Blog / Quality management (QHSE)

ISO 9001:2015 – Top management’s view

Søren Pommer
Last updated on 23/03/2024

The final version of ISO 9001:2015 is soon to be a reality. However, it can be difficult to find the most suitable way to handle the new version. Here at Gluu, we have done more than 119 qualitative interviews with Danish Quality Managers in 2014. In this article, you can