Building a QMS Foundation Using Documentation

By ETQ on November 5, 2021

Building a quality management system (QMS) foundation requires spending time on the fundamentals. The building blocks of a good QMS ensure that every function and process implemented can be understood easily, used collaboratively, and updated automatically. Ensuring this is a reality involves using proper documentation.

With your documentation, only including what’s genuinely needed (lean documentation) is an essential first step as this stops QMS documentation from becoming overwhelming. This documentation should cover all the vital processes while considering the needs of your workforce, your legal obligations, and the professional standards from which you measure and record quality.

Is it worth it?

Creating QMS documentation might seem like a significant amount of work, but it’s essential for compliance and the smooth running of your business. This documentation doesn’t have to be a binder full of paperwork — in fact; we suggest it isn’t. Digital documentation is not only good for the planet, but it also makes critical documents much more accessible to those who need it.

There are several reasons QMS documentation can be beneficial, and these span industries. ISO 9001-certified documentation is advantageous to these industries and more:

  • Construction
  • Engineering
  • Technology
  • Healthcare
  • Hospitality
  • Manufacturing

The ISO 9001 standards bring efficiency, and your QMS documentation means all the moving parts of the business can be easily viewed and understood. That allows different departments to know how others work, giving greater insight into business processes. That can help improve the business across all departments, especially within manufacturing, where quality management is vital for delivering the best product to a customer.

Organizations must consider many challenges regarding creating hard copies of their documentation. These include:

  • Updates requiring ongoing print runs
  • Manually changing pages across all copies
  • Unreliable tracking methods of employee adherence
  • Inability to update or add functionality
  • Lack of enterprise-wide portal for sharing information and data
  • Excessive paper consumption
  • No AI support or process automation
  • No automatic quality control warning system

An electronic QMS is a no-brainer, no matter the business size and digital documentation can make life infinitely easier for you. Not only will updates be easier to manage across the company, but you’ll get a deeper insight into employee engagement and the ability to add additional functionality.

Information needed for QMS documentation

The purpose of QMS documentation is to provide company-wide insight into quality within the business. To create these documents, you’ll need to gather the following information.

Process and workflow instructions

Within this, you’ll break down each process into sub-processes. That helps with training, cross-department collaboration, and compliance. Gathering deeper insight into these processes can also show areas for improvement, helping the business become even more efficient.

Information on education and training tools

For quality to be maintained, staff must receive training in the various processes they’ll be part of. This education also includes training on machinery and workflows, which also helps increase safety.

Regulatory measurements

Where businesses must adhere to regulatory standards, it’s essential to include this in your QMS documentation. That helps with compliance and ensures all employees know what they need to do.

Metrics

Within your documentation, it’s also worth covering the metrics you use to track quality, efficiency, and performance. These metrics ensure that everyone is working toward the same goals.

Mandatory documentation required for an ISO 9001-certified QMS

Compliance with ISO 9001 means your QMS documentation must include:

  • Quality policy
  • Quality manual
  • Procedures
  • Work instructions
  • Quality plans
  • Records

What quality looks like in your business may differ from another company. While documentation is a crucial aspect of ISO 9001 certification, your documents are specific to your organization and how you work. This requirement means it’s down to you to record the processes and procedures used within your business. Detailing how each work (or should work) helps maximize quality.

Just having the documents isn’t enough. However, the entire company needs to comply with these documents, too. This compliance means everything outlined in your QMS documentation should be meaningful to the business’s success, and everything within should have a clear purpose.

Where to begin

Start by thinking about the documentation needed to help implement the QMS. It’s also worth identifying whether you want a digital version or hard copies of these documents early on. The more complex your business and its procedures, the more documentation you’ll need to cover its intricacies.

Start with a workflow document to map your processes and how they interact. This document should help you identify areas where other documents are needed. It’s also worth looking over the ISO 9001 requirements to see which documents could be easy wins and which might take a bit more work. Planning out your documentation needs at this stage helps save time and effort later on.

Benefits of building documentation in this way

Planning your documentation needs makes your QMS even more powerful in the future. A well-designed system backed up with the relevant documentation ensures quality standards are met, minimizes error, reduces downtime, and gives more comprehensive visibility into the business. A QMS might seem complex. But, with the correct documentation to support it, employees will have access to the most relevant and up-to-date documents relevant to their role.

How ETQ Reliance can help

ETQ Reliance has built-in document control to make life easier for everyone involved. Not only will employees have access to documentation that helps them to do their jobs, but the system removes the need for updating and managing hard copies. Keeping everything digital ensures critical documents are kept up-to-date — this saves both time and money in the long run.

It’s essential that all documentation is legible, retrievable, and reviewed regularly. This process is complex with hard copies, but ETQ Reliance’s Document Control software acts as a single source of truth, so everyone works from the same information. On top of this, it also allows you to monitor workflows for increased collaboration and monitor employee training needs.

Book a demo here if you’re interested in finding out more about ETQ Reliance and its document control features.

Because quality is based so heavily on the procedure, a QMS is only as powerful as its documentation. In creating documents that outline your quality policy, workflows, processes, and more, you’re building a solid foundation on which your digital tools can work. That leads to increased reporting opportunities, the ability to find areas for improvement, and so much more.

FAQ

How do you structure quality management system documentation?

The purpose of quality documentation is to provide a clear framework for your company’s operations. That means you need to include all the relevant information to facilitate this consistency. Typically, QMS documentation looks like this:

  • Quality policy
  • Quality manual
  • Procedures
  • Work instructions
  • Quality plans
  • Records

What is a QMS document?

A quality management system document is usually part of broader documentation covering an organization’s structure, processes, workflow, and quality control procedures. Following this should lead to a consistently high-quality product being delivered to the customer.

What are the QMS processes?

These are the steps your organization takes to monitor and improve quality within the business. Within these processes are the defined measures that help track the performance of the business and the quality of everything that reaches the customer.