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Step 5: Create ISO 9001 Documentation

Documenting Your System

A.General Requirements

Have the team review the requirements in section 4.1, notice that many are very general and will be a natural outcome of building your Quality Management System (QMS). However, this team must identify the processes that will make up the QMS and outline these processes to show how they interrelate. How do you design a documentation system?

Identifying Processes

  • Start by outlining broad categories or by listing your departments. For example:
  • Purchasing, Receiving, Production Control, Sales and Marketing, Customer Service, Production (or Service), Quality Control, Shipping,
  • You will need to show how these processes relate to each other, by use of a flow chart or diagram. A simple way of diagramming is to chart the processes. Download free trial of flow charting software
  • Once you have listed the categories or departments, have management in those departments add the detail. You will want to include all the QMS processes, and all production, service and administrative processes that affect the quality of your product or service. The chart or flow chart that you come up with should be included in your Quality Manual.

B. Documentation Requirements

  • As you review the requirements for QMS documentation, pay particular attention to the requirement for your organization to identify documents that are needed for your quality system and production or service processes. You will need to have a method to identify what processes must be documented. Remember that as you add new processes, products or services to your organization in the future you will need a method of identifying when documentation is required.
  • During implementation, set guidelines for identifying processes that need documentation as part of their control. Have management identify the processes that need documentation as they identify the processes to be included in the QMS.
  • After implementation, include the identification of documentation requirements as part of your quality planning for new processes and changes. The "Planning of Product Realization Procedure" from the The 9000 Store covers this step for you.
  • What are the ISO 9001 Documentation requirements?

C. Quality Manual & Procedures

  • A complete quality manual and procedures package, with text to help you customize the manual for your organization, is available at The 9000 Store. It will definitely save you money over the hours you would spend developing one from scratch. It is designed with the same approach to the QMS as we follow in these sessions, so you will find it very compatible with this approach.

D. Document and Records Control

  • You must have a procedure for control of documents and control of quality records. This task should be on your task list and assigned to a team or individual for completion.