System Procedure: Master File MR Dept Heads

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ABC Ltd Document No.

SP-102 Revision 1 Date 03/12/09 Page 1 of 3


SYSTEM PROCEDURE

Distribution Master File MR Dept heads Prepared Approved Issued

DOCUMENT CONTROL PROCEDURE


1.1. Purpose
To define and control the generation, distribution and storage of controlled documentation
that is needed to support ABC Limited's Quality Management System.

1.2. Scope
This procedure applies to all documents that are subject to changes and revisions. These
include, but are not limited to, the following:

 Quality Control Manual,


 System Procedure,
 Other Procedures
 Work Instructions and formats,
 Flow charts
 Drawings (internal or customer provided),
 Standards.
1.3. References
ISO 9001:2008 Section 4.2.3 Control of Documents

1.4. Procedure
1.4.1 Responsibilities

The Management Representative controls, distributes and monitors all Quality


Management System documentation.

1.4.2. Approval and Issue

1.4.2.1 Quality Manual

Managing Director has authority to approve Quality Policy and Quality


Manual.

1.4.2.2 Approvals

Department heads have the authority to approve documents pertaining to


products manufactured by ABC Limited .

1.4.2.4 Issue/Distribution

The Management Representative has the responsibility for the issue of


quality documents. Documents may be translated from English to
ABC Ltd Document No. SP-102 Revision 1 Date 03/12/09 Page 2 of 3
SYSTEM PROCEDURE
other languages. However,such translated documents shall be
considered as uncontrolled copies and in case of doubt , the
English version shall be used as reference.

The Management Representative shall insure that all manuals, procedures,


work instructions and specifications required are correct and the
Document Master Register is maintained.

1.4.3. Document Creation Guidelines

All pages shall have a header or title that clearly identifies the document and
includes:

 A "SP-XXX" prefix to denote a system Procedure


where XXX is a unique number for each procedure.

 A "WI-XXXX" prefix to denote a Work Instruction


where XXXX is a unique number for each work instruction

 Document number or Drawing number

 Date of Issue,

 Revision number.

Required information for procedures shall include:

 Purpose – States the reason the document was


created,

 Scope – States the company’s intention in regards to


the procedure or work instruction,

 References – States the reference documents


included in the procedure or work instruction,

 Procedure – Describes the process,

1.4.4. Revisions All Controlled Documents are approved by those responsible


for the approval of the previous issue. When a document is revised , the
revision number is incremented by 1.

Exceptions – In the event that an urgent change is needed to a procedure or


other controlled document for production reasons, the Management
Representative may authorize a procedural exception. All exceptions are
temporary and require documentation. If permanent changes are necessary they
shall be incorporated into the procedure as a matter of priority and the revised
ABC Ltd Document No. SP-102 Revision 1 Date 03/12/09 Page 3 of 3
SYSTEM PROCEDURE
procedure formally reviewed, approved and reissued.

1.4.5. Control of documents

All controlled documents and related files are clearly identified as "Controlled"
material. All documents shall be stamped "CONTROLLED".

Document Control – New or revised documents shall be logged on the


Document Control Register, by document number, revision number, and date
of issue and to whom it is issued.

Superseded Documents – Controlled documents that have been replaced shall


be returned to the Management Representative as evidence that the current
version is in use, and shall be destroyed. In cases where obsolete documents are
retained they are clearly stamped OBSOLETE.

Standards – Standards used for quality reference purposes are separated into
current and superseded issues. Superseded standards may be kept for reference
(for the purpose of checking past quality conformance) but are clearly
identified as superseded .

1.4.6. Document Retrieval and Access

All controlled documents shall be readily accessible to any employee who is


required to work in accordance with any procedure or work instruction. Work
Instructions are kept at or near work areas.

Electronic Data Control – The intent of the electronic data control system is
identical to the hard copy system. The level of control for editable documents
is determined by access passwords where only the Management Representative
has the ability to change.

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