How is The PDCA Cycle Connected to ISO 9001
Updated: Apr 22
Think of PDCA (Plan Do Check Act) Cycles as a wheel in constant motion. PDCA is not as simple as it may seem, but if you're interested in ISO 9001 Quality Management Systems (QMS), you'll discover that an ISO 9001 PDCA cycle provides the firm foundation. If you learn the PDCA process approach, you will also master your ISO 9001 QMS. Yet how are PDCA and ISO 9001 related?
What Does PDCA Stand For in ISO?
One of the top quality experts, Dr. Walter Shewhart, created Plan Do Check Act. The acronym PDSA, or Plan, Do, Study, Act, was favored by Dr. W. Edwards Deming because he believed that "check?" placed more emphasis on inspection than analysis. The first two steps, Plan and Do, are where most people focus their attention, whereas Check and Act are frequently neglected.
Let's examine PDCA in relation to ISO 9001 by dissecting the ISO 9001 standard into its key components and then allocating each to a component of the PDCA process.
ISO 9001 refers to PDCA as the process approach and its a central focus in each clause of the ISO 9001 standard. Understanding the environment is the focus of clause 4, leadership is in clause 5, planning is in clause 6, resource is in clause 7, doing is in clause 8, checking is in clause 9, and acting (or continuous improvement) is in clause 10. Which clause do you believe people struggle with the most?
The most challenging clauses are 9 and 10, which concentrate on checking and acting. Planning and doing give people more satisfaction than checking and acting do. That's just how people are.
ou must thus break the tendency and allocate more time for the checking and action phases of clause 9 and 10 if you want to be effective using ISO 9001:2015. Let's now examine each PDCA component individually to determine how ISO 9001 and Plan Do Check Act correspond.
The P in PDCA – Stands for PLAN
A regular planning cycle for your company should result in yearly business plans that include information about your stakeholders, vision, mission, and quality policy, operational goals, budgets, risk management strategies, established information standards, milestones, and new product, market, and process introductions. Planning according to ISO 9001 might boost your business' competitiveness.
Seven sections of ISO 9001 make use of these planning components:
Plan your QMS environment strategy. (4)
QMS Planning (5)
QMS Leadership (6)
Manage QMS resources. (7)
Document the QMS. (7.5)
Product Realization Plan (8.1)
Audit Program (9.2)
The D in PDCA – Stands for DO
As a result of carrying out the annual plans, your do steps are more frequent, sometimes occurring on a monthly cycle, producing data records for measurement and analysis. Your efforts have largely been directed at clause 8, Product Realization. The production of clause 8, which is product or service realization, results in the majority of your documented information.
Design, Develop, Realize (8)
Product & Service Provisions (8.5)
Record Nonconforming Product (8.7)
The C in PDCA – Stands for CHECK
Remember Deming's PDSA, which reminds us to Plan, Do, Study, and Act. Once you have data from your doing steps, you must analyze or study the data. We don't want to verify if a step was completed or whether data was generated.
All that is being done is inspection. We must examine and comprehend what the facts are trying to tell us. By transforming the data into information, we do this.
The check procedures, which are cycles of measurement and analysis to ascertain how well the organization is carrying out the annual goals, are precisely defined by the ISO 9001:2015 standard.
Monitor & Measuring (9.1)
Customer Satisfaction (9.1.2)
Data Analysis (9.1.3)
Internal Auditing (9.2)
Management Reviews (9.3)
These are ongoing occurrences. These checks are ongoing, which reminds me of trend lines on charts as a means of turning data into information.
Although many businesses opt for an annual audit and management review or customer satisfaction survey as an adequate check on the ISO 9001 QMS, a monthly or quarterly check event is highly feasible. Maybe you can get away with a yearly inspection if your business model is extremely solid, there is little to no competition, and your environment, industry, or market is stable.
Are there still companies like that? However, if the market is rapidly changing, you should regularly (monthly) assess your QMS and implement the necessary corrective measures.
The A in PDCA– Stands for ACT
Actions conducted without unnecessary delay are meant to close the gap between the annual plans and the actual data records generated during execution, measurement, and analysis. Of course, there is a component of action in management reviews since you are required to assign action items to people so they can conduct the appropriate corrective steps after reviewing the required inputs. (and maybe preventive actions). The secret to complying with ISO 9001 is to take action.
A few distinct action stages are included in ISO 9001, such as isolating nonconforming items, taking corrective action, and perhaps even preventing risk.
Risk Management (6.3)
Corrective Action (10.2)
The PDCA cycle described in ISO 9001 is not unique. Actually, it is a collection of embedded PDCA cycles. Clause 8 goes beyond simply doing. Planning requirements and realization needs are the first steps in the ISO 9001 PDCA cycle, which leads to product realization.
Development (doing), Development Reviews (checking), and Development Revisions (actions). Training, paperwork, purchasing, auditing, corrective action, etc. all follow the same Plan Do Check Act cycle. PDCA is the foundation of the continuous improvement paradigm.
PDCA and ISO 9001's Seven Quality Management Principles
The process approach's guiding principles are used in the seven quality management principles of ISO 9001:2015. These principles, which management uses as a roadmap for enhancing performance and defining the essential components of a good and solid quality system, are at the heart of the Plan Do Check Act cycle.
1. Customer Focus
Because businesses rely on their consumers, they must comprehend their needs today and in the future, satisfy their demands, and work to exceed their expectations.
The aim and course of the organization are set by leaders. They must establish and uphold an internal atmosphere that encourages individuals to actively participate in attaining the goals of the firm.
3. People Engagement
All ranks of employees make up an organization. Their complete participation opens up possibilities for utilizing their skills in a way that benefits the organization.
4. Process Approach
When activities and associated resources are handled as a process that has a beginning, middle, and end, the desired result is attained more effectively. There is constant conversion of inputs into outputs.
A effective long-term company strives to continuously improve overall performance.
6. Evidence Based Decision Making
Solid knowledge and unbiased data analysis constitute the foundation of effective decision-making.
7. Relationship Management
A mutually advantageous partnership strengthens the capacity of a business, its suppliers, and stakeholders (interested parties) to create value.
PDCA and ISO 9001 are Connected
A quality management system's foundation is in ISO 9001 certification, and to maintain it operating efficiently, you must respect each PDCA component equally and avoid favoring one (e.g., Plan, Do) above the others (Check, Act). The Plan Do Check Act cycle is used by the Seven Quality Management Principles of ISO 9001:2015 as a roadmap for enhancing performance and utilizing the essential components of a strong and effective quality management system. Combining the two results in a QMS that is always improving.
For more information on developing Lean ISO Quality systems, establishing clearly defined procedures, or maximizing the benefits of your quality management system, look into Bizmasterz's Internal Auditor Training classes.