
You decide to raise a nonconformity.

Nonconformity report

ISO 9001 Clause Number: 7.1.6

Nature of problem: The business has not maintained its organisational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve
ISO 9001 requirement that has not been fulfilled:
conformity products and services."

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7.2 Competence
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the performance and
effectiveness of the quality management system; Skill Matrix/ competency Matrix

b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
Training Or External Competent person
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
Evaluation after interview
Or Training Evaluation
d) retain appropriate documented information as evidence of competence. Or Performance Appraisal
Employee File

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of
currently employed persons; or the hiring or contracting of competent persons.

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You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of
cosmetics. You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for
providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"
TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry.
" You: "How is their regulatory competence maintained?"
TD: "They are dedicated individuals with lots of contacts in the sector."
You: "How does the business enable them to maintain their understanding of current regulatory requirements?"
TD: "We leave that up to them."
You decide to raise a nonconformity.

Nonconformity report

ISO 9001 Clause Number:

Nature of problem:

ISO 9001 requirement that has not been fulfilled:

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 44
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of
cosmetics. You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for
providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"
TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry.
" You: "How is their regulatory competence maintained?"
TD: "They are dedicated individuals with lots of contacts in the sector."
You: "How does the business enable them to maintain their understanding of current regulatory requirements?"
TD: "We leave that up to them."
You decide to raise a nonconformity.

Nonconformity report

ISO 9001 Clause Number: 7.2

The organisation has not determined the necessary competence of the Regulatory Experts with
Nature of problem:
respect to relevant regulatory requirements
The organization shall ensure that persons are competent on the basis of appropriate education,
ISO 9001 requirement that has not been fulfilled:
training, or experience"

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 45
 Quality Institution For
Engineering & Management Consultancy

Quality Records
Provide objective evidence that the Documented Quality Management System has been effectively implemented and
demonstrated the conformance to requirements. The ISO Standard makes a number of reference notes to keeping quality records.
‫تيي ت عت ى لاادضت ى قومينتىاتات‬ISO ‫علييلتيىيدت ت تلتتيلتلعتمادلتتي قات ىو يات ى شظتهيتعلتعمتيدقتعثودتامددت لا قت ىع اظت نت ى ع يعدضوتيليلت ميدقت‬
‫ةولضت ىو ياو‬
An interim record may be made and then promoted to a permanent record once the complete information is available.
‫ي وعتت دتةودت مهضتشلتعقهيعمتتىلتةودتي ىلتع وقيتع اقت ى مي دضت ىود ين‬
- Record what has happened / been achieved ‫ةودت دتاي ت تعلتعاليلم‬
- Should not change (snapshot at a point in time) ‫يوعتلتتععييقتطىل نتالت هضت ميعي‬
Examples:
Inspection Records
Test Records
Training Records
Audit Records
Management Review Records
Design Review Records

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 11
 Quality Institution For
Engineering & Management Consultancy

What is the purpose of retaining documented information in a QMS?

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 12
 Quality Institution For
Engineering & Management Consultancy

The purpose of retaining documented information in a QMS is to is to demonstrate proof of conformity.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 13
 Quality Institution For
Engineering & Management Consultancy

Speedymatic supplies component parts to the automotive repair sector and the Sales Department mostly
receives orders by telephone for immediate delivery. The customer usually quotes part numbers from the
product catalogue. The paperwork usually follows days later.
Select three options of objective evidence you would seek associated with Speedymatic's process of
managing customer requirements to determine conformance with ISO 9001 clause 8.2.
- A conversation with a sales operative about telephone calls.
- Evidence that customer requirements are reviewed for availability for delivery.
- Internal audit reports of the Sales Department.
- Evidence of continual improvement in delivery times.
- Evidence of warranty claims for defective products,
- Notes by sales staff of verbal customer orders to reconcile with the paperwork received later.
- Product specifications for part numbers that are clearly defined in the product catalogue.
- Date stamping of the documented customer orders when received

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 23
 Quality Institution For
Engineering & Management Consultancy

Speedymatic supplies component parts to the automotive repair sector and the Sales Department mostly
receives orders by telephone for immediate delivery. The customer usually quotes part numbers from the
product catalogue. The paperwork usually follows days later.
Select three options of objective evidence you would seek associated with Speedymatic's process of
managing customer requirements to determine conformance with ISO 9001 clause 8.2.
- A conversation with a sales operative about telephone calls.
- Evidence that customer requirements are reviewed for availability for delivery. ✔
- Internal audit reports of the Sales Department.
- Evidence of continual improvement in delivery times.
- Evidence of warranty claims for defective products,
- Notes by sales staff of verbal customer orders to reconcile with the paperwork received later. ✔
- Product specifications for part numbers that are clearly defined in the product catalogue. ✔
- Date stamping of the documented customer orders when received

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 24
 Quality Institution For
Engineering & Management Consultancy

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 37
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which of the following options is the basis for the nonconformity?
• 8.3.4.d Design validation is not conducted systematically. It is omitted about half of the time.
• 8.6 Course materials are released without proper approval. A course for 24/7 Insurance was released on an urgent basis.
• 8.3.2.c Design planning does not include design validation. Design verification is part of the planning process.
• 8.3.6 Design changes are not systematically actioned. Changes may be made if customers request them.
• 8.3.3 Design inputs do not include customer priorities for course delivery.
• 8.3.5 The improvements made to course designs are not documented. Feedback from customers is not always actioned.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 38
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which of the following options is the basis for the nonconformity?
• 8.3.4.d Design validation is not conducted systematically. It is omitted about half of the time.
• 8.6 Course materials are released without proper approval. A course for 24/7 Insurance was released on an urgent basis.
• 8.3.2.c Design planning does not include design validation. Design verification is part of the planning process.
• 8.3.6 Design changes are not systematically actioned. Changes may be made if customers request them.
• 8.3.3 Design inputs do not include customer priorities for course delivery.
• 8.3.5 The improvements made to course designs are not documented. Feedback from customers is not always actioned.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 39
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product
packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used
to help control the product development process.
Audit evidence ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people in
his team to cope with the demand for new products.
The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer
feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails
are kept on SWIFT.

