Management system guidance

6.0 Planning

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6.1 Actions to address risks and opportunities

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6.1.2 Plan the actions needed to address the risks and opportunities

When deciding how to plan and control the management system, including its component processes and activities, your organization needs to consider both the type and level of risk associated with them. Ensure that your organization is taking a planned approach to addressing risks and realizing opportunities, and that any actions taken have been recorded. Options to address risks and opportunities can include:

  1. Avoiding risk;
  2. Taking risk in order to pursue an opportunity;
  3. Eliminating the risk source;
  4. Changing the likelihood or consequences;
  5. Sharing the risk;
  6. Retaining risk by informed decision;
  7. SWOT analysis by the organization as part of its business strategy to identify the external risk and opportunities and action plans to address them;
  8. Formal business risk assessment performed by the organization talking into consideration its context, associated risk and opportunities and mitigation plan;
  9. Use of process approach by organization to identify sources of input, activities, output, receiver of output, performance indicators to control and monitor processes, the risks and opportunities associated with them and action plan to address them.

Formal business risk assessment performed by the organization talking into consideration its context, associated risk and opportunities and mitigation plan. The use of the process approach by your organization to identify sources of input, activities, output, end-user/customer, performance indicators to control and monitor processes and the risks and opportunities associated with them, and action plans to address them:

  1. Meeting minutes;
  2. SWOT and/or PESTLE analysis;
  3. Planning, analysis and evaluation activities;
  4. Risk determination or evaluation records.

Risk management methodology

Understanding the risks and managing them appropriately will enhance your organization’s ability to make better decisions, safeguard assets, and enhance your ability to provide products and services and to achieve your mission and goals.
By considering risk throughout your organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service. Risk-based thinking therefore helps to:

  1. Improve customer confidence and satisfaction;
  2. Assure consistency of quality of goods and services;
  3. Establishes a proactive culture of prevention and improvement;
  4. Intuitively take a risk-based approach.

We suggest that you use the familiar Plan-Do-Check-Act (PDCA) methodology to manage your organization’s transition to risk-based thinking; using an approach that ring-fences processes into ‘risk themes’ or groups such as:

  1. Business planning and strategic direction;
  2. Process risk;
  3. Product and service risk;
  4. Risk associated with the control of externally provided product and service.

Risk and opportunity assessment

Assessment of the severity of a risk drives management attention and supports planning for risk mitigation. A qualitative risk assessment scheme consisting of qualitative probability and impact scales is undertaken to ensure consistency. Ensure that all accountable managers should engage with risk owners to:

  • Identify the control measures already applied to each risk i.e. existing control measures. These may be pro-active (reducing the probability) or reactive (reducing the impact);
  • Rank the probability and impact of each risk after taking into account the actual effectiveness of the existing control measures;
  • Enter the existing control measures and the associated current risk probability and impact scores into the risk and opportunity register.

Forecast probability, cost and time data is assessed for each risk based on the causes and effects described, taking into account the existing controls and active responses. Probability or likelihood estimations are established giving due consideration to the effectiveness of existing control measures. The consequence evaluation criteria define the consequence criteria, assessed against potential financial loss, reputation impact, health and safety, legal and regulatory compliance and management time and effort.

Risk assessments are undertaken to provide an improved understanding of the risk profile and derive a more detailed understanding of certain cost and time risks. Forecast probability, cost and time data is assessed for each risk based on the causes and effects described, considering the existing controls and active responses.

Probability or likelihood estimations are established giving due consideration to the effectiveness of existing control measures. The consequence evaluation criteria define the consequence criteria, assessed against potential financial loss, reputation impact, health and safety, legal and regulatory compliance and management time and effort.

Risk treatment and mitigation

The objective of this step is to identify how the identified risks will be treated. Risk treatment involves identifying the options for treating each risk, evaluating those options, assigning accountability (for Very High, High and Moderate residual risks) and taking relevant action.

For each risk, the risk owner must establish an appropriate level of treatment. Control measures in addition to those already existing may be needed to achieve this level of mitigation. Accountable managers should engage with risk owners to develop a satisfactory response each risk in order to:

  1. Identify a response strategy to treat, terminate, tolerate or transfer the risk;
  2. Identify response actions to improve control measures as required. These will be SMART;
  3. Identify a response action owner for each action and confirm with them that they accept accountability for implementing the action within the time allowed.

The risk owner is responsible for the development of the response. When a response action is completed, the risk should be reassessed to reflect any newly introduced control measure

Monitoring

Continuous systematic and formal monitoring of implementation of the risk and opportunity process and outputs take place against appropriate performance indicators to ensure process compliance and effectiveness. Monitoring takes a variety of forms and range from self-assessment, inspections and internal audits, to detailed reviews by independent external experts.

Escalation

On occasion, it may be appropriate to escalate a health and safety risk to ensure it is assessed and/or managed by the person or party best placed to do so (able and with appropriate authority). For example, where a more substantial or coordinated response is required than the current risk owner can authorise or implement will justify higher level assessment and/or management, as appropriate:

  1. Escalate through established lines of management accountability all hazards and risk that may require mitigation;
  2. This may take place during formal reviews, or through other simple mechanisms at management meetings;
  3. Issue reports in accordance with requirements;
  4. Provide key information such as statistical data on numbers of active hazards, unassessed risks, overdue actions, and others as appropriate

Managing opportunities

Your organization recognizes an ‘opportunity’ as a set of circumstances which makes it possible to leverage positive factors and attributes, for example:

  1. Develop new products, services and processes;
  2. Develop new markets, or increase market share;
  3. Improve the work environment;
  4. Improve productivity;
  5. Improve operational efficiency (reduction of resource use, reduction of waste, etc.).

