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Control of Documented Information Procedure Sample

This document outlines an organization's procedures for controlling documented information as required by ISO 9001:2015. It describes how the organization approves, reviews, identifies changes to, stores, retains, and disposes of documents and records. It also discusses how organizational knowledge from various sources is captured and maintained. The purpose is to ensure all documented information that forms part of the quality management system is properly managed and controlled.

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1K views

Control of Documented Information Procedure Sample

This document outlines an organization's procedures for controlling documented information as required by ISO 9001:2015. It describes how the organization approves, reviews, identifies changes to, stores, retains, and disposes of documents and records. It also discusses how organizational knowledge from various sources is captured and maintained. The purpose is to ensure all documented information that forms part of the quality management system is properly managed and controlled.

Uploaded by

ingventor
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 4

www.iso-9001-checklist.co.

uk

Insert your company’s name or logo, and address.

ISO 9001:2015
Control of Documented Information

This procedure is the property of Your Company. It must not be reproduced in whole or in part or otherwise
disclosed without prior written consent.

The official controlled copy of this quality manual is the digitally signed PDF document held within our network
server and visible to all authorised users. All printed copies, and all electronic copies and versions, except the ones
described above, are considered uncontrolled copies which should be used for reference only.
Insert your company’s name or logo.
ISO 9001:2015
Control of Documented Information

Contents
1 Control of Documented Information ____________________________________________________________________ 3

1.1 Introduction & Purpose _____________________________________________________________________________ 3


1.1.1 Process Activity Map______________________________________________________________________________ 3
1.1.2 References ________________________________________________________________________________________ 3
1.1.3 Terms & Definitions ______________________________________________________________________________ 3

1.2 Application & Scope _________________________________________________________________________________ 4

1.3 Requirements_________________________________________________________________________________________ 4

1.4 Creating, Updating & Controlling Documented Information _____________________________________ 4


1.4.1 General ___________________________________________________________________________________________ 4
1.4.2 Document & Data Identification, Approval and Use _____________________________________________ 5
1.4.3 Revising a Controlled Document _________________________________________________________________ 5
1.4.4 External Documents ______________________________________________________________________________ 5
1.4.5 Uncontrolled Documents _________________________________________________________________________ 5
1.4.6 Document Change Requests _____________________________________________________________________ 6
1.4.7 International Standards & Specifications _________________________________________________________ 6
1.4.8 Obsolete Documents _____________________________________________________________________________ 6

1.5 Management System Records _______________________________________________________________________ 6


1.5.1 Protection, Storage and Retrieval of Documented Information __________________________________ 6
1.5.2 Retention Period for Records _____________________________________________________________________ 7
1.5.3 Disposal of Records_______________________________________________________________________________ 7
1.5.4 Register of Documented Information ____________________________________________________________ 7

1.6 Organizational Knowledge __________________________________________________________________________ 8


1.6.1 General ___________________________________________________________________________________________ 8
1.6.2 Sources of Organization Knowledge _____________________________________________________________ 8

1.7 Forms & Records _____________________________________________________________________________________ 9

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Insert your company’s name or logo.
ISO 9001:2015
Control of Documented Information

1 Control of Documented Information


1.1 Introduction & Purpose
The purpose of this procedure is to ensure that all relevant documented information and organizational
knowledge which forms an integral part of our quality management system is managed under controlled
conditions and that all documented information is reviewed and approved by authorized personnel prior to
issue.

1.1.1 Process Activity Map

With what With who

• Retained information • Document Control


• Maintained information • Quality Manager

Input Activity Output

• Revised QMS documents Controlling documented • Document approval


• Standards information and • Process control
• Customer drawings organizational knowledge • Continual improvement
• Specifications • Document changes
• Process changes • Record control

How With what measure

• Documented information • No. of incorrect documents


register • No. of document errors
• Disaster recovery • No. of document changes

1.1.2 References
Standard Title Description
BS EN ISO 9000:2015 Quality management systems Fundamentals and vocabulary
BS EN ISO 9001:2015 Quality management systems Requirements
BS EN ISO 9004:2000 Quality management systems Guidelines for performance improvements
BS EN ISO 19011:2011 Auditing management systems Guidelines for auditing

1.1.3 Terms & Definitions


Term ISO 9000:2015 Definition
Documented Information Information (3.8.2) Required to be Controlled and Maintained
Record Document (3.8.5) Stating Results Achieved or Providing Evidence
Quality Manual Specification (3.8.7) for the Quality Management System
Specification Document (3.8.5) Stating Requirements
Objective Evidence Data (3.8.1) Supporting The Existence or Verity of Something

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Insert your company’s name or logo.
ISO 9001:2015
Control of Documented Information

1.2 Application & Scope


Documented information is retained to provide evidence of conformity to the requirements specified by ISO
standards, customer requirements and of the effective operation of our management system. Your
Organization uses standard forms and templates accessed via a local area network computer system. This
documented procedure defines the controls for:

1. Approving documents for adequacy prior to issue;


2. Reviewing and revising as necessary and re-approving documents;
3. Ensuring that changes and current revision status of documents are identified;
4. Ensuring that relevant versions of applicable documents are available at points of use;
5. Ensuring that documents remain legible and readily identifiable;
6. Ensuring that documents of external origin are identified and their distribution controlled;
7. Preventing the unintended use of obsolete documents;
8. Ensuring that documents of external origin are identified and their distribution controlled.
This procedure applies to all quality management system documentation and is to be followed by all
personnel where appropriate.

1.3 Requirements
Top management ensures that when we create documented information it is appropriately identified and
described (e.g. title, date, author, reference number) and is available in an appropriate format (e.g. language,
software version, graphics, etc.) and on appropriate media (e.g. paper, electronic). All documented
information is reviewed and approved for suitability and adequacy.

An electronic document management system, which is backed up and updated as required, is used to retain
documented information ensuring only the current versions are available to users. Records from process
outputs are generated and maintained by the departments responsible for their creation. For electronic
records, back up procedures are established, employees are responsible for backing up their data.

1.4 Creating, Updating & Controlling Documented Information


Your Organization applies the following criteria to all types of ‘documented information’ in order to assess
whether the information is necessary for demonstrating the effectiveness of our QMS, and whether it should
be formally controlled.

1. Communicates a message internally or externally;


2. Provides evidence of process and product conformity;
3. Provides evidence that planned outputs were achieved;
4. Provides knowledge sharing.
1.4.1 General
All documents and data are reviewed and approved by authorized personnel prior to issue. Each department
issues and maintains its own documents. Current revisions of appropriate documents are available at
locations where they are used. Documents controlled by this procedure include but are not limited to the
following:

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