Documented Information – Pt 1
John Mason, GAICD
Managing Director, Managing Consultant, Non Executive Director, Author
According to ISO themselves, two of the most important objectives in the revision of the ISO 9001:2015 are:
a) to develop a simplified set of standards?that will be equally applicable to small as well as medium and large organizations, and
b) for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities.
The standard now allows organisation flexibility in the way it chooses to document its quality management system (QMS).?This enables each company to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS
What is documented information? - Definitions and references
The definition of documented information can be found in ISO 9000 clause 3.8. and can be summarized as information that is required to be controlled and maintained by and organization and the medium on which it is contained. This can be in any format and media and from any source and can refer to the management system, related processes, any information that is created in order for the organization to operate (documentation) and evidence of any results achieved (records).
Documented information can be used to communicate a message, provide evidence of what was planned has actually been done, or knowledge sharing.
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The following are some of the main objectives of an organization’s documented information independent of whether or not it has implemented a formal QMS;
a) Communication of Information
b) Evidence of conformity
c) Knowledge sharing
d) Dissemination and preservation of company experiences.
A list of commonly used terms and definitions relating to documented information is presented in ISO 9001:2015 Annex A. It must be stressed that, according to ISO 9001:2015 clause 7.5.3 Control of documented information requirements, documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2015 clause 3.8.5 gives the following examples: paper; magnetic; electronic or optical computer disc; photograph; master sample and so on.?