The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.

The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trails on some
formulations during product development.
“8.3.2e) …internal… resource needs for the design and development of products...“
"8.3.2e) ... external... resource needs for the design and development of products...”
"8.3.5) ... retain documented information...”
"8.3.6) ... retain documented information..."
“8.3.4d) … conducted to ensure that the design and development outputs meet...”

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 40
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product
packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used
to help control the product development process.
Audit evidence ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD
“8.3.2e) …internal… resource needs for the design
Manager explains he has not got enough people in his team to cope with the
and development of products..."
demand for new products.
The NPD Manager explains many changes are made to cosmetic formulations
during product development owing to retailer feedback. Only when confirmed "8.3.6) ... retain documented information..."
by the retailer is the agreed formulation documented on SWIFT.
The NPD Manager explains that the customer confirms their approval to
"8.3.5) ... retain documented information...”
proceed with a new formulation by email. These emails are kept on SWIFT.
The NPD Manager shows you evidence of consumer trials that are carried out “8.3.4d) … conducted to ensure that the design
for some new products prior to full-scale launch. and development outputs meet...”
The NPD Manager explains that an approved external laboratory is used to
perform shelf-life stability trails on some formulations during product
"8.3.2e) ... external... resource needs for the
development. design and development of products...”

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 41
 Quality Institution For
Engineering & Management Consultancy

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 11
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which of the following options is the basis for the nonconformity?
• 8.3.4.d Design validation is not conducted systematically. It is omitted about half of the time.
• 8.6 Course materials are released without proper approval. A course for 24/7 Insurance was released on an urgent basis.
• 8.3.2.c Design planning does not include design validation. Design verification is part of the planning process.
• 8.3.6 Design changes are not systematically actioned. Changes may be made if customers request them.
• 8.3.3 Design inputs do not include customer priorities for course delivery.
• 8.3.5 The improvements made to course designs are not documented. Feedback from customers is not always actioned.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 12
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which of the following options is the basis for the nonconformity?
• 8.3.4.d Design validation is not conducted systematically. It is omitted about half of the time.
• 8.6 Course materials are released without proper approval. A course for 24/7 Insurance was released on an urgent basis.
• 8.3.2.c Design planning does not include design validation. Design verification is part of the planning process.
• 8.3.6 Design changes are not systematically actioned. Changes may be made if customers request them.
• 8.3.3 Design inputs do not include customer priorities for course delivery.
• 8.3.5 The improvements made to course designs are not documented. Feedback from customers is not always actioned.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 13
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product
packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used
to help control the product development process.
Audit evidence ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people in
his team to cope with the demand for new products.
The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer
feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails
are kept on SWIFT.

The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.

The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trails on some
formulations during product development.
“8.3.2e) …internal… resource needs for the design and development of products...“
"8.3.2e) ... external... resource needs for the design and development of products...”
"8.3.5) ... retain documented information...”
"8.3.6) ... retain documented information..."
“8.3.4d) … conducted to ensure that the design and development outputs meet...”

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 14
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product
packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used
to help control the product development process.
Audit evidence ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD
“8.3.2e) …internal… resource needs for the design
Manager explains he has not got enough people in his team to cope with the
and development of products..."
demand for new products.
The NPD Manager explains many changes are made to cosmetic formulations
during product development owing to retailer feedback. Only when confirmed "8.3.6) ... retain documented information..."
by the retailer is the agreed formulation documented on SWIFT.
The NPD Manager explains that the customer confirms their approval to
"8.3.5) ... retain documented information...”
proceed with a new formulation by email. These emails are kept on SWIFT.
The NPD Manager shows you evidence of consumer trials that are carried out “8.3.4d) … conducted to ensure that the design
for some new products prior to full-scale launch. and development outputs meet...”
The NPD Manager explains that an approved external laboratory is used to
perform shelf-life stability trails on some formulations during product
"8.3.2e) ... external... resource needs for the
development. design and development of products...”

