Risk-Based Thinking and the Process Approach in ISO 9001, ISO 14001, ISO 45001

ISO 9001, ISO 14001 and ISO 45001 are internationally recognized management system standards for quality, environmental, and occupational health & safety (OH&S) management, respectively.  All three share the Annex SL (High-Level Structure) framework and emphasize proactive, process-oriented management.  Two key concepts embedded in these standards are Risk-Based Thinking (RBT) and the Process Approach.  RBT means anticipating and addressing uncertainties (risks and opportunities) throughout the system rather than reacting after the fact.  

The process approach means viewing the organization as an interconnected system of processes transforming inputs into outputs. Together with the Plan-Do-Check-Act (PDCA) cycle, these concepts ensure continuous improvement.  This white paper explains how these ideas appear in each ISO standard, compares their focus, and provides practical implementation strategies (tools, steps and examples) for organizations.

1. Risk-Based Thinking in ISO Management Standards

What is Risk-Based Thinking (RBT)?  In ISO terms, risk-based thinking is a broad, proactive mindset to “address risks and opportunities”.  It is not a rigid new system but rather a culture of anticipating what could go wrong (or right) and embedding preventive or improvement actions into every process.  RBT replaces the old “preventive action” clause; ISO 9001:2015, for example, no longer has a separate preventive-action section because “risk-based thinking is key to achieving continual improvement within the QMS”.  In practice, this means leadership and all staff constantly ask “what if?” for every decision and process.

• Key elements of RBT: Identifying potential hazards, threats or opportunities; analyzing their likelihood and impact; prioritizing them; and planning actions to mitigate risks or exploit opportunities.  This involves tools like risk registers, matrices (likelihood vs. severity), FMEA (Failure Mode and Effects Analysis), scenario planning, etc. For example, creating a simple risk register helps document the risk description, owner, likelihood, impact, and mitigation plan.
• Benefits of RBT: A risk-based approach makes systems proactive. As one ISO guidance notes, it ensures an organization can “identify risks and opportunities more effectively, improving operational efficiency and saving time and money”.  It builds a proactive culture, optimizes resources, and drives consistency.  For instance, organizations that applied RBT in response to COVID-19 found they adapted faster because risks had already been considered.

Click Here to Download Readymade ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HACCP, Food Safety & Integrated Management Systems (IMS) Templates.

1.1. Risk-Based Thinking in ISO 9001:2015 (Quality Management)

ISO 9001:2015 integrates RBT throughout the Quality Management System (QMS).  Clause 6.1 (“Actions to Address Risks and Opportunities”) explicitly requires determining risks/opportunities that affect the QMS’s ability to achieve quality objectives.  However, ISO 9001 does not mandate a specific risk-management process.  Instead, organizations choose suitable methods.  The standard simply notes that “risks that may impact objectives and results must be addressed by the management system” and encourages thinking about risk at every PDCA stage.

• Focus in ISO 9001: Risks to product/service quality, customer satisfaction and process performance.  Examples include supply-chain disruptions, equipment failures, design defects, or changing customer requirements.  For each identified risk, a corresponding opportunity should also be sought (e.g. innovation, process improvement).  Clause 4 (Context), 5 (Leadership) and 6 (Planning) all mention thinking about risk.  Although no formal method is prescribed, many organizations use risk registers or FMEA in quality planning.
• Implementation:  Practical RBT in ISO 9001 means embedding risk checks into all processes.  For example: when mapping a production process, the team notes where errors could occur (e.g. wrong material input, equipment breakdown) and puts controls in place (e.g. mistake-proofing, backup plans).  Management reviews and audits should explicitly review risk treatment effectiveness.  SGS recommends a simple strategy: Assess risks → Implement mitigations → Record actions → Monitor results.  Documenting (even via a log or register) helps ensure consistency.  Top management should “promote risk-based thinking” in policies and objectives.

