Audit Situation Non-Conformity
/Conformity
1. In an adequacy audit, There is no nonconformity yet
the organization chart and further investigation is
for Company A showed needed on corrective action
that the Quality 5.3
Assurance Manager It is an opportunity for
reports to the improvement. Advised to amend
Production Manager. the organogram, by changing
Quality Manager reporting
directly to the top management.
Further audit investigation
(audit trail) and evidence sought
1. Review the organogram to
ensure incorporation of
change in reporting authority
2. Check to see if the production
manager was exercising
influential control over QA
Manager.
3. Determine the extent of
improvement observed by
incorporating the
recommended change
2. The quality system It is a nonconformity
documentation for
company B showed no Failure in the system:
evidence or procedure No evidence or procedure for
for quality management quality management system
system planning planning was incorporated in the
company’s QMS documentation.
QMS is not planned which may
lead to undesirable outcomes
and subsequent failure of the
QMS
Evidence:
The Quality Managemet system
documentation was checked for
corresponding QMS planning
procedure.
Applicable ISO Clause
5.3
Top management shall assign
the responsibility and authority
for:
c)reporting on the performance
of the quality management
system and on opportunities
for
improvement (see 10.1), in
particular to top management
10.1
c) improving the performance
and effectiveness of the quality
management system.
ISO 9001:2015 clause and
requirement:
6.1.1
When planning for the quality
management system, the
organization shall consider the
issues
referred to in 4.1 and the
requirements referred to in 4.2
and determine the risks and
opportunities that
need to be addressed to:
a) give assurance that the quality
management system can achieve
its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired
effects;
d) achieve improvement.