Guide to Clause . Quality Management System and its Processes

Guide to Clause 4.4 ISO 9001 Quality Management System and its Processes

In my years of ISO certification auditing, I have observed that many organizations have struggled to understand the full meaning of Clause 4.4. In my most recent piece, I’ll do my best to break down this provision of the ISO 9001 standard and show how it specifies what has to be in place to create a solid QMS. Emphasizing the importance of a process-based approach and making sure that all activities effectively contribute to achieving customer and regulatory requirements is essential if you want to understand the whole ISO 9001 standard. How does it function in practice?

What Does Clause 4.4 ISO 9001 Cover?

From what I’ve seen, the breadth of a QMS is heavily dependent on Clause 4.4 of ISO 9001. Determining the QMS’s reach and scope within the company is a part of the process. From production to customer service, all key areas must be properly defined in order to avoid missing anything.

A quick refresher: ISO Clause 4 Context of the organisation has the last sub-section i.e., Clause 4.4 Quality Management System and its Processes

When I was auditing a manufacturing company, I found out that the design department wasn’t initially part of the quality management system. They were able to greatly enhance the general consistency and quality of their products by integrating this section.

Complete Guide to Implementing Clause 4.4

In my opinion, there are many more advantages to a well-executed QMS than just meeting regulatory requirements. Any business that wants to reliably satisfy its customers must have a strong Quality Management System (QMS) using process-based approach. This is where the magic happens. Part of Clause 4.4 is making sure your organisational processes are not only identified, but also tracked and enhanced over time.

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Implementing Clauses 4.4 of ISO 9001 requires the following 07 steps:

  • Identifying and Mapping Processes
  • Determining Process Interactions
  • Establishing Criteria and Methods
  • Risk-Based Thinking
  • Assign Resources and Responsibilities
  • Monitoring, Measurement, and Analysis
  • Process Improvement

Step 1: Identifying and Mapping Processes

Step Identifying and Mapping Processes
Step Identifying and Mapping Processes

A strong Quality Management System (QMS) begins with the identification of critical processes in any organization. This necessitates differentiating between management processes, which supervise the operations of the organization and support processes, which enable the core activities to directly give value to the client.

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I remember when I audited a software development company, I observed that the testing part of the business was core process, the human resources were support processes and that project management and strategic planning were higher level management processes.

The company can therefore easily concentrate on continuous development and allocate resources efficiently when these processes have been identified, which is an additional perk of ISO 9001!

After the processes have been identified, I recommend the following stage is to create a map of them. Flowcharts, SIPOC diagrams (Suppliers, Inputs, Process, Outputs, and Customers), and swimlane diagrams are process mapping tools that are incredibly helpful for this task.

The best is to visually represent each process using such tools, which can help to identify the most important processes, roles and possible bottlenecks.

Step 2: Determining Process Interactions

Step Determining Process Interactions
Step Determining Process Interactions

It is very important for the efficiency and unity of a quality management system to know how different processes affect each other.

The different parts of a business don’t work separately; instead, they depend on each other, with the results of one process often being used as inputs for another. Take an online retailer as an example; their return policy, logistics, and customer support all function together.

A single hiccup in the system could have a domino effect on consumer satisfaction levels. Being aware of these dependencies can help with risk management and ensuring smooth operations.

Flowcharts and connection diagrams are great visualization tools for showing how processes work together. These diagrams can show the order of events and point out important paths and choice points.

During an audit of a logistics company, I observed a thorough flowchart that showed the whole process, from getting the order to delivering it. This helped not only with knowing the flow but also with finding places where things were not working well and possible delays. These kinds of visual aids are necessary to show all stakeholders how the process works and to teach new workers.

Step 3: Establishing Criteria and Methods

Step Establishing Criteria and Methods
Step Establishing Criteria and Methods

To keep processes consistent and high-quality, it’s important to set clear success criteria. Some examples of these criteria are the rate of production output, the rate of errors and the rate of customer happiness.

In a financial services business, for example, they sometimes set standards for how long it takes to process transactions and how accurate they are. These standards become their important key performance indicators (KPIs). These measures are very important for checking how well a process is working and finding places where it can be improved. The second step in ensuring quality is choosing the right ways to control processes.

Picking the right control methods is important for keeping the organization’s processes honest and dependable.

It’s entirely up to you to decide which method you wish to utilise. This can be done with monitoring programs such as inspections, process control or regular meeting reviews and reporting. One food manufacturing facility I recently audited had a system in place based on Hazard Analysis Critical Control Points (HACCP). In addition to ensuring compliance with regulations, this strategy contributed to maintaining high quality standards.

