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In the shipping area, the auditor looks at six finished products, serial numbers X245 to X250, in
individual cardboard cartons. The auditor asked the shipper why the items are packed in
corrugated cardboard instead of plastic containers as required by packaging work instruction
PWI 6, revision 2. The shipper replied that the shipping supervisor had instructed them to use
corrugated cardboard when they ran out of plastic containers three weeks ago.
(5 Marks)
ii. Determine the applicable ISO 9001-2015 clauses in each situation. Explain.
Conformity to the prerequisites will be confirmed when nonconforming outputs are remedied.
In the Quality Management (QMO) office, the auditor flips through the management review
minutes for the past year. She noticed the last one was dated 28/11/08; the previous one dated
13/06/08 which made reference to a 22/02/08 review? When asked about the frequency of such
reviews, the QMO said that they were done when senior management is in town and definitely
before an external audit. On reviewing 2007 records, the auditor noticed that management
reviews were held in May and October.
(5 Marks)
ii. Determine the applicable ISO 9001-2015 clauses in each situation. Explain.
The circumstance will be arranged under Section 9: Performance and assessment with
provision 9.3.2 Management audit inputs. It is no issues if the administration survey
was held after inner review and before outer review. The administration survey will
be arranged and completed the administration audit thinking about:
The executives survey can be held before outside review insofar as top administration will
audit the association's QMS at an arranged interim to guarantee:-
• Its proceeding
• Appropriateness
• Adequacy
SITUATION E
In the ABC Inc, Medical Center, which is within the scope of QMS registration, the auditor?
Asks to see the work instructions for a nurse. There are no written instructions on how to
administer first aid treatment for cuts and minor injuries, nor are there any written instructions of
what to do if a patient's heart stops beating. The guide says that ABC employs three nurses all of
whom have been professionally trained as Registered Nurses and have certificates of competence
issued by a recognized university teaching hospital.
(5 Marks)
(Total: 25 Marks)
ii. Determine the applicable ISO 9001-2015 clauses in each situation. Explain
The circumstance will be characterized under Section 4: Context of the association. The
relevant provision would be under 4.4.2 where the association will:
• Maintain reported data to help the activity of procedures. (Reports)
• Retain recorded data to the degree important to have certainty that the procedures are
being done as arranged. (Records).
Under this condition 4.4 Quality Management System and its procedures whereby the
association is required to set up, actualize, keep up, and ceaselessly improve a quality
administration framework, including the procedures required and their collaborations, per this
standard. The association is required to decide the procedures required for the QMS and their
application in the association.