Tools and Techniques That Can Be Used in Conjunction with ISO 9001:2015

ISO 9001:2015 is a quality standard that provides a framework for creating a functional Quality Management System in organizations across industries. It defines the QMS as a system created to improve the standard of quality by implementing policies and objectives into processes.

The ISO standard is also a foundation block for most regulations, thereby making compliance with ISO an added advantage for businesses. It helps to demonstrate the organization’s ability to supply products and services that consistently meet the requirements of customers and statutory and regulatory bodies.

The ISO begins by establishing the basic tenets needed to create a Quality Management System that can help achieve the goals appropriate to the company’s industry and the organization’s individual goals. The main changes from ISO 9001:2008 include:

In 2015, the ISO was revised to incorporate a risk-based approach to quality, encourage innovation, assign leadership responsibility to set the tone, and make them responsible for processes, products, and services sourced from external sources.

Setting the Context

Clause 4 of ISO 9001:2015 helps set the context for the QMS aligned with the business strategy. This is a 4-step process that involves:

Gaining an understanding of the organization and its context
Determining the requirements and expectations of various stakeholders
Defining the management system’s scope
Implementing the management system

The role of leadership or top management is critical for the successful implementation of the ISO system in the organization. Therefore, ISO clearly defines the roles and responsibilities of leadership in implementing the QMS and integrating it with key processes. The success of the implementation depends on the effective unification of the key stakeholders around the key objectives of the Quality Management System.

Once the key objectives and a detailed implementation plan are established, the next step is to identify risks and opportunities and implement risk prevention or mitigation measures. Allocating the right resources, building the right team, and providing the right infrastructure are some key aspects that ensure the successful implementation of the ISO QMS.

Monitoring and tracking key performance indicators is critical to ISO QMS implementation. This helps identify new gaps and effect continuous improvement.

Tools Used in Conjunction with ISO 9001:2015

Some of the tools and techniques that can help with the implementation and continuous improvement of the ISO-based quality management system in your organization include:

Tool #1. Fishbone Diagram

The fishbone diagram helps to identify possible causes of an issue using a template that looks like a fishbone. Because of its use in determining the source of a problem, it is also called the cause and effect diagram. The quality-related problem is noted on the right-hand side of the diagram, while the individual root causes and sub-causes are marked on the left to identify the true cause of the problem.

Tool #2. Check Sheet

A check sheet enables the identification of defects based on type, location, or caused by the same person gathering data repeatedly from the production process. Preliminary data distribution and its frequency are recorded when measuring out processes, helping to identify the number of times a particular value has occurred. This helps to take corrective action and remove defects or errors from processes, products, or services.

Tool #3. Control Chart

Also called the Shewhart chart, it helps analyze changes in the process over a period of time. This helps determine whether a process variation happened in a controlled manner or whether various causes were responsible for any variation. This helps ensure the stability and predictability of a process.

Tool #4. Pareto Chart

A Pareto chart helps determine the most critical error in the production process that needs corrective action as a priority. Line and bar graphs note the frequency at which the issues occur in the production process. By using several parameters, the most impactful influence on a specific process or system can be determined and analyzed. This helps prioritize efforts to rectify errors based on criticality.

Tool #5. Stratification Analysis

The stratification analysis helps identify patterns by classifying data obtained from different sources for informed decision-making on quality.

Tool #6. Histogram

A histogram is similar to a bar graph and uses numerical data to show frequency distribution. This helps understand how a process has changed over a period of time and can be presented in various formats, including normal distribution, skewed distribution, multimodal distribution, or plateau, and dog food distribution, among others.

Tool #7. Scatter Diagram

The scatter diagram is used to demonstrate the cause-effect relationship between two variables. It uses the X and Y axes to plot different variables and identify the correlation between two effects and their source.