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ISO 9001: 2015
DOCUMENTED
INFORMATION
GUIDANCE
The documents needed to
establish your Quality
Management System
MOHAMMAD ELSHAHAT
EDITION
2016
Contact me: Muhammad.elshahat@gmail.com 1 | P a g e
Even you’re an External or Internal Auditor or a Quality
Manager in your organization; You need to know, What are the
most important changes to the new version of ISO 9001:2015?
In this guide, I’ll walk you through one aspect of these changes.
A quality management system needs to be documented as an
evidence for establishment and implementation. In this new
version of ISO 9001, Documents Look Like This:
THE THREE TIERS OF THE
DOCUMENTED INFORMATION
Tier#1
• Documented information defined by the
standard and needs to be maintained.
Tier#2
• Documented information defined by the
organization and needs to be maintained.
Tier#3
• Documented information defined by the
standard and needs to be retained
Contact me: Muhammad.elshahat@gmail.com 2 | P a g e
TIER NO. 1
Serial Clause No Documented Information to be maintained
1 4.3 The scope of the organization’s quality management system
2 4.4.2 a) Documented information to support the operation of its processes;
3 5.2.2 a) The quality policy
4 6.2.1 The quality objectives.
TIER NO. 3
Serial Clause No Documented information to be retained
1 4.4.2 b Documented information to have confidence that the processes are being carried out as
planned.
2 7.1.5.1 Fitness for purpose of the monitoring and measurement resources.
3 7.1.5.2 a) The basis used for calibration or verification, when no such standards exist
4 7.2 d Evidence of personnel competence.
5 8.2.3.2 a)b) The results of the review and any new requirements for the products and services.
6 8.3.2 Records that demonstrate that design and development requirements have been met
7 8.3.3 Design and development inputs.
8 8.3.4 f) Design and development process control activities
9 8.3.5 Design and development outputs.
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 Evidence of the unique identification of the outputs when traceability is a requirement
13 8.5.3 Records of the property of a customer or external provider which is lost, damaged or
otherwise found to be unsuitable for use, and of its communication to the owners
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 Results of the evaluation of the performance and the effectiveness of the quality
management system.
18 9.2.2 f) Evidence of the implementation of the audit programme and the audit results.
19 9.3.3 Evidence of the results of management reviews.
20 10.2.2 a) Evidence of the nature of the nonconformities and any subsequent actions taken;
21 10.2.2 b) The results of any corrective action.

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Iso 9001:2015 Documented Information Guidance

  • 1. ISO 9001: 2015 DOCUMENTED INFORMATION GUIDANCE The documents needed to establish your Quality Management System MOHAMMAD ELSHAHAT EDITION 2016
  • 2. Contact me: Muhammad.elshahat@gmail.com 1 | P a g e Even you’re an External or Internal Auditor or a Quality Manager in your organization; You need to know, What are the most important changes to the new version of ISO 9001:2015? In this guide, I’ll walk you through one aspect of these changes. A quality management system needs to be documented as an evidence for establishment and implementation. In this new version of ISO 9001, Documents Look Like This: THE THREE TIERS OF THE DOCUMENTED INFORMATION Tier#1 • Documented information defined by the standard and needs to be maintained. Tier#2 • Documented information defined by the organization and needs to be maintained. Tier#3 • Documented information defined by the standard and needs to be retained
  • 3. Contact me: Muhammad.elshahat@gmail.com 2 | P a g e TIER NO. 1 Serial Clause No Documented Information to be maintained 1 4.3 The scope of the organization’s quality management system 2 4.4.2 a) Documented information to support the operation of its processes; 3 5.2.2 a) The quality policy 4 6.2.1 The quality objectives. TIER NO. 3 Serial Clause No Documented information to be retained 1 4.4.2 b Documented information to have confidence that the processes are being carried out as planned. 2 7.1.5.1 Fitness for purpose of the monitoring and measurement resources. 3 7.1.5.2 a) The basis used for calibration or verification, when no such standards exist 4 7.2 d Evidence of personnel competence. 5 8.2.3.2 a)b) The results of the review and any new requirements for the products and services. 6 8.3.2 Records that demonstrate that design and development requirements have been met 7 8.3.3 Design and development inputs. 8 8.3.4 f) Design and development process control activities 9 8.3.5 Design and development outputs. 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 Evidence of the unique identification of the outputs when traceability is a requirement 13 8.5.3 Records of the property of a customer or external provider which is lost, damaged or otherwise found to be unsuitable for use, and of its communication to the owners 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 Results of the evaluation of the performance and the effectiveness of the quality management system. 18 9.2.2 f) Evidence of the implementation of the audit programme and the audit results. 19 9.3.3 Evidence of the results of management reviews. 20 10.2.2 a) Evidence of the nature of the nonconformities and any subsequent actions taken; 21 10.2.2 b) The results of any corrective action.