The Role of Process Approach in Quality Management

In today’s complex and competitive business world, organisations are under increasing pressure to deliver high-quality products and services, satisfy customers, comply with regulatory requirements, drive continual improvement and manage risks. The standards developed by the International Organisation for Standardisation (ISO)  most notably ISO 9001  provide a globally-recognised framework for a Quality Management System (QMS). Within this framework, one of the key enablers of success is the process approach.

Rather than treating individual functions, departments or silos in isolation, the process approach emphasises managing and controlling a network of interrelated processes that together achieve an organisation’s quality objectives. As ISO describes it: “Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

In this blog we examine:

1. What is the process approach?

2. How it is embedded in ISO 9001 and other quality-management standards.

3. Why organisations adopt it the role it plays in quality management.

4. How to implement the process approach in practice.

5. The benefits, pitfalls and lessons learned.

6. A conclusion and summary of key take-aways.

What is the Process Approach?

Definition and key features

At its simplest, a process is defined by ISO as: “a set of inter-related or interacting activities which use inputs to deliver an intended result.The process approach is a way of thinking, planning and managing an organisation’s activities as a system of such processes.

According to ISO 9000’s guidance:

“The systematic identification and management of the processes employed by an organisation, and especially the interactions among such processes, can be called a ‘process-approach’.”

In other words, rather than treating each function or department independently, an organisation views its operations as a set of processes which have:

• Inputs (e.g., materials, data, resources)

• Activities / transformations which add value

• Outputs (products, services, information)

• Interactions – the output of one process may become the input of another.

Key features of the process-approach include:

• Identifying processes (what they are, boundaries, sequence)

• Understanding how they interrelate and how their outputs feed into other processes

• Managing and controlling those processes to achieve the desired outputs and objectives

• Continually measuring, analysing and improving the processes.

Why is it called an “approach”?

The term “approach” emphasises that this is not just a set of isolated process maps, but a mindset: viewing an organisation as a system of processes, managing them, controlling their interactions, and steering them toward intended outcomes. As one source puts it:

“The process approach is a method of thinking and planning to understand and plan the sequence and interactions of processes in the system.”

The process approach asks organisations to move from thinking in terms of departments or jobs (“we do X, you do Y”) to seeing how work flows, how value is created, how processes link and how control and improvement can happen at the system-level.

Relationship to other concepts: PDCA and risk-based thinking

The process approach is closely tied to other foundational concepts in ISO standards, such as the Plan‑Do‑Check‑Act (PDCA) cycle and risk-based thinking. For example, ISO 9001:2015 states that the process approach “incorporates the Plan–Do–Check–Act (PDCA) cycle and risk-based thinking.”

Thus, each process should:

• Be planned (Plan),

• Be carried out under controlled conditions (Do),

• Be monitored and measured (Check),

• Be acted upon to improve (Act).

In addition, risk-based thinking asks: What can go wrong in this process? What opportunities for improvement exist? How can control and improvement be embedded proactively? The process approach provides the structure for those questions to be applied across all processes.

Embedding the Process Approach in ISO 9001

Process Approach in ISO 9001 Requirements

The process approach is not an optional extra in ISO 9001  it is intrinsic to the standard. For instance, clause 0.3 of ISO 9001:2015 states:

“This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system.”

Clause 4.4 (the “Quality management system and its processes” requirement) then asks organisations to determine the processes needed for the QMS, their sequence and interactions, criteria and methods for effective operation and control, the resources needed, responsibilities and authorities, and monitoring, measurement, analysis and improvement.

Moreover the “Auditing Practices Group” guidance from ISO states:

“The use of the ‘process approach’ is a mandatory requirement for ISO 9001:2015 and one of the most important for a quality management system.”

In summary: organisations wanting to implement ISO 9001 must adopt a process-based mindset and reflect it in their QMS.

The Process Approach as a Quality Management Principle

Beyond the requirements, the process approach is also one of the core Quality Management Principles (QMPs) defined in ISO 9000 and referenced by ISO 9001. According to ISO, these principles guide organisations in establishing, operating and improving their QMS. One of those is:

Process approach: “An inter-related approach across all of your business processes will drive consistency and efficiency in results.”

In the list of seven QMPs:

• Customer focus

• Leadership

• Engagement of people

• Process approach

• Improvement

• Evidence-based decision making

• Relationship management

Thus, an organisation implementing ISO 9001 is expected to embed the process approach both architecturally (in how its QMS is structured) and culturally (in how its people think about their work).

Process Approach and System Thinking

A key advantage of the process approach is that it promotes system thinking: viewing the QMS and organisational operations as an integrated system of interrelated processes rather than disparate functions. Clause 0.3.1 of ISO 9001:2015 states:

“Understanding and managing inter-related processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its intended results.”

