4.2.3 Document control procedure

This is a mandatory procedure. Your document control procedure must define:

  • How you approve documents (e.g. procedures, flow-charts, process maps, etc.) prior to use e.g. signed-off paper versions, or added to your computer network via a password protected system.
  • How you update and re-approve amended documents computer based systems are so much easier to maintain.
  • how you identify changes e.g. by date or issue number, identify changes with different fonts or colours.
  • How you ensure that documents are available where they are needed
  • How you control documents of external origin
  • How you prevent the inadvertent use obsolete documents obsolete-but-still-in-use is the single most common non-compliance.

Document definition: a "document" is an instruction of some sort e.g. any information where an unauthorised change could cause a problem.

Sample documents: quality manual, procedures, project plans, national or international Standards (e.g. ISO 9001), industry specific codes-of-practice, customer specifications, drawings, software, samples of visual standards.

Learn more about the difference between Documents and Records in document control procedures.

Why do we need document control?

A robust document control process lies at the heart of a quality management system; almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence.

Clause 4.2.3 tells us that an organization must control the documentation required by the quality management system and that a suitable document control procedure must be implemented to define the controls needed to; approve, review, update, identify changes, identify revision status and provide access. The document control procedure must clearly define the scope, purpose, method and responsibilities required to implement these parameters.

In order to comply with the document control clause, it is essential that all personnel understand:

  • what type of documents should be controlled
  • how this control should be exercised

To get the most out of your document control procedure it must communicate the steps necessary to ensure that staff and other users of the organisation’s documentation understand what they must do in order to manage that information effectively and efficiently.

Departmental managers should always be responsible for promoting good document and record management practices in their area whilst supporting overall compliance to the document control procedure.

Individuals and their line managers should be responsible for the documents and records that they create, as well as being responsible for their retention and disposal in line with legislative requirements and organisational procedures and practices.


ISO 9001:2015 Documented Information Template

Written by ISO Auditors and Quality Manager Trainers

  • Everything you need to establish your documentation processes
  • Save time and money
  • Quick, simple to use
  • Do everything yourself without a consultant
  • Includes step-by-step guides
  • Documents are MS Word files, fully editable
  • All documents use styles – format quickly and easily to your branding

What's Included?

  • Control of Documented Information Procedure
  • Document Management Forms
  • Document Management Guidance

View all our templates

Control of Documented Information Procedure

  • MS Word, easy for you to edit and customise
  • Addresses ISO 9001:2015 7.5
  • Procedure
  • Introduction
  • Terms and definitions
  • Application and scope
  • Requirements
  • Responsibilities
  • Processes
  • View sample

4.2.4 Control of Records Procedure

  • MS Word, easy for you to edit and customise
  • Addresses ISO 9001:2008 4.2.4 Control of Records Procedure
  • Introduction
  • Terms and definitions
  • Application and scope
  • Requirements
  • Responsibilities
  • Processes

Document Management Forms

  • MS Word, easy for you to edit and customise
  • Master Document Index
  • Document Issue Sheet
  • Document Change Request
  • Master Quality Record Index
  • Form 1 sample

Document Management Guidance

  • 8 pages, MS Word, easy for you to edit and customise
  • Difference between documents and records, requirements for controlling documents and records, the 21 records required by ISO 9001:2008 and more
  • View Document Management Guidance sample


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View PDF samples (the actual documents are in MS word)

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        We use the same numbering sequence as ISO 9001 in our quality manual templates. You are free to replace these with a system that works best for your staff and for the business - as long as the system is logical, documented and communicated, it should be more than adequate.

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