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ISO Documentation and Control System

One of the goals of the ISO 9000 Quality Management System standard is to bring control and consistency to your processes. The year 2000 revision of the standard asks you to identify your key processes, and manage and improve those processes. Documentation is one of the ways you manage and control your processes. By writing procedures and work instructions you will make sure that everyone is performing the process the same way.

ISO 9000 documentation comprises four tiers. Each tier should point to the next.

The Quality Manual

Your quality manual briefly describes how you meet the requirements of the standard via the system you implemented. Write this document last. It will be hard to write it before you implement your system, and it will have to be rewritten as you fine-tune your system. If you write the quality manual at the end of your project it will be a simple summary of what you have implemented for each clause. Your quality manual must include or reference your procedures.


Procedures describe how to perform a task in general, outlining the key steps and their order. A purchasing procedure may describe who is responsible for approving purchases, and what records need to be kept, for example. Procedures can be described as looking at "what" you do (not necessarily how you do it). Procedures should reference related work instructions.

Work Instructions

Work instructions provide detailed step-by-step descriptions of a task, not just an outline. They should describe "how" you perform a task. A purchase order work instruction would tell you how to fill out a purchase order, line by line. Work instructions should reference related records.


Records are the documents you keep to show that you follow your quality system. Your completed purchase order would be a record. Records are a history of what has occurred and as such should not change.

Setting up your document control system to be simple, sustainable and effective is critical to the success of your quality management system. Some of our suggestions are included below:

  • Build effective documents.
  • Make them clear, concise, and user-friendly.
  • Use short sentence starting with a command verb.
  • Use present tense (e.g.: is, are). Make it clear who is performing the task.
  • Format your documents to make them easy to read: use headings and white space.
  • Have the right amount of documentation.
  • Too much
  • Overlap and repetition - including a process in more than one work instruction
  • Work instructions written for virtually everything
  • Too little

The goal is consistency for your processes. If two trained employees were to perform this task, would they do it the same way? If the answer is "maybe not," a work instruction is appropriate.

  • Just right
  • You have SOPs and work instructions to cover key processes.
  • Outline your document control system.
  • Clarify your terminology.
  • Procedure: describes the process
  • Work instructions: tells how to perform the process
  • Attachment: information attached to the procedure for clarification
  • Determine what to control.
  • Procedures
  • Work instructions
  • Forms
  • Attachments
  • External documentation
  • Prints
  • Drawings
  • Routers/travelers
  • Determine where to keep your documents.
  • Planning your infrastructure
  • ISO gives you the specifications.
  • You prepare your own blueprint.
  • You choose your document control system.
  • A simple word processing program
  • An existing database program
  • A packaged document control software
  • What will be best for your company?
  • Consider the following when choosing a system for your company.
  • Company size
  • Computer setup and availability
  • Number of different processes performed
  • Rate of change for your processes or documents
  • Your company may need more than one system.

If documents are different enough, it may be best to have two distinct systems. For example,: one for quality system documents, and one for engineering documents

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