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    CMS Control of Management System Documentation

    Uploaded by

    Amine Rached
    This document outlines the procedures for controlling management system documentation at Short Name. It describes how documents are created, reviewed, approved, distributed, revised and made obsolete. The document controller is responsible for maintaining a register of controlled documents and ensuring documents are re-evaluated every three years. It also describes controlling external documents, revisions requiring regulatory approval, and segregating obsolete documents.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    CMS Control of Management System Documentation

    Uploaded by

    Amine Rached
    161 views5 pages
    This document outlines the procedures for controlling management system documentation at Short Name. It describes how documents are created, reviewed, approved, distributed, revised and made obsolete. The document controller is responsible for maintaining a register of controlled documents and ensuring documents are re-evaluated every three years. It also describes controlling external documents, revisions requiring regulatory approval, and segregating obsolete documents.

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    This document outlines the procedures for controlling management system documentation at Short Name. It describes how documents are created, reviewed, approved, distributed, revised and made obsolete. The document controller is responsible for maintaining a register of controlled documents and ensuring documents are re-evaluated every three years. It also describes controlling external documents, revisions requiring regulatory approval, and segregating obsolete documents.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    161 views5 pages

    CMS Control of Management System Documentation

    Uploaded by

    Amine Rached
    This document outlines the procedures for controlling management system documentation at Short Name. It describes how documents are created, reviewed, approved, distributed, revised and made obsolete. The document controller is responsible for maintaining a register of controlled documents and ensuring documents are re-evaluated every three years. It also describes controlling external documents, revisions requiring regulatory approval, and segregating obsolete documents.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5

    <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

    Control of Management System Documentation Page 1 of 5


    <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

    Control of Management System Documentation Page 2 of 5


    <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

    Control of Management System Documentation Page 3 of 5


    <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).

    Control of Management System Documentation Page 4 of 5


    <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.

    Control of Management System Documentation Page 5 of 5

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