PURPOSE

  • This procedure outlines the process for controlling quality related documents such that no obsolete document is used in the company.

 

SCOPE

  • This procedure is applicable to all documents used in our Quality Management System (QMS).

 

DEFINITIONS

Internal documents

  • Quality manual, procedures, and relevant forms, working instructions, plans and relevant forms.

External documents

  • ISO 9001 Standards; legislations and regulations; other requirements and regulations; drawings and project specification from Client.

Obsolete documents

  • No longer serve their intended purpose.

 

REFERENCE DOCUMENTS

  • ISO 9001 (* all undated reference is latest revision and its addendum, errata.)

 

RESPONSIBILITIES

The Quality Manager shall be responsible for the control of all QMS documents, including internal and external documents.

 

PROCEDURE

Review and approval control

  • Internal documents.
  • All management system documents defined in Section 3.1 of this procedure must be reviewed and approved by the Director prior to issuing.

 

External Documents

  • For all external documents such as other requirements, regulations and legislations, where applicable or is necessary, will be adopted for using.
  • The department managers are in-charge to see which external documents need to be applied in their activities. A list of external documents is established basing on that consideration.
  • All external documents are kept in relevant departments in accordance with list of external documents.

 

Document control

Internal documents

  • All internal documents defined in Section 3.2 of this procedure must bear a document number, revision level and the effective date, with the name and signature of the person who approves the documents.
  • All internal documents are controlled with a stamp ‘Controlled Document’ on the first page of the document, with the exception of the master copy or original copy that is kept by the Document Controller (DC).
  • The master copy or original copy, which is maintained by the DC, they will be stamped ‘Master Document’.
  • An updated master register showing the latest revision level will be maintained in the following form.

External documents

An updated master register of all external standards, Legislations and Regulations will be recorded and maintained, which is subjected to be sent to QC for information.

 

Distribution Control

Internal Documents

  • A distribution list will be maintained to keep record of the holders of the quality manual and quality system procedures.
  • Whenever a new revision of the controlled document or the specific section or page(s) is issued, the DC will destroy the old revision and replace it with the latest revision. The DC will accordingly notify all the other recipients of the changes.

 

External Documents

  • The external standards and regulatory documents are available at relevant department for reference by our staff.

 

Obsolete Document

  • For all documents defined in Section 3.1 and Section 3.2 of this procedure, obsolete documents that are kept for legal or knowledge-preservation purpose must be identified as ‘Superseded – See Latest Revision’, and where possible, filed separate from the active copy.

 

Control of changing Document

Internal Documents

  • Any change to the document referred to in section 3.1 of this procedure will be reviewed by the Management Committee and approved by the Director.
  • Changes and the reason of change must be clearly stated in the revision history of the document.
  • Upon effecting the change, a new revision will be assigned to the document incorporating all proposed changes.

External Documents

  • When there is a revision to the external standards, legislations and regulations, arrangement will be made to purchase the latest revision, where possible or is required.

Record maintenance system

  • A list showing the records and its retention period will be maintained as shown in Appendix A for quality records.
  • Paper copy is the primary means for the maintenance of records.
  • As a measure to ensure that records are not disposed off prematurely, the Director must approve any change to the retention period for such records.
  • Records must be legible and, where possible, any alteration to such records should be initialed by the person who makes the alteration.
  • Where records are stored as electronic files, proper backup in the form of soft copy or other suitable access when required.
  • The MR will ensure that the records listed in Appendix A are filed, stored and maintained to minimize deterioration and to prevent loss.
  • Records exceeding the retention period specified in Appendix A may be destroyed.
  • Confidential records must be shredded at point of disposal.

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