Quality Management: Become an Expert in ISO 9001 Processes
The voluntary ISO 9001 standard provides a framework for addressing quality through a management system. This involves a process-based approach. Under the ISO 9001:2015 standard, a process is defined as “a set of interrelated or interacting activities that uses inputs to produce an intended outcome.” In practical terms, each process transforms inputs (information, materials, customer requests, etc.) into outputs (delivered product, service provided, decision, etc.), adding measurable value. The ISO 9001:2015 standard requires that any organization seeking certification identify, control, and continuously improve its processes: this is known as the process approach (§4.4 of the standard).
What is a management system?
The International Organization for Standardization (ISO) offers the following definition: a management system is the set of processes through which an organization manages the interrelated or interacting elements of its activities in order to achieve its objectives. In the case of quality management, the objective here is to continuously improve. The processes therefore encompass all the resources and procedures deployed to achieve this goal.
In this sense, a management system is closely linked to the concepts of process control and continuous improvement. Process managers, in fact, base their work on the well-known Deming Wheel, which outlines four self-sustaining steps—known as PDCA—that:
- Plan (to plan)
- Do (deploy)
- Check
- Act (to act)
The structure of the ISO 9001:2015 standard itself is organized around this PDCA cycle: Chapters 4 through 6 correspond to the Plan phase, Chapters 7 and 8 to Do, Chapter 9 to Check, and Chapter 10 to Act.
What is the process-based approach in ISO 9001?
The process approach is a fundamental requirement of the ISO 9001:2015 standard (§4.4). It involves identifying, managing, and continuously improving all of an organization’s processes and their interactions, rather than managing services or functions in isolation. Implementing the process approach required by ISO 9001 involves:
- Identify all processes within the organization (sales, production, purchasing, HR, maintenance, communications, etc.)
- Define their input and output elements as well as their interactions
- Appoint a process manager responsible for its smooth operation and performance
- Establish performance metrics to measure the effectiveness of each process
- Identify risks and opportunities associated with each process
- Continuous improvement processes using the PDCA cycle (Plan-Do-Check-Act)
This process-based approach required by the standard enables a cross-functional organization that goes beyond the traditional organizational chart and reveals the actual interactions between teams, directly contributing to the customer satisfaction and at the reduction in non-conformities.
What are the three types of ISO 9001 processes?
The ISO 9001 standard identifies three main categories of processes that form the framework for an organization’s quality management system (QMS):
1. Management processes
They define the organization's strategy, direction, and quality objectives. Examples: strategic planning, management review, quality policy, risk and opportunity management.
2. Operational (or implementation) processes
These are the core business processes that directly create value for the customer. Examples include sales, design and development, production or service delivery, procurement, and delivery.
3. Support processes
They provide the resources necessary for the smooth operation of business processes. Examples include human resources, maintenance, IT, accounting, internal communications, and logistics.
Process mapping is the key document that visually represents these three categories and their interactions within the QMS. It is implicitly required by Clause 4.4 of ISO 9001:2015.
What are the 6 mandatory procedures under the ISO 9001 standard?
The ISO 9001:2015 version removed the requirement for the six documented procedures that existed in the 2008 version of the standard (document control, record control, internal audit, control of nonconforming product, corrective actions, and preventive actions). The current standard—and the one to be updated in 2026—now requires documented information without prescribing a specific format, leaving it up to each organization to adapt its documentation to its specific context. However, certain processes remain essential: internal audits, management reviews, control of nonconformities, and corrective actions.
Note that "process" and "procedure" are not synonyms:
- one process answers the question "What should be done, and what value does it add?": it describes an activity from a cross-functional perspective.
- one procedure answers the questions "How, who, and when?": it outlines the operational procedures for carrying out a given process.
Example of an ISO 9001 process: the sales process
To provide a concrete example of the ISO 9001 process-based approach, here is a typical description of a sales process:
| Element | Contents |
| Subject | Process customer requests through to the final order |
| Input data | RFP, requests for quotes, marketing information |
| Key Activities | Analysis of customer needs, preparation of the proposal, negotiation, order entry |
| Output elements | Order recorded and forwarded to production or the department |
| Process Driver | Sales Manager |
| Performance indicators | Quote success rate, turnaround time, customer satisfaction rate |
| Associated risks | Misunderstanding of customer needs, missed deadlines, non-compliance with the order |
This type of process sheet serves as the foundation of the quality management system. Every ISO 9001 process must be documented, monitored, and evaluated on a regular basis as part of the continuous improvement process.
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Please note: AFNOR offers tools and training to help you implement your quality management system and obtain the ISO 9001 certification .
What resources should I consult regarding ISO 9001 processes?
AFNOR Editions, a specialist in accessible publications on standards and management systems, presents the Guide to Process-Based Management (CBOK), a publication developed in collaboration with the Process Pilots Club. Topics covered include:
- Process-based management
- Process modeling
- Process Analysis
- Process design
- Process Performance Measurement
- Technology and Transformation
- Building a process-oriented organization and culture
- Business Process Management
What is the ISO 9001 certification process?
ISO 9001 certification is issued by an accredited certification body (distinct from AFNOR Normalisation, which brings together the standard’s drafters, represents their interests at ISO, and publishes the text in the French edition). It aims to provide a mark of recognition that highlights your commitment to quality. It includes a preparation phase, a document review (Stage 1), followed by an on-site audit (Stage 2). The certification is valid for 3 years with annual surveillance audits.
How can you become an expert in ISO 9001 processes?
AFNOR Compétences, a leader in training for management systems and ISO 9001 processes, offers training courses to help you become a quality management leader. You’ll gain the expertise to become an expert in ISO 9001 processes—and even an internal auditor!
