Tentang QMS Prosedur Wajib

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