Evidence-based decision making in ISO 9001: What you need to know
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Evidence-based decision making in ISO 9001: What you need to know
Evidence-Based Decision Making is One of the 7 Quality Management Principles
The ISO 9001 standard for quality management systems (QMS) is based on seven quality management principles. One of those principles is evidence-based decision-making. But what is evidence-based decision-making in ISO 9001? And what does it look like in practice? We’ll look at evidence-based decision-making, why it’s important and how you can empower your team to make easier, better decisions.
What is evidence-based decision-making in ISO 9001?
As part of ISO 9001, top management are expected to review the QMS based on data – this is where the importance of the evidence-based decision-making quality management principle comes to the fore.
EBDM is a systematic and logical approach that can be used in any decision-making situation. By basing decisions on data and evidence, top management are more likely to make decisions that are in line with the organisation’s goals and with the ISO 9001 standard.
Evidence-based decision making definition
Evidence-based decision-making in ISO 9001 involves using verifiable data and factual information to inform and justify organisational decisions, ensuring a systematic and reliable approach to quality management and continual improvement.
Evidence-based decision-making is a process that:
- Relies on high-quality data
- Ensures important decisions are made with precision
- Minimises guesswork
- Uses multiple sources of information
- Is objective and unbiased
- Takes into account all relevant factors
- Considers the consequences of different decisions
- Identifies risks and opportunities early on
The role of monitoring and measuring
The most important use for data in decision making is in reviewing current results and comparing them with the desired outcome. For example, a customer satisfaction rating of 95% or higher may be the goal, but your current level may be only 88%. In order to make decisions that improve your processes (and your business), you need to gather the data first to discover where the opportunities to improve lie – this makes monitoring and measuring results is vital in improving your quality management.
The Importance of Evidence-Based Decision Making in ISO 9001
While instinct and experience play a role in decision-making, serious analysis and data evaluation is the best way to achieve your objectives.
According to ISO 9000:
“Facts, evidence, and data analysis lead to greater
objectivity and confidence in decision making”.
– ISO 9000, Clause 2.3.6.2 Rationale excerpt
Good record keeping and management have a flow-on effect on the rest of the quality management process: if you aren’t gathering the right data, you can’t make decisions or plan for the future in a way that will benefit your business.
To make those decisions, business leaders need to gather evidence. If you monitor key indicators of QMS performance and collect data, you’ll be better placed to make decisions regarding future improvements.
Maintaining thorough records and continually gathering valuable data is crucial to the success of your quality management system – and your business. The only way to know if a process, policy or procedure is performing as it should is through data – whether it’s related to KPIs, customer satisfaction levels, delivery rates, auditing or any other aspect of the quality management process.
The Benefits of Evidence-Based Decision Making
Evidence-based decision making is integral to the successful implementation and sustained effectiveness of ISO 9001 standards. By adopting an evidence-based approach, organisations can derive several key benefits, including:
- Enhanced Quality and Consistency: Evidence-based decision making ensures that organisational processes and practices are rooted in reliable data and information, leading to improved product and service quality, as well as consistency in meeting customer requirements.
- Informed Risk Management: Organisations can effectively identify, assess, and mitigate risks by basing their decisions on credible evidence, thereby safeguarding their operations and enhancing resilience in dynamic business environments.
- Continuous Improvement: Evidence-based decision making fosters a culture of continual improvement, enabling organisations to identify areas for enhancement, implement data-driven solutions, and drive ongoing progress in line with ISO 9001 principles.
Key Components of Evidence-Based Decision Making
There are many different ways to implement EBDM in an organisation. The most important thing is to ensure that data and evidence are used in a way that is helpful and informative. One approach is to use ISO 9001 management software to help with decision-making. This type of software can be used to track data and evidence and help ensure that decisions are made systematically and logically.
Data collection
Data is the evidence you need to adhere to the ISO 14001 principle of evidence-based decision making. Identifying which data is most valuable to your business is the first step in gathering information. Examples of data sources include:
- Client satisfaction ratings
- Customer complaints
- Delivery times
- Compliance activities
- Team training records
- Non-Conformances
- Corrective actions
- Supplier statistics
- Supplier and internal KPIs
Risk-Based Thinking
By integrating risk-based thinking into decision-making processes, organisations can prioritise actions based on the potential impact on quality objectives and the fulfilment of ISO 9001 requirements.
Analysis and Evaluation
Once you’ve identified and gathered information, the next step is to analyse and evaluate data. Regular evaluation of key performance indicators and process metrics enables organisations to assess the effectiveness of their quality management system and make informed decisions to drive improvement.
The Role of Data Visualisation
Collecting data is one thing, being able to understand it is another. Using data visualisation tools such as graphs, charts and reports can help you make sense of the data and use it to make evidence-based decisions.
The Impact of Evidence-Based Decision-Making on Your Quality Management System
Incorporating evidence-based decision-making into a quality management system yields profound impacts on organisational processes and outcomes. By leveraging verifiable data and factual information, organisations can make informed decisions that directly contribute to the enhancement of product and service quality, operational efficiency, and overall customer satisfaction.
How ISO 9001 Management Software can help
Evidence-based decision making relies heavily on one thing: data. You can’t make evidence-based decisions if you haven’t got the data in front of you. Specialist ISO management software like Mango can collect, collate and interpret data for you and help you make evidence-based decisions with ease.
How does it work?
Mango makes the evidence gathering aspect of ISO 9001 simple. It provides a central hub for audits, policies, plant and equipment, documentation and more. Its user-friendly dashboard brings together compliance information, event management, reports, audit information and much more, allowing you to gain an instant overview of quality management activities and evaluate data in an instant.
Learn more about Mango and get in touch today.