Case Studies - ISO 9001:2015 Questions
Case Studies - ISO 9001:2015 Questions
Questions:
a) There is sufficient evidence to report your findings as a nonconformity with evidence:
b) ISO 9001:2015 clause and requirement
c) If there is not a non-conformity, reason for same
d) Audit trails, including, evidence sought and purpose
1)
During an audit of an insurance company, you ask the Training Manager to show you the ------------------------------
training records for three people who work in the Claims Department. You see from the ------------------------------
training records that each has attended a course on customer care. ------------------------------
You ask the Training Manager how they evaluated the training and are told “We ask every ------------------------------
person who attends a training course to complete a questionnaire on whether they ------------------------------
enjoyed the course, how useful they found the training and how good the tutor was. This ------------------------------
information helps us decide whether to send other staff on the course”. ------------------------------
You examine the questionnaires completed by the three people who attended the ------------------------------
customer care course. All three awarded high marks on how enjoyable they found the ------------------------------
course and the usefulness of the course. All three also awarded a satisfactory score for the ------------------------------
tutor. ------------------------------
2)
In the final inspection and despatch area you are examining the inspection and despatch ------------------------------
records for order number 1234. This relates to product XYZ that is due to be sent out to a ------------------------------
customer. ------------------------------
You note that in the final inspection section of the records the word ‘OK’ is written with ------------------------------
the initials JW alongside it. The Despatch Supervisor tells you that JW is one of the junior ------------------------------
inspectors. ------------------------------
You ask the supervisor: ‘Who has authorised the release of the product?’ The supervisor ------------------------------
replies that authorisation is not necessary for this type of routine product and it is clear ------------------------------
from the records that the inspection was satisfactory. He says: ‘If there has been any ------------------------------
problem we get a signature from David Manvers, the Chief Inspector, but only if they had ------------------------------
to do some rework to the product.’ ------------------------------
You check the organisation’s documented information for the product release process and ------------------------------
find it states that the Chief Inspector is responsible for authorising final release of all ------------------------------
products. ------------------------------
3)
You are auditing the design and development process in an organisation that designs and ------------------------------
manufactures industrial equipment. ------------------------------
They are currently dealing with a serious customer complaint relating to faulty safety ------------------------------
mechanisms. They have sent engineers to this customer to repair some equipment they ------------------------------
designed, manufactured and supplied two years earlier for contract number A123. ------------------------------
You find a recent note on file that states that the engineers are currently having difficulty ------------------------------
in repairing the equipment. They have been issued with the latest drawings for the ------------------------------
equipment (serial number X134, revision 3). The drawings do not contain a modification ------------------------------
to the safety mechanism that was made prior to delivery and installation of the equipment. ------------------------------
You confirm with the Design Manager that revision 3 is the current version of the drawings ------------------------------
and that revision 3 does not include the change to the safety mechanism. You ask the ------------------------------
Design Manager why the modification to safety mechanism was not made to the drawing ------------------------------
and he replies that the change was reviewed and considered to be minor with no impact ------------------------------
on the equipment and it didn’t affect the customer’s contract specification. ------------------------------