ISO 9001 is the most popular standard on the market when it comes to Quality Management Systems (QMS). It is recognized in over 170 countries and provides clear guidelines for establishing, implementing, maintaining, and continually improving any QMS.
Implementing this standard brings numerous benefits to companies, such as increased customer trust, higher rates of effective complaint resolution, process improvement, and, of course, ongoing quality optimization. In other words, the standard is essential for any company seeking greater sustainability and profitability in an increasingly competitive market!
However, even though it’s a clear standard that outlines requirements (something “mandatory” in the world of standards), ISO 9001 does not specify the “how”—meaning it doesn’t dictate specific tools for meeting its guidelines. It’s up to companies to select and apply the tools that help them comply with the standard and, more importantly, improve their processes.
That’s why, in today’s content, we’ve decided to introduce a few tools for ISO 9001. With these tools, you will be able to meet specific requirements of the standard, as well as achieve significant leaps in excellence within your organization! Ready? Let’s go!
Tools for ISO 9001: Organization’s Context
In requirement 4.1 of ISO 9001:2015, the standard presents the need and importance of properly understanding the context of our companies. In summary, this means analyzing and understanding the internal and external factors that can influence the quality management system and, consequently, the expected outcomes for the company.
Context analysis includes various factors, such as identifying market issues and trends, competition, regulatory environment (laws), organizational culture, and stakeholder expectations. All of this helps align quality objectives with the needs and strategy of the company.
One of the best tools for this is the SWOT Analysis! It is one of the most commonly used tools for ISO 9001 and is relatively easy to use. It is widely employed for scenario analysis and is particularly effective because it helps define four key factors, covering both internal and external elements (strengths and weaknesses in the internal environment – opportunities and threats in the external environment).
Tools for ISO 9001: Risk Management
Another key requirement of ISO 9001:2015 specifically addresses actions for risks and opportunities (6.1). This item surprised many professionals back in 2015 during the latest revision of the standard.
Simply put, item 6.1 requires companies to identify, analyze, and address risks and opportunities that could impact the quality management system and customer satisfaction. To do this, actions must be proportional to the severity of the occurrences, whether to mitigate or eliminate risks or to pursue opportunities.
In this context, FMEA (Failure Mode and Effect Analysis) fits perfectly. Originally developed in the automotive sector, this tool can be applied to any situation involving risks (such as quality or environmental management).
One of the unique features of FMEA is the “detection” quadrant, which is not present in other risk methodologies. In this quadrant, you can technically assess how easy or difficult it is to detect a risk once it materializes. This enables faster action and a much more agile response in case of risk incidents.
Tools for ISO 9001: Action Plans
Another fundamental aspect of any QMS is the ability to plan and execute effective action plans. This is essential because various elements within the system will generate inputs that need to be addressed with these plans. Whether it’s non-conformities requiring corrective actions, risks needing treatment or contingency plans, or even context analysis generating the need to eliminate weaknesses or seize opportunities, action plans are key.
In this regard, we can rely on the tried-and-true 5W2H! This tool stands out for its simplicity and effectiveness. It helps organize and clarify the basic elements of any action plan by addressing the following factors:
- What – What will be done?
- Why – Why will it be done?
- Where – Where will it be done?
- When – When will it be done?
- Who – Who will do it?
- How – How will it be done?
- How Much – How much will it cost?
The name of the tool refers to the initials of these five questions (5 Ws and 2 Hs), and it can be applied with minimal training, bringing clarity and organization to business action plans. Due to its versatility, 5W2H is highly recommended and can be used to meet various requirements of the standard.
ISO 9001:2015 – A Versatile Standard
It’s worth mentioning that these tools are not mandatory, nor are they the only ones that can help you meet the standard. There are many other tools available, such as Porter’s Five Forces (for context analysis), the 8D method (for problem-solving), and even Kanban for structuring and managing action plans.
However, the tools we’ve selected are simple to use, applicable to almost any scenario, and therefore are widely used in thousands of companies around the world. It’s up to you to analyze your processes, company, and customers, and then select the best tool for your needs!
Building Quality with Strong Foundations
To use a metaphor, implementing a quality management system, whether based on the standard or not, is like building a house. ISO 9001 provides a sort of blueprint, but the tools you use for construction are up to you. It’s only with the right tools that construction becomes possible.
Each tool plays a specific role, contributing to the whole, and the right choices ensure that your house or building remains standing and, more importantly, withstands the test of time and market challenges!
By selecting the right tools, you will be able to understand the context, manage risks, and plan actions, among many other needs of your organization. In doing so, you ensure that your company’s foundations are strong and always ready for the next challenge!
