Type of

Clause Topic documented Requirement

information
Determining the The scope of the organization’s QMS shall be available and be
4.3 Document
scope of the QMS maintained as documented information.
QMS and its To the extent necessary, the organization shall maintain
4.4.2 a Document
processes documented information to support the operation of its processes.
To the extent necessary, the organization shall retain documented
QMS and its
4.4.2 b Record information to have confidence that the processes are being carried
processes
out as planned.
Communicating the The quality policy shall be available and maintained as documented
5.2.2 a Document
quality policy information.
Quality objectives The organization shall maintained documented information on the
6.2.1 and planning to Document quality objectives.
achieve them
Monitoring and The organization shall retain appropriate documented information as
7.1.5.1 measuring Record evidence of fitness for purpose of the monitoring and measurement
resources resources.
Measuring equipment shall be calibrated or verified, or both, at
specified intervals, or prior to use, against measurement standards
Measurement
7.1.5.2 a Record traceable to international or national measurement standards; when
traceability
no such standard exists, the basis for calibration or verification shall
be retained as documented information.
The organization shall retain appropriate documented information as
7.2 d Competence Record
evidence of competence.
The organization’s QMS shall include documented information
Documented
7.5.1 b Document determined by the organization as being necessary for the
information
effectiveness of the QMS.
Review of the The organization shall retain documented information, as applicable,
requirements for on the results of review and on any new requirements for products
8.2.3.2 Record
products and and services.
services
Design and The organization shall consider the documented information needed
8.3.2 j development Record to demonstrate that design and development requirements have
planning been met.
Design and The organization shall retain documented information on design and
8.3.3 Record
development inputs development inputs.
Design and The organization shall apply controls to the design and development
8.3.4 f development Record process to ensure that documented information of these activities is
controls retained.
Design and The organization shall retain documented information on the design
8.3.5 development Record and development outputs.
outputs
Design and The organization shall retain documented information on design and
8.3.6 development Record development changes and the results of reviews.
changes
Control of The organization shall retain documented information of these
externally provided activities and any necessary actions arising from the evaluations.
8.4.1 Record
process, products
and services
The organization shall control the unique identification of the outputs
Identification and
8.5.2 Record when traceability is a requirement, and shall retain documented
traceability
information necessary to enable traceability.
When the property of a customer or external provider is lost,
Property belonging
damaged or otherwise found to be unsuitable for use, the
8.5.3 to customers or Record
organization shall report this to the customer or external provider
external providers
and retain documented information on what has occurred.
 Type of
Clause Topic documented Requirement
information
The organization shall retain documented information describing the
8.5.6 Control of changes Record results of the review of changes, the person(s) authorizing the
change, and any necessary actions arising from the review.
The organization shall retain documented information on the release
Release of
of products and services. The documentation shall include evidence
8.6 products and Record
of conformity with the acceptance criteria and traceability to the
services
person(s) authorizing the release.
The organization shall retain documented information that describes
Control of
the nonconformity, actions taken, any concessions obtained and
8.7.2 nonconforming Record
identifies the authority deciding the action in respect of the
outputs
nonconformity.
Monitoring, The organization shall retain documented information as evidence of
measurement, the results [of QMS performance evaluation].
9.1.1 Record
analysis and
evaluation
The organization shall retain documented information as evidence of
9.2.2 f Internal audit Record
the implementation of the audit program and the audit results.
Management The organization shall retain documented information as evidence of
9.3.3 Record
review outputs the results of management reviews.
The organization shall retain documented information as evidence of
Nonconformity and
10.2.2 Record the nature of the nonconformities and any subsequent actions taken
corrective action
and the results of any corrective action.