4 Principles T 42

 

4.1 Management principles

Quality management principles

4.1

The seven quality managementactivities allowing the control of an organization with regard to quality (see also ISO 9000, 3.3.4) principles (cf. figure 4-1) will help us achieve sustained success (ISO 9001, sub clause 0.2).

principles
Figure 4-1. The 7 quality management principles

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4.2 Audit principles

Audit principles for the auditor, the audit and the auditee

4.2

Certain principles must be followed for an auditsystematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives (see also ISO 19011, 3.1) to be a value added tool.

For the auditoreveryone who is trained to carry out audits (see also ISO 19011, 3.8)  :

But also:

For the auditsystematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives (see also ISO 19011, 3.1):

For the auditeeeveryone who is audited (see also ISO 19 011, 3.7):

An auditoreveryone who is trained to carry out audits (see also ISO 19011, 3.8)   cannot audit their own department as

No-one should be a judge in his own case. Latin proverb

smileyMinute of relaxation. Cf. joke "The engineer and the shepherd"

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4.3 Performance of the QMS

Performance, effectiveness, efficiency

4.3

For a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) what is of interest is the degree of achievement of objectives or, in other words, performance. The performance of a QMSQuality Management System is measured by its effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   and, above all, by its efficiencyfinancial relationship between achieved results and resources used (see also ISO 9000, 3.7.10) (see figure 4-2).

performance

Figure 4-2. Performance of a QMS

Effectiveness: capacity to perform planned activities with minimum effort
Efficiency: financial relationship between achieved results and resources used

N.B. We can be effective because we achieved our objective, but are not efficient if we used too many resources or tolerated and produced too much waste!

Minute of relaxation. Game: Audit principles

The rest of the T 42v16 ISO 13485 internal audit version 2016 training is accessible on this page.

See also the training T 22v16 ISO 13485 readiness version 2016 and the training package ISO 13485 version 2016.

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