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 15
 Quality Institution For
Engineering & Management Consultancy
ABC is a car washing company with 25 automated stations around residential areas of large cities. Thinking about awarding a large
contract to ABC for cleaning its cars, a national taxi chain (CAR XX) decided to audit ABC's ISO 9001 management system.
You, as audit team leader, are interviewing the ABC Station 1 Supervisor (S1).
You: "Could you please tell me which quality objectives apply to the washing process?"
SI: "The key objective is to wash cars in less than 15 minutes. Our policy is that if it takes more than 15 minutes from the start, the next
wash will be free. We monitor the start and finish by camera, which records the time taken. You see on screen that in the last two hours, we
had an average of 13.5 minutes per car."
You: "Are there any other improvement objectives?"
S1: "We have a set of recording video cameras that continuously record the washing process. They recycle every two weeks. This is the
only documented information that we have on the process. We use them for regularly training our employees. We aim to improve on the
number of vehicles needing a second wash."
You: "How do you plan to do this?"
S1: "I personally control the quality of the service for each car before we give the keys to the owner. I hope to reduce the rewash rate to
not more than one or two cars in a week. I'll get a bonus when we achieve that."
On the basis of the interview, which four of the following controls are being applied?
- ABC uses suitable monitoring and measuring devices to verify acceptance criteria.
- ABC implements monitoring at appropriate stages of the process
- ABC appoints competent personnel to undertake operations.
- ABC Implements actions to prevent human error.
- ABC implements release activities.
- ABC exercises care with property belonging to customers,
- ABC has sufficient documentation to control the process.
- ABC is using suitable infrastructure for the service.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 24
 Quality Institution For
Engineering & Management Consultancy
ABC is a car washing company with 25 automated stations around residential areas of large cines. Thinking about awarding a large
contract to ABC for cleaning its cars, a national taxi chain (CAR XX) decided to audit ABC's ISO 9001 management system.
You, as audit team leader, are interviewing the ABC Station 1 Supervisor (S1).
You: "Could you please tell me which quality objectives apply to the washing process?"
SI: "The key objective is to wash cars in less than 15 minutes. Our policy is that if it takes more than 15 minutes from the start, the next
wash will be free. We monitor the start and finish by camera, which records the time taken. You see on screen that in the last two hours, we
had an average of 13.5 minutes per car."
You: "Are there any other improvement objectives?"
S1: "We have a set of recording video cameras that continuously record the washing process. They recycle every two weeks. This is the
only documented information that we have on the process. We use them for regularly training our employees. We aim to improve on the
number of vehicles needing a second wash."
You: "How do you plan to do this?"
S1: "I personally control the quality of the service for each car before we give the keys to the owner. I hope to reduce the rewash rate to
not more than one or two cars in a week. I'll get a bonus when we achieve that."
On the basis of the interview, which four of the following controls are being applied?
- ABC uses suitable monitoring and measuring devices to verify acceptance criteria.
- ABC implements monitoring at appropriate stages of the process✔
- ABC appoints competent personnel to undertake operations.
- ABC Implements actions to prevent human error. ✔
- ABC implements release activities. ✔
- ABC exercises care with property belonging to customers,
- ABC has sufficient documentation to control the process. ✔
- ABC is using suitable infrastructure for the service.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 25
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office
and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of
these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the
company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop
managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these
shops over the next five years.

You raised a nonconformity against clause 8.5.1 of ISO 9001. Select the words that best complete the sentence:

"The […………...] failed to control the laundry operations provided for […………....]in five shops. The [……………....]used was not
capable of [……………..] producing the required service."

To complete the sentence click on the blank section you want to complete so it is highlighted in red and then click on
the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

[quality system] [organisation] [consistently] [procedure] [people] [equipment]

[facility] [efficiently] [customers] [normally] [manager] [services]

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 26
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office
and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of
these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the
company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop
managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these
shops over the next five years.

You raised a nonconformity against clause 8.5.1 of ISO 9001. Select the words that best complete the sentence:

"The [organisation..] failed to control the laundry operations provided for […customers..]in five shops. The […equipment..]used
was not capable of […consistently] producing the required service."

To complete the sentence click on the blank section you want to complete so it is highlighted in red and then click on
the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

[quality system] [organisation] [consistently] [procedure] [people] [equipment]

[facility] [efficiently] [customers] [normally] [manager] [services]

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 27
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of Head Office
and e sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of
these complaints related to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the
organisation. The cleaning equipment needs replacing but the organisation cannot afford it at the moment. You learn that the
shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials. On raising
the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next
five years. Then reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer
over damage to an expensive cashmere coat. Select the best option for how this should be handled by the Quality
Management System.

• Give an explanation to the customer of what went wrong.

• Make an offer to replace the coat with a new one.
• Report the situation to the customer with suggested remedial action.
• Settle the court case by negotiation with the customer.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 30
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of Head Office
and e sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of
these complaints related to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the
organisation. The cleaning equipment needs replacing but the organisation cannot afford it at the moment. You learn that the
shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials. On raising
the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next
five years. Then reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer
over damage to an expensive cashmere coat. Select the best option for how this should be handled by the Quality
Management System.

• Give an explanation to the customer of what went wrong.

• Make an offer to replace the coat with a new one.
• Report the situation to the customer with suggested remedial action.
• Settle the court case by negotiation with the customer.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 31
 Quality Institution For
Engineering & Management Consultancy

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 5
 Quality Institution For
Engineering & Management Consultancy

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing
structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the
adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour."
You: "What happens if the colour is wrong?"
Operator: The billet goes back into the furnace."
You: "Is the pyrometer ever used?"
Operator: "Only in borderline cases.
You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the
borderline cases.
Select three options that would provide evidence of conformance with cause 9.1.1 of ISO 9001.
A. Certification showing that the pyrometer is calibrated to standards.
B. A procedure that provides instruction in taking billet temperature.
C. A quality objective to achieve lower recycle rates for billets.
D. An increase in the use of the pyrometer by operators.
E. Periodic analysis of the results of temperature checks.
F. Training records for furnace operators.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 11
 Quality Institution For
Engineering & Management Consultancy

