Control of Documents
Version:
03
Page:
1 of 5
Issue Date:
21 December 2000
Authorised by: Marjorie Dickenson
WORK INSTRUCTION
1.
PURPOSE
The purpose of this procedure is to control the documents used by SimuLab - in particular, their
identification, issue and revision.
2.
SCOPE
Controlled documents include, but are not restricted to:

Company Policies.

Manuals.

Test and calibration procedures.

Work instructions.

Forms.

Laboratory Worksheets.

Registers.

Logbooks.

National / International quality or technical standards, and codes of practice.
Documents may be printed or in the form of computer data.
3.
REFERENCES
AS ISO/IEC 17025:1999 – General requirements for the competence of calibration and testing laboratories –
Section 4.3
07-001 – Document Control Register
Form – Document Change Request
Form – Request for Update/Amendment to Standards File
4.
RESPONSIBILITY
Managing Director or approved
delegate
Quality Assurance Manager
Manual Holders
All personnel
5.
 Review and approve all quality management system (QMS)
documentation.
 Maintain a master list of all system documentation.
 Request National & International standard and codes of practice
updates.
 Make approved changes to laboratory quality management system
documentation.
 Issue approved amendments to QMS documents. Ensure that all
obsolete QMS documents are returned and maintain historical record
of document changes by keeping one copy of the obsolete
documents. Discard all other obsolete copies.
 Remove obsolete documents and replace them with the amended
sheets. Sign and date the new amendment sheet and insert in the
document.
 Return all obsolete sheets to the Quality Assurance Manager.
 Advise the Quality Assurance Manager if any change to quality
management system documents or test methods is considered
necessary.
ACTION / METHOD
5.1.
Identification
All system documents are identified by a document number. The document number consists
two (2) parts and has the following format:
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Control of Documents
Version:
03
Page:
2 of 5
Issue Date:
21 December 2000
Authorised by: Marjorie Dickenson
WORK INSTRUCTION
TT – NNN
Where:
TT
NNN
is the document type. Document types are defined in Appendix 1 of this document
is the sequence number of the document. This number increases sequentially for
each document within the “document type”.
The document filename is printed in the bottom right hand corner of each page of the
document next to the Document Holder number, as detailed below.
5.2.
Document Header
All documents have a header box. All documents except forms and laboratory worksheets
have a header format as detailed below, the header for forms and laboratory worksheets
differs in that the Document Description and the Authorised by fields are missing. All
documents are prepared with a date of issue, a version number and are paginated.
SIMULAB logo here
Section 5
SimuLab Pty Ltd
Version:
Page:
Issue Date:
Authorised by:
QUALITY MANUAL
5.3.
of
Document Holder
The Document Holder is the officer to whom the manual/proforma is issued and is identified
by a 2-digit number in the double box
in the footer. The same identifier is used for
each manual / proforma issued to a particular officer.
Where an officer is not being issued with a manual / proforma, the identifier assigned is not
used.
5.4.
New Documents or Document Changes
When the Quality Assurance Manager generates a new document in the quality
management system, the following procedure shall be followed:

Obtain the first unused sequence number for the document type listed in the
Document Control Register, this is used as the document number.

Fill in the information columns in the Document Control Register.

Write a draft document or have a technically competent staff member write the
proposed document. Have it checked by suitably qualified staff members and make
the appropriate technical or editorial changes.

Gain approval to issue the document from the Managing Director or delegate.

