Management system guidance
What is the process approach?
ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret and better implement the requirements of ISO 9001:2026, ISO 14001:2026 and ISO 45001:2018.
Our range of ISO templates cover the requirements of ISO 9001:2026, ISO 14001:2026 and ISO 45001:2018, and offer an easy way to implement your next management system.
The process approach and the PDCA cycle
The process approach and the iterative, four-step plan-do-check-act (PDCA) cycle, also known as the Deming Cycle, are central themes in management system standards like ISO 9001:2026, 14001:2026 and 45001:2018.
The process approach is promoted as one of the seven principles of successful quality management, which remain unchanged in name in ISO 9000:2026. ISO standards can be purchased and downloaded from their on-line store.
Key benefits of the process approach
The process approach and the iterative, four-step PDCA cycle are central themes in management system standards like ISO 9001:2026, ISO 14001:2026 and ISO 45001:2018. ISO standards can be purchased and downloaded from their on-line store.
Use the process approach, coupled with the PDCA cycle and risk-based thinking, to align and integrate your management system with the requirements of the standards. The plan, do, check, act (PDCA) cycle provides a methodology to develop and implement process orientated management systems. The PDCA cycle should be applied to all functions, processes and levels within your organization.
Process approach in ISO 9000:2026 and ISO 9001:2026
ISO 9000:2026 has sharpened the wording of the seven principles and now groups the ideas behind them into fundamental concepts. Process management and risk-based thinking both sit among those fundamental concepts, which confirms that managing activities as interrelated processes, and thinking ahead about what could go wrong or better, belong together.
ISO 9001:2026 makes the same link. Its Annex A explains that clause 4.4 is tied to the process approach principle, which brings together the PDCA cycle, risk-based thinking and the newly named opportunity-based thinking. In practice this affects several clauses:
- Top management must promote the process approach, and risk-based and opportunity-based thinking (Clause 5.1.1);
- Each process needs defined inputs, outputs, criteria, resources, responsibilities and authorities (Clause 4.4.1);
- Risks and opportunities are now planned for separately, with risk actions in Clause 6.1.2 and opportunity actions in Clause 6.1.3, both built into your processes;
- Changes to processes and the QMS are planned and their results reviewed (Clause 6.3);
- Process performance is analysed and evaluated (Clause 9.1.3) and processes are continually improved (Clause 10.1).
ISO 9001:2026 Process approach
For an organization to function effectively, it has to identify and manage a number of linked activities. All activities use resources (e.g. people, plant, equipment) to transform a process inputs into a process outputs (products). The output of one process is often the input of the next process.
The quality management system (QMS) should be regarded as an inclusive system that describes your business and provides you with useful information (e.g. data analysis), rather than some strange, set of books that the Quality Manager runs exclusively for the benefit of the Certification Body.
ISO 9001:2026 includes specific requirements necessary for the adoption of processes when developing, implementing and improving a management system. This requires your organization to systematically define and manage processes and their interactions so that it achieves its intended results in line with both the policy and strategic direction. Certification Auditors will want to determine:
- How well is the ‘process approach’ understood in your organization?
- Is the quality management system in line with your organization’s context, and requirements of interested parties?
- Is it likely the established management system will achieve its intended outcomes and enhance quality performance?
- Does it include the enhancement of quality management system performance?
- Does it support the fulfilment of applicable requirements and quality objectives?
Some documented information can be used to verify that your organization has implemented all required management system processes. If these are working well for your organization then there is no need to replace them.
Existing operational procedures, turtle diagrams, work instructions, process maps and flow charts are valid examples of documented information and can be used to evidence the requirement for ‘documented information to support the operation of processes is being met’.
Check that process inputs and outputs are defined and review how each of the processes are sequenced and how they interact. Click here if you want to read more about the benefits of turtle diagrams and process maps. Look for evidence that your organization has:
- Assigned duties/process owners; (Clause 5.3)
- Determined and addressed risks and opportunities; (Clause 6.1)
- Provided resources; (Clause 7.1)
- Made documented information available to support processes and as evidence; (Clause 7.5)
- Implemented measurement criteria; (Clause 9.1)
- Improved the management system and its processes. (Clause 10.1)
Your organization should begin using quality performance indicators to control and monitor issues, and associated risks and opportunities. These types of objective evidence will indicate that your organization has successfully integrated the quality processes into its business processes.
Evidence may include management reviewing KPI’s as part of regular business reviews, awareness of contractors and employees of QMS goals and expectations, etc.
How to apply the process approach to your management system
The development of a quality management system, using the ISO 9001:2026 clauses and the PDCA cycle as a framework, will enable any organization to identify and integrate the processes needed to achieve customer satisfaction, employ risk-based and opportunity-based thinking to continually monitor risks and opportunities, and manage your management system processes.
The management system requirements are divided into four sequential stages; Plan, Do, Check, Act. Each stage is linked to the underlying ISO 9000:2026 quality principle and the related ISO 9001:2026 clauses to explain them in plain English with practical guidance. The action summary outlines ways to comply, whilst the links in the guidance column provide more detailed information on meeting each requirement.
