If your business has many specific policies, procedures, processes and guidelines, it’s best to document them in a way that's easy to understand for both internal employees and external regulators. The International Organization for Standardization, or ISO, has developed a series of standards on how to create documents that ensure quality, efficiency and safety in the workplace through a quality management system. Use the ISO 9000 series to create documents in your organization that meet regulatory standards.

Understanding the Need for ISO Documentation Standards

For businesses that are looking to develop and maintain an efficient quality management system, the ISO 9000 series can help to document all the elements that employees need to follow. However, the ISO 9000 series is not specific to one industry, so businesses need to understand the regulations and apply what's relevant to their business.

The goals of creating documentation that abides by ISO standards include:

  • Meeting industry regulatory requirements.
  • Offering high-quality products and services.
  • Continually improving the efficiency of processes.
  • Satisfying the needs of customers.

Ensuring ISO Documentation Standards Are Met

There are many different types of documentation that are required in order to maintain an efficient quality management system. To maintain ISO standards, your business documentation needs to include:

  • Quality policy and quality objectives.
  • Quality manual.
  • Documented procedures.
  • Planning, operation and control documents for internal processes.
  • Records.

It’s important to note that writing down a procedure for the quality management system isn't enough. ISO requires that the procedure also has to be implemented and maintained. Only then will it result in the efficient quality that's required. Procedures include the control of documents, control of records, internal audits, control of nonconforming products, corrective action and preventative action.

Since ISO standards are applicable to different industries, they may be applied differently depending on the kind of business you have. For example, the size of your business, the industry you're in, the complexity of your processes and the expertise of your employees will affect the kind of documentation that's required to develop your quality management system. While they're not required by ISO, businesses can also include maps, flowcharts, organizational charts, supplier lists, internal communication and quality plans in their quality management system documentation.

Demonstrating Conformity With ISO Documentation Standards

If your business needs to prove that you're following ISO standards for documentation to regulatory authorities or other entities, it’s critical to showcase the implementation of an effective quality management system. Keep in mind that you don’t need extensive ISO documents to do this. The evidence that your documents are effective can be shown through other means such as observation, quantifiable measurements or tests.

Follow Writing Best Practices

While it can be daunting to write with international documentation standards in mind, it’s best to keep your audience front and center. While external regulatory bodies may be reviewing your content from time to time, your main audience will be the employees in the business. As a result, it’s best to ensure that the content is helpful, clear and easy to understand.

Use plain language that all of the employees in the business will understand. Avoid overly technical language when possible so as not to confuse your audience. Logically structure each document, stating your goal for the document at the very beginning. Avoid writing overly long documents. Stick to the scope of each process, procedure or manual, and try not to include tangential information that's not pertinent to that specific topic.

To make it easy for your employees to find the documentation they're looking for, include a table of contents and an index. If you need to frequently make revisions to the content, be sure to include a revision history page that outlines the changes made and the date they were made on.