PDCA PLAN

Your business should have an annual planning cycle that produces business plans that contain
your: interested parties, vision/mission/quality policy, operational objectives, budgets, risk
management actions, documented information standards, milestones, and new
product/market/process introductions. These are all planning elements. ISO 9001 calls out
these planning elements in seven areas.

Maintain QMS (4)

Document QMS (7.5)
Leadership (5)
Planning (6)
Manage Resources (7)
Plan Product Realization (8.1)
Control Monitor & Measurement Equipment (7.1.5)

PDCA DO
Your do steps are more frequent, possible occurring on a monthly cycle that produces data
records for measurement and analysis as a result of executing the annual plans. A lot of your
doing is focused on clause 8, Product Realization. Most of your documented information is
produced in clause 8.

Competence (7.2)
Design, Develop, Realize (8)
Purchasing (8.4)
Product & Service Provisions (8.5)

PDCA CHECK
Once you have data from your doing steps you need to analyze or study the data (remember
Demings PDSA reminding us to Plan, Do, Study, Act). We do not want to check to see if a step
was done or check to see if data was produced. This is nothing but inspection. We need to
analyze and understand what the data is telling us. We do this by converting the data into
information.
The ISO 9001:2015 standard clearly defines various check processes, which are cycles of
measurement and analysis to determine how well the organization is executing the annual
plans.

Management Reviews (9.3)

 Monitor & Measuring (9.1)
Customer Satisfaction (9.1.2)
Internal Auditing (9.2)
Data Analysis (9.1.3)

These are not one-time events. These check processes continuously occur, which brings to mind
trend lines on charts as a way to convert data into information.
A monthly or quarterly check event is very realistic, although many companies choose an
annual audit, management review or customer satisfaction survey as a sufficient check on the
ISO 9001 QMS. I guess if you have an incredibly stable business model with little to no
competition and a static environment, industry or market then maybe you can get away with an
annual check. Are there any businesses like that anymore?

PDCA ACT
Actions taken without undue delay to close the gap, identified during measurement and
analysis, between the annual plans and the data records produced during execution. Of course
there is an element of act in the management reviews because after you review the required
inputs you are supposed to assign action items to individuals to take the necessary corrective
actions (and maybe preventive actions).
ISO 9001 has a few clear action steps like isolating nonconforming product, taking corrective
action, and maybe preventing risk too.

Nonconforming Product (8.7)

Corrective Action (10.2)
Risk Management (6.3)? (I know some of you want this here)

ISO 9001 PDCA cycle is not a singular thing. It is actually a series of embedded PDCA cycles.
Clause 8 is not just about doing. Product realization is itself an ISO 9001 PDCA cycle that starts
with planning requirements and realization needs. Next comes development (doing),
development reviews (checking), and finally development revisions (actions). This same PDCA
cycle is occurring within training, documentation, purchasing, auditing, corrective action, etc.
The whole concept of continuous improvement relies on PDCA.

Seven Quality Management Principles

The Seven Quality Management Principles of ISO 9001:2015 utilize the philosophy of the
process approach. This plan-do-check-act cycle centers around the eight principles, which are
used by management as a guide toward improving performance and identifying the main
elements needed in a good and robust quality system.
1. CUSTOMER FOCUS
Organizations depend on their customers and therefore have to understand their current and
future customer needs, meet their customers requirements and strive to exceed their
customers expectations.

2. LEADERSHIP
Leaders establish a unity of purpose and the direction of the organization. They need to create
and maintain an internal environment in which people can become fully involved in achieving
the organizations objectives.

3. ENGAGEMENT of PEOPLE
People at all levels are the essence of an organization. Their full involvement creates
opportunities for their abilities to be used for the organizations benefit.

4. PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are managed
as a process, which has a beginning, middle and end. Inputs are clearly transformed into
outputs, repeatedly.

6. IMPROVEMENT
Continuous overall performance improvement is the objective of a successful long-term
organization.

7. EVIDENCE BASED DECISION-MAKING

Effective decisions are based on solid information and objective data analysis.

8. RELATIONSHIP MANAGEMENT
An organization, its suppliers, and stakeholders (interested parties) are interdependent and a
mutually beneficial relationship enhances the ability of both to create value.
1. Focus on customers and interested parties

2. Provide leadership for your organization

3. Engage and involve your people

4. Use a process approach

5. Encourage improvement

6. Use evidence to make decisions

7. Manage your corporate relationships