Step 4: Risk-Based Thinking

Step Risk Based Thinking
Step Risk Based Thinking

The latest versions of ISO standards are heavily driven by a Risk-based thinking. I personally love them because it stresses the need to find and fix possible problems in processes before they happen.

From what I’ve seen, this way helps businesses see problems coming and take steps to lessen their effects before they become major crises. As an example, one food processing company had a past of breaking the rules because they didn’t do enough risk assessments.

By doing risk assessments more often, they were able to find the weakest control points and improve total safety and quality standards.

Once risks have been discovered, the next step is to put in place the right ways to reduce them. Some of these tactics are changing the way things are done and adding more checks and balances to the process.

I found that putting in place dual control procedures greatly lowered the risk of fraud at a financial services business I was auditing. These kinds of plans are necessary not only for following the rules but also to keep customers trusting the business’s methods.

Step 5: Assign Resources and Responsibilities

Step Assign Resources and Responsibilities
Step Assign Resources and Responsibilities

From my time spent auditing, I’ve learned that allocating resources correctly is crucial to the smooth rollout of any Quality Management System (QMS). Various resources, including as people, machinery, software, and supplies, are needed for the various processes that make up the quality management system.

Establishing distinct functions and duties inside the quality management system is another critical component. All processes will run smoothly and with accountability guaranteed.

When I was auditing a bottle maker not long ago, for example, I saw that confusion about responsibilities frequently caused production delays and mistakes.

A quality control manager or process owner can help organizations improve communication and efficiency by clearly assigning tasks. Understanding one’s function and how it fits into the bigger picture of quality goals is essential for everyone engaged.

Step 6: Monitoring, Measurement and Analysis

Step Monitoring, Measurement and Analysis
Step Monitoring, Measurement and Analysis

Measurement and monitoring are cornerstones of any quality management system (QMS) for assessing process performance. The use of Key Performance Indicators (KPIs) allows for the evaluation of process effectiveness. My recommendation is to establish and regularly review necessary KPIs to allow better objective results of a process’s efficacy and efficiency.

During my audit of a healthcare facility, I saw firsthand how the organization used KPIs such as patient wait times and error rates in patient records to pinpoint where they needed improvement.

Collecting and analyzing data are important steps for making smart decisions. Stats, trend analysis, and comparisons are all common ways to shed light on a situation. This data-driven method can help with many things, like quality control, predicting problems, and planning what to do next.

Step 7: Process Improvement

Step Process Improvement
Step Process Improvement

One of the main ideas behind ISO 9001 is continuous improvement. To help with this, many methods are used, such as PDCA (Plan-Do-Check-Act), Lean and Six Sigma. These methods are all about finding flaws, cutting down on issues and improving the quality of the process as a whole.

Each of these methods gives you an organized way to solve problems and make processes better. Creating a mindset of constant improvement is just as important for long-term success as using the right methods. This means getting people at all levels of the organization involved in quality projects and encouraging honest talk about how things could be better.

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Clause 4.4 Challenges: Overcoming Common Obstacles

As an auditor, I’ve seen a lot of the usual mistakes companies make when they try to follow Clause 4.4 of ISO 9001.

One big problem is that it’s not always clear how processes work together. Gaps in the QMS happen when companies don’t list all the processes that are important or don’t understand how these processes connect to each other.

Companies should conduct thorough process mapping exercises, ensuring all critical and support processes are well-documented and understood.

In my recent audit at a construction firm, I discovered that they lack clear processes for managing subcontractors on projects (resulted in non-conformance!).

Another common problem is that stakeholders aren’t involved enough. Companies sometimes forget how important it is to include all stakeholders in the QMS development process, such as workers, customers, and suppliers.

Final Thoughts

I hope this article offered you a general understanding of ISO 9001 Clause 4.4 standards and provided some real-world examples. Remember that this is the most crucial component of a Quality Management System because your specified processes serve as the foundation for the entire system. Using a risk-based approach, identify all processes and how they interact with one another. Add some KPIs, and you have some beautiful QMS processes.

Please let me know if you have any questions. Happy to help!

  • Last updated: September 28, 2024
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dilawar laghari certbetter

Hi, I'm Dilawar!

🎯 ISO Certification Auditor – QHSE Professional

I founded CertBetter to bring ISO experts together in one place, so you can find and connect ‘Better‘.

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