Planning - Context, leadership and management system planning
This is the 'Plan' part of the PDCA process. Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizational policies. This is often implemented using stated objectives, work instructions or procedures as required for consistent process output.
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Process approach and engagement of people | Clause 2 Normative reference (ISO 9000:2026) | Use the 20 core terms now defined in clause 3 (for example, risk as the effect of uncertainty, documented information and continual improvement) and ISO 9000:2026 for all other terms, so that everyone shares the same quality vocabulary. | 3 Terms and Definitions |
| Process approach and Relationship management | 4.4.1 Processes (a, b, & c) | Determine the external and internal issues relevant to your organization's purpose and strategic direction, including whether climate change is a relevant issue. Monitor and review information about these issues. | 4.1 Understanding Context |
| Relationship management | 4.4.1 Processes (a, b, & c) | Determine the relevant interested parties (stakeholders), their relevant requirements, and which of those requirements your quality management system will address. Monitor and review this information for change. | 4.2 Interested Parties |
| Process approach | 4.4.1 Processes (a, b, & c) | Base the scope of the management system on the external and internal issues - 4.1, relevant interested party requirements - 4.2, and your products and services. State the types of products and services covered and justify any requirement you determine is not applicable. | 4.3 Determining Scope |
| Process approach | 4.4.1 Processes (a, b, c & d) | Define the management system processes, their inputs, outputs, sequence and interaction, and the criteria, methods and performance indicators needed to monitor and control them. | 4.4 Management System Processes |
| Leadership and customer focus | 4.4.1 Responsibilities (f) | Demonstrate leadership and commitment: take accountability for the QMS, promote a quality culture and ethical behaviour, the process approach, and risk-based and opportunity-based thinking. Maintain a focus on customer satisfaction. | 5.1 Leadership and Commitment |
| Customer focus | 4.4.1 Responsibilities (f) | Establish a quality policy that takes your context into account and supports your strategic direction. Make it available, communicated, understood and applied, and review it when context or interested party requirements change. | 5.2 Quality Policy |
| Leadership | 4.4.1 Responsibilities (f) | Develop and communicate an organization chart and job descriptions to define roles, responsibilities and authorities, including who reports QMS performance and improvement opportunities to top management. | 5.3 Roles, Responsibilities and Authorities |
| Evidence-based decision making | 4.4.1 Risks and opportunities (g) | Determine the risks and opportunities that need to be addressed, taking account of your organization's context 4.1 and relevant interested parties 4.2. Integrate risk-based and opportunity-based thinking into processes 4.4. | 6.1.1 Determining Risks and Opportunities |
| Determine, analyse and evaluate risks to conforming products and services and customer satisfaction, including during and after a disruption. Plan proportionate actions, build them into your processes and evaluate their effectiveness. | 6.1.2 Actions to Address Risks | ||
| Improvement and evidence-based decision making | 4.4.1 Risks and opportunities (g) | Determine, analyse and evaluate opportunities, such as new practices, products, services, partnerships or technologies, separately from risks if you wish. Plan actions, build them into your processes and evaluate their effectiveness. | 6.1.3 Actions to Address Opportunities |
| Evidence-based decision making | 4.4.1 Criteria and methods (d) | Establish measurable quality objectives at relevant functions, levels and processes, consistent with the quality policy. Plan what will be done, resources, responsibilities, timescales and how results will be evaluated. | 6.2 Quality Objectives and Planning |
| Evidence-based decision making and improvement | 4.4.1 Evaluate and change (h) | Plan changes to the QMS, considering: a) purpose and possible consequences; b) QMS integrity; c) resources and information; d) responsibilities and authorities; e) communication; f) how effectiveness will be monitored and evaluated; g) how results will be reviewed. | 6.3 Planning of Changes |
Doing - Support and operations
This is the 'Do' part of the PDCA process. Ensure the availability of resources and information necessary to support the operation and monitoring of your processes. This may be through management review or other methods that define resource requirements.