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing
structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the
adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour."
You: "What happens if the colour is wrong?"
Operator: The billet goes back into the furnace."
You: "Is the pyrometer ever used?"
Operator: "Only in borderline cases.
You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the
borderline cases.
Select three options that would provide evidence of conformance with cause 9.1.1 of ISO 9001.
A. Certification showing that the pyrometer is calibrated to standards.
B. A procedure that provides instruction in taking billet temperature.
C. A quality objective to achieve lower recycle rates for billets.
D. An increase in the use of the pyrometer by operators.
E. Periodic analysis of the results of temperature checks.
F. Training records for furnace operators.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 12
 Quality Institution For
Engineering & Management Consultancy

9- Performance evaluation

Takitup is a small fabrication company that manufactures steel fencing, stairs, and platforms for the construction
sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit
plan during a surveillance audit covers the company's improvement actions and the auditor asks to see the
most recent management review meeting minutes.
Which three statements would represent output audit evidence for the management review?

- Actions for quality system improvement

- Report of performance of quality objectives in the last year
- Positive and negative customer comments
- Revisions required to the quality system documentation
- Procurement of a laser measuring tool
- Updates to the risk register

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 21
 Quality Institution For
Engineering & Management Consultancy

9- Performance evaluation

Takitup is a small fabrication company that manufactures steel fencing, stairs, and platforms for the construction
sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit
plan during a surveillance audit covers the company's improvement actions and the auditor asks to see the
most recent management review meeting minutes.
Which three statements would represent output audit evidence for the management review?

- Actions for quality system improvement✔

- Report of performance of quality objectives in the last year
- Positive and negative customer comments
- Revisions required to the quality system documentation✔
- Procurement of a laser measuring tool ✔
- Updates to the risk register

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 22
 Quality Institution For
Engineering & Management Consultancy

10- Improvement

Which three of the following are required by ISO 9001:2015 as

documented information?
- Results of management reviews
- Quality manual
- Quality policy
- Evidence of competence
- Process diagrams
- Work instructions

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 23
 Quality Institution For
Engineering & Management Consultancy

10- Improvement

Which three of the following are required by ISO 9001:2015 as

documented information?
- Results of management reviews✔
- Quality manual
- Quality policy✔
- Evidence of competence✔
- Process diagrams
- Work instructions

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 24
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality
Manager (QM)
You: "Would you tell me about your management review process?"
QM: "The senior management team plans to review the management system every six months. The review follows a set
agenda and records are maintained."
You: "May I see the records from the last two management reviews?"
Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine
months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest
review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
Nonconformity report
ISO 9001 Clause Number:
Nature of problem:
ISO 9001 requirement that has not been fulfilled:

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 25
 Quality Institution For
Engineering & Management Consultancy

You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality
Manager (QM)
You: "Would you tell me about your management review process?"
QM: "The senior management team plans to review the management system every six months. The review follows a set
agenda and records are maintained."
You: "May I see the records from the last two management reviews?"
Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine
months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest
review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
Nonconformity report
ISO 9001 Clause Number: 9.3.1
Nature of problem: Management review has not been conducted at the defined frequency.
ISO 9001 requirement that has not been fulfilled: Top management shall review the organization's quality management
system at planned intervals.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 26
 Quality Institution For
Engineering & Management Consultancy

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory
equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12
months?"
Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house."
You: "That sounds like quite a significant change. What has been the impact of that?"
Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own
brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20%
of our workforce, so this has been quite a challenging time"
This scenario presents a number of audit trails to different ISO 9001 requirements. Which six of the following requirements would be
relevant audit trails for this scenario?
• Control of externally provided processes, products, and services
• Documented information
• Measurement traceability
• Design and development of products and services
• Leadership and commitment
• Planning of change
• Organisation roles and responsibilities
• Preservation of product
• Property belonging to customers or external providers
• Resources
Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 27
 Quality Institution For
Engineering & Management Consultancy

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory
equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12
months?"
Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house."
You: "That sounds like quite a significant change. What has been the impact of that?"
Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own
brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20%
of our workforce, so this has been quite a challenging time"
This scenario presents a number of audit trails to different ISO 9001 requirements. Which six of the following requirements would be
relevant audit trails for this scenario?
• Control of externally provided processes, products, and services
• Documented information
• Measurement traceability
• Design and development of products and services
• Leadership and commitment
• Planning of change
• Organisation roles and responsibilities
• Preservation of product
• Property belonging to customers or external providers
• Resources
Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 28
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of Head
Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same
region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the
oldest shops in the organisation. The cleaning equipment needs replacing but the organisation cannot afford it now. You
learn that the shop managers were told to dismiss most of the claims based on the poor quality of the laundered
materials. On raising the matter with senior management, you are told that there are plans to replace the equipment in
these shops over the next five years.

• The organisation informing customers of the reason for the damage to their laundry:
• Management allocating sufficient resources to replace outdated equipment:
• Corrective action to deal with customer complaints:
• Top management addressing the risk of damage to customer property:
• Management setting a quality objective for the level of customer complaints:

10.2.1 b 5.1.2 b 8.5.3 7.1.3 b 6.2

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 29
 Quality Institution For
Engineering & Management Consultancy

XYZ is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of Head
Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same
region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the
oldest shops in the organisation. The cleaning equipment needs replacing but the organisation cannot afford it now. You
learn that the shop managers were told to dismiss most of the claims based on the poor quality of the laundered
materials. On raising the matter with senior management, you are told that there are plans to replace the equipment in
these shops over the next five years.

