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Documented information

As part of the alignment with other management system standards, a common clause on "documented information" has been adopted without significant change or addition (see 7.5).

Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, "documented information" is used for all document requirements.

Where ISO 9001:2008/AS 9100C used specific terminology such as "document" or "documented procedures", "quality manual" or "quality plan", these editions (ISO 9001:2015/AS 9100D) of the International Standards define requirements to "maintain documented information".

Where ISO 9001:2008/AS 9100C used the term "records" to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to "retain documented information". The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention.

A requirement to "maintain" documented information does not exclude the possibility that the organization might also need to "retain" that same documented information for a particular purpose, e.g. to retain previous versions of it.

Where the International Standards refer to "information" rather than "documented information" (e.g. in 4.1: "The organization shall monitor and review the information about these external and internal issues"), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information."

While the ISO 9001:2015/AS 9100D Standards do not specifically require a documented quality manual and/or documented procedures, many organizations feel that the best way to achieve compliance to the new Standards is to still continue to use documentation."

Your company's ISO 9001/AS 9100 documentation is the very centerpiece of your ISO 9001/AS 9100 quality management system. Writing your own, company-specific ISO 9001/AS 9100 quality/business system manual, ISO 9001/AS 9100 documented procedures and other required documents is usually considered the most difficult part on the way to ISO 9001/AS 9100 certification.

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