Mastering the Process Approach in ISO 9001:2015

Introduction

The Process Approach is one of the seven quality management principles and a requirement of ISO 9001:2015 (Clause 4.4). It involves understanding and managing interrelated processes as a system that contributes to the organization’s effectiveness and efficiency.

What is a Process?

A process is a set of interrelated or interacting activities that use inputs to deliver an intended result (output).

Inputs: Materials, information, energy, etc.
Activities: Transformation steps.
Outputs: Product, service, decision, etc.

How to Implement the Process Approach

1. Identify Your Processes

Determine the processes needed for your Quality Management System (QMS). Common examples include:

Sales / Order Processing
Design and Development
Purchasing / Procurement
Production / Service Provision
Quality Control
Maintenance

2. Determine Interactions

No process exists in isolation. The output of one process is often the input of another.

Example: The output of “Sales” (a confirmed order) is the input for “Production Planning.”

3. Define Process Characteristics

For each process, define:

Inputs and Outputs: What goes in and what comes out?
Resources: What equipment, people, and environment are needed?
Responsibilities: Who is the process owner?
Risks and Opportunities: What could go wrong?
KPIs: How do you measure success?

The Turtle Diagram

A “Turtle Diagram” is a useful tool for visualizing a process.

Head: Inputs
Tail: Outputs
Body: The Process Steps
Leg 1: With What? (Equipment/Resources)
Leg 2: With Who? (Personnel/Competence)
Leg 3: How? (Procedures/Methods)
Leg 4: How Measured? (KPIs/Metrics)

Benefits of the Process Approach

Consistency: Predictable results every time.
Efficiency: Efficient use of resources.
Transparency: Clear understanding of roles and responsibilities.
Improvement: Easier to identify bottlenecks and waste.