Documented Information Control Procedure

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GENERAL REQUIREMENT

This procedure provides guideline to extent information explained in clause 7.5 Documented Information of the Quality Manual.

The requirement requirement is also enable to provide conformity to clause 7.5 Documented Information of ISO 9001:2015 Standard Requirement. (Clause 7.5.1, 7.5.2 and 7.5.3)

Type of Documented information applied in Company is as follows;
  • a) Information type 1: Instruction or guideline document such as manual, procedure, work instruction, flow chart and others.
  • b) Information type 2: Blank format
  • c) Information type 3: Filled-up document such as record.

COMMON DEFINITION USED

The definitions addressed are mainly refer to IS0 9000:2015 RESPONSIBILITY AND

INFORMATION CONTROL PROCESS

New Creation of Document

  1. Document that required to be controlled is as defined in clause clause 7.5 Documented Information of the Quality Manual. It applies to documented information type 1 and type 2.
  2. Any new document proposal must be approved by QMR. Endorsement will be made Managing Director where necessary
  3. Approved document shall be listed in the Document Master List
  4. Revision history should be determined through;
    1. Revision history table at front page of document (e.g. procedure or work instruction)
    2. Address in the footer of the document in case of form, checklist or other similar type of document
  5. Document will consider as official once being formated in PDF version and retained by QMR.
  6. Document shall be controlled as section Management of Controlled Document of this procedure

Amendment of Existing Document

  1. Any proposal of revision to the existing document must through QMR. It applies to documented information type 1 and type 2.
  2. Those changes made for the form, old version of document need to be cleared first before use of revised document. Where applicable, Document Controller or QMR has authority to stop the usage of old document if reflected to the quality service conformity.
  3. Revision history as determined in #4 of section New Creation of Document shall be updated

Management of Controlled Document

  1. Control requirement for document is covered for internal and external document.
  2. Master Copy shall be in soft copy, protected in PDF file and retained by QMR.
  3. Copy of document is allowed but shall obtain approval from QMR before issuance.
  4. Original soft copy only kept by the Document Controller for reference or to be used upon requires for changed.
  5. Maintenance of soft copy should be in appropriate manner and back-up system should be activated through external hard disc or USB drive or other appropriate methods
  6. No hard copy is allowed. However, QMR will justify the method of distribution if hard copy of controlled document is really need and does not against MISB‘s integrity of quality management system.
  7. Distributed copies shall be indicated with CONTROLLED in red on the first page of Revision History. 8 Any controlled document need to be distributed to the third party, it shall be approved by QMR and indicated with UNCONTROLLED

Management of Controlled Records

This section is applied to documented information type 3.

Identification and traceability of Records

  1. All records shall be filed in sequence and/or dated to allow easy identification and retrieval.
  2. Unique identification of the version used is generated as described in #3 and #4 of section New Creation of Document of this procedure.
  3. Unique identification for referring to the product, services or output of Company can refer to clause 8.5.2 Identification and traceability of the Quality Manual
  4. QMR shall be responsible to maintain the List of Records. If any changes to the list of their records, the list shall be updated accordingly.
  5. Records should be kept at the designated location to ensure the traceability and person in charge is defined

Storage, Protection and Retention

  1. All records shall be stored and maintained and retrievable by the respective functions.
  2. Record’s legibility must be preserved.
  3. Records shall be stored in hard copy and/or soft copy as appropriate. For non-critical records, storage in normal file cabinet is sufficient. For critical records, if any, the records shall be protected from potential fire, theft, unauthorized removal and other damage.
  4. Also, critical records on electronic media shall be secured from inadvertent deletion, computer viruses and corruption of files; hard copies shall be produced and kept at a different location / area.
  5. Records on soft copy shall be backed-up and back-up records shall be protected accordingly from damage or loss.
  6. All records shall be retained for a minimum period as specified in the List of Records. Designated person shall be responsible to establish the retention period.

Retrieval and Disposal

  1. All records shall be made available for inspection by management committee or as requested by the interested parties.
  2. The records shall be stored in such a way that they are readily retrievable for review. For any request for records by external parties,
  3. Records only can be disposed once obtained approval from QMR
  4. Records shall be disposed-off by any suitable means. Confidential records shall be disposed-off by shredding.
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