RECAPITULATION EXERCISES

These exercises may be used as a part of a recapitulation session at the start

of each day to test delegate understanding of the previous day’s learning
objectives.

Tutors are able to vary these depending on the particular circumstances on

each course

DAY 2 Quiz

1 ISO 9001:2015 requires an internal audit programme to be

planned, taking into consideration ‘the importance of the
processes and changes affecting the organisation’.

What is meant by this phrase.

The importance is based on risk/impact of the process, ie on customer/product

or service. Important processes need to be audited more frequently and in
greater depth than others.

Changes affecting the organisation can be to the context, customers, products

and services, production or service provision, external provision, processes,
and people.

2 What does it mean when we say a person is competent?

A; means that the person must have the knowledge, skills, education
and/or experience to perform effectively in the workplace
 3 ISO 9001:2015 clause 4.3 states that “Conformity to this
International Standard may only be claimed if the requirements
determined as not being applicable, do not affect the
organisation’s ability or responsibility to ensure the conformity
of its products and services and the enhancement of customer
satisfaction.”

Give an example of where it is acceptable for a requirement to

be “not applicable” and, in your own words, the circumstances
under which this could be justified.

Section 8.3 Design and development of products and services - might be

excluded by a builder who uses the services of an architect to create and
control a building design. This justification must be stated in the QMS scope.

Note to marker: Award 2 marks for this or other examples that are provided
with an appropriate justification.

Deduct 1 mark if the scope is not mentioned.

4 In the context of a QMS and ISO 9001:2015, what is the

difference between a ‘risk’ and an ‘opportunity’.

A risk is the effect of uncertainty. An effect is a deviation from the expected —

positive or negative.

An opportunity is a favourable situation to getting an intended result. It may be

taken or not.

5 What is the difference between correction and corrective action?

A: Correction: immediate resolution of a nonconformity
Corrective action: investigation of the root cause and action to prevent
recurrence of a nonconformity.

6 State four clauses of ISO 9001:2015 that relate to top

management responsibilities or activities.

5.1 Leadership and commitment

5.1.2 Customer focus
5.2 Quality policy
5.3 Organisational roles, responsibilities and authorities
9.3 Management review.

7 What are the four factors that affect the extent of QMS documented
information?

A:
 The size of the organisation.
 The activities, processes products and services of the organisation.
 The complexity of processes and their interactions.
 The competence of persons.

8 What is the difference between design verification and design

validation?

A: Verification is where design output is checked against design input to

ensure that the output is correct.
Validation is confirmation that the final product or service that has been
designed is able to achieve its specified use or application. This may
include the physical testing of the end product.

9 How is analysed data used in an ISO 9001 QMS?

A: Clause 9.1.3
The output of analysis and evaluation must be used to:
a) demonstrate conformity of products and services to requirements;
b) assess and enhance customer satisfaction;
c) ensure conformity and effectiveness of the QMS;
d) demonstrate that planning has been successfully implemented;
e) assess the performance of processes;
f) assess the performance of external provider(s);
g) determine the need or opportunities for improvements within the QMS
The results of analysis and evaluation shall also be used to provide inputs to
management review. (9.1.3)

10 ISO 9001 refers to the ‘monitoring’ and ‘measurement’ of

processes and the ‘monitoring’ and ‘measurement of products.
What is the difference between monitoring and measurement?

A: Monitoring is the observing, supervising, checking or keeping under

review often over a period of time.
Measurement is determining the size, amount or performance of something
using measuring equipment.