• The organisation informing customers of the reason for the damage to their laundry: 8.5.3
• Management allocating sufficient resources to replace outdated equipment: 7.1.3 b
• Corrective action to deal with customer complaints: 10.2.1 b
• Top management addressing the risk of damage to customer property: 5.1.2 b
• Management setting a quality objective for the level of customer complaints: 6.2

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 30
 Quality Institution For
Engineering & Management Consultancy

You are conducting a third-party audit of an organization that, eight months before your audit, underwent a significant restructuring and
reduction in the number of employees. You review the organization’s internal audit arrangements. You determine that:
- There is an internal audit programme for the current year, authorized by top management.
- The audit programme shows that each department is to be audited once every six months, giving a total for the year of 18 audits.
- The audit programme has been the same for the previous three years.
- At the time of your review, 12 internal audits should have been completed but in fact, none have been carried out.
- Results of internal audits from the previous two years show 37 nonconformities were reported; 19 of which originated in the sales department
Your auditee tells you the internal audit programme has not been implemented because, at the start of the year, all of the trained internal auditors
were either redeployed to other sites or left the organization. Your audit guide confirms this is correct and provides evidence that the ask to the
internal audit system was brought to the attention of top management before the organizational changes were made but no action has been
taken
Which three of the following ISO 9001 requirements relate to the non-conformity or non-conformities in the scenario?
- 5.1.1-Leadership and commitment
- 6.1.1-Determine the risks and opportunities
- 6.3 - Planning of changes
- 7.1.5-Moriitoring and measuring resources
- 7.1.6-Organizational knowledge
- 9.2-Internal audits
- 10.2 - Non-conformity and corrective action

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 13
 Quality Institution For
Engineering & Management Consultancy

You are conducting a third-party audit of an organization that, eight months before your audit, underwent a significant restructuring and
reduction in the number of employees. You review the organization’s internal audit arrangements. You determine that:
- There is an internal audit programme for the current year, authorized by top management.
- The audit programme shows that each department is to be audited once every six months, giving a total for the year of 18 audits.
- The audit programme has been the same for the previous three years.
- At the time of your review, 12 internal audits should have been completed but in fact, none have been carried out.
- Results of internal audits from the previous two years show 37 nonconformities were reported; 19 of which originated in the sales department
Your auditee tells you the internal audit programme has not been implemented because, at the start of the year, all of the trained internal auditors
were either redeployed to other sites or left the organization. Your audit guide confirms this is correct and provides evidence that the ask to the
internal audit system was brought to the attention of top management before the organizational changes were made but no action has been
taken
Which three of the following ISO 9001 requirements relate to the non-conformity or non-conformities in the scenario?
- 5.1.1-Leadership and commitment✔
- 6.1.1-Determine the risks and opportunities
- 6.3 - Planning of changes✔
- 7.1.5-Moriitoring and measuring resources
- 7.1.6-Organizational knowledge
- 9.2-Internal audits✔
- 10.2 - Non-conformity and corrective action

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 14
 Quality Institution For
Engineering & Management Consultancy

- ABC is a worldwide fast-food organization. One of the branches, in downtown Cape Town, decided to implement an ISO 9001
quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits,
Stage 2.
ABC receive the orders by phone or internet, some of the employees deliver the ordered food to indicated addresses. The normal
menu includes 15 afferent types of hamburgers; however, in the last two weeks, due to a shortage of a special type of meat, they
can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the
reception of orders from customers (via phone or internet) and the communication of Ure orders to the kitchen. She noticed that
the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she
observed many customers reluctantly accepting something other than the hamburger they preferred.
She discusses different options with the team. Match each option to the relevant clause of the standard:
Options discussed by the team
ABC has not determined the risk associated with a shortage of meat 10.2
ABC has not identified the shortage of meat as a nonconformity to its OMS 6.1
ABC does not meet the claims for the products it offers 7.3
ABC did not take action to amend its website content to reflect menu changes 8.4
ABC did not monitor the performance of the supplier of meat 7.4
The employee that receives the orders is not aware of how to deal with the problem within the 8.2.3
QMS

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 15
 Quality Institution For
Engineering & Management Consultancy

- ABC is a worldwide fast-food organization. One of the branches, in downtown Cape Town, decided to implement an ISO 9001
quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits,
Stage 2.
ABC receive the orders by phone or internet, some of the employees deliver the ordered food to indicated addresses. The normal
menu includes 15 afferent types of hamburgers; however, in the last two weeks, due to a shortage of a special type of meat, they
can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the
reception of orders from customers (via phone or internet) and the communication of Ure orders to the kitchen. She noticed that
the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she
observed many customers reluctantly accepting something other than the hamburger they preferred.
She discusses different options with the team. Match each option to the relevant clause of the standard:
Options discussed by the team
ABC has not determined the risk associated with a shortage of meat 6.1
ABC has not identified the shortage of meat as a nonconformity to its OMS 10.2
ABC does not meet the claims for the products it offers 8.2.3
ABC did not take action to amend its website content to reflect menu changes 7.4
ABC did not monitor the performance of the supplier of meat 8.4
The employee that receives the orders is not aware of how to deal with the problem within the 7.3
QMS

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 16
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course. The auditor decides to
review the training course design process in more depth. Select six options that provide a meaningful audit trail for this
process.
• What risks and opportunities have been identified as significant?
• What input does a customer have in the course design process?
• What training does a tutor have in the completed course?
• How is design documentation controlled and managed?
• How are students advised about prior learning requirements?
• What are the qualifications of the development staff?
• How is technical content of courses verified as correct?
• How is the cost of the course calculated?
• How is customer feedback integrated into the course?
Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 30
 Quality Institution For
Engineering & Management Consultancy

