Plan Do Check Act ISO 9001

Plan-Do-Check-Act (PDCA) cycle is a cycle of continuous improvement that forms the solid foundation of ISO 9001. In this article, we will talk about how the PDCA cycle is integrated across the ISO 9001 standard.

ISO 9001 and PDCA cycle

Process approach of ISO 9001 is what integrates the PDCA cycle into its very foundation. Every clause within the standard has a specific focus, and each focus highlights a specific part of the cycle. For example, clause 4 is focused on understanding the environment, leadership is highlighted in clause 5, planning in clause 6, resource allocation in clause 7 and clause 8 focuses on operation. Clause 9 and clause 10 focus on performance evaluation and constant improvement, becoming the checking and acting phase of the cycle.

It is human nature to be more comfortable in planning than in actual implementation, and this cycle breaks this tendency by guiding organisations in each phase of the cycle. Let us explore how ISO 9001 aligns with Plan-Do-Check-Act.

ISO 9001 PDCA- Plan

Ideally, your business should contain an annual plan to re-initiate the PDCA cycle, so that the business is constantly evolving. Appropriate planning can make your Quality Management System (QMS) more competitive and sustainable. Clause 4 helps to strategise the environment of your QMS, clause 5 helps to plan about the leadership commitment and clause 6 helps to plan about the inherent risks that your QMS will face.

Clause 7.5 helps plan the documentation related to the QMS, so that you can manage your resources appropriately. Clause 8.1 helps in planned product realisation. iso consultant help you to plan for iso 9001 implementation based on clauses.

ISO 9001 PDCA- Do

The next step of the cycle is to actually implement the plan. This phase more frequently occurs on a monthly cycle, so that data can be produced for records and measurement. This data is also utilised to analyse the execution of the annual plans. Majority of the focus is on clause 8, namely product realisation. Additionally, this clause also provides most of the guidance regarding documented information, which serves as evidence of the steps that you have taken.

Clause 7.2 outlines how you must evaluate the competence of your personnel and clause 8 helps you realise design development. Clause 8.4 helps with purchasing and clause 8.5 outlines the provisions for products and services. Lastly, clause 8.7 outlines the steps to record nonconforming products. Having a checklist that includes all these items can help you not to leave anything out. For example, see the ISO 45001 audit checklist.

ISO 9001 PDCA- Check

Once you have collected the appropriate data from implementing your steps, you need to analyse your results. The purpose of analysis is to check if a particular step was done appropriately and if any discrepancies arose. In other words, it is nothing but inspecting the efficiency of the implemented steps. As implementation creates a lot of data, we need to convert this data into information by analysing and understanding what the data is trying to tell us.

The ISO 9001:2015 standard outlines various check processes as a form of measurement and analysis to determine how well the organisation is implementing its annual plans. Clause 9.1 outlines monitoring and measuring requirements, clause 9.1.2 teaches business owners how to measure customer satisfaction, clause 9.1.3 focuses on data analysis, clause 9.2 on internal auditing and clause 9.3 on management reviews.

Remember, analysis is not a one time event, rather a continuous process that converts data into information. So, it is very important to be realistic when planning your inspections. A monthly or quarterly inspection is practical, although, majority of the companies choose to have an annual audit. However, if you are in an industry where customer demands or trends change quickly, it is beneficial to have frequent or monthly inspections

ISO 9001 PDCA- Act

Action should be taken without unnecessary delay to close any deficiencies identified during the measurement and analysis. Therefore, this is the bridge between annual plans and creates data records for execution. Acting is the final step to becoming ISO 9001 compliant. The standard outlines few clear action steps like taking corrective actions, isolating nonconforming products or preventing risks. This is outlined in clause 10.2, which focuses on corrective actions and clause 6.3 that deals with risk management.

Again, the PDCA cycle in ISO 9001 is not a singular event and instead, contains a series of embedded cycles. This means that clause 8 is not just about action, rather realisation of all the previous plans. PDCA cycle begins with planning requirements and realisation needs, going on to develop reviews and finally develop revisions.

Seven quality management principles of ISO 9001

The PDCA cycle centres around the seven quality management principles, which act as a guide to improve performance and to highlight the main elements needed for a robust QMS. These include customer focus, leadership, engagement of people, process improvement, continuous improvement, evidence-based decision-making and relationship management. Essentially, these principles identify the areas where the planning should focus on, so that the results can be efficient, reliable and sustainable.

To acquire ISO 9001 certification, you need to implement a quality management system. To keep your QMS working efficiently, you need to value each step of the PDCA cycle, so that your QMS is trained for continuous improvement.