ISO 9001:2015 CS 6 Desktop Audit - 2017

CASE STUDY #6
Desktop Audit
Time Allowed = 60 minutes
Working in teams defined by your tutor, appoint a team leader. The leader may assign tasks to each team member for better
time management.
Conduct a desktop audit of Czerka documented information. There is insufficient time for detailed work here, concentrate
on the principal issues that you feel need addressing. Please make sure that in your report you address all the requirements
of the standard.
Your report shall include your group’s recommendations, observations and decision to:
PROCEED WITH THE ON-SITE AUDIT STAGE 1 OR REQUIRE FURTHER DEVELOPMENT
Ensure the report is complete and identifiable to your team with the group name at the top.
The group’s report must be handed-in for assessment.
ISO 9001:2015 Clause Conformity/ Comments

Documented information needed to be
maintained by the organization for the
purposes of establishing a QMS (high level
transversal documents). These include:
• The scope of the quality management
system (clause 4.3).
• Documented information necessary to
support the operation of processes
(clause 4.4).
• The quality policy (clause 5.).
• The quality objectives (clause 6.2).
• This documented information is subject
to the requirements of clause 7.5.
b) Documented information maintained by

the organization for the purpose of
communicating the information necessary for
1
the organization to operate (low level,
specific documents). See 4.4. Although ISO
9001:2015 does not specifically requires any
of them, examples of documents that can
add value to a QMS may include:
• Organization charts
• Process maps, process flow charts
and/or process descriptions
• Procedures
• Work and/or test instructions
• Specifications
• Documents containing internal
communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans
• Quality manuals
• Strategic plans
• Forms
Where it exists, all such documented
information, is also subject to the
requirements clause 7.5.
c) Documented information needed to be

retained by the organization for the purpose
of providing evidence of result achieved
(records). These include:
• Documented information to the extent
necessary to have confidence that the
processes are being carried out as
planned (clause 4.4).
• Evidence of fitness for purpose of
monitoring and measuring resources
(clause 7.1.5.1).
• Evidence of the basis used for
calibration of the monitoring and
measurement resources (when no
international or national standards exist)
(clause 7.1.5.2).
• Evidence of competence of person(s)
doing work under the control of the
organization that affects the
2
performance and effectiveness of the
QMS (clause 7.2).
• Results of the review and new
requirements for the products and
services (clause 8.2.3).
• Records needed to demonstrate that
design and development requirements
have been met (clause 8.3.2)
• Records on design and development
inputs (clause 8.3.3).
• Records of the activities of design and
development controls (clause 8.3.4).
• Records of design and development
outputs (clause 8.3.5).
• Design and development changes,
including the results of the review and
the authorization of the changes and
necessary actions (clause 8.3.6).
• Records of the evaluation, selection,
monitoring of performance and re-
evaluation of external providers and any
and actions arising from these activities
(clause 8.4.1)
• Evidence of the unique identification of
the outputs when traceability is a
requirement (clause 8.5.2).
• Records of property of the customer or
external provider that is lost, damaged
or otherwise found to be unsuitable for
use and of its communication to the
owner (clause 8.5.3).
• Results of the review of changes for
production or service provision, the
persons authorizing the change, and
necessary actions taken (clause 8.5.6).
• Records of the authorized release of
products and services for delivery to the
customer including acceptance criteria
and traceability to the authorizing
person(s) (clause 8.6).
• Records of nonconformities, the actions
taken, concessions obtained and the
identification of the authority deciding
the action in respect of the
nonconformity (clause 8.7).
3
• Results of the evaluation of the
performance and the effectiveness of
the QMS (clause 911)
• Evidence of the implementation of the
audit programme and the audit results
(clause 9.2.2).
• Evidence of the results of management
reviews (clause 9.3.3).
• Evidence of the nature of the
nonconformities and any subsequent
actions taken (clause 10.2.2).;
• Results of any corrective action (clause
10.2.2).
Additional documented information developed

by the organization:

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CASE STUDY #6

Time Allowed = 60 minutes

PROCEED WITH THE ON-SITE AUDIT STAGE 1 OR REQUIRE FURTHER DEVELOPMENT

ISO 9001:2015 Clause Conformity/ Comments

b) Documented information maintained by

c) Documented information needed to be

Additional documented information developed

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