When the organisation thinks in systems rather than silos:

• The overall big-picture objectives can be aligned with the processes

• Interdependencies and hand-offs between processes are visible and managed

• Performance of one process can be seen in relation to other processes

• Improvement opportunities can be optimised across the system rather than within individual silos.

Process Approach, Value-Added, and Performance

ISO 9001’s clause 0.3.1 goes further to say the process approach enables:

1. Understanding and consistency in meeting requirements;

2. The consideration of processes in terms of added value;

3. The achievement of effective process performance;

4. Improvement of processes based on evaluation of data and information.

So, managing the organisation as a set of processes is not just about mapping and controlling them—it’s about ensuring those processes add value, are monitored for performance, and are improved in a data-driven way.

Why the Process Approach Matters in Quality Management

Focus on delivering consistent, predictable results

One of the primary goals of a QMS is to ensure that organisations consistently meet customer requirements and enhance customer satisfaction. Using the process approach helps deliver on that goal because processes, when properly managed, help produce predictable and reproducible results. ISO’s Auditing Practices Group guidance emphasises:

“The QMS consists of interrelated processes. Understanding how results are produced by this system enables an organisation to optimise the system and its performance.”

By understanding processes and how they link, organisations reduce surprises, reduce variability, and improve control.

Breaking down silos, improving cross-functional flow

Traditional organisational structures often rely on function-based silos: procurement, production, sales, customer service, etc. Such siloed thinking can hinder quality, as the interfaces between functions are poorly managed. The process approach encourages organisations to view work horizontally (end-to-end processes) rather than vertically (within functions). According to NVT Quality:

“The process approach organises and manages work horizontally … rather than being isolated in a ‘silo mode’.”

By aligning processes across functional boundaries and identifying inputs/outputs and interactions, organisations can more easily improve flow, reduce hand-off delays, improve communication and enhance customer value.

Better resource utilisation and cost-effectiveness

When processes are defined, measured and managed, organisations can more clearly see resource usage, identify inefficiencies, eliminate waste, and optimise cycle-times. As one blog notes:

“With all departments working together under the process approach … you should see increased efficiency as resources are being used more effectively. … You should see … reduced costs and shorter cycle times.”

Hence, the process approach contributes not only to quality but to operational efficiency and competitiveness.

Enhanced transparency, accountability and measurement

When each process is defined with inputs, outputs, owners, and performance measures, transparency is improved. People know who is responsible for what; hand-offs and interactions are clear; potential breakdowns or bottlenecks stand out. The process approach promotes measurable performance of processes, enabling fact-based decision making (another QMP). As the 9001 Coun­cil explains:

Process approach leads to “greater consistency, more efficient use of resources and less barriers between different functions.”

Supports continual improvement and risk-based thinking

By treating processes as controllable entities, organisations can monitor their performance, identify variances, root-cause problems, and implement corrective/preventive actions. This aligns perfectly with the continual improvement principle. Further, processes can be evaluated for risks and opportunities helping embed risk-based thinking throughout the QMS. As an article states:

“Risk-based thinking is used throughout the process approach to: • Decide how risk (positive or negative) is addressed in establishing the processes … • Define the extent of process planning and controls needed … • Improve the effectiveness of the quality management system.”

Aligning strategic objectives and operational execution

When you adopt a process-based architecture, there is a clearer linkage between strategic goals (quality policy, objectives) and the operational processes that deliver output. The process approach helps ensure that the QMS is not a layer of “extra paperwork” but integrated into how the organization actually works  thus increasing relevance, engagement and value. One commentary observes:

“How can an international standard unite with a strategic business plan and facilitate process improvement … ?”

Therefore, the process approach helps elevate the QMS from compliance exercise to a strategic enabler of performance.

How to Implement the Process Approach in Practice

Implementing the process approach in an organisation seeking ISO 9001 (or improving its QMS) is both a practical and a cultural endeavour. Below are key steps and considerations.

1. Understand the organisational context and scope

Before mapping processes, it is essential to understand the organisation’s context (external and internal issues), the needs and expectations of interested parties, and to define the scope of the QMS (Clause 4 of ISO 9001). This sets boundaries and ensures relevance. Accordingly, you then identify the processes that fall within that scope. The guidance document from ISO 9000 states:

“This guidance document provides an understanding … [of the process-approach] … The purpose of the process approach is to enhance an organisation’s effectiveness and efficiency in achieving its defined objectives.”

