ISO 9001: 2015 – Leadership and Business Context

This new requirements is going to cause a few headaches!

Firstly, the organisation will need to determine external and internal issues that are relevant to its purpose, i.e. what are the relevant issues, both inside and out, that have an impact on what the company does, or that would affect its ability to achieve the intended outcome(s) of its management system.

I should point out that that the term ‘issue’ covers not only problems (which would have been the subject of preventive action in previous standards), but also important topics for the management system to address, such as any market assurance and governance goals that the organisation might set for its management system. This means that senior managers need to be able to demonstrate an understanding of the wider business environment, social, cultural and regulatory and how that impacts or could impact on the organisation’s ability to meet customer requirements.

In the same context they need to have a grasp of the organisation’s internal strengths and weaknesses and how these could impact on the ability to deliver their products or services. This will strengthen the concept of business process management including the need now to allocate specific responsibilities for processes, and demonstrate an understanding of the key risks associated with each process and the approach taken to manage, reduce or transfer the risk. I personally think this is positive and powerful addition to the new version of the standard.

Top management now have a greater involvement in the management system. They (not one person) have to ensure that the requirements of the management system are integrated into the organisation’s processes and that the policy and objectives are compatible with the strategic direction of the organisation.

Although this might sound a little complicated, the end result will be a business management system that drives the business forward and ultimately meets the goals and objectives it has set.

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