Opportunities may be identified as positive effects of risks; as in a risk forcing implementation of a risk reduction measure that is beneficial in a broader context than just reducing a particular risk. For example, health risks may require measures to improve working environment.

However, these measures also create opportunities to attract and retain better qualified employees, improve morale and job satisfaction, and reduce turnover; and so, the initial health risk creates positive opportunities to improve the overall job satisfaction.

Check that any actions taken to address the risks and opportunities are recorded, and ensure that the effectiveness of each action was effective at addressing the issue, and that the action taken was proportionate to the risk or opportunity. Objective evidence could be in the following various forms:

  1. Meeting minutes;
  2. SWOT analysis;
  3. Reports on customer feedback;
  4. Competitor analysis;
  5. Quality manual;
  6. Brain-storming activities;
  7. Planning, analysis and evaluation activities;
  8. Strategic planning documents;
  9. Design and development reviews;
  10. Marketing and sales data;
  11. Production inspections and service reviews;
  12. Corrective actions;
  13. Non-conformance reports;
  14. Management review minutes;
  15. Risk determination or evaluation records.

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More information on PDCA

Planning

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

4.1 Organizational Context

4.1 Organizational Context

4.1 Organizational Context

4.2 Relevant Interested Parties

4.2 Relevant Interested Parties

4.2 Relevant Interested Parties

4.3 Management System Scope

4.3 Management System Scope

4.3 Management System Scope

4.4 QMS Processes

4.4 EMS Processes

4.4 OH&S Management System

 
ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

5.1 Leadership & Commitment

5.1 Leadership & Commitment

5.1 Leadership & Commitment

5.2 Quality Policy

5.2 Environmental Policy

5.2 OH&S Policy

5.3 Roles, Responsibilities & Authorities

5.3 Roles, Responsibilities & Authorities

5.3 Roles, Responsibilities & Authorities

 

 

5.4 Consultation & Participation

 
ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

6.1.1 Address Risks & Opportunities

6.1.1 Address Risks & Opportunities

6.1.1 Address Risks & Opportunities

6.2.1 Quality Objectives

6.1.2 Environmental Aspects

6.1.2 Hazard Identifcation

6.2.2 Planning to Achieve Objectives

6.1.3 Compliance Obligations

6.1.3 Legal & Other Requirements

6.3 Planning for Change

6.1.4 Planning Action

6.1.4 Planning Action

 

6.2.1 Environmental Objectives

6.2.1 OH&S Objectives

 

6.2.2 Planning to Achieve Objectives

6.2.2 Planning to Achieve Objectives

 

Doing

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

7.1.1 Resources - General

7.1 Resources

7.1 Resources

7.1.2 People

7.2 Competence

7.2 Competence

7.1.3 Infrastructure

7.3 Awareness

7.3 Awareness

7.1.4 Operational Environment

7.4.1 Communcation - General

7.4.1 Communcation - General

7.1.5 Monitoring & Measuring

7.4.2 Internal Communcation

7.4.2 Internal Communcation

7.1.6 Organizational Knowledge

7.4.3 External Communcation

7.4.3 External Communcation

7.2 Competence

7.5 Documented Information

7.5 Documented Information

7.3 Awareness

 

 

7.4 Communcation

 

 

7.5 Documented Information

 

 

 
ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

8.1 Operational Planning & Control

8.1 Operational Planning & Control

8.1.1 General

8.2.1 Customer Communication

8.2 Emergency Preparedness

8.1.2 Eliminating Hazards

8.2.2 Determining Requirements

 

8.1.3 Management of Change

8.2.3 Reviewing Requirements

 

8.1.4 Outsourcing

8.2.4 Changes in Requirements

 

8.2 Emergency Preparedness

8.3.1 Design Development - General

 

 

8.3.2 Design Development - Planning

 

 

8.3.3 Design Development - Inputs

 

 

8.3.4 Design Development - Controls

 

 

8.3.5 Design Development - Outputs

 

 

8.3.6 Design Development - Changes

 

 

8.4.1 External Processes - General

 

 

8.4.2 Purchasing Controls

 

 

8.4.3 Purchasing Information

 

 

8.5.1 Production & Service Provision

 

 

8.5.2 Identification & Traceability

 

 

8.5.3 3rd Party Property

 

 

8.5.4 Preservation

 

 

8.5.5 Post-delivery Activities

 

 

8.5.6 Control of Changes

 

 

8.6 Release of Products & Services

 

 

8.7 Nonconforming Outputs

 

 

 

Checking

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

9.1.1 Performance Evaluation

9.1.1 Performance Evaluation

9.1.1 Performance Evaluation

9.1.2 Customer Satisfaction

9.1.2 Evaluation of Compliance

9.1.2 Evaluation of Compliance

9.1.3 Analysis & Evaluation

9.2 Internal Audit

9.2 Internal Audit

9.2 Internal Audit

9.3 Management Review

9.3 Management Review

9.3 Management Review

 

 

 

Acting

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018

10.1 Improvement - General

10.1 Improvement - General

10.1 Improvement - General

10.2 Nonconformity & Corrective Action

10.2 Nonconformity & Corrective Action

10.2 Incident, Nonconformity & Corrective Action

10.3 Continual Improvement

10.3 Continual Improvement

10.3 Continual Improvement

 

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