By Jackie Stapleton

Documented information, blah blah blah. Is that how you feel sometimes too? Recently, one of our students also felt this way which compelled them to write this email to me.

Hi Jackie,

I hope this email finds you well. I’m currently working through the ISO 9001 training module and I’m feeling a bit overwhelmed by the documented information requirements. To be honest, it feels like the focus on paperwork is over the top. From my perspective, it seems like all these documentation requirements are just slowing us down and complicating processes that should be straightforward.

I’ve always believed that it’s better to get the job done rather than spending half the time writing about how we’re supposed to do it. Isn’t there a risk that we’re focusing too much on ticking boxes and creating files, rather than actually delivering quality and value to our customers? I’m really struggling to see how maintaining all these records is going to prevent issues with our products or improve customer satisfaction.

Could you help me understand why there is so much emphasis on this? Is there really a benefit to all this paperwork, or are we just burying ourselves in documents at the expense of efficiency and adaptability?

Thanks for clarifying this for me.

My first thought? Oh no. This is not the impression we want any ISO standard to give. This used to be the case decades ago where I’m sure consultants got paid by the weight of documents and folders they created however, the more documented information there is, isn’t an indication of a ‘better’ system at all. It may be an indication of the size or risk profile of the business though.

Even the ISO standards in clause 7.5 Documented information state that the extent of documented information for a management system can differ from one organization to another due to:

1. The size of the organization.
2. The type of activities, processes, products and services.
3. The complexity of processes and their interactions.
4. The competence of people or workers.

However, what is documented information really there for? I see documented information as a control. It ensures that the output to the customer (if we are talking ISO 9001) is consistent.

The Great San Fran Pan Mystery: What Will You Get Today?

This reminds me of when I was in San Francisco with my husband and youngest son in 2012. We were staying in a hotel and every morning we would go down to the hotel café and order our breakfast. On day 1, I ordered what was called the San Fran Pan, it was brought to our table, and it was delicious! 2 sausages, bacon, eggs, mushroom, with a lovely sourdough and butter. It was so good, that I ordered it the next morning too. But something changed.

The San Fran Pan was now transformed into 1 small sausage, bacon, scrambled eggs, no mushroom and instead of sourdough, it was a huge white bun. I thought “interesting”. It was still nice, but I was now simply interested in what I would receive on day 3, so of course I had to order the San Fran Pan again just to see what came to the table. I was not disappointed. This time I was presented with the sausage, bacon and egg on the bun, with the mushroom on the side and what looked like a hashbrown as well.

My head was spinning, with wondering how they communicated in the kitchen as to what was in each menu item. How the staff knew what each meal included and how to present it so that it was the same each time for their customers. How was this impacting their customers and even their business? Without any hospitality experience, however with a lot of ISO 9001 experience, I could see an easy solution to this and it involved … documented information!

This quote by Henry Ford emphasizes the intrinsic value of having standards and systems in place to ensure quality, regardless of oversight. It supports the idea that documented information isn’t just about conformance, but about consistency and reliability in delivering quality outcomes.

Furthermore, this robust framework of documentation plays a critical role in enabling organizations to make evidence-based decisions. By moving away from subjective judgments and towards data-driven insights, businesses can ensure their strategies and processes are rooted in facts, not feelings.

This is further supported by the Harvard Business School article called The Advantages of Data-Driven Decision-Making, where it is stated that more than half of Americans rely on their “gut” to make a decision. While intuition can provide a hunch or spark that starts you down a particular path, it’s through data that you verify, understand and quantify. According to a survey of more than 1000 senior executives, highly data-drive organizations are three times more likely to report significant improvements in decision-making compared to those who rely less on data. This data IS documented information!

Document Control Cycle Model

Building on the essential role documented information plays in ensuring quality and efficiency, we have created a practical model that illustrates this concept in action. This model starts with the thorough documentation of our system—detailing every process, procedure, and requirement. This is more than a compliance exercise; it is the foundation upon which we gather data, make informed decisions, and implement effective strategies.

By visualizing how each element—from system documentation to decision-making and review—interacts within a continual feedback loop, we can see the tangible benefits of a well-documented management system in driving organizational success and customer satisfaction.

1. System Documentation: Start by documenting the system itself, which includes detailed descriptions of processes, procedures, and requirements. This foundational documentation serves as the basis for training, consistency, and standardization across all operations.
2. Data Collection: Gather data from various operational sources, customer interactions, and compliance checks. This step relies on the frameworks established in the system documentation to ensure that data collection is systematic and aligned with defined procedures. Further document the data collected, ensuring all information is recorded in a consistent, standardized format that is easy to access and interpret.
3. Analysis and Decision Making: Analyze the documented information to identify trends, inefficiencies, or areas for improvement. Base decision-making on this comprehensive analysis to ensure that actions are informed and targeted.
4. Implementation: Implement the decisions, documenting the changes made and their impacts. This step ensures that all modifications are traceable and transparent.
5. Review and Feedback: Review the outcomes of the implementations against the expected results, using documented reports and feedback to assess effectiveness and identify any new issues.

The feedback from the review influences the next cycle, beginning with updating system documentation if necessary, and proceeding through each subsequent step. This loop emphasizes continual improvement and adaptation based on a well-documented and systematically controlled process.

This article first appeared on Auditor Training Online‘s Lead The Standard newsletter and is published here with permission.