Place the original in the master document file and issue manual holders with the new
document.
The Managing Director or delegate will review and approve changes to controlled documents
prior to the issue of any revision by the Quality Assurance Manager.
Where personnel consider that a change to controlled quality management system
documents is necessary, they may request the change by completing and issuing a
“Document Change Request” to the Quality Assurance Manager. The request should include
or refer to any background information upon which the Managing Director may base the
review and approval.
03-003
WORK INSTRUCTION
Control of Documents
Version:
03
Page:
3 of 5
Issue Date:
21 December 2000
Authorised by: Marjorie Dickenson
Where a change to the quality management system documentation is approved, the Quality
Assurance Manager will update the Document Control Register. If a document needs to be
amended quickly pending its reissue, then the Quality Assurance Manager is authorised to
make hand-written amendments, these amendments must be clearly marked, initialled and
dated. The amended document must be updated and reissued as soon as practicable.
The version number always contains two (2) characters with the original issue of the
approved quality system documentation described as issue 01. Any change in the revision
status will be dated and that document given a new consecutive revision number.
The Quality Assurance Manager will ensure that all controlled copies are effectively updated.
5.5.
Document Approval and Issue
All documents in the quality management system shall have the date of issue and version
number. All these documents shall be reviewed and approved by the Managing Director or
delegate prior to issue. Confirmation of approval is indicated by the document being entered
in the “Document Control Register” and the authorising staff members name included in the
document header.
The Document Control Register will include details of the distribution and revision status of
quality management system documents. The Quality Assurance Manager holds the
Document Control Register.
The Quality Assurance Manager will ensure that quality management system documentation
is available on the SimuLab intranet as Portable Document Format (PDF) with password
security to prevent unauthorised editing and amending. Documents will be stored and
backed up on the company servers. When company personnel print a controlled document
from the intranet it is watermarked with:
UNCONTROLLED COPY
CHECK VALIDITY BEFORE USE
Copies of controlled documents may only be issued to external parties with the approval of
the Managing Director or delegate. In this event, Quality Assurance Manager will mark the
document / data as an “Uncontrolled” copy for which no amendments will be issued.
5.6.
Check Validity before Use
It is the responsibility of all company personnel to check the validity of the printed copy to
ensure it is the current issue.
5.7.
Historical Record
All superseded documents that are retained by the Quality Assurance Manager in historical
record files (e.g. to meet legal requirements, or for knowledge preservation purposes) will be
identified:

as being obsolete;

with the reason for retention; and

with the period / final date of retention.
5.8.
Document Control Database
An electronic file detailing all controlled documents produced, copy holders, and version
status, are held by the Quality Assurance Manager. A hard copy of the file, the Document
Control Register, is also retained by the Quality Assurance Manager and shall be updated at
least every three months.
5.9.
Control of data stored on computer disk
The Quality Assurance Manager will ensure all controlled quality documents stored on
company servers are backed up on a regular basis to prevent their loss in the event of
03-003
WORK INSTRUCTION
Control of Documents
Version:
03
Page:
4 of 5
Issue Date:
21 December 2000
Authorised by: Marjorie Dickenson
equipment malfunction, fire or theft. The back-up media will be suitably labelled to indicate
the contents and the date of the back-up. At least one back-up copy will be stored away from
the premises. In the event of any discrepancies, the most recent back-up will be considered
to be the master copy.
5.10.
Updating National & International from Standards Australia
The Quality Assurance Manager maintains register of relevant National & International
Standards in the Document Control Register. Every six (6) months the Quality Assurance
Manager provides the list to Standards Australia with a covering letter requesting of updates
available. When the update list is returned to the Quality Assurance Manager, a purchase
requisition shall be raised for the Australian Standards updates and the Purchase Order
forwarded to Standards Australia. When updates are received, the Quality Assurance
Manager will complete a “Request for Update/Amendment to Standards File” form and
ensure that the relevant updates, filing and distribution is carried out as per the form
checklist.
03-003
WORK INSTRUCTION
Control of Documents
Version:
03
Page:
5 of 5
Issue Date:
21 December 2000
Authorised by: Marjorie Dickenson
Appendix 1
Document Type
Number
01
02
03
04
05
06
07
08
09
Type Listing
Corporate policies
Manuals
Work Instructions
Logbooks
Forms
Test Procedures
Registers
Reserved
Reserved
03-003