2. Identify and map the processes

Begin by identifying the key organisational processes  often including leadership, planning, support, operations, performance evaluation, improvement. Then map their interrelationships: which process feeds which, what are the inputs/outputs, who is responsible. Tools such as process-flow diagrams, SIPOC (Suppliers-Inputs-Process-Outputs-Customers), process maps can be used. As one blog describes:

“Identify and define core processes … Map out critical operations from input to output, including interactions and dependencies.”

3. Define criteria, methods and responsibilities

For each process: define its purpose/objective (what outcome it should achieve), the inputs and resources needed, the key activities, expected outputs, process owner(s), performance indicators (KPIs), risks and opportunities, methods for monitoring and control, and interfaces with other processes. ISO 9001 clause 4.4 outlines these kinds of requirements.

4. Manage the processes and their interactions

Once defined, the processes must be operated under controlled conditions. That means ensuring resources are available, responsibilities are clear, documentation (where needed) is present, interfaces (handoffs) are managed. The organisation must also monitor process performance: measure, analyse, evaluate. The process approach emphasises that outputs from one process become inputs to another, so the interactions/handoffs must be managed. As described in “What is a Process Approach?”:

“The output of one process is the input of another process … This stresses the importance of not treating each process as an individual silo (department, job, etc).”

5. Use the PDCA cycle and risk-based thinking

Operationalising each process means following the PDCA methodology: plan the process (what, who, when, how), do the process (execute), check (monitor, measure, evaluate) and act (improve). Additionally, integrate risk-based thinking: identify what could go wrong or what opportunities exist in each process, and determine appropriate controls or enhancements.

6. Measure, analyse, evaluate, and improve

Key to the process approach is measuring process performance: e.g., process efficiency, cycle time, error rates, customer satisfaction, cost of poor quality etc. Then analyse data, identify opportunities, implement corrective or improvement actions, and monitor their effectiveness. The process-approach emphasises continual improvement of processes based on evaluation of data and information.

7. Communicate, train, and embed culture

For the process approach to succeed, people at all levels must understand the concept, how their activities fit into processes, how their work interacts with others, and how they can contribute to monitoring, controlling and improving processes. Training, awareness-raising, top-management leadership, and alignment of roles and responsibilities are vital.

8. Review the system and adapt

At periodic intervals (e.g., during management review) the QMS should examine how well the process-based architecture is performing: are processes delivering their intended results? Are interactions and hand-offs effective? Are risks being managed? Are improvements being realised? Based on this review, refinements may be needed: redefining processes, merging, splitting, realigning responsibilities, updating measures, etc.

Benefits, Challenges and Key Considerations

Benefits of the Process Approach

1. Improved performance and efficiency
   By managing processes end-to-end and removing silos, organisations can streamline workflows, reduce duplication, decrease cycle times, and optimise resource use. For example, IMSM GB highlights that the approach leads to reduced costs and shorter cycle times.

2. Greater consistency, reliability and predictability
   Processes that are defined, controlled and monitored tend to deliver more consistent output. This boosts customer confidence and meets requirement expectations.

3. Better visibility, transparency and accountability
   Process mapping and ownership mean that responsibilities are clearer, hand-offs are visible, and performance is measurable. This transparency helps root-cause problems and drive improvement.

4. Focus on value-added activities
   The process approach emphasises considering processes in terms of added value not just activity for its own sake. Clause 0.3.1 of ISO 9001 encourages organisations to do this.

5. Facilitates continual improvement and risk-based thinking
   When processes are measured and managed, opportunities for improvement are more evident, and risks (and opportunities) can be addressed systematically.

6. Strategic alignment and integration
   The process approach roots the QMS in the actual operations of the organisation, rather than as a parallel or detached compliance exercise. This creates better alignment of quality management with strategic objectives.

7. Enhanced customer satisfaction
   Ultimately, better control, consistency and improvement lead to better products/services, fewer defects, more reliable delivery and, in general, higher customer satisfaction. The ISO guidance emphasises that the purpose of the process approach is to enhance the organisation’s effectiveness in achieving its defined objectives—such as meeting customer requirements.

Challenges and Pitfalls

1. Over-documenting or bureaucratising processes
   Sometimes organisations misinterpret process mapping as needing extensive documentation or rigid controls. This can stifle agility and become a compliance burden rather than value-add. As one commentary noted: many organisations treat the QMS as “separate from how we run the business.

2. Not properly identifying interfaces and interactions
   The success of the process-approach depends heavily on identifying and managing the interactions between processes. If these are ignored, things fall back into silos and the value of the approach is lost.

3. Lack of ownership or accountability for processes
   If process owners are not clearly assigned, or if people don’t understand their responsibilities, processes might not be managed effectively.

