Rekaman Wajib menurut ISO9001:2008 adalah:
1.
Management review; Records from management reviews shall be maintained
2.
Competence, training and awareness; maintain appropriate records of education,
training, skill and experience
3. Planning
of product realization: evidence that the realization processes and resulting
product meet requirements
4. Review of
requirements related to the product; Records of the results of the review and
actions arising from the review shall be maintained
5. Design
and development inputs; Inputs relating to product requirements shall be determined and record maintained
6. Design
and development review; Records of the results of the reviews and any necessary
actions shall be maintained
7. Design
and development verification; Records of the results of the verification and
any necessary actions shall be maintained
8. Design
and development validation; Records of the result of validation and any
necessary actions shall be maintained
9. Control
of design and development changes; Record of the result of the review of
changes and any necessary actions shall be maintained
10.
Purchasing process; Criteria for selection, evaluation and re-evaluation shall
be established. Records of the results of evaluations and any necessary actions
arising from the evaluation shall be maintained
11.
Validation of processes for production
and service provision: requirements for records
12.
Identification and traceability: Where traceability is a requirement, the
organization shall control and record the unique identification of the product
and maintain records
13. Customer
property: If any customer property is lost, damaged or otherwise found to be unsuitable
for use, the organization shall report this to the customer and maintain
records.
14. Control
of monitoring and measuring equipment: Records of the results of calibration
and verification shall be maintained
15. Internal
audit: Records of the audits and their result shall be maintained
16.
Monitoring and measurement of product: Records shall indicate the person(s)
authorizing release of product for delivery to the customer
17. Control
of nonconforming product: Record of the nature of nonconformities and any
subsequent actions taken, including concessions obtained, shall be maintained
18.
Corrective action: records of the results of action taken, and
19.
Preventive action: records of results of action taken
Berdasar Klausul di bawah ini:
5.6
Management review
5.6.1
General
Top
management shall review the organization’s quality management system, at
planned intervals, to ensure its continuing suitability, adequacy and
effectiveness. This review shall include assessing opportunities for
improvement and the need for changes to the quality management system,
including the quality policy and quality objectives.
Records from
management reviews shall be maintained
(see 4.2.4)
6.2.2
Competence, training and awareness
The
organization shall
a) determine the necessary competence
for personnel performing work affecting conformity to product requirements,
b) where applicable, provide training
or take other actions to achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware
of the relevance and importance of their activities and how they contribute to
the achievement of the quality objectives, and
e) maintain appropriate records of
education, training, skill and experience (see 4.2.4)
7.1 Planning
of product realization
The
organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the
requirements of the other processes of the quality management system (see 4.1)
In planning
product realization, the organization shall determine the following, as
appropriate :
a) quality objectives and requirements
for the product;
b) the need to establish processes and
documents, and to provide resources specific to the product;
c) required verification, validation,
monitoring, measurement, inspection and test activities specific to the product
and criteria for product acceptance;
d) records needed to provide evidence
that the reali-zation processes and resulting product meet re-quirements (see
4.2.4)
The output
of this planning shall be in a form suitable for the organization’s methods of
operation.
NOTE 1: A
document specifying the processes of the quality management system (including
the product realization processes) and the resource to applied to a specific
product, project or contract, can be referred to as a quality plan.
NOTE 2: The
organization may also apply the requirements given in 7.3 to the development of
product realization processes.
7.2.2 Review of requirements related to the
product
The
organization shall review the requirements related to the product. This review
shall be conducted prior to the organization’s commitment to supply a product
to the customer (e.g. submission of tenders, acceptance of contract or orders, acceptance
of changes to con-tracts or orders) and shall ensure that
a) product requirements are defined
b) contract or orders requirements
differing from those previously expressed are resolved, and
c) the organization has the ability to
meet the defined requirements.
Records of
the results of the review and actions arising from the review shall be
maintained (see 4.2.4).
Where the
customer provides no documented statement of requirement, the customer
requirements shall be confirmed by the organization before acceptance.
Where
product requirements are changed, the organization shall ensure that relevan
documents are amended and that relevan personnel are made aware of the changed
requirements
NOTE: In
some situations, such as internet sales, a formal review is impractical for
each order. Instead the review can cover relevant product information such as
catalogues or advertizing material.
