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<Short Name> Management Procedure

Control of Management System Documentation


(Digital Distribution)
1 Introduction

1 Scope
This procedure sets out <Short Name>’s arrangements for the creation, review, approval,
distribution, use and revision of all management system documentation which sets out
requirements that staff must follow.
Such documents are termed ‘controlled documents’ and include: the management system
manual and its associated documentation, including; procedures, pro formas, standards,
instructions, drawings, specifications etc.
Records which provide evidence of conformity to requirements and of the effective operation
of the management system are controlled in accordance with the Control of Management
System Records Procedure.
External documents for non-critical use, such as user manuals, advisory documents (even if
referenced in controlled documents), reference books, marketing materials, and supplier
directories are not controlled documents in the context of this procedure.

2 Revision History
Revision Date Record of Changes Approved By

0.0 [Date of Issue] Initial Issue

3 Control of hardcopy versions


The digital version of this document is the most recent version. It is the responsibility of the
individual to ensure that any printed version is the most recent version. The printed version
of this manual is uncontrolled, and cannot be relied upon, except when formally issued by
the <Document Controller> and provided with a document reference number and revision in
the fields below:
Document Ref. Rev. Uncontrolled Copy X Controlled Copy

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<Short Name> Management Procedure
4 Process I/O Map
With What With Who
 Maintained Documents  Document Control
 Management System
Manager(s)

Input Activity Output


 Revised Management  Document Approval
System Documents  Process Control
 Standards Control of Management  Continual Improvement
 Customer Drawings System Documentation
 Document Changes
and Specifications
 Process Changes

How Metrics
 Management System  No. of Document Errors
Document Register  No. of Document
 Disaster Recovery Changes

5 Terms and Definitions


 “staff” and “users” means all of those who work under our control, including
employees, contractors, interns etc.

 “we” and “our” refer to <Short Name>

6 Responsibilities
The <Document Controller> is responsible for all aspects of the implementation and
management of this procedure, unless noted otherwise.

2 General
The <Document Controller> ensures that:

 a specific folder, or folders, is maintained on the network server, to contain the up-to-
date versions of controlled documents

 all controlled documents are only made available in a ‘read only’ format

 all out-of-date controlled documents are archived to an archive folder and retained for
future reference

 a Controlled Documents Register of documents on release, and indicating the current


versions, is maintained and made readily accessible

 all electronic folders containing either current or archived controlled documents are
subject to periodic and secure backup

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<Short Name> Management Procedure
3 Document Creation
Internal controlled documents are only to be created by those with good knowledge of the
subject matter.
All internal controlled documents share a single electronic format and documents of a similar
type are consistently formatted.
All controlled internal documents are subject to review and approval.
The initial release of a new controlled document is given the revision indicator “0.0”
(zero.zero).

4 Document Review and Approval


The management system manual, and any changes to it, are subject to approval by the most
senior manager with direct responsibility for its contents.
All other management system documents are reviewed and approved by a senior manager
who, wherever practicable, is not the author but is knowledgeable regarding the subject
matter.
The reviewer indicates approval of the document by forwarding it to the <Document
Controller> and requesting distribution.

5 Document Distribution
All controlled documents are made available to all staff via the intranet and must not be
edited or copied except by those authorised to do so.
All staff who require access to controlled documents to properly undertake their roles are
trained in their access and use.
Uncontrolled copies of documents are not issued to staff or outside parties who manage,
perform, or verify work that is directly affected by the document.
Where permitted, and coordinated by the <Document Controller>, individual departments
may issue and maintain their own documents, and maintain a local Controlled Documents
Register of all documents and their current revision.

6 Periodic Re-evaluation of Documents


The <Document Controller> ensures that:

 details of all controlled documents are listed in the Controlled Documents Register

 all controlled documents are re-evaluated by a subject matter expert at least every
three years and updated as required

 the Controlled Documents Register identifies when controlled documents are due for
re-evaluation

 where a controlled document is determined to require updating, the changes are


made, and a revised version issued, according to the procedure set out below

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<Short Name> Management Procedure
7 Document Revisions
Staff may request a change to a controlled document using a Document Change Request
Form.
Revisions to controlled documents go through the same steps as if the document were a
new document.
Each controlled document contains a revision history table within its text. The first digit of the
revision indicator is to be incremented to indicate a major revision and the second to indicate
a minor revision.
Only those authorised to change controlled documents may do so.
Re-evaluation, inspection (where applicable) and internal auditing will be used to confirm the
effectiveness of revisons.

7 Changing High Level Process Documentation


Documents defining processes are changed by undertaking the following steps:

 the request for a process change is documented, including its justification, typically
using a Corrective and Preventative Action Reporting (CPAR) Form.

 the change is reviewed and approved in advance of implementation, by the


responsible managers, including the ‘process owner’

 the appropriate document defining the process is updated to reflect the change and
reviewed and approved in accordance with this procedure

 following implementation, it is verified, in accordance with the CPAR system, that the
change has had the intended effect

8 Revisions to Documents Requiring Regulatory or Customer


Approval
Any changes to documents that require customer or regulatory review and / or approval are
not released until such approval has been obtained in writing.

9 Controlling Third-Party Documents


External documents which are referenced in a customer purchase order or contract, such as
standards or third party specifications may be maintained without control:

 where the customer has indicated a document version number that version is used

 where the customer has not provided a version number, the most recently available
version is used
External documents necessary for the planning and operation of the management system,
such as standards, regulatory guidance or third party are to be controlled.
The <Document Controller> ensures that the most recent version of each third-party
controlled document is maintained on the network server (for electronic versions) or in a in a
binder of controlled external documents (for hardcopies).

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<Short Name> Management Procedure
10 Obsolete Documents
Obsolete controlled documents are clearly marked “OBSOLETE” and removed from use.
Obsolete controlled documents retained for reference are kept separate from active
documents.
Filing cabinets and electronic folders containing obsolete documents are segregated and
labelled ‘OBSOLETE’.

11 Forms
All forms are controlled wherever they impact on the outcomes of our activities or
management systems or where they are used to create controlled records.
However, where this is not the case, managers and supervisors may create and approve
local “forms”, for use in their area of control. Such local “forms” do not require an approval
signature nor a revision history table.
Forms may be photocopied but it is preferred that they are printed directly from the intranet.

12 Records
Records retained in support of this procedure are listed in the appropriate Controlled
Records Register and controlled according to the Control of Management Systems Records
Procedure.

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