ABC is an organisation specialising in the design and production of e-learning training materials for the insurance market.
During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used
for validation of the final course design. She states that they usually ask customers to validate the product with volunteers.
She says that the feedback received often leads to key improvements. The auditor samples the design records for a recently
completed course for the 24/7 Insurance organisation. Design verification was carried out but there was no validation report.
The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was
omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for
feedback and often make changes. There is no record of feedback in the design file for the course. The auditor decides to
review the training course design process in more depth. Select six options that provide a meaningful audit trail for this
process.
• What risks and opportunities have been identified as significant?
• What input does a customer have in the course design process?
• What training does a tutor have in the completed course?
• How is design documentation controlled and managed?
• How are students advised about prior learning requirements?
• What are the qualifications of the development staff?
• How is technical content of courses verified as correct?
• How is the cost of the course calculated?
• How is customer feedback integrated into the course?
Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 31
 Quality Institution For
Engineering & Management Consultancy

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 8
 Quality Institution For
Engineering & Management Consultancy

Which of the following three options could be considered potential threats to impartiality in an audit
context?

§ Competence
§ Experience
§ Self-audit
§ Intimidation
§ Familiarity

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 14
 Quality Institution For
Engineering & Management Consultancy

Which of the following three options could be considered potential threats to impartiality in an audit
context?

§ Competence
§ Experience
§ Self-audit✓
§ Intimidation ✓ ‫يهوت‬ ‫فيوخ‬
§ Familiarity ✓ ‫فلألا‬

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 15
 Quality Institution For
Engineering & Management Consultancy

Which two of the following auditors would not participate in a first-party audit?
An auditor certified by IRCA
An auditor employed by an external consultancy organisation
An auditor from a customer
An auditor from an interested party
An auditor trained in the IRCA scheme
An auditor trained in-house

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 19
 Quality Institution For
Engineering & Management Consultancy

Which two of the following auditors would not participate in a first-party audit?
An auditor certified by IRCA
An auditor employed by an external consultancy organisation
An auditor from a customer ✔
An auditor from an interested party ✔
An auditor trained in the IRCA scheme
An auditor trained in-house

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 20
 chec
Plan Do k
act

5.2 Establishing audit programme 5.7 Reviewing and improving

objectives audit programme

5.3 Determining and evaluating audit

programme risks and opportunities

5.4 Establishing the audit 5.5 Implementing audit 5.6 Monitoring audit
programme programme programme

6.2 Initiating audit

6.7 Conducting audit follow-up

6.3 Preparing audit activities 6.4 Conducting audit activities

6.5 Preparing and distributing 6.6 Completing audit

audit report 26
 Quality Institution For
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5.3 Determining and evaluating audit programme risks

Plan
failure to set relevant audit objectives and determine the extent, number, duration, locations and
planning schedule of the audits;

allowing insufficient time, equipment and/or training for developing the audit programme or
resources conducting an audit;

selection of the audit

insufficient overall competence to conduct audits effectively
team

communication ineffective external/internal communication processes/channels

ineffective coordination of the audits within the audit programme, or not considering information
implementation security and confidentiality
ineffective determination of the necessary documented information required by auditors and
control of documented
relevant interested parties, failure to adequately protect audit records to demonstrate audit
information programme effectiveness
monitoring, reviewing and
ineffective monitoring of audit programme outcomes
improving the audit programme

availability and cooperation

availability of evidence to be sampled
of auditee evidence

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 27
 Quality Institution For
Engineering & Management Consultancy

Plan
5.3 Determining and evaluating audit programme opportunities

allowing multiple audits to be conducted in a single visit

minimizing time and distances travelling to site

matching the level of competence of the audit team to the level of competence needed to achieve the audit
objectives

aligning audit dates with the availability of auditee’s key staff

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 28
 Quality Institution For
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Plan
5.4 Establish audit programme:
5.4.1 Roles and responsibilities of the individuals managing the audit programme:

the the
coordination establishment audit follow-up
and scheduling of external and if applicable
of all audits internal
within the communication reporting to
audit processes, as the audit client
programme appropriate and relevant
the
interested
establishment of
audit objectives, parties, as
scope(s) and appropriate
criteria of the evaluating
audits, auditors
determining the resolutions
audit methods of disputes and
and selecting the handling of
audit team
complaints
‫ةج فأموفتاع ينلاألا‬
‫فأكشاي‬

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 29
 Quality Institution For
Engineering & Management Consultancy

What factors should be considered, by the audit programme manager, when determining the size and
composition of the audit team for a certification audit? Select four factors that should be considered.
- The overall competence of the audit team needed to achieve audit objectives, considering audit scope and
criteria
- The audit scope and criteria
- The cost of the audit
- Customer relationships
- Number of employees of the auditee
- Type and complexity of the processes to be audited
- Seniority of the audit team leader
- The duration preferred by the auditee

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad
 Quality Institution For
Engineering & Management Consultancy

What factors should be considered, by the audit programme manager, when determining the size and composition
of the audit team for a certification audit? Select four factors that should be considered.
- The overall competence of the audit team needed to achieve audit objectives, considering audit scope and
criteria✔
- The audit scope and criteria✔
- The cost of the audit
- Customer relationships
- Number of employees of the auditee✔
- Type and complexity of the processes to be audited✔
- Seniority of the audit team leader
- The duration preferred by the auditee