7.3.2 Design
and development inputs
Inputs
relating to product requirements shall
be determined and record maintained (see 4.2.4). These shall include
a) functional and performance
requirements,
b) applicable statutory and regulatory
requirements
c) where applicable, information
derived from previous similar designs, and
d) other requirements essential for
design and development.
The inputs
shall be reviewed for adequacy. Require-ments shall be complete, unambiguous
and not in conflict with each other.
7.3.4 Design
and development review
At suitable
stages, systematic reviews of design and development shall be performend in
accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the
results of design and development to meet requirements, and
b) to identify any problems and propose
necessary actions
Participants
in such reviews shall include representatives of function concerned with the
design and development stage(s) being reviewed. Records of the results of the
reviews and any necessary actions shall be maintained (see 4.2.4).
7.3.5 Design
and development verification
Verification
shall be performed in accordance with planned arrangements (see 7.3.1) to
ensure that the design and development outputs have met the design and
development input requirements. Records of the results of the verification and
any necessary actions shall be maintained (see 4.2.4)
7.3.6 Design
and development validation
Design and
development validation shall be per-formed in accordance with planned
arrangements (see 7.3.1) to ensure that the resulting product is capable of
meeting the requirements for the specified application or intended use, where
known. Wherever practicable, validation shall be completed prior to the
delivery or implementation of the product. Records of the result of validation
and any necessary actions shall be maintained (see 4.2.4).
7.3.7 Control
of design and development changes
Design and
development changes shall be identified and record maintained. The changes
shall be reviewed, verified and validated, as appropriate, and approved before
implementation. The review of design and development changes shall include
evaluation of the effect of the changes on constituent parts and product
already delivered. Record of the result of the review of changes and any
necessary actions shall be maintained (see 4.2.4)
7.4.1
Purchasing process
The organization
shall ensure that purchased product conforms to specified purchase
requirements. The type and extent of control applied to the supplier and the
purchased product shall be dependent upon the effect of the purchased product
on subsequent product realization or the final product.
The
organization shall evaluate and select suppliers based on their ability to
supply product in accordance with the organization’s requirements. Criteria for
selection, evaluatition and re-evaluation shall be established. Records of the
results of evaluations and any necessary actions arising from the evaluation
shall be maintained (see 4.2.4).
7.5.2 Validation
of processes for production and service provision
The
organization shall validate any processes for production and service provision where resulting output cannot be
verified by subsequent monitoring or measurement and as consequence,
deficiencies become apparent only after the product is in use the service has
been delivered.
Validation
shall demonstrate the ability of these processes to achieve planned results.
The
organization shall establish arrangements for these processes including, as
applicable
a) defined criteria for review and
approval of the processes,
b) approval of equipment and
qualification of per-sonnel,
c) use of specific methods and
procedures,
d) requirements for records (see
4.2.4), and
e) revalidation
f) 7.5.3 Identification and
traceability
g)
h) Where appropriate, the organization
shall identify the product by suitable means throughout product realization.
i)
j) The organization shall identify the
product status with respect to monitoring and measurement requirements
throughout product realization.
k)
l) Where traceability is a
requirement, the organization shall control and record the unique
identification of the product and maintain records (see 4.2.4).
m)
n) NOTE: In some industry sectors,
configuration management is a means by which identification and traceability
are maintained.
o)
p) 7.5.4 Customer property
q)
r) The organization shall exercise
care with customer property while it is under the organization's control or being used by organization. The
organization shall identify, verify, protect and safeguard customer property
provided for use or incorporation into the product. If any customer property is
lost, damaged or otherwise found to be unsuitable for use, the organization
shall report this to the customer and maintain records (see 4.2.4).
s)
t)
u) NOTE: Customer property can include
intellectual property and personal data
7.6 Control
of monitoring and measuring equipment
The
organization shall determine the monitoring and measurement to be undertaken
and the monitoring and measurement equipment needed to provide evidence of
conformity of product to determined requirements
The
organization shall establish processes to ensure that monitoring and
measurement can be carried out and are carried out in a manner that consistent
with the monitoring and measurement requirements.
