Beruflich Dokumente
Kultur Dokumente
DOCUMENTED
INFORMATION
GUIDANCE
The documents needed to
establish your Quality
Management System
MOHAMMAD ELSHAHAT
EDITION
2016
Tier#1
Tier#2
Tier#3
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TIER NO. 1
Serial
Clause No
4.3
4.4.2 a)
5.2.2 a)
6.2.1
Serial
Clause No
4.4.2 b
7.1.5.1
7.1.5.2 a)
7.2 d
8.2.3.2 a)b)
8.3.2
Records that demonstrate that design and development requirements have been met
8.3.3
8.3.4 f)
8.3.5
10
8.3.6
Design and development changes, the results of the review, the authorization of the changes
and taken actions to prevent adverse impacts
11
8.4.1
Control activities on external providers include (criteria for evaluation, selection, monitoring
of performance and re-evaluation) and any necessary actions arising from the evaluations.
12
8.5.2
13
8.5.3
14
8.5.6
The results of the review of changes for production and services provision, the person(s)
authorizing the change, and any necessary actions arising from the review.
15
8.6
Records of the release of products and services that include evidence of conformity with the
acceptance criteria; and traceability to the person(s) authorizing the release.
16
8.7.2
Records that describe the nonconformity; the actions taken; any concessions obtained; and
identify the authority deciding the action in respect of the nonconformity.
17
9.1.1
18
9.2.2 f)
Results of the evaluation of the performance and the effectiveness of the quality
management system.
Evidence of the implementation of the audit programme and the audit results.
19
9.3.3
20
10.2.2 a)
Evidence of the nature of the nonconformities and any subsequent actions taken;
21
10.2.2 b)
Documented information to have confidence that the processes are being carried out as
planned.
Fitness for purpose of the monitoring and measurement resources.
The basis used for calibration or verification, when no such standards exist
Evidence of personnel competence.
The results of the review and any new requirements for the products and services.
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