Facing the Challenge of Documenting your ISO System

1. Starting with a blank page
2. Making the different QMS procedures work together
3. Creating an efficient document control system

There are several options to helping employees produce good documentation including technical writing services or already prepared templates.

Technical Writing Services

Many technical writers and technical writing firms specialize in ISO 9000 documentation. This approach is often used in larger organizations, with large amounts of documentation to prepare. A common approach taken is to have the technical writer interview people responsible for the process, and document the process. This approach must be combined with incorporating any changes to the process that are being made to comply with ISO 9001. Involving the technical writer in meetings as you plan for your ISO 9001 QMS will help coordinate the process and documentation changes.

Benefits of this approach can be:

• Clear, concise documentation with a professional look
• Good coordination of documentation if the writer is involved in the project meetings

Drawbacks can include:

• Cost
• Lack of ownership for the documentation from the employees

Prepared Templates or Documents

Templates prepared by your organization or an outside organization can be very helpful to employees.

To prepare your own templates, develop a standard format that you want to use for procedures and a format for work instructions. You may also want to write a work instruction for “Writing a Procedure” and “Writing a Work Instruction”. Useful items to include are:

• Definitions for common items such as Records, Forms and Attachments.
• Definitions for Procedures and Work Instructions.
• General writing guidelines. For example, “Start sentences with an action word” and “Include the job title of the person responsible for the action”.

Providing clear definitions will help employees create documents that are consistent with other employees’ documents and prevent the need for additional edits towards the end of your project.

Using a prepared documentation system can save a tremendous amount of time and effort if it is well prepared. The 9000 Store has a complete documentation system available. It has been prepared by ISO 9000 Professionals (registered Lead Assessors) that provide the information for our site, and answer your technical questions. If you are familiar with the quality of information on our site, you can be confident in the documentation system that they provide. The 9000 Store also offers a satisfaction guarantee on their products.

When using a prepared set of procedures and related quality manual and forms, follow the steps below:

• Purchase a Quality Management System from a reliable source that will provide professionals to answer your questions as you use their product (The system referenced here is available at the9000store.com).
• Give each procedure to the team or individual responsible for that section of the standard.
• Have the team or individual review the procedure and compare it to the Task List.
• The procedure documents how the requirements can be met. Evaluate this approach to determine if any changes need to be made to the documented process to make it work for your organization.
• Determine what changes need to be made to your organizations practices to meet the requirements.
• Edit the documentation as needed, and train employees on changes to previous processes or practices.
• Implement the new procedure, collect records on the forms provided.
• Ask questions along the way from the documentation system supplier.

Benefits:

1. Procedures and Quality Manual have been designed to work together to address the requirements of the ISO 9001 requirements.
2. This saves time and effort in determining what procedures to have for your QMS, designing the QMS system, coordinating the procedures, determining how to address the requirements and document the procedures.
3. Technical support is available for your questions.
4. Documentation is professional in presentation.
5. Employees do not have to face a blank page to fill.