SITUATION C

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)

i. Determine whether the situation is under NONCONFORMITY or NOT.

The situation will lead to the NONCONFORMITY if it is a repetitive incident in

the next cycle of audit process.

ii. Determine the applicable ISO 9001-2015 clauses in each situation. Explain.

The circumstance will be arranged under Section 8: Operation. The material

condition would be under 8.7.1 Control of nonconforming yield. The association will
guarantee that yields that don't fit in with their necessities are recognized and
controlled to forestall their unintended use or conveyance. The association will make
fitting move dependent on the idea of the nonconformity and its impact on the
similarity of items and administrations. This will likewise apply to nonconformity
items and administrations recognized after conveyance of items, during or after the
arrangement of administrations.
 The organization shall deal with nonconforming outputs in one or more of the
following ways:
 Correction
 segregation, containment, return or suspension of provision of
products and services;
 informing the customer
 Obtaining authorization for acceptance under concession.

Conformity to the prerequisites will be confirmed when nonconforming outputs are remedied.

i. If the answer in (i) is NONCONFORMITY classify whether it is MAJOR or

MINOR and then justify.

It is a MINOR NONCONFORMITY. The circumstance is characterized as an occurrence

that does not meet the ISO 9001 necessities, however that does not have any real results. The
shipper needs to advise the client about the influenced six items and will hold the archived data
that portrays the nonconformity and move made towards to determine the issue.
SITUATION D

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)

i. Determine whether the situation is under NONCONFORMITY or NOT.

The situation is NOT NONCONFORMITY.

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:

• Status of activities from past administration audits

• Changes in outer and inside issues pertinent to QMS

• Information on quality execution and viability of the QMS

 iii. If the answer in (i) is NOT NONCONFORMITY, then state your reasons

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

• Effectiveness and arrangement with the key bearing of the organization.

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)

i. Determine whether the situation is under NONCONFORMITY or NOT.

The situation is under NONCONFORMITY.

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.

iii. If the answer in (i) is NONCONFORMITY classify whether it is MAJOR or

MINOR and then justify.

We will characterize the circumstance as MAJOR NONCONFORMITY. With a

nonattendance of an ISO 9001 necessity, it was an all-out breakdown of framework, control and
methodology. For sure, the enlisting of three medical attendants every one of whom have been
expertly prepared as Registered Nurses and have endorsements of capability issued by a
perceived college showing clinic, by and by individuals are planned to leave the association for
improvement. Be that as it may, the system stays to connect with the association. Henceforth, it
is an essential for ABC Inc Medical Center to build up a composed guidance so as to consent to
the ISO 9001 prerequisite.