Where
necessary to ensure valid result, measuring equipment shall :
a) be calibrated or verified, or both
at specified intervals, or prior to use, against measurement standards
traceable to international or national measure-ment standards; where no such
standards exist, the basis used for calibration or verification shall be
recorded;
b) be adjusted or re-adjusted as necessary;
c) have identification in order to
determine its calibration status;
d) be safeguarded from adjustments that
woukd invalidate the measurement result;
e) be protected from damage and
deterioration during handling, maintenance and storage.
In addition,
the organization shall assess and record the validity of the previous measuring
result when the equipment is found not conform to requirements. The
organization shall take appropriate action on the equipment and any product
affected.
Records of
the results of calibration and verification shall be maintained (see 4.2.4)
When used in
the monitoring and measurement of specified requirements, the ability of
computer software to satisfy the intended application shall be confirmed. This
shall be undertaken prior to intial use and reconfirmed as
necessary.
NOTE.
Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration
management to maintain its suitability for use
8.2.2
Internal audit
The
organization shall conduct internal audits at planned intervals to determine
whether the quality management system
c) conforms to the planned arrangements
(see 7.1), to the requirements of this International Standard and to the
quality management system requirements established by the organization, and
d) is effectively implemented and
maintained.
An audit
programme shall be planned, taking into consideration the status and importance
of the processes and areas to be audited, as well as the result of previous
audits. The audit criteria, scope, frequency and methods shall be defined. The
selection of auditors and conduct of audits shall ensure objectivity and impartiality
of the audit process. Auditors shall not audit their own work.
A documented
procedure shall be established to define the responsibilities and requirements
for planning and conducting audits, establishing records and reporting results.
Records of
the audits and their result shall be maintained (see 4.2.4)
8.2.4
Monitoring and measurement of product
The
organization shalll monitor and measure the characteristic of the product to
verify that product re-quirements are met. This shall be carried out at appropriate
stages of the product realization process in accordance with planned
arrangements (see 7.1). Evidence of conformity with the acceptance criteria
shall be maintained
Records
shall indicate the person(s) authorizing release of product for delivery to the
customer (see 4.2.4)
The release
of product and delivery of service to the customer shall not proceed until all
the planned arrangements (see7.1) have been satisfactorily completed, unless
otherwise approved by a relevant authority, and where applicable by the
customer.
8.3 Control
of nonconforming product
The
organization shall ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or
delivery. A documented procedure shall be established to define the control and
related responsibilities and authorities for dealing with non conforming
product.
Where
applicable, the organization shall deal with nonconforming product by one or
more of the following ways :
d) by taking action to eliminate the
detected non-conformity
e) by authorizing its use, release or
acceptance under concession by a relevant authority and, where applicable, by
the customer;
by taking
action to preclude its original intented use or application
b) by taking action appropriate to the
effects, or potential effects, of the nonconformity when nonconforming product
is detected after delivery or used has started
When
nonconforming product is corrected it shall be subject to re-verification to
demonstrate conformity to the requirement
Record of
the nature of nonconformities and any subsequent actions taken, including
concessions obtained, shall be maintained (see 4.2.4)
8.5.2
Corrective action
The
organization shall take action to eliminate the causes of non conformities in
order to prevent recurrence. Corrective actions shall be appropriate to the
effects of the non conformities encountered.
A documented
procedure shall be established to define requirements for
d) review non conformities (including
customer complaints)
e) determining the cause of non
conformities,
f) evaluating the need for action to
ensure that
non-conformities
do not recur,
d) determining and implementing action
needed
e) records of the results of action
taken (see 4.2.4), and
f) reviewing the effectiveness of the
corrective action taken
8.5.4 Preventive action
The
organization shall determine action to eliminate the cause of potential,
nonconformities in order to prevent their occurrence. Preventive actions shall
be appropriate to the effect of the potential problems.
A documented
procedure shall be established to de-fine requirements for
f) determining potential
nonconformities and their cause,
g) evaluating the need for action to
prevent occurr-ence of nonconformities,
h) determining and implementing action
needed,
i) records of results of action taken
(see4.2.4), and
j) reviewing the effectiveness of
preventive action