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Leadership | 4.4.1 Resources (e) | Determine and provide the resources needed for the QMS: people, infrastructure (on site, remote or hybrid), the process environment, monitoring and measuring resources, and organizational knowledge that is retained, applied and shared. | 7.1 Resources |
| Engagement of people | 4.4.1 Resources (e) | Determine the competence needed, ensure people are competent through education, training or experience, act to close any gaps, and keep evidence of competence available. | 7.2 Competence |
| Leadership and engagement of people | 4.4.1 Resources (e) | Ensure all persons working under the remit of the management system are aware of the quality policy, relevant objectives, their contribution, the implications of not conforming, and the organization's quality culture and ethical behaviour. | 7.3 Awareness |
| Engagement of people and relationship management | 4.4.1 Resources (e) | Plan internal communication with employees, and external communication relating to the quality management system with relevant parties: what, when, with whom, how, and who communicates. | 7.4 Communication |
| Process approach | 4.4.2 Documented information (a & b) | Create, update and control documented information so that it is available to support the operation of processes and as evidence that they are carried out as planned. | 7.5 Documented Information |
| Process approach | 4.4.1 Processes (a, b, c, d & e) | Plan, implement and control operational processes that generate customer output, e.g. planning, engineering, operations, purchasing, warehousing, and delivery. Control planned changes and review the consequences of unintended changes. | 8.1 Operational Planning and Control |
| Customer focus | 4.4.1 Processes (a, b & c) | Establish arrangements to provide the customer with product information, enquiry handling and orders, feedback and complaints handling, and information on contingency actions, including those related to disruptions. Review requirements before committing to supply. | 8.2 Requirements for Products and Services |
| Customer focus | 4.4.1 Processes (a, b & c) | Implement and maintain a design and development process appropriate to the types of products or services provided, involving customers and other relevant interested parties where appropriate. | 8.3 Design & Development of Products and Services |
| Customer focus and relationship management | 4.4.1 Risks and opportunities (g) | Ensure that externally provided processes, products or services meet requirements, communicate your requirements to external providers, and monitor their performance. | 8.4 Control of Externally Provided Processes, Products and Services |
| Customer focus | 4.4.1 Processes (a, b & c) | Control the way your products are produced and services provided, including identification and traceability, customer and external provider property, preservation, post-delivery activities and control of changes. | 8.5 Production and Service Provision |
| Customer focus and evidence-based decision making | 4.4.1 Processes (a, b & c) | Ensure planned arrangements are completed prior to the release of the product or service. Verify that product or service requirements have been met and keep evidence of who authorized release. | 8.6 Release of Products and Services |
| Customer focus and improvement | 4.4.1 Evaluate (h) | Identify and control outputs that do not conform to requirements to prevent their unintended use or delivery. Take suitable action and keep evidence of the nonconformity, the action taken and who decided it. | 8.7 Nonconforming Outputs |
Checking - monitoring, measuring, analysing and evaluating
This is the 'Check' part of the PDCA process. Monitor, measure and analyse process performance. Monitor and measure processes and products against policies, objectives and requirements, and report the results. The methods employed and the timing of such analysis should be based upon priorities established by the organization.
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Customer focus and evidence-based decision making | 4.4.1 Evaluate (h) | Determine what to monitor and measure, the methods and the timing. Decide how customer satisfaction information is obtained and reviewed, and analyse results, including the effectiveness of actions on risks and on opportunities. | 9.1 Monitoring, Measurement, Analysis and Evaluation |
| Evidence-based decision making | 4.4.1 Evaluate (h) | Implement an internal audit programme. Define objectives, criteria and scope for each audit, select objective and impartial auditors, report results to relevant managers and take corrective action without undue delay. | 9.2 Internal Audit |
| Customer focus and evidence-based decision making | 4.4.1 Evaluate (h) | Conduct management reviews at planned intervals, covering inputs a) to h), including changes in interested party needs and the effectiveness of actions on risks and on opportunities. Record decisions on improvement, changes and resources. | 9.3 Management Review |
Acting - implementing improvement actions
This is the 'Act' part of the PDCA process. Implement the actions necessary to achieve the planned results, and for the continual improvement of those processes. Auditors will expect to see evidence that corrective action is taken when measurable objectives and performance indicators fall below target or a pre-defined action level.
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Improvement and customer focus | 4.4.1 Improve (i) | Continually improve the suitability, adequacy and effectiveness of the QMS. Use the results of analysis and evaluation (9.1.3) and management review (9.3) to find opportunities, and address them by improving processes, products and services and meeting future needs. | 10.1 Continual Improvement |
| Improvement and evidence-based decision making | 4.4.1 Improve (i) | React to nonconformities, determine their causes, take corrective action to prevent recurrence and review its effectiveness. Keep evidence of the nonconformity, the actions taken and their results. | 10.2 Nonconformity and Corrective Action |
More information on quality management principles
The latest and current quality management principles (QMPs), stated in ISO 9000:2026, are intended to provide the foundation by which any organization can continually improve its performance.
| Customer focus | Meeting customer requirements, exceeding expectations and customer experience |
| Leadership | Establishing strategic direction, purpose and a quality culture |
| Engagement of people | Competence, knowledge, empowerment and quality culture |
| Improvement | Innovation, opportunities, root cause analysis, and change management |
| Evidence‐based decision making | Data analysis, process performance assessment, and risk-based thinking |
| Relationship management | Maintaining relationships with interested parties and providers in the supply chain |
Want to know more?
- Read our customer's feedback
- Client list - who's using our templates?
- How the templates are formatted and download examples
- Why we use turtle diagrams and process maps
- What's the difference between a process and a procedure?
- About documented information
SSL certification
A certificate guarantees the information your internet browser is receiving now originates from the expected domain - https://www.iso9001help.co.uk. It guarantees that when you make a purchase, sensitive data is encrypted and sent to the right place, and not to a malicious third-party.
Free PDCA guidance
ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.