CASE STUDIES EXERCISES

1. A company had installed the latest model of a pressure calibrator Serial no PC

3145 for measurement of their pressure gauges. On requesting evidence of
calibrator’s current calibration status the auditor was shown a certificate, issued
by the original manufacturer, bearing the statement “calibration traceable to
international standards” and giving full details of the equipment’s performance
data. There was no equipment serial number or date of issue on the certificate.

2. When auditing the Quality Department, the auditor asked about the collection
and analysis of data relating to the quality management system. The quality
Manager responds that data on customer feed backs/complaints,
product/process discrepancies, reject and return product is all collected and
analyzed. When asked about data relating to suppliers, the auditor was told the
records of supplier selection and annual evaluation were maintained. Other than
the entry on the management review minutes that stated that all current suppliers
were OK, there was no other data collected on annual evaluation.

3. When the auditor asked about quality management system planning. The
company representative replied that since their products are fairly standardized
and produced over the years there was no need of QMS planning other than
production planning

4. As the audit Team leader one of the auditors gave you a report on lack of
measurements of quality objectives – clause 6.2.2
Which other related clauses will you have expected the auditor to have explored?
5. Adebowale Electronics is building a new factory to perform manufacturing of
mobile phones, as a subcontractor it has only one customer and this customer
maintains responsibility and authority for product design. Adebowale Electronics
is responsible for purchasing of all components and for performing the
manufacturing activities. The customer provides Adebowale with the
manufacturing and parts specifications, and is also responsible for notifying
Adebowale of any design changes and providing the appropriate change
information. Adebowale Electronics, in the development of its QMS, has the
requirements of ISO 9001: 2015clause 83 design and development are not
applicable. Adebowale Electronics considers the customer specifications as a
customer supplied product and therefore controls this according to ISO 9001:
2015clause 8.5.3 property. Belonging to external customers or providers
• Issue
 Can Adebowale Electronic not sapply clause 8.3. Design and
development from its QMS and claim conformity to ISO 9001: 2015?
6 Godwin Eze Construction Limited provides engineering and construction
services for various developers but does not have in-house design
capabilities. The company employs a project manager who is responsible for
the management of design activities. These activities are outsourced to
chop-I-chop Engineering Limited, an engineering consulting company.
The activities of chop-I-chop Engineering Limited, are managed through
the application of the requirements of clause 7.4 purchasing. The project
Manager of Godwin Eze Construction Limited oversees the design activities and
is involved in design review meetings and design verification and validation
activities .In addition , the project manager is responsible for ensuring that the
design activities are in accordance with the requirements of ISO 9001:2008
clause7.3 Design and Development. However ,Godwin Eze and co. has
excluded clause 7.3 design and development from its QMS, since the design
activities have been outsourced.
• ISSUE:
Can Godwin Eze and co. exclude clause 7.3 design and development
From its QMS and claim conformity to ISO 9001:2008?
6. Chat designs and fabricates pressure vessels for electricity generating
Stations ,in accordance with various mandatory pressure vessels regulations
Chat has a QMS that was originally certified/registered according to ISO
9002:1994,rather than ISO 9001:1994, because the regulations did not
Require pressure vessel manufacturers to include design in their QMSs. The
Regulatory authority has not yet revised its requirements to take ISO 9001:
2008 into account, but has confirmed that it will continue not to require
Manufacturers QMSs to include design. On this basis Chat decides to exclude
clause 7. 3 Design and development from its QMS and to claim
Conformity to ISO 9001:2008
ISSUE:
Can Chat exclude clause 7.3 Design and development from its QMS and
claim conformity to ISO 9001:2008
7. Godwin Eze Construction Limited provides engineering and construction services
for various developers but does not have in-house design capabilities. The
company employs a project manager who is responsible for the management of
design activities. These activities are outsourced to chop-I-chop Engineering
Limited, an engineering consulting company.
The activities of chop-I-chop Engineering Limited, are managed through
the application of the requirements of clause 7.4 purchasing. The project
Manager of Godwin Eze Construction Limited oversees the design activities and
is involved in design review meetings and design verification and validation
activities .In addition , the project manager is responsible for ensuring that the
design activities are in accordance with the requirements of ISO 9001:2008
clause7.3 Design and Development. However ,Godwin Eze and co. has
excluded clause 7.3 design and development from its QMS, since the design
activities have been outsourced.
• ISSUE:
Can Godwin Eze and co. exclude clause 7.3 design and development
From its QMS and claim conformity to ISO 9001:2008?
8. Nanrit corp. is a company that manufactures electric motors for sale by licensed
distributors. Traceability of the component parts of the Product is not an internal
or external requirement of this company.
The organisation has excluded the traceability requirement of sub-
Clause 7.5.3 Identification and traceability from its QMS, while
Claiming conformity to ISO 9001: 2008.
ISSUES
Can Nanrit corp. exclude the traceability requirement of clause
7.5.3
9. A bank provides a variety of services to its internet banking services. For
this service the bank has claimed conformity to ISO 9001: 2000. The bank
clearly states in its quality manual which services are covered by the QMS. The
bank applies all the requirements of ISO 9001: 2008 for the realization of its
internet banking services, with the exception of clause 7.5.4 customer property.
The bank does not feel that it has possession of any customer property as part of
its internet banking services and has stated this in the justification for exclusion of
clause 7-5-4 customer property from its QMS.
Issues
 Can the bank exclude clause 7.5.4 customer property from its QMS and claim
conformity to ISO 9001: 2008?

S/No NC MAJOR/ MINOR RELEVANT ISO

9001 CLAUSE