Prosedur yang wajib ada dalam ISO9001:2008, adalah: (red font)
1. Prosedur Pengendalian Dokumen
2. Prosedur Pengendalian Rekaman
3. Prosedur Internal Audit
4. Prosedur Pengendalian Produk Tidak Sesuai
5. Prosedur Tindakan Perbaikan
6. Prosedur Tindakan Pencegahan
Berdasarkan Klausul di bawah ini:
4.2.3 Control of
documents
4.2.3
control of documents
Documents
required by the quality management sys-em
shall be controlled. Records are
special type of document and shall be controlled according to the requirements
given in 4.2.4
A documented procedure shall be established to
define the controls needed
a) to approve documents for adequacy
prior to issue
b) to review and update as necessary
and re-approve documents.
c) to ensure that changes and the
current revision status of documents are identified,
d) to ensure that relevant versions of
applicable documents are available at points of use.
e) to ensure the documents remain
legible and readily identifiable,
f) to ensure that documents of
external origin determined by the organization to be necessary for the planning
and operation of the quality management system are identified and their
distribution controlled, and to prevent the unintended use of obsolete
documents, and apply suitable identification to them if they are retained for
any purpose.
4.2.4 Control of records
Records
established to provide evidence of conformity to requirements and of the effective
operation of the quality management system shall be controlled.
The organization shall establish a documented procedure
to define the controls needed for the identification, storage, protection,
retrieval, retention and disposition of records.
Record shall
remain legible, readily identifiable and retrievable.
8.2.2 Internal audit
The
organization shall conduct internal audits at planned intervals to determine
whether the quality management system
a) 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
b) 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
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 :
a) by taking action to eliminate the
detected non-conformity
b) by authorizing its use, release or
acceptance under concession by a relevant authority and, where applicable, by
the customer;
c) by taking action to preclude its
original intented use or application.
a) 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
a) review non conformities (including
customer complaints)
b) determining the cause of non
conformities,
c) evaluating the need for action to
ensure that non-conformities do not recur,
a) determining and implementing action
needed
b) records of the results of action
taken (see 4.2.4), and
c) reviewing the effectiveness of the
corrective action taken
8.5.3 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 define
requirements for
a) determining potential
nonconformities and their cause,
b) evaluating the need for action to
prevent occurrence of nonconformities,
c) determining and implementing action
needed,
d) records of results of action taken
(see4.2.4), and
e) reviewing the effectiveness of preventive
action
