ISO 9001:2015
Documented Information Video

Documented Information

ISO 9001:2015 Documented Information
Warren explains the ISO 9001:2015 requirements for QMS Documented Information.

Posted: 2016-03-23
Format: Mp4
Duration: 05:53
Tags: Documented Information, ISO 9001:2015 Quality Management System, documents, records, ISO 9001 QMS

ISO 9001:2015 Documented Information

This short video is about documented information and the requirements of the new ISO 9001:2015 standard. As we saw in the Introduction to ISO 9001:2015 QMS Requirements video, documented information is used to describe all Quality Management System documents and records. Documents are maintained, usually with version controls and records are retained. Records are the 'evidence of activity' although documents may also be retained if prior versions are required to be kept or archived. Information is defined as "meaningful data" not required to be documented information. Documented information may be images or graphics; it may be audio, video, or both; it may be magnetic, electronic, optical, or analog; it may be interactive, dynamic, or static.

Documented information is required under ISO 9001:2015, Clause 7.5. Documented information must have adequate identification and description; it must be reviewed and approved for suitability and adequacy; it must be available when and where needed; it must have adequate controls; it must be protected, stored, and preserved from destruction and unintentional alterations. The organization must address documented information distribution, access, retrieval, use, storage, and preservation of legibility, control of changes and versions, retention, and disposition. Documented information from external sources must be identified and adequately controlled. There are two types of required documented information; the first is required by the ISO 9001:2015 standard and the second is "as determined necessary by the organization for Quality Management System (QMS) effectiveness".

The ISO 9001:2015 standard requires certain documented information such as the QMS scope must be maintained; information that supports process operation must be maintained; information to provide confidence of process operation must be maintained; the Quality Policy, Quality Objectives and evidence of fitness for purpose; monitoring and measuring resources; the basis for calibration where no calibration standard exists; evidence of competence of the people performing the work; documents of external origin; evidence of conformity of products and services; results of reviews and new requirements; documented information to demonstrate design and development requirements have been met; design and development inputs, control, and activity; design and development outputs; design and development changes; record of review activities related to external provider evaluations and necessary actions; characteristics of products and services or activities and results to be achieved; unique identification of outputs when traceability is a requirement; customer or external provider property loss damage or otherwise unusable; results of review of changes, the person authorizing the changes and necessary actions; evidence of conformance with acceptance criteria and the person or persons authorizing the release of non-conforming output; evidence of monitoring measuring analysis and evaluation results; evidence of audit program implementation and audit results; evidence of management review results and finally, documented information that describes the nature of nonconformity, the actions, and the results of any corrective action.

I hope this has been helpful in understanding the ISO 9001:2015 documented information requirements.

Warren Alford
Cybersecurity and Quality Management

Introduction to ISO 9001:2015 Video by Warren Alford

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