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ISO/DIS 9001:2015 - Required Documents

Number
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02
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06

Maintain as Documented Information


Documented information stating the scope of quality management system
Documented information to extent necessary to support operation of processes

Documented information available for quality policy


Documented information required by this International Standard
Documented information determined by the organization as being necessary for
the effectiveness of the quality management system
Documented information of external origin determined by the organization to be
necessary for the planning and operation of the quality management system

ISO 9001
4.3
4.4
5.2.2.a
7.5.1.a
7.5.1.b
7.5.3.2

3.11 Documented Information


Documented information is the information required to be controlled and maintained by an organization and
the medium on which it is contained.
Note 1: Documented information can be in any format and media and from any source.
Note 2: Documented information can refer to:
- the quality management system, including related processes;
- information created in order for the organization to operate (documentation);
- evidence of results achieved (records).
A.1 Structure and Terminology
There is no requirement for the terms used by an organization to be replaced by the terms used in ISO
9001:2015 to specify quality management system requirements. Organizations can choose to use terms which
suit their operations, e.g., records, documentation, protocols, etc. rather than documented information.
A.6 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 below). Where appropriate, text
elsewhere in ISO 9001:2015 has been aligned with its requirements. Consequently, the terms documented
procedure and record have both been replaced throughout the requirements text by documented information.
Where ISO 9001:2008 would have referred to documented procedures (e.g., to define, control, or support a
process), this is now expressed as a requirement to maintain documented information.
Where ISO 9001:2008 would have referred to records, this is now expressed as a requirement to retain
documented information.

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ISO/DIS 9001:2015 - Required Records


Number
01
02
03
04
05
06
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08
09
10
11
12
13
14
15
16
17
18
19
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Retain as Documented Information


Documented information to extent necessary to have confidence that processes
are being carried out as planned
Documented information on the quality objectives
Documented information as evidence of fitness for purpose of monitoring and
measurement resources
Documented information on basis used for calibration or verification where no
such standards exist
Documented information as evidence of competence
Documented information required by this International Standard
Documented information determined by the organization as being necessary for
the effectiveness of the quality management system
Documented information to the extent necessary to have confidence that the
processes have been carried out as planned
Documented information to the extent necessary to demonstrate conformity of
products and services to requirements
Documented statement of customer requirements (or confirmation)
Documented information on results of requirements review
Documented information to confirm that design and development requirements
have been met
Documented information resulting from the design and development process
Documented information on design and development changes
Documented information on the results of the evaluations, monitoring of the
performance, and re-evaluations of the external providers
Documented information that defines the characteristics of the products and
services
Documented information that defines the activities to be performed and the
results to be achieved
Documented information necessary to maintain traceability
Documented information describing the results of the review of changes,
the personnel authorizing the change, and any necessary actions
Documented information to provide traceability to the person(s) authorizing
release of products and services for delivery to the customer
Documented information of actions taken on nonconforming process outputs,
products and services, including on any concessions obtained and on the person
or authority that made the decision regarding dealing with the nonconformity
Documented information as evidence of the results of monitoring and
measurement activities
Documented information as evidence of the implementation of the audit
program and the audit results
Documented information as evidence of the results of management reviews
Documented information as evidence of the nature of the nonconformities and
any subsequent actions taken
Documented information as evidence of the results of any corrective action

ISO 9001
4.4
6.2.1
7.1.5
7.1.5
7.2.d
7.5.1.a
7.5.1.b
8.1.e
8.1.e
8.2.3
8.2.3
8.3.2.g
8.3.5
8.3.6
8.4.1
8.5.1.a
8.5.1.b
8.5.2
8.5.6
8.6
8.7
9.1.1
9.2.2.f
9.3.2
10.2.2.a
10.2.2.b

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6175 Hickory Flat Highway Suite 110-303 Canton, GA 30115 770.517.7944

ISO/DIS 9001:2015
7.5 Documented Information
7.5.1 General
The organizations quality management system must include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the
quality management system.
NOTE: The extent of documented information for a quality management system can differ from one
organization to another due to the:
a) size of organization and its type of activities, processes, products, and services;
b) complexity of processes and their interactions;
c) competence of persons.

7.5.2 Creating and Updating


When creating and updating documented information the organization must ensure appropriate:
a) identification and description (e.g., a title, date, author, or reference number);
b) format (e.g., language, software version, graphics), and media (e.g., paper, electronic);
c) review and approval for suitability and adequacy.

7.5.3 Control of Documented Information


7.5.3.1 Documented information required by the quality management system and by this International
Standard must be controlled to ensure it is:
a) available and suitable for use, where and when it is needed;
b) adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the organization must address the following activities, as
applicable:
a) distribution, access, retrieval, and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g., version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and
operation of the quality management system must be identified as appropriate, and controlled.
NOTE: Access can imply a decision regarding the permission to view the documented information only, or the
permission and authority to view and change the documented information.

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6175 Hickory Flat Highway Suite 110-303 Canton, GA 30115 770.517.7944

ISO/DIS 9001:2015
Definition References to Documented Information
3.03 Requirement
Requirement is the need or expectation that is stated, generally implied, or obligatory.
A note to this definition states that a specified requirement is one that is stated, for example, in documented
information.

3.47 Product
Product is the output that is a result of activities where none of them necessarily is performed at the interface
between the provider and the customer.
A note to this definition states that software consists of information and is generally intangible and can be in the
form of approaches, transactions, or documented information.

3.54 Verification
Verification is the confirmation, through the provision of objective evidence, that specified requirements have
been fulfilled.
A note to this definition states the objective evidence needed for verification can be the result of an inspection
or of other forms of determination, such as, performing alternative calculations or reviewing documented
information.

3.55 Validation
Validation is the confirmation, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled.
A note to this definition states the objective evidence needed for a validation is the result of a test or other form
of determination, such as, performing alternative calculations or reviewing documented information.

3.60 Audit Criteria


Audit criteria is the set of policies, documented information, or requirements used as a reference against which
audit evidence is compared.

3.64 Release
Release is the permission to proceed to the next stage of a process.
A note to this definition states in the context of software and documented information, the word release is
frequently used to refer to a version of the software or the documented information itself.

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6175 Hickory Flat Highway Suite 110-303 Canton, GA 30115 770.517.7944