1.2. Risk-Based Thinking in ISO 14001:2015 (Environmental Management)

ISO 14001:2015 also requires addressing risks and opportunities, especially those affecting environmental objectives.  It extends the concept to environmental issues, such as pollution risks, resource use and compliance obligations.  Like ISO 9001, ISO 14001 does not define a formal risk-management methodology; instead, “the organization determines its own method for determining its risks and opportunities”.

• Focus in ISO 14001: Environmental aspects and impacts, legal and stakeholder requirements, climate or resource risks.  For example, risks might include chemical spills, non-compliance fines, extreme weather disrupting operations, or wasted energy.  Opportunities might include new green technologies or efficiency projects.  Clause 6.1.1 requires establishing processes to determine these risks/opportunities so the Environmental Management System (EMS) can achieve its intended results (improved environmental performance) and “undesirable effects are prevented or reduced”.
• Implementation:  Use aspect-impact analysis combined with risk criteria.  Identify significant environmental aspects (e.g. waste, emissions) and then ask “what risks do these pose to our objectives?”.  For instance, a chemical manufacturer may list the risk of a solvent leak and put in place spill containment and regular inspections.  A risk matrix can help rank issues by likelihood/severity.  Importantly, ISO 14001 explicitly ties risk-based thinking to compliance and sustainability: one guidance notes that integrating RBT into the EMS “shifts the system from reactive to proactive” and drives better environmental performance.  In practice, environmental audits and management reviews should include reviewing changes in context (new regulations, community concerns) and adjusting risk registers accordingly.

1.3. Risk-Based Thinking in ISO 45001:2018 (Occupational Health & Safety)

ISO 45001:2018 puts hazard identification and OH&S risk assessment at the core of its planning.  It explicitly requires systematic identification of hazards and assessment of risks (and opportunities for improvement) in Clause 6.1.2 and integrates RBT throughout the OH&S management system.  

Unlike 9001/14001, ISO 45001 is very prescriptive: organizations must establish, implement and maintain processes to “determine the hazards, assess the risks and opportunities” that may impact worker safety.

• Focus in ISO 45001: Workplace hazards and OH&S risks.  This includes physical hazards (machinery, slips), chemical hazards, ergonomic and psychosocial risks, etc.  The standard asks, for each activity or equipment, “what can go wrong and how bad could it be?”  In ISO’s own words, 45001 “requires an organization to anticipate and prevent hazards instead of simply responding to them after they’ve happened”.  It frames risk as both a danger to people and an opportunity to improve safety culture.
• Implementation:  Conduct thorough hazard surveys and risk assessments (e.g. HAZOPs, Job Safety Analyses, risk matrices) for all operations.  Use a hierarchy of controls (eliminate the hazard first, then engineer controls, etc.).  Training and participation are crucial: workers should report hazards and near-misses, feeding back into the risk process.  A key practice is to tie RBT into PDCA: for example, at the Plan stage set OH&S objectives based on risk (as shown by ISO’s PDCA model for 45001), at Do implement controls and training, at Check monitor incidents and audits, and at Act update procedures.  For instance, if a risk assessment finds a high risk of cuts in a workshop, the organization might install guards and train staff – these controls would be documented and then reviewed for effectiveness during audits.  A well-maintained Hazard & Risk Register (or digital EHS software) is often used to track these actions.

Click Here to Download Readymade ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HACCP, Food Safety & Integrated Management Systems (IMS) Templates.

1.4. Commonalities and Practical Steps for RBT

All three standards share these RBT principles:

• Leadership and Context: Top management must ensure that context (Clause 4.1) and stakeholder needs (4.2) are considered as sources of risk/opportunities.  For example, a strategic objective may be at risk if key customers demand stricter standards (quality risk), or if a community pressures for pollution reduction (environment risk).
• Planning Integration: In each, planning (Clause 6) explicitly ties to RBT.  The organization “shall establish, implement and maintain processes to determine the risks and opportunities” relevant to its context.  These should be proportionate to scale and complexity.  Smaller companies might use simple risk matrices; larger ones might adopt ISO 31000 or enterprise risk management for strategic RBT.
• Continual Review: Identified risks and controls should be reviewed at planned intervals (e.g. in management review meetings) and whenever there is a major change.  For example, if a new regulation or technology arises, the risk analysis must be updated.

