Questions 1

ISO 9001:2015 requires that “personnel” shall be competent, please explain it in your own words.
Explain, in your own words, the terms ‘audit scope’ and ‘audit criteria’ and give an example of each.
State four clauses of ISO 9001:2015 that relate to top management responsibilities or activities.
Explain, in your own words, the difference between ‘design verification’ and ‘design validation’.
In your own words and using examples as appropriate, briefly explain the difference between
‘monitoring’, ‘measuring’ and ‘measuring equipment’.
Monitoing: Determining the status of a system a process, a product a service, or an activity.
Measuring: Process to determine a value
Measuring equipment - Measuring instrument, software, measurement standard, reference

material or auxiliary apparatus or combination thereof necessary to realize a measurement
process
You are the audit team leader conducting the opening meeting of an external audit. The Managing
Director is very insistent that your audit team start the audit by watching a video of the company
history, followed by a short tour of the site to give you an understanding of the company. Outline
five issues you should consider before deciding whether or not to go ahead with their suggestion.
1. Whether video will give the full details of the organization?

2. Whether video tour was part of the audit plan or not?
3. Has the time been allowed in the audit plan for this?
4. Can the audit program be adjusted to clear this?
5. How long tour will take for the presentation?
6. Would the audit would be more effective through video?
In an audit situation: a) Give one example of documented information for audit an auditor would
prepare before an audit.
Audit checklist is to be prepared by the auditor before an audit.
Briefly describe how an auditor would use it during the audit. Include at least four uses in your
description.
1. Audit checklist will be useful to guide the auditor

2. Audit checklist will be considered as an objective evidenced of an audit
3. Audit checklist will cover all the questions
4. Audit checklist will be helpful as reminder, so that no any questions will be missed
5. Audit checklist will be used to record the audit findings
List three subjects to include in a closing meeting and briefly describe the purpose of each.
1. Findings of an audit
2. Opportunities for improvement
3. Positive feedback
4. Thank all the auditee
5. Audit findings and reporting methodologies
6. Confirmation of the scope statement of the audit
7. Audit findings closure time line and closure action plan acceptance
8. Recommendation
You are conducting an external audit with ISO 9001:2015 as audit criteria. The next item is a meeting
with top management to audit the quality policy, quality objectives and management commitment.
Outline in a checklist how you will perform this audit by developing a series of ten audit checkpoints
that together cover these three areas. For each checkpoint, identify examples of the audit evidence
you would want to gather and give the appropriate ISO 9001:2015 reference.
1. Has the organization established the quality policy as per the context and strategy of the
organization? (Objective evidence – Quality Policy), Clause No: 5.2.1
ISO 9001:2015 suggests that: “The extent of documented information for a QMS can differ from one
organisation to another”.
a) Outline three benefits to the organisation of an appropriately documented QMS.

1. Nobody can change the format of the documents, which will save the organization from
unauthorized access or duplication of the documentation.
2. Documented information will be helpful in identification and traceability of the
documents smoothly or easily
3. Current revision of the documents will be maintained within the organization
4. Whenever documents will be modified then same communicated with all concerned
person within the organization which demonstrate the continual improvement
b) Outline three disadvantages of an overly documented system.
1. It will take a lot of time to find the correct documents
2. Overly documented system will confuse the latest version the documents
3. Unauthorized person can reach to the documents easily and confidential information can be
shared outside
c) ISO 9001:2015 includes specific requirements for the control of ‘documented information of
external origin’.
1. Delivery note received from the supplier/customer
2. API Specification document
3. ISO 9001:2015 standard copy
4. Contract/PO
5. Third test result/certification or calibration certification
You are conducting an ISO 9001:2015 audit of the Human Resource department. You ask the Human
Resource Manager how the organisation ensures that personnel performing work are suitably
competent. He replies that all personnel are qualified and trained. You then sample the records of
five people working in the customer service department. On each person’s record is a list of the
academic qualifications they hold, as well as a list of the in-house training courses they have
attended. You note that all five people have attended the same courses: an induction course, a
behavioural safety course, a managing people course and a basic IT course.
a) Explain what a concern here may be.
Whether the organization has determined the competence needed and assessed the competence of
the individual within the department and their roles and roles responsibilities.
Training Plan for the concerned persons
Training attendance sheet
Training evaluation records
b) Briefly describe four audit trails you would follow to determine conformity or nonconformity
to the requirements of ISO 9001:2015. For each, identify the applicable clause(s) of ISO
9001:2015 and any audit evidence you would gather.
Does organization determine the necessary competence of person(s) doing work under its
control that affects the performance and effectiveness of the quality management system?
Clause No. 7.2 a;
Has organization ensured that these persons are competent on the basis of appropriate
education, training, or experience;? (Clause No. 7.2b)
Whether organization has considered - where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness the actions taken;? (Clause 7.2 C)
Has organization retained appropriate documented information as evidence of competence?
(Clause No 7.2d).
Has the organization established the roles, responsibility and authority for all the positions
within the organization? (Clause 5.3)

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ISO 9001:2015 requires that “personnel” shall be competent, please explain it in your own words.

Monitoing: Determining the status of a system a process, a product a service, or an activity.

Measuring: Process to determine a value

Measuring equipment - Measuring instrument, software, measurement standard, reference

1. Whether video will give the full details of the organization?

Audit checklist is to be prepared by the auditor before an audit.

1. Audit checklist will be useful to guide the auditor

a) Outline three benefits to the organisation of an appropriately documented QMS.

1. Delivery note received from the supplier/customer

2. API Specification document

3. ISO 9001:2015 standard copy

5. Third test result/certification or calibration certification

a) Explain what a concern here may be.

Training Plan for the concerned persons

Training attendance sheet

Training evaluation records

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