25579772-Control-of-Documents.pdf

7/28/2019 25579772-Control-of-Documents.pdf

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Logo ABC Limited

Controlled Copy

Document Title: Control of Documents Document Type: Procedure

Document No: Revision No: 00 Effective date: Page 1 of 7


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Logo Control of Documents


1.0 Revision History

Revision number DAF # Effective date Revision description

00 Initial issue


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Legend: DAF # Document Approval Form Number

2.0 Purpose

1.1 To define the control process for the management of documents in terms of

their

1.1.1 identification,

1.1.2 approval,

1.1.3 review, amendments and re-approval,1.1.4 identification of changes and current revision status,

1.1.5 distribution and availability at points of use,

1.1.6 retention and disposal.

3.0 Scope

3.1 The scope of application covers all documents used within the quality

management system, where applicable.

4.0 References

4.1 Clause 4.2.3, ISO 9001:2008 Quality Management Systems Requirements

4.2 ISO 9000:2005 Quality Management Systems - Fundamentals and vocabulary

4.3 Clause 10.0, Quality Manual

5.0 Terms and definitions

5.1 Top-level documents

5.1.1 Quality Manual

5.1.2 Quality Policy

5.1.3 Control of Documents

5.1.4 Control of Records

5.1.5 Internal Audit


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5.1.6 Control of Nonconforming Products

5.1.7 Corrective Action

5.1.8 Preventive Action

5.2 Process-level documents

5.2.1 All other documents that are used within the quality management

system such as manuals, procedures, work instructions and forms.

6.0 Responsibilities

6.1 The Document Controller is responsible for the implementation of this

procedure.

7.0 Records

7.1 Registry of Documents

7.1.1 This form is used to facilitate the designations of serial numbers and

identification of all documents that have been approved for distribution.

7.2 Document Approval Form

7.2.1 This form is used to facilitate the approval of new and reviewed

documents.

7.3 Document Approval Form Log

7.3.1 This log is used to record the issuance of serial numbers for all

Document Approval Forms and their statuses (whether open or closed).

7.3.2 The serial numbers shall bear a prefix of DAF followed by a

hyphen and start from 1. Example the first DAF issued shall bear the number DAF-1,

while the second DCF shall bear the number DAF-2, and so on.

7.4 Document Distribution Form

7.4.1 This form is used to facilitate the distribution of documents.


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7.4.2 This form contains the planned effective dates of the documents

being distributed and the assigned document number.

8.0 Procedure

8.1 Identification

8.1.1 All documents shall bear the following identification:

8.1.1.1 Title,

8.1.1.2 Document number,

8.1.1.3 Revision number,

8.1.1.4 Effective date,

8.1.1.5 Page numbers.

8.2 Formats

8.2.1 All manuals and procedures shall contain the following clauses:

8.2.1.1 Clause 1.0 Revision history

8.2.1.2 Clause 2.0 Purpose

8.2.1.3 Clause 3.0 Scope

8.2.1.4 Clause 4.0 References

8.2.1.5 Clause 5.0 Terms and definitions

8.2.1.6 Clause 6.0 Responsibility

8.2.1.7 Clause 7.0 Records

8.2.1.8 Clause 8.0 Content 1

8.2.1.9 Clause 9.0 Content 2 and so on.

8.2.2 Formats for work instructions and forms are not controlled.

8.3 Numbering system


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8.3.1 The control number for documents shall be assigned a serial number by the

Document Controller as they are entered sequentially into the Registry of Documents. The

first number shall be 1 for the first document.

8.3.2 Documents that are generated internally shall have a prefix of QMS

followed by a hyphen and the assigned number. Example: The first document created will

have its number as QMS-1, while the next document will have its number as QMS-2.

8.3.3 External documents shall have a prefix of QMX followed by a hyphen

and the assigned number. Example: QMX-20.

8.4 Review and approval of documents

8.4.1 All new and revised documents within the quality management system shall

be approved prior to its distribution, including external documents.

8.4.2 Approval of documents shall be based on content adequacy and suitability

of the document for its targeted users.

8.4.3 Top-level documents shall be approved by the CEO and reviewed by the

Management Representative.

8.4.4 Process-level documents, including all formats, shall be approved by the

Management Representative and reviewed by the respective Quality Representatives.

8.4.5 All documents are subject to reviews based upon a need-basis.

8.4.6 If an existing document needs to be reviewed and amended for any purpose,

it shall be re-approved.

8.4.7 All amendments shall be described in the Revision History section of the

relevant document along with the citations of the Document Approval Forms date and

number.

8.4.8 The revision statuses of documents shall be updated and recorded

appropriately. Initial use of a document shall bear the number 00, while the first revision

shall bear the number 01 and continue onwards.


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8.4.9 All approved documents shall be made available at all points of use prior to

the effective dates.

8.5 Distribution

8.5.1 Original documents shall be stamped with Master Copy in red and

filed.

8.5.2 The distribution of documents shall be determined by their relevance

to the users.

8.5.3 Manuals and procedures that are distributed shall be stamped with

Controlled Copy in red.

8.5.4 Work instructions and forms that are being distributed shall not be

stamped but their distribution and availability at points of use shall be controlled.

8.6 Disposal

8.6.1 Obsolete documents shall be removed and disposed of from all

points of use.

8.6.2 Original documents which are obsolete shall be retained and filed for

reference purposes.