Actionable RBT Recommendations:

• Establish a risk register or log. Even if not mandatory, it provides a central reference. List risks/opportunities by process or department, with owners and status.
• Use cross-functional teams. Risk often spans silos (e.g. a production risk might involve quality, environment and safety). Teams ensure all angles are covered.
• Embed in documents. Include risk considerations in SOPs, training, internal audit checklists and management review agendas. For instance, internal audits can focus on whether “actions to address risks” have been implemented (as ISO Audit guidance suggests for Clause 6.1).
• Monitor leading indicators. Beyond lagging metrics (incidents, defects), track “leading” metrics like frequency of risk reviews, near-miss reports, or percent of processes with a documented risk assessment.

2. The Process Approach in ISO Management Standards

What is the Process Approach?  The process approach means managing an organization as a system of interconnected processes, rather than isolated departments.  Each process has inputs, activities, controls and outputs.  For example, a manufacturing process takes raw materials and transforms them into finished goods (output), using workers, machines and methods (inputs).  These outputs then feed into another process (e.g. shipping or sales).  The overall management system is thus the network of these processes (both core operations and support functions) interacting to achieve objectives.

• Key elements:  Every process should have a clear owner (responsible person) and documented steps (to the level needed).  Inputs and outputs are identified, as are criteria and resources (people, equipment, information).  Processes are managed by the PDCA cycle: Plan the process (set targets, define steps), Do it (implement), Check performance (monitor KPIs, internal audit), and Act to improve.  Risk-based thinking is applied in each PDCA stage.
• Benefits of process approach: It improves efficiency by removing handoff confusion and duplication.  For example, instead of a “hierarchical” setup where Production and Quality operate separately, the process approach makes them part of one “Production” process so they coordinate continuously.  This horizontal view reduces errors (each step anticipates the next) and clarifies accountability.  As ISO guidance emphasizes, with process approach “outputs from one process serve as inputs for another” and must be coordinated, or else the entire system can fail.

2.1. Process Approach in ISO 9001:2015

ISO 9001 requires a process approach by design.  Clause 4.4 says the organization shall “establish, implement, maintain and improve” the QMS processes and their interactions.  The focus is on customer-driven outcomes: all processes should contribute to meeting customer requirements and quality objectives.

• Implementation in ISO 9001:  Organizations typically map their core processes (e.g. Product Design, Production, Purchasing, Sales, Service, etc.) and support processes (HR, Finance, etc.).  For each process, define inputs/outputs, criteria, and responsibilities.  Use flowcharts or written procedures to ensure everyone knows their role.  For example, in a service company, the “order processing” process would be mapped from receiving an order (input) through invoicing and delivery (output).  The process owner then tracks KPIs (order turnaround time, error rate) and adjusts as needed.
• Risk integration:  When designing processes, apply RBT: use risk assessments to set control points.  For instance, ISO guidance notes that risk-based thinking “decides how risk (positive or negative) is addressed in establishing the processes to improve process outputs”.  Concretely, if a process step is high-risk (e.g. data entry prone to error), introduce a check or automation.  If a risk is identified, the process documentation should include mitigating steps or controls.

Click Here to Download Readymade ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HACCP, Food Safety & Integrated Management Systems (IMS) Templates.

2.2. Process Approach in ISO 14001:2015

The EMS also uses a process approach.  Clause 4.4 of ISO 14001 says the system shall include the processes needed and how they interrelate.  Processes here include those for identifying environmental aspects (e.g. raw material use), setting objectives (Plan), operational controls (Do), compliance evaluation (Check), etc.

