ISO 9001 Requirements - Leadership

The ISO 9001 requirements now expect top management to understand and engage with your organisation’s quality management system, providing you with the opportunity to drive business performance.

Demonstration of leadership and commitment

The involvement of top management in your organisation’s quality management system should be explicit and hands-on. 

Top management are required to demonstrate commitment and take responsibility for the effective running of your organisation’s quality management system. To do this they need to become accountable for its effectiveness by ensuring the quality policy and objectives are compatible with the context and strategic direction of your organisation. 

Top management should have a clear line of sight from your organisation’s business plans and strategy, to the objectives and business measures. These should provide the basis for developing the quality policy. 

Leadership from your top management needs to ensure the integration of the quality management system requirements into your organisation’s business processes. The quality management system can no longer be a ‘stand-alone’ function of the business, but an integral aspect of business-as-usual activities, from highest level business planning to process outputs. 

To ensure demonstration of leadership, top management need to be seen to be promoting the use of a process and risk- based thinking approach. The risk based approach should work at all levels within your organisation, from identification and mitigation of risk at strategic planning level, to process risk management and control. 

To demonstrate commitment, top management are required to make sure the quality management system achieves its intended outcome(s) and has adequate resources assigned. 

Additionally, they are required to engage, direct and support all individuals where the quality management system applies. They need to communicate its importance and ensure it continues to succeed by encouraging all individuals to contribute to the overall effectiveness of the management system. 

To encourage engagement, top management should support relevant roles within the quality management system and always promote improvement. 

Leading by example, top management are required to demonstrate customer commitment by ensuring there is a focus on products and services meeting customer requirements, applicable statutory and regulatory requirements are being determined and met, and risk and opportunities are being addressed.

Establishing a quality policy

The quality policy should be developed in line with the purpose and context of the organisation. Top management have an explicit requirement to apply the policy and ensure it provides a framework for the organisation’s quality objectives. These should include the commitment to satisfying interested party requirements and promote the continual improvement of the quality management system.

Top management are now responsible for making sure the policy is available as documented information and communicated and understood by all relevant parties.

Roles and responsibilities

Top management need to ensure that individuals are given the responsibility and authority to enable them to carry out their roles in relation to the quality management system.

All individuals should be assigned and communicated their relevant roles within the quality management system by top management. Top management should then make sure these roles are understood and the quality management processes are delivering their intended outputs.

The ISO 9001:2015 requirements do not require a specific management representative, as the responsibility now resides with top management to assign and manage all the quality management roles and responsibilities.

Read Next: ISO 9001 Requirements - Planning

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