4. Insufficient performance measurement or unrealistic KPIs
   Without meaningful metrics, processes won’t be monitored or improved effectively. Having irrelevant or poorly designed indicators reduces the benefit.

5. Cultural resistance and lack of awareness
   Changing from functional/silo thinking to process-thinking requires culture change, training, leadership. If people don’t buy-in, process maps will just sit on a shelf.

6. Failure to link process approach to business strategy
   If the process approach is seen purely as a “QMS project” rather than integral to how the organisation operates and achieves its objectives, then it might not deliver strategic benefit.

7. Neglecting risk-based thinking
   The process approach should embed risk and opportunity identification in each process. If organisations ignore this dimension, they lose a key part of modern QMS thinking.

Key Considerations & Best Practices

• Start with key or core processes rather than trying to map every minor process at once. Prioritise those that are critical to customer value or business strategy.

• Use simple, clear maps and diagrams  avoid over-complexity. Tools such as SIPOC, value-stream mapping, process flow-charts are fine.

• Define process owners and responsibilities explicitly.

• Identify clear, measurable process objectives and KPIs (cycle time, defect rate, customer satisfaction, cost, throughput, etc).

• Ensure that each process has documented inputs, activities, outputs, resources, risks, interactions.

• Show the sequence and interaction of processes  i.e., how outputs feed into other processes, how they chain.

• Link to strategic objectives and quality policy  ensure the process architecture supports what the organisation wants to achieve.

• Embed monitoring, measurement, analysis, and continual improvement in every process. Use data and feedback.

• Use PDCA and risk-based thinking. Review processes periodically to identify improvements or address risks/opportunities.

• Communicate and train the workforce in process thinking; foster a process-centric culture rather than function-centric.

• Use technology and tools where beneficial (process modelling, monitoring dashboards, workflow systems) but don’t lose the human/organisational perspective.

• Avoid treating the process approach as a paperwork exercise make sure it links to real operations and value creation.

• Management commitment and leadership are essential. Without leadership buy-in, process approach initiatives often stall.

Case Example / Practical Illustration

To illustrate how the process approach might play out in a typical organisation seeking ISO 9001 certification or improvement, consider a simplified manufacturing operation with the following high-level processes:

• Process A: Supplier/Vendor Management & Incoming Materials

• Process B: Production/Manufacturing

• Process C: Quality Inspection & Product Release

• Process D: Delivery/Shipment & Customer Feedback

• Process E: Management Review & Continual Improvement

Using the process approach:

1. Map each process, identify inputs/outputs, resources, activities.

   • For Process A: Inputs = supplier materials, supplier quality information; Activities = supplier evaluation, incoming inspection; Outputs = approved materials to production.

   • For Process B: Inputs = approved materials, production plan, machinery; Activities = manufacturing operations, in-process monitoring; Outputs = finished product ready for inspection.

   • And so on.

2. Identify interactions: output of Process A → input of Process B; output of Process B → input of Process C; output of Process C → input of Process D; Process D provides customer feedback that may feed Process E which may lead back to Process A or B.

3. Define process owners: a senior manager for each process, responsible for performance, resources, monitoring.

4. Define performance indicators: e.g., for Process C (Quality Inspection) maybe percentage of first-pass yield, number of non-conformances, cycle time of inspection.

5. Apply PDCA & risk-based thinking:

   • Plan: set objectives (e.g., reduce non-conformances by X%), plan resources, define controls.

   • Do: execute inspection according to plan.

   • Check: monitor data on non-conformances, feedback from customers.

   • Act: if non-conformances exceed target, root-cause analysis, corrective action, update inspection process.
     Risk-based thinking: identify risk of defective materials from suppliers (Process A) affecting production (Process B) and quality (Process C). Implement supplier audits, tighter specs, etc.

6. Continual improvement: data from all processes feed into management review (Process E) to identify improvement opportunities, resource requirements, training, changes to process flows.

By managing these processes as a coherent system rather than siloed functions, the organisation improves flow, reduces waste, ensures quality is built into each process, aligns with ISO 9001’s requirements, and drives continual performance improvement.

Challenges in Real-Life Adoption & How to Overcome Them

Challenge: Resistance to change

Transitioning to a process-based view can feel uncomfortable to managers used to functional silos. Overcoming this requires leadership commitment, clear communication of benefits, involvement of staff, training, and sometimes change management initiatives.

Challenge: Too much documentation / bureaucracy

Some organisations over-engineer the process approach: creating huge process libraries, overly detailed maps, excessive controls. This often leads to low engagement. The antidote: focus on value, keep it simple, only document what is necessary to control and communicate the process effectively.

