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What are quality records?
Quality records are descriptions of the ACTUAL status
(unlike documents, which are descriptions of the REQUIRED
status). They set out how a review or test has proceeded,
what results a contractual test has yielded, what QA
measures have been initiated during the report period,
etc. Quality records describe real (past) results and
have no versions. Quality records therefore record the
status of an event, a development result or a state of
affairs and provide a snapshot of the situation
characterized by the creator, unique project
identification and date.
What is special about quality records?
Standard EN ISO 9001 stipulates that quality records must
be kept in order to demonstrate
that specified quality requirements have been satisfied
and to record the effectiveness of the QM system.
Associated quality records from subcontractors must also
be included in our archiving system.
Quality records should be evaluated and used for
initiating corrective and preventive measures.
Archiving requirements
The period for which quality
records are to be kept must be
defined and documented (in the QA plan). All quality
records should (according to the CM plan) be archived so
as to ensure the following aspects:
- Easy recovery
- Protection against damage
- Accessibility within defined storage periods
(corresponding to the legal or contractual
requirements)
Examples of quality records
- All records occurring
during the course of the project, e.g. review
records, test records, records relating to
project meetings, etc.
- All reports such as
monthly reports, quality reports, quality problem
reports, phase termination reports, final
reports, reports on contract checks, etc.
- Plans or test case lists are
considered quality records if the individual
planning stages are identified as being reached
or as having been dealt with.
- Further possible quality records include: Results
of the SW quality evaluation, quality records
from subcontractors, supplier assessments,
supplier evaluations, audit reports, training
documents, etc.
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