• Implementation in ISO 14001:  Map EMS processes around how you manage environmental aspects.  For example, a manufacturing plant might have a “Chemical Handling” process: inputs (chemicals, permits), activities (storage, usage), outputs (residual waste, emissions).  The process should define controls (spill containment, safe storage protocols).  Each EMS process should link to objectives (e.g. reduce waste) and to corresponding KPI (waste generation rate).  By examining processes end-to-end, organizations can spot inefficiencies – one case study notes how unnecessary steps (collecting unused reports) were eliminated by reviewing process flows.
• Risk-based checks:  In each environmental process, apply RBT.  For instance, in the “Waste Management” process, identify if any steps could lead to environmental incidents (illegal dumping, leaks).  The EMS should include processes for emergency response (responding to spills), as required by ISO 14001 Clause 6.1.2.2.  Use the process map to ensure resources (training, equipment) are in place at the right steps.

2.3. Process Approach in ISO 45001:2018

Similarly, ISO 45001 demands a process approach to OH&S.  The system’s processes include hazard identification, risk assessment, incident investigation, training, emergency preparedness and others.

• Implementation in ISO 45001:  Map all OHS processes.  For example, a “Machinery Maintenance” process would be defined from scheduling preventive maintenance to repair work, with inputs (machines, maintenance plan) and outputs (functional equipment, maintenance records).  Each process step must consider safety risks (e.g. lockout/tagout procedures before maintenance) and have controls.  Mapping helps ensure no step skips critical safety checks.
• PDCA with RBT:  ISO 45001 explicitly ties the PDCA cycle to risk actions.  In the Plan phase, identify hazards (process: risk planning) and set OH&S objectives (e.g. reduce incidents by 20%).  In Do, implement controls and training.  In Check, monitor incidents, compliance audits and worker feedback.  In Act, use findings to revise risk assessments and processes.  This closed-loop ensures that processes continually improve safety performance.

3. Practical Implementation Strategies

Implementing RBT and the process approach effectively means weaving them into day-to-day operations and the management system. The following strategies and examples can help:

• Map and document key processes:  Start by identifying your organization’s major processes (both operational and support). Use flowcharts, swimlane diagrams or simple lists. For each process, record: inputs, outputs, resources, sequence of activities, responsibilities and performance indicators. A clear process map highlights where to assess risk and where to focus improvement efforts.
• Conduct risk assessments during planning:  For each process, hold a risk workshop. Ask “What could go wrong?” (threats) and “What could go better?” (opportunities).  Use a risk matrix (e.g. 1–5 scale of likelihood vs severity) to rank the items.  For example, a logistics company might rate the risk of fuel leaks as high severity but low probability, and ensure spill kits and training are in place.  Prioritize actions for high-risk items (e.g. redesign a step, add a control, find alternatives).
• Assign risk owners and process owners:  Accountability is crucial. Appoint someone to each risk to drive its mitigation, and someone to each process to oversee its performance.  This avoids “no one is responsible” gaps.
• Integrate controls into processes:  Instead of separate checklists, build risk controls into the process itself. For instance, if quality risk requires machine calibration, make calibration a mandatory step in the production process flow with its own record. If safety risk requires PPE, ensure the process documentation lists PPE checks before operations begin.
• Embed RBT in routine activities:  - Internal audits: Incorporate questions about risk and process effectiveness.  E.g., audit “Have we identified all major risks in this process and are the controls working?”  - Management Review: Regularly review the status of top risks and the performance of key processes. Discuss emerging risks (new regulations, market changes).  - Training: Educate staff on RBT and the process approach so they can identify and escalate issues.
• Use PDCA at the organizational level:  Organize tasks around PDCA.  For instance:
  1. Plan: Set context (Clause 4), define quality/environmental/OHS objectives, map processes, identify risks, and decide actions. (Use strategic planning sessions and risk registers here.)
  2. Do: Implement processes, controls and documentation. Train people and allocate resources.
  3. Check: Monitor process outputs (KPIs), audit processes, gather data on incidents or defects. Check whether risk treatments are effective (are there fewer incidents or fewer nonconformities?).
  4. Act: Hold management review meetings. Based on data, update processes and risk assessments. For example, if a new hazard emerged, revise the process or add a safety task.
• Leverage Software and Tools:  Consider integrated management system software that can link processes, documents, audits and risk registers. Such tools often allow flagging risks against processes and generating reports.
• Iterate and Improve:  After implementing changes, re-assess risks and processes.  As one ISO guideline puts it, RBT and process approach help an organization answer “What if?” and look beyond corrective action to continuous improvement.  For example, if a product defect led to a customer complaint, not only fix the defect (corrective) but also update the process and risk log to prevent future issues.

