ISO 9001:2015 Section 6 “Planning” Understanding ISO 9001:2015 QMS

Sustainable success cannot be achieved without careful planning. Section 6 of ISO 9001 describes how organisations can minimise risks and prepare for uncertainties through structured planning.Section 6 of ISO 9001 describes how organisations can minimise risks and prepare for uncertainties through structured planning. This section explains the establishment of these planning processes, which focus on identifying risks, achieving quality objectives and planning significant changes to the quality management system to ensure its continuous improvement.

6.1 Measures to manage risks and opportunities

The aim of section 6.1 is to proactively identify and manage potential risks and opportunities that could impact the ability of the quality management system to achieve the intended results, avoid undesirable effects and drive continuous improvement.

What does that mean in concrete terms?

Clause 6.1 of ISO 9001:2015 requires organisations to consider the internal and external issues identified in clause 4.1 and the requirements of interested parties from clause 4.2 when planning the quality management system. Based on this context, organisations need to determine the risks and opportunities that need to be addressed in order to:

• Ensure that the QMS can achieve the intended results
• Reinforce desirable effects
• Prevent or reduce undesirable effects
• Achieve an improvement

The organisation must plan the following:

1. a) Measures to manage risks and opportunities
2. b) How measures are integrated into the QMS processes, implemented and their effectiveness evaluated.

The measures taken should be proportionate to the potential impact on the conformity of products and services.

How can this be implemented in practice?

Identify risks and opportunities:

• Deal with internal and external issues (clause 4.1) and the requirements of interested parties (clause 4.2) in a team meeting.
• Carry out risk assessments using a SWOT analysis, FMEA or risk assessment.
• Consider the risks to achieving quality targets, customer satisfaction and process performance, at least in your core processes.

Plan measures to manage risks and opportunities:

The following steps can be taken to ensure effective risk management:

Plan measures to manage risks and opportunities:

Define an appropriate approach for all identified risks, for example by avoiding, minimising, transferring or accepting the risks. Thoroughly justify your decision in favour of the accepted risks. In addition, define specific measures for all risks that cannot be accepted in order to reduce the probability or impact of these risks and at the same time optimise opportunities. Ensure that the planned measures are proportionate to the potential impact on the conformity of products and services to ensure effective risk management.

Integrate measures into the QMS:

• Assign responsibilities and set timetables for the implementation of risk/opportunity measures.
• Update relevant processes, procedures and controls to embed planned actions.
• Provide the necessary resources and carry out training to ensure effective implementation of the measures.

Evaluate the effectiveness of the measures taken:

• Monitor process performance and compliance of products and services to identify improvements.
• Check the status and results of the measures during internal audits and in management reviews.
• Adjust the action plans as needed based on changes in context and the results of the assessments.

Although a formal risk management process is not prescribed, a systematic methodology for identifying, prioritising, handling and monitoring risks and opportunities is nevertheless recommended. The key is to apply risk-based thinking throughout the QMS and take proportionate measures to proactively manage uncertainty.

6.2 Quality objectives and planning to achieve them

The aim is to establish measurable quality objectives in relevant functions, levels and processes within the organisation. These objectives should be consistent with the quality policy and drive continuous improvement of the quality management system (QMS).

What does that mean in concrete terms?

Quality objectives are specific, operational objectives that are derived from a company’s general quality policy. The aim of these objectives is to improve the quality of products and services and increase customer satisfaction.

Development and definition of quality targets

Quality objectives are developed on the basis of a company’s strategic quality policy. These objectives should not only be relevant for the management, but for all areas of the company and hierarchical levels that have an influence on quality. Ideally, it should be possible to track quality targets with quality indicators. Regular monitoring, communication and updating of these targets is crucial to their effectiveness.

Planning to achieve the quality targets

The realisation of quality objectives requires clear planning and the definition of measures. Questions such as “What should be done?” and “Who is responsible?” need to be clarified. It is also important to define the necessary resources and a time frame for implementation. The results should be regularly monitored and evaluated to ensure that the objectives are being met.

How can this be implemented in practice?

In larger companies, existing key performance indicator and evaluation systems can be expanded to include quality aspects in order to support the achievement of objectives. In smaller companies, company-wide targets can be defined and publicised to all relevant employees. The measurability of the targets is achieved through specific key figures or the completion of defined projects.

Control of implementation tracking

The implementation of quality objectives must be clearly regulated in order to ensure that objectives are effectively achieved. It is necessary to define concrete measures, responsibilities and time frames. Success is monitored by regularly reviewing the achievement of objectives and adjusting the measures if necessary.

6.3 – Planning changes

ISO 9001:2015 section 6.3 emphasises how important it is to plan changes to the quality management system (QMS) in a structured and controlled manner. The clause requires organisations to consider the purpose, potential consequences, integrity of the QMS, availability of resources and allocation of responsibilities when planning changes.

What does that mean in concrete terms?

In practice, clause 6.3 means that organisations:

Following the definition of quality objectives, section 6.3 of ISO 9001:2015 extends this structured approach to the planning of changes within the quality management system (QMS). This integration ensures that changes complement and improve existing quality frameworks.

Organisations start by identifying the need for change that may arise from changes in customer feedback, performance trends or evolving external contexts. This identification aligns change initiatives with the company’s strategic goals.

Assessing the purpose and potential impact of these changes ensures that changes strengthen the QMS rather than jeopardise it. This assessment helps to maintain system integrity and continuity.

Last but not least, resource planning must be carried out for the implementation of these changes. Adequate staff, infrastructure and budget must be ensured, along with robust mechanisms to monitor the progress and effectiveness of the changes.

Assigning clear responsibilities ensures effective management of the change process. This includes monitoring communication, training and continuous reviews, which help to adapt the QMS to new challenges and thus promote a culture of continuous improvement.

How can this be implemented in practice?

Establish a change management process:

Firstly, set up a structured change management process. This also includes the development of a documented procedure that guides the planning and implementation of changes to the QMS. It is necessary to define clear roles and responsibilities for initiating, evaluating, approving and implementing these changes. In addition, the creation of standardised forms and templates for change requests, impact assessments and communication plans facilitates a consistent approach throughout the company.

Identify and evaluate potential changes:

Continuously review both internal and external factors that could trigger the need for changes to the QMS. Foster a culture where employees are encouraged to suggest improvements and identify potential areas for change. Any proposed change should be subject to a thorough impact assessment to consider its risks, opportunities and the resources required.

Plan and implement approved changes:

For each approved change, develop a detailed implementation plan that defines objectives, timelines and assigned responsibilities. Allocate the necessary resources and provide training to support these changes. It is also important to communicate planned changes to all relevant stakeholders inside and outside the organisation to ensure transparency and prepare all those affected.

Monitor and evaluate the effectiveness of changes:

Define key performance indicators (KPIs) to measure the success of the implemented changes. Regularly review progress and results through audits, management reviews and stakeholder feedback. Based on this monitoring and evaluation, adjust the change plan as necessary to continuously refine and improve processes.