ISO9001 Documentation refers to any information in whatever medium presented. This includes, but is not limited to, forms, software, reference guides, presentations, web-based information, etc... Documented Information refers to information that must be controlled and maintained. This includes the medium (i.e. the form itself) as well as the information (i.e. the record created when filling out the form).
The information that is included in ISO 9001 Documentation shall include 1. documented required by ISO 9001, and 2. documents determined by the organization as being necessary for the effectiveness of the QMS. This includes documents of External Origin (i.e. User Manuals, Regulations, Reference Documents). Documents provide consistency of how a process is executed and protect the organization from loss of knowledge in the event of sudden employee turnover.
he following is a cross-reference to every section of the 9001 Standard where ISO 9001 Documentation is required:
ISO 9001 Documentation
Clause |
Topic |
Type of documented
information |
Requirement |
4.3 |
Determining the scope of the QMS |
Document |
The scope of the organization’s QMS shall
be available and be maintained as documented information. |
4.4.2 a |
QMS
and its processes |
Document |
To
the extent necessary, the organization shall maintain documented information
to support the operation of its processes. |
4.4.2 b |
QMS and its processes |
Record |
To the extent necessary, the organization
shall retain documented information to have confidence that the processes are
being carried out as planned. |
5.2.2 a |
Communicating
the quality policy |
Document |
The
quality policy shall be available and maintained as documented information. |
6.2.1 |
Quality objectives and planning to achieve
them |
Document |
The organization shall maintain documented
information on the quality objectives. |
7.1.5.1 |
Monitoring
and measuring resources |
Record |
The
organization shall retain appropriate documented information as evidence of
fitness for purpose of the monitoring and measurement resources. |
7.1.5.2 a |
Measurement traceability |
Record |
Measuring equipment shall be calibrated or
verified, or both, at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards;
when no such standard exists, the basis for calibration or verification shall
be retained as documented information. |
7.2 d |
Competence |
Record |
The
organization shall retain appropriate documented information as evidence of
competence. |
7.5.1 b |
Documented information |
Document |
The organization’s QMS shall include
documented information determined by the organization as being necessary for
the effectiveness of the QMS. |
8.2.3.2 |
Review
of the requirements for products and services |
Record |
The
organization shall retain documented information, as applicable, on the
results of review and on any new requirements for products and services. |
8.3.2 j |
Design and development planning |
Record |
The organization shall consider the
documented information needed to demonstrate that design and development
requirements have been met. |
8.3.3 |
Design
and development inputs |
Record |
The
organization shall retain documented information on design and development
inputs. |
8.3.4 f |
Design and development controls |
Record |
The organization shall apply controls to
the design and development process to ensure that documented information of
these activities is retained. |
8.3.5 |
Design
and development outputs |
Record |
The
organization shall retain documented information on the design and
development outputs. |
8.3.6 |
Design and development changes |
Record |
The organization shall retain documented
information on design and development changes and the results of reviews. |
8.4.1 |
Control
of externally provided process, products and services |
Record |
The
organization shall retain documented information of these activities and any
necessary actions arising from the evaluations. |
8.5.2 |
Identification and traceability |
Record |
The organization shall control the unique identification
of the outputs when traceability is a requirement, and shall retain
documented information necessary to enable traceability. |
8.5.3 |
Property
belonging to customers or external providers |
Record |
When
the property of a customer or external provider is lost, damaged or otherwise
found to be unsuitable for use, the organization shall report this to the
customer or external provider and retain documented information on what has
occurred. |
8.5.6 |
Control of changes |
Record |
The organization shall retain documented
information describing the results of the review of changes, the person(s)
authorizing the change, and any necessary actions arising from the review. |
8.6 |
Release
of products and services |
Record |
The
organization shall retain documented information on the release of products
and services. The documentation shall include evidence of conformity with the
acceptance criteria and traceability to the person(s) authorizing the
release. |
8.7.2 |
Control of nonconforming outputs |
Record |
The organization shall retain documented
information that describes the nonconformity, actions taken, any concessions
obtained and identifies the authority deciding the action in respect of the
nonconformity. |
9.1.1 |
Monitoring,
measurement, analysis and evaluation |
Record |
The
organization shall retain documented information as evidence of the results
[of QMS performance evaluation]. |
9.2.2 f |
Internal audit |
Record |
The organization shall retain documented
information as evidence of the implementation of the audit program and the
audit results. |
9.3.3 |
Management
review outputs |
Record |
The
organization shall retain documented information as evidence of the results
of management reviews. |
10.2.2 |
Nonconformity and corrective action |
Record |
The organization shall retain documented
information as evidence of the nature of the nonconformities and any
subsequent actions taken and the results of any corrective action. |
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