Click Here to Download Readymade ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HACCP, Food Safety & Integrated Management Systems (IMS) Templates.

Comparing ISO 9001, 14001, 45001

All three standards share a common structure and philosophy (Annex SL, PDCA, leadership commitment), but their focus areas differ. The table below summarizes key differences in how risk-based thinking and process approach apply in each:

This comparison shows that while the underlying approach is the same (consider risks and manage processes), the context and types of controls differ.  For instance, ISO 45001 explicitly requires addressing hazards, whereas ISO 9001/14001 take a broader risk view.  However, all encourage continual improvement through PDCA and RBT.

Recommendations and Examples

• Case Example – Manufacturing: A factory producing electronics might map its Assembly Process.  Inputs: components, assembly instructions. Output: finished units.  Applying RBT: the team identifies that soldering stations have a risk of overheating causing product defects (quality risk) and fire hazard (safety risk).  Controls: install temperature monitors (risk control) and update assembly SOP to include regular solder station checks (process control).  Environmental risk might be the emissions from solder fumes; the EMS team adds a scrubber (control) and treats fumes in the emissions monitoring process.  By mapping the assembly process across QMS/EMS/OHSMS, the plant ensures each risk is addressed in the appropriate procedure.
• Example – Service Industry: A call center uses a process approach for “Order Fulfillment”.  Quality risks: incorrect information, long wait times.  EMS/OSHA risks: none directly, but ergonomic hazards (calls for 8 hours) arise.  The company identifies these risks during process mapping: training agents (quality control) and rotating shifts or adjustable chairs (OHS control).  Customer satisfaction KPI and employee safety KPI are linked back to the process outcomes.
• Recommendation – Integrate Systems: If an organization has multiple ISO systems, integrate them to avoid duplication.  Many clauses overlap (context analysis, audits, reviews).  For example, a single management review can cover quality, environment and safety objectives.  A unified risk register can list different types of risk side by side, and integrated process maps can show where quality, environment and safety interact.  ISO 45001 itself encourages an Integrated Approach to EHSQ (Environmental, Health, Safety, Quality).
• Recommendation – Engage All Staff: Embed RBT and process thinking in culture.  Use training and communication to show employees how their daily tasks fit into processes and impact risks.  For instance, factory floor workers might be briefed on how accurate data logging (a process step) prevents both quality defects and environmental non-compliance (by tracking chemical usage).  Encourage workers to suggest process improvements – e.g. a janitor who notices a small leak can initiate a hazard report that feeds into the risk-based management process.
• Recommendation – Use Visual Aids: Where possible, use simple visuals (flowcharts, process maps, risk heat maps) on walls or dashboards.  This makes processes and key risks visible to everyone.  For example, a wall chart might show the PDCA cycle for the sales process, with notes on monthly risk review dates.
• Frameworks and Tables:  Develop checklists that cross-reference risks, processes and controls.  For example, a table in the QMS manual might list each quality process and column entries for “Quality Risks Identified” and “Environmental/OHS Risks Identified” (if any) along with mitigation actions.  This ensures RBT is part of procedure documents.

In summary, Risk-Based Thinking and the Process Approach are intertwined pillars of modern ISO management systems.  By systematically mapping processes and embedding risk awareness at each step, organizations can meet ISO 9001, 14001 and 45001 requirements and build resilience.  The strategies above – from risk registers and process mapping to PDCA cycles with risk checkpoints – provide practical ways to turn these standards’ requirements into real-world practices that improve quality, protect the environment and ensure workplace safety.

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