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Documentation Iso 9001 2015

ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by an organization. Documented information replaces procedures, records and other documentation from the previous standard. Documented information can exist in any format or media and refers to the quality management system, documentation, and records. The standard provides organizations flexibility in how they document their quality management system.
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0% found this document useful (0 votes)
26 views1 page

Documentation Iso 9001 2015

ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and maintained by an organization. Documented information replaces procedures, records and other documentation from the previous standard. Documented information can exist in any format or media and refers to the quality management system, documentation, and records. The standard provides organizations flexibility in how they document their quality management system.
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DOCUMENTATION ISO 9001:2015

ISO 9001:2015 defines documented information as meaningful data that is required to be controlled and
maintained by the organization and the medium on which it is contained. Notes to this definition
indicate that documented information can refer to the Quality Management System (QMS) and its
processes, documentation, and records.

Documented information replaces the requirement for procedures, records and other items of
documentation in ISO 9001:2015. Documented information can be of two types:
1. Documented information that needs to be maintained. This will cover procedures, policies, etc. that
would have been referred to as “documented procedures” or just “documents” in ISO 9001:2008

2. Documented information that needs to be retained. This will cover what ISO 9001:2008 called
“records”

Documented information can be used to communicate a message, provide evidence of what was
planned has actually been done, or knowledge sharing. Documentation Information is the information
required to be controlled and maintained by an organization and the medium on which it is contained. It
can be in any format and media and from any source such as paper, magnetic, electronic, or optical
computer disc, photograph, master sample, etc. It can refer to:

 quality management system, including related processes;


 information created in order for the organization to operate (documentation);
 Evidence of results achieved (records).

One of the important objectives in the revision of the ISO 9001 series of the standard had been that the
amount and detail of documentation required by the organization have to be more relevant to the
desired results of the organization’s process activities. ISO 9001:2015 allows organization flexibility in
the way it chooses to document its quality management system (QMS).

The following are some of the main objectives of an organization’s documented information:

1. Communication of Information: As a tool for information transmission and communication. The


type and extent of the documented information will depend on the nature of the organization’s
products and processes, the degree of formality of communication systems and the level of
communication skills within the organization, and the organizational culture.
2. Evidence of conformity: Provision of evidence that what was planned has actually been done.
3. Knowledge sharing
4. To disseminate and preserve the organization’s experiences. A typical example would be a
technical specification, which can be used as a base for the design and development of a new
product or service.

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