7 Support Do
7.1 Resources
7.1.1 General
78 7.1.1 Provide the necessary resources In order to support the QMS
79 7.1.1 a Take into account existing And their capabilities and constrains
resources
80 7.1.1 b Take into account the need for the In order to provide necessary services not
use of external providers available inside the company
7.1.2 People
81 7.1.2 Provide suitable people for the "But in the long run - and I emphasize this
effective operation of the QMS and - no matter how good or successful you are
its processes or how clever or crafty, your business and
its future are in the hands of the people you
hire". Akio Morita
7.1.3 Infrastructure
82 7.1.3 Provide and maintain the In order to achieve conformity of products and
infrastructure necessary to the services. Examples: buildings, equipment,
functioning of processes transportation, hardware, software
7.1.4 Process environment
83 7.1.4 Provide and maintain the suitable In order to achieve conformity of products and
environment necessary to the services. Examples: corporate culture, work
functioning of processes atmosphere, temperature, ergonomics
Monitoring and measuring
7.1.5
resources
7.1.5.1 General
84 7.1.5.1 Provide suitable monitoring and In order to obtain expected inspection results
measuring resources
85 7.1.5.1 Provide adequate resources to the To inspect is to monitor and measure. Cf. sub-
a specific inspections clause 7.2
86 7.1.5.1 Maintain resources In order to ensure fitness for their purpose
b
87 7.1.5.1 Retain documented information on Cf. sub-clause 7.5
the adequacy of inspection
resources
7.1.5.2 Measurement traceability
88 7.1.5.2 Verify or calibrate regularly the In order to have confidence in the
a measuring equipment measurement results. When no such standards
exist retain documented information on the
reference used, cf. sub-clause 7.5
89 7.1.5.2 Identify the measuring equipment In order to monitor the validity of their
b calibration (or verification)
90 7.1.5.2 Protect the measuring equipment Against activities that may invalidate the
c results of the measurement (settings or
deterioration)
91 7.1.5.2 Conduct corrective action on When the verification or calibration of a
previous measurement results measuring instrument is not in conformity
7.1.6 Organizational knowledge
92 7.1.6 Determine the necessary In order to control the processes and the
knowledge conformity of products and services
93 7.1.6 Acquire, maintain and make In order to maintain the performance of the
organizational knowledge available QMS
to the extend necessary
94 7.1.6 Take into account the need for When needs and trends have changed
additional knowledge
7.2 Competence
95 7.2 a Determine the necessary Clarify quality competence
competence requirements. Identify people who have an
influence on the quality performance
96 7.2 b Ensure the competence Which are based on appropriate training or
experience
97 7.2 c Undertake activities to acquire the Training, coaching, external providers
necessary competence and evaluate
the effectiveness of these activities
98 7.2 d Retain documented information on Cf. sub-clause 7.5
staff competence
7.3 Awareness
99 7.3 a Ensure the staff is aware of the Including people who carry out work under
quality policy the company's control. Cf. sub-clause 5.2
100 7.3 b Ensure the staff is aware of the Cf. sub-clause 6.2
quality objectives
101 7.3 c Ensure the staff is aware of its In order to improve the performance of the
contribution QMS
102 7.3 d Ensure the staff is aware of If QMS requirements are not met
negative impacts
7.4 Communication
103 7.4 a Define the subjects on which to Internally and externally. "Good news walks,
communicate bad news runs". Swedish proverb
104 7.4 b Define when to communicate Respond quickly to claims
105 7.4 c Define with whom to communicate Communication goes both ways
106 7.4 d Define how to communicate Orally, in writing; Internet, video
107 7.4 e Assign who will communicate The one who is closest to the subject
7.5 Documented information
7.5.1 General
108 7.5.1 a Include the documented Documented information to maintain
information required by the ISO (documented procedures) :
9001 standard
scope of the QMS (sub-clause 4.3)
process control (sub-clause 4.4.2 a)
quality policy (sub-clause 5.2.2 a)
quality objectives (sub-clause 6.2.1)
operational control (sub-clause 8.1)
Documented information to retain (records) :
process performance (sub-clause 4.4.2
b)
fitness for purpose of inspection
resources (sub-clause 7.1.5.1)
calibration (sub-clause 7.1.5.2)
staff competence (sub-clause 7.2)
necessary for the effectiveness of the
QMS (sub-clause 7.5.1)
achieving processes as planned,
conformity of products and services
(sub-clause 8.1)
results of the review of products and
services' old and new requirements
(sub-clause 8.2.3.2)
design and development inputs (sub-
clause 8.3.3)
design and development expected
results, reviews, verifications and
validations (sub-clause 8.3.4)
design and development outputs (sub-
clause 8.3.5)
design and development changes (sub-
clause 8.3.6)
evaluation activities and actions of
external providers (sub-clause 8.4.1)
product and service characteristics or
activities to be performed, results to be
achieved (sub-clause 8.5.1)
traceability of products and services
(sub-clause 8.5.2)
situation of the property of a customer
(sub-clause 8.5.3)
results of the review of changes (sub-
clause 8.5.6)
release of products and services (sub-
clause 8.6)
treatment of nonconforming products
and services (sub-clause 8.7.2)
inspection results (sub-clause 9.1.1)
audit programme and audit results
(sub-clause 9.2.2)
management review outputs (sub-
clause 9.3.3)
nonconformities, actions and results
(sub-clause 10.2.2)
109 7.5.1 b Select the documented information "Spoken words fly away, written one stay".
deemed necessary to the Latin proverb
effectiveness of the QMS
7.5.2 Creating and updating
110 7.5.2 a Create, identify and describe the Codification, title, author, subject, product
documented information
111 7.5.2 b Choose the format and the media of Language, graphics; paper, electronic
the documented information
112 7.5.2 c Review and approve the adequacy Who writes, codifies, who approves
of the documented information
Control of documented
7.5.3
information
113 7.5.3.1 Control the availability of the Where and when required in a form that is
a documented information suitable for use
114 7.5.3.1 Control the protection of the Loss of confidentiality, loss of integrity,
b documented information misuse
115 7.5.3.2 Control the distribution, access and Who is in charge, method to use, rule to
a use of the documented information follow
116 7.5.3.2 Control the storage of the Including preservation, protection and
b documented information readability
117 7.5.3.2 Control the changes of the Use of updated versions, restricted access to
c documented information obsolete versions
118 7.5.3.2 Control the retention time and the Retention period, disposal method
d removal of the documented
information
119 7.5.3.2 Control the documented Unique codification, access, protection
information of external origin
120 7.5.3.2 Protect the documented Who has the right to read, who has the right to
information change
