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QP01 Document Control

To the Requirements of ISO 9001:2015

Name Function Date Signature

Created by

Reviewed by

Approved by

Document Ref: QP01 Document Control

Version: 1
Date of Version: [dd/mm/yyyy]
Confidentiality Level: Controlled: Uncontrolled if printed

Amendment History
Amendment History
Date Version Created By Description of Change
[dd/mm/yyyy] 1 [Name 2] Initial Release

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Table of Contents
1. INTRODUCTION ....................................................................................................................................... 3

2. SCOPE ...................................................................................................................................................... 3

3. PROCEDURE............................................................................................................................................. 3

3.1 MANAGEMENT SYSTEM DOCUMENTATION ..................................................................................................... 3

3.2 DOCUMENT CHANGE CONTROL .................................................................................................................... 3
3.3 EXTERNAL DOCUMENTS............................................................................................................................... 4
3.4 COMPUTER SECURITY.................................................................................................................................. 4
3.5 OBSOLETE DOCUMENTS .............................................................................................................................. 4

APPENDIX 1: NEW AND EXTERNAL CONTROLLED DOCUMENT FLOW CHART ................................................... 5

APPENDIX 2: DOCUMENT CHANGE AND OBSOLESCENCE FLOW CHART ........................................................... 6

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1. Introduction
The purpose of this procedure is to describe the process of controlling the issue and changes made to
documents in the Quality Management System (QMS). Data kept on any electronic media is treated
as a document.

2. Scope
3.1 Management System Documentation
3.2 Document Change Control
3.3 External Documents
3.4 Computer Security
3.5 Obsolete Documents

3. Procedure
It is the responsibility of the Managing Director to ensure the appropriate control and issue of
[Company Name] QMS documentation. The Managing Director or delegate is responsible for the
preparation, review, authorisation, issue and amendment of key QMS documents.

3.1 Management System Documentation

A Master Document & Record List is used to identify the latest issue of controlled documents. It is the
responsibility of the Managing Director to maintain the Master Document & Record List and controlled
document files.

While a hard copy of the Quality Manual and associated procedures may be maintained as a reference
copy, the master-controlled copy resides in soft copy only. Only the latest issue of any document is
held in the reference or master soft copy files.

Quality Procedures (QP’s) are prepared by the Managing Director/process owner and formally
approved by the Managing Director - evidenced by signature in the Document Management section
of each procedure.

Each quality system document includes title, reference number, issue date and page number.
The Managing Director shall ensure that all released QMS documents are updated in a controlled
manner and superseded documents are withdrawn from the master document folder on the system.
Document change is carried out in accordance with section 3.2.

The Managing Director or delegate maintains the Master Document & Record List identifying the issue
status of procedures and related controlled documents.

3.2 Document Change Control

Upon the need to make an amendment the document is revised accordingly by the Managing Director
and the issue level of the document raised to the next sequential number.

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Amendments are marked with a dash at the left edge of the document. This is ensured via the "Track
changes" function within Microsoft Word.

The document revision table is then completed detailing the date of amendment, the new issue status
and brief details of the change, including page and/or section references.

The revised document is then electronically approved by the Managing Director or delegate, the
obsolete copies withdrawn and replaced by the updated version in the master document folder on
the system; the Master Document & Record List is also electronically updated.

On subsequent updates, the previous amendment is ‘accepted’ (changed to standard text) so only
new amendments are marked.

3.3 External Documents

External documents may include industrial standards and specifications such as ISO 9001:2015, and
other publications where relevant (See QF20 Legislation Register).

These documents are checked periodically and at least annually via the Internet to ensure the latest
version is in use. External documents such as Standards or Codes of Practice are also listed on the
Master Document & Record List where appropriate.

Customer supplied documentation is reviewed on receipt and is maintained in accordance with

section 3.6 of QP07 Product and Service Provision and Operations.

3.4 Computer Security

Key office computer information resides on a shared server which is backed-up on to tape/secure
drive/cloud. The backup is carried out daily and current back up is stored onsite in the company fire-
proof safe for security.

An anti-virus program and Internet security is installed to protect all incoming data from corruption
and unauthorised access. Any disks of external origin are virus checked before use in the company
systems.

3.5 Obsolete Documents

Obsolete documents are, depending on type, either retained for the lifetime of the related
product/service (considering regulatory requirements and record retention periods) or promptly
removed from use by the Managing Director and deleted.

Retained obsolete documents are clearly identified as “obsolete” by electronic storage

location/access restriction or physical marking, as appropriate, to prevent inadvertent use.

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Appendix 1: New and External Controlled Document Flow Chart

New controlled
document identified

Y
Is new document
of external
origin?

Document produced in
format as described in
3.1
Requirement for new /
updated external document
identified

Document checked for

accuracy by process owner/
MR and approved

Updated
New copy of external Document forwarded to MD Master
document obtained or delegate for entry on to Document &
Master Document & Record Record Index
Index

Superseded document
marked as “obsolete” if Controlled copies of new
retained document released to
relevant areas

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Appendix 2: Document Change and Obsolescence Flow Chart

Requirement for change

to controlled document
identified

Document changed by
MD (or delegate)
accordingly

Amendments indicated in text

by bold underlined
(Or alternative)

Document revision table

updated to include new issue
status and summary of
change

Updated
Controlled copies of new
Master document index Master
document released to
updated to reflect new issue document
relevant areas
status index

Obsolete document
removed and either
destroyed or if retained,
marked as “obsolete”

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