Challenge: Poor understanding of process interactions

If the hand-offs between processes are not identified or managed, bottlenecks and hidden defects can persist. To address this: map the interactions explicitly, involve cross-functional teams, visualise the process chains, highlight key interfaces and control points.

Challenge: Lack of meaningful metrics

Without data, processes become uncontrolled. Ensure each key process has relevant KPIs, baseline data, targets, and review mechanisms. Use dashboards and reports to keep visibility high.

Challenge: Risk and opportunity not embedded

If risk­-based thinking is not applied, processes may be reactive rather than proactive. Ensure that each process identifies key risks and opportunities, and that controls/mitigations are built in. Training and leadership support are vital.

Challenge: Silo mentality remains

Even with process maps, if functional silos persist culturally, the benefits of process thinking are limited. Overcome by promoting horizontal workflows, encouraging process-owner accountability, fostering cross-functional teams, and aligning incentives with process performance rather than just departmental KPIs.

Challenge: Process approach perceived as only for certification

If the process approach is implemented just to “get the certificate” without linking to actual operations, then it often fails. To avoid this: ensure the QMS is integrated with business operations, processes are aligned with business goals, and metrics reflect real value added.

Best practices to overcome:

• Start small: identify key processes and roll out incrementally.

• Link process improvement to business value: cost savings, customer satisfaction, shorter lead-times.

• Use visual management: process maps, value-stream diagrams, dashboards.

• Foster process ownership: empower process owners, provide training, define roles.

• Monitor implementation and improvement: regular reviews, audits, management review.

• Engage staff from the start: involve them in mapping, defining processes, measuring performance.

• Align incentives to process outcomes, not just functional metrics.

The Role of Process Approach in Future Quality Management Trends

Looking ahead, the process approach remains a vital pillar as organisations face new pressures: digitalisation, globalised supply chains, sustainability, agile manufacturing, service models, regulatory complexity and customer expectations for customisation and speed. Within that context:

• Process approach supports end-to-end digital workflows, by defining, mapping and integrating processes across digital platforms.

• It enables organisations to pivot and adapt: by having defined processes with monitoring and improvement built-in, organisations can respond more quickly to change.

• In a service-economy context, the process approach helps treat even intangible services as processes: inputs (data, customer request), activities (service delivery), outputs (customer experience) and review.

• With increasing emphasis on risk management, the process approach provides the architecture to embed risk-based thinking into every major organisational process.

• With the rise of integrated management systems (e.g., combining quality, environment (ISO 14001), health & safety (ISO 45001)), the process approach allows organisations to view processes holistically across multiple standards, rather than in standalone silos.

• For continual improvement and innovation, the process approach makes improvement systematic: map, measure, analyse, improve.

In short  as organisations move from static compliance to dynamic performance, the process approach remains the operational backbone.

Summary and Key Take-aways

• The process approach is a way of thinking and managing an organisation as a set of inter-related and interacting processes, rather than isolated functions or departments.

• In the context of ISO 9001 (and QMS more generally), the process approach is a mandatory requirement, and one of the core quality-management principles.

• It emphasises identifying processes, their sequence and interactions; defining inputs, outputs, activities; assigning ownership; measuring performance; improving continually; and managing risk.

• The process approach leads to benefits such as improved consistency, efficiency, resource utilisation, transparency, strategic alignment and customer satisfaction.

• Realising those benefits requires leadership commitment, effective mapping of processes and interactions, relevant metrics, embedding of PDCA and risk-based thinking, strong process ownership, and a culture shift from silo-thinking to process-thinking.

• Pitfalls include over-documenting, ignoring hand-offs, weak metrics, cultural resistance, and treating the process approach only as a certification exercise.

• The process approach is essential for future-oriented organisations dealing with digitalisation, integrated management systems, rapid change and complex value-chains.

• Ultimately, the process approach transforms a QMS from a static checklist into a dynamic system of value-creating processes.

If one message stands out, it is this: quality management is not just about setting policies and writing procedures  it’s about how work gets done, measured, controlled and improved. The process approach centres the QMS on the real workings of the organisation. When thoughtfully implemented, it becomes a driver of performance, not just compliance.

Organisations at every size and in every sector can benefit from adopting process-thinking: mapping how they convert inputs into outputs, how those outputs feed into other processes or deliver value to customers, how they measure and monitor each process, how they detect faults before they become defects, and how they continuously improve. In doing so, they align with ISO 9001’s intent, satisfy customers, manage resources, mitigate risk and set up a culture of sustainable improvement.

If you are working on implementing or upgrading your QMS, focusing on the process approach is a strategic investment  not just for certification, but for real operational effectiveness and competitiveness.