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How to Successfully Write ISO Documentation

The International Organization for Standardization, or ISO, develops and publishes international standards for industries in which there is a clear market requirement. These standards ensure sustainability and a consistent level of quality, safety, and efficiency. They also share knowledge, management best practices, and advances in technology.

writing-webOne of the most popular standards, the ISO 9000 series, exists to help companies effectively document and maintain an efficient quality system. The series includes ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009 (continuous improvement). Since this standard is not specific to one industry, many companies use it to establish a quality system to meet regulatory requirements or satisfy a customer’s quality requirements.

Although popular, ISO9001 certification is a big undertaking. It requires thoughtful planning, onboarding, strategizing, documenting, training, and implementing. Not to mention, nearly all employees will have to change the way they work to some extent. If your company is lean, you can’t afford to put production on hold for months so each operational function can document and contribute their process expertise to create a quality system.

To ensure you’re making the best use of your time and documenting ISO 9001 requirements most efficiently, here are Novatek’s tips:

4 Tips for Writing ISO Documentation

  1. Understand the requirements
    ISO 9001:2008 is approximately 30 pages of quality management system requirements. It specifies the required quality documentation, including a manual, policy, objectives, procedures, flowcharts, and work instructions and forms, as necessary. Since these requirements will affect all areas of your business operation and each area may require a variety of documentation types, it is important to understand the impact and get buy-in from all others in the company.
  1. Thoughtfully plan your documentation approach
    The ISO 9001:2008 requirements are not templates or a set of generic documents, which makes putting your “pen to paper” a challenge. Your company must interpret the requirements and determine what types of documents and number of procedures are necessary for your unique operation. Utilize a technical communications expert to create a content strategy to ensure your specific processes are documented in a format that your team will understand and follow.
  1. Write with your co-workers in mind
    When writing technical documentation, the most important consideration is your audience. Most users of ISO 9001:2008 procedures will be your fellow co-workers, so write with them in mind. Use simple language and terms that are well understood and not likely to be misinterpreted.
  1. Document your procedures with technical writing best practices
  • Length – Standards should be as short as feasible. Keep information within the scope of the requirement and only include 1 idea per sentence.
  • Structure – Standards should be as clear, logical, and easy to follow as possible.
  • Tables and figures – Standards should include charts, graphs, and drawings to visually support a process, when possible. Ensure tables and figures have labels and titles.
  • Table of Contents – Include a Table of Contents when the documentation is more than 10 pages long.
  • Revisions – Include a revision history page to ensure that changes made to a previous version are clear in the new and revised standard.
More technical writing best practices can be read our blog, How to Create Good Technical Documentation that’s User-Friendly. 

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Topics: technical writing, Quality System documentation

 EU MDR