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad
 Quality Institution For
Engineering & Management Consultancy

In the context of a third-party certification audit, match the roles with the following responsibilities:
1. Conduct the audit to the assigned area.[………..……..]
2. Assist the auditors in identifying personnel to participate in the audit.[………………]
3. Assign each team member's responsibility for the audit.[………………]
4. Respond to questions and provide evidence to the auditor.[……………….]
To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the
applicable to the correct responsibility.
a) Auditee
b) Auditors
c) Audit team leader
d) Guide

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 5
 Quality Institution For
Engineering & Management Consultancy

In the context of a third-party certification audit, match the roles with the following responsibilities:
1. Conduct the audit to the assigned area.[………B..……..]
2. Assist the auditors in identifying personnel to participate in the audit.[………D………]
3. Assign each team member's responsibility for the audit.[………C………]
4. Respond to questions and provide evidence to the auditor.[………A……….]
To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the
applicable to the correct responsibility.
a) Auditee
b) Auditors
c) Audit team leader
d) Guide

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 6
 Quality Institution For
Engineering & Management Consultancy

Select which one of the following statements is true .

A. A technical expert can replace a qualified auditor on an audit team.

B. An audit team can include non-qualified auditors.
C. Audit leading to auditor qualification are undertaken annually.
D. The team leader shall be an auditor that is qualified in the scheme.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 7
 Quality Institution For
Engineering & Management Consultancy

Select which one of the following statements is true .

A. A technical expert can replace a qualified auditor on an audit team.

B. An audit team can include non-qualified auditors.
C. Audit leading to auditor qualification are undertaken annually.
D. The team leader shall be an auditor that is qualified in the scheme. ✔

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 8
 Quality Institution For
Engineering & Management Consultancy

An auditor of organization ABC has conducted a second-party audit of their external provider XYZ. Which
three of the following actions could represent a breach of confidentiality by the auditor having identified
findings in the XYZ quality management system?
- He shares his findings with the quality manager of ABC
- He shares his findings with the other auditors of ABC
- He shares his findings with the office staff of XYZ
- He shares his findings with XYZ's auditors
- He shares his findings with the procurement manager of ABC

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 14
 Quality Institution For
Engineering & Management Consultancy

An auditor of organization ABC has conducted a second-party audit of their external provider XYZ. Which
three of the following actions could represent a breach of confidentiality by the auditor having identified
findings in the XYZ quality management system?
- He shares his findings with the quality manager of ABC
- He shares his findings with the other auditors of ABC ✔
- He shares his findings with the office staff of XYZ ✔
- He shares his findings with XYZ's auditors ✔
- He shares his findings with the procurement manager of ABC

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 15
 Quality Institution For
Engineering & Management Consultancy

Select which one of the following statements is true .

A. A technical expert can replace a qualified auditor on an audit team.

B. An audit team can include non-qualified auditors.
C. Audit leading to auditor qualification are undertaken annually.
D. The team leader shall be an auditor that is qualified in the scheme.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 19
 Quality Institution For
Engineering & Management Consultancy

Select which one of the following statements is true .

A. A technical expert can replace a qualified auditor on an audit team.

B. An audit team can include non-qualified auditors.
C. Audit leading to auditor qualification are undertaken annually.
D. The team leader shall be an auditor that is qualified in the scheme. ✔

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 20
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Stage 1 , Initial Audit , Documentation Review Audit

- Review All System Documentation
- Internal Audit Report
- Management Review Report

Stage 2 , Main Audit , Certification Audit

- Review all Records

- Review Implementations

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 29
 Quality Institution For
Engineering & Management Consultancy

Which one of the following options best describes the purpose of a Stage 1 third-party
audit?
To determine the auditees understanding of ISO 9001.
To get to know the organisation's customers.
To introduce the audit team to the client.
To learn about the organisation's procurement processes.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 31
 Quality Institution For
Engineering & Management Consultancy

Which one of the following options best describes the purpose of a Stage 1 third-party
audit?
To determine the auditees understanding of ISO 9001. ✔
To get to know the organisation's customers.
To introduce the audit team to the client.
To learn about the organisation's procurement processes.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 32
 Quality Institution For
Engineering & Management Consultancy

Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
• Checklist
• Procedures
• Audit Plan
• Audit Report
• Findings
• Risk Matrices

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 36
 Quality Institution For
Engineering & Management Consultancy

Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
• Checklist
• Procedures
• Audit Plan
• Audit Report
• Findings
• Risk Matrices

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 37
 Quality Institution For
Engineering & Management Consultancy

Which four of the following should be included in an audit plan?

