1 Scope T 42

Defining the scope of the audit, audit types

1

The word 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) comes from Latin "audire" = to listen.

Audit: a systematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives

Auditssystematic 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) are mostly internal or external.

Internal auditssystematic 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), also called first party audits, are a requirementexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of the ISO 13485 standard (cf. sub-clause 8.2.4).

External, customeranyone who receives a product (see also ISO 9000, 3.2.4)   (or supplierentity that provides a product (see also ISO 9000, 3.2.5)) and certification auditssystematic 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), also called second and third party audits, are not within the scope of this module.

Internal auditssystematic 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) are the most widespread tool for checking and evaluating the effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   of a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) (QMS). It is never intended to find the weak points in personnel. The internal 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) has entered many company's daily lives as it has become inseparable from:

It's only through other people's eyes that one can really see one's weakness. Chinese proverb

An internal 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) is of (cf. figure 1-1):

audit types
Figure 1-1. Internal audit types

Process: activities that transform inputs into outputs

The internal 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) results are part of the inputs of the management reviewperiodic survey carried out by top management of the management system for its continual improvement and allow the identification of fields in which to improve the quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) as

No system is perfect

As shown in figure 1-2, for the processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) "Perform an audit", top managementgroup or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1) (via the management reviewperiodic survey carried out by top management of the management system for its continual improvement) is considered as an audit clientEveryone requesting an audit with needs and expectations, which are themselves related to the processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) and various requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4). processus

perform an audit
Figure 1-2. Perform an audit process

In the 1980s internal auditssystematic 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) were mostly documentary - did you write down what you do?

Later, in the early 2000s, internal auditssystematic 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) were more about conformityfulfillment of a specified requirement (see also ISO 9000, 3.6.11) - does what you do meet the requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of the standard?

Now internal auditssystematic 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) are essentially about effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   - how do you improve your performancemeasurable and expected results of the management system (see also ISO 9000, 3.7.8)?

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