A. Date of next audit.

B. Times of opening and closing meeting.
C. List of findings from the last audit.
D. Signature of Certification Body Technical Reviewer.
E. Required resources for the audit.
F. Name of auditees and auditors.
G. Sequence and timings of audit activities.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 42
 Quality Institution For
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Opening Meeting

Purpose Of Opening meeting:

1. confirm the agreement of all participants (e.g. auditee, audit team) to the audit plan;

2. Introduce the audit team

3. Ensure that all planned audit activities can be performed

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 44
 Quality Institution For
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Conducting audit

• Methods of collecting information include, but are not limited to the following:
— interviews;
— observations;
— review of documented information.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 46
 Quality Institution For
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Overview of a typical process of collecting and verifying information

Source of information

Collecting by means of appropriate

sampling

Audit evidence

Evaluating against audit

criteria

Audit findings

Reviewing

Audit conclusion

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 47
 Quality Institution For
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Audit finding definition

The evaluation of the audit findings is based on the following definitions:

Major Nonconformities (MaNC)

The absence or total failure of a system to meet a requirement. It may be either:
 A number of minor nonconformities against one requirement can represent a total failure of the system and thus be
considered a major nonconformance; or
 Any nonconformance that would result in the probable shipment of a nonconforming product. A condition that may result in
the failure or materially reduce the usability of the products or services for their intended purpose
Minor Nonconformities (MiNC)
A nonconformance that judgment and experience indicate is not likely to result in the failure of the quality system or reduce
its ability to assure controlled processes or products. It may be either:
 A failure in some part of the supplier's documented quality system relative to a requirement; or
 A single observed lapse in following one item of a company’s quality system.
Observations (OBS)
Any issues which are likely to become a NC, if not treated until the next audit are marked as observations (OBS). No response
is required.
Opportunities for Improvement (OFI)
If certain aspects which generally comply with the requirements of the standard should be improved, then they are marked as opportunities for
improvement (OFI). These OFIs help to improve the management system as a whole or named processes. No response is required.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 49
 Quality Institution For
Engineering & Management Consultancy

ABC is a world-wide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will

carry out the initial certification audit, Stage 2.

ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks, due to a

shortage of a special type or meat, they can only prepare six of the 15 varieties.

During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the kitchen; during her visit she found a set of 20–25 hamburgers in the waste cabin. She asked how

often they must discard products; the supervisor said several times every day because the hamburgers end up overcooked. The timer of the oven is not working properly, and the alarm does not work either.

They try to give these hamburgers to the customers, some of them do not complain, others complain, and we must change the hamburger. We do nothing, because the manager said: “Do not worry, we will buy a new oven with

a new design.” They said so two years ago and, so far, we do not have any news of the oven.

The audit team agreed that this was a minor nonconformity and the audit team leader included it in the audit report.

Few weeks later, ABC submitted an answer to the audit report as follows:

a) Immediate action: we will stop offering overcooked products to customers. Doing this, we will have customers 100% satisfied, one of the key expected results from ISO 9001:2015.

b) Analysis of the cause: oven not working properly.

c) Corrective action: install a new oven in four months.

What would you do? Choose the best answer from the following options:
A- OK, the nonconformity is closed. I will recommend to my Certification Body to certify your management system. The effectiveness will be checked during the next
surveillance audit, in six months’ time.
B- OK, but the manager must commit to speeding up the purchase of the new oven. I will close the nonconformity and recommend certification when the oven is operating.
C- OK, but you must hire a new employee in one week’s time to take care of the oven to prevent overcooking food. I will close the nonconformity and recommend
certification when the person starts working in the kitchen.
D- OK, but I will close the nonconformity and will recommend certification when all employees of the kitchen and customer service are retrained in relation to the QMS.
E- OK, but the manager must commit to speed up the purchase of the new oven. I will close the nonconformity and recommend certification when you send me a copy of
the purchase order of the oven.
F- OK, the nonconformity is closed. I will recommend to my Certification Body to certify your management system, but I will recommend them to carry out a short audit soon
after the new oven is installed.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 55
 Quality Institution For
Engineering & Management Consultancy

ABC is a world-wide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will

carry out the initial certification audit, Stage 2.

ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks, due to a

shortage of a special type or meat, they can only prepare six of the 15 varieties.

During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the kitchen; during her visit she found a set of 20–25 hamburgers in the waste cabin. She asked how

often they must discard products; the supervisor said several times every day because the hamburgers end up overcooked. The timer of the oven is not working properly, and the alarm does not work either.

They try to give these hamburgers to the customers, some of them do not complain, others complain, and we must change the hamburger. We do nothing, because the manager said: “Do not worry, we will buy a new oven with

a new design.” They said so two years ago and, so far, we do not have any news of the oven.

The audit team agreed that this was a minor nonconformity and the audit team leader included it in the audit report.

Few weeks later, ABC submitted an answer to the audit report as follows:

a) Immediate action: we will stop offering overcooked products to customers. Doing this, we will have customers 100% satisfied, one of the key expected results from ISO 9001:2015.

b) Analysis of the cause: oven not working properly.

c) Corrective action: install a new oven in four months.

What would you do? Choose the best answer from the following options:
A- OK, the nonconformity is closed. I will recommend to my Certification Body to certify your management system. The effectiveness will be checked
during the next surveillance audit, in six months’ time.
B- OK, but the manager must commit to speeding up the purchase of the new oven. I will close the nonconformity and recommend certification when the oven is operating.
C- OK, but you must hire a new employee in one week’s time to take care of the oven to prevent overcooking food. I will close the nonconformity and recommend
certification when the person starts working in the kitchen.
D- OK, but I will close the nonconformity and will recommend certification when all employees of the kitchen and customer service are retrained in relation to the QMS.
E- OK, but the manager must commit to speed up the purchase of the new oven. I will close the nonconformity and recommend certification when you send me a copy of
the purchase order of the oven.
F- OK, the nonconformity is closed. I will recommend to my Certification Body to certify your management system, but I will recommend them to carry out a short audit soon
after the new oven is installed.

Quality management System ISO 9001 : 2015 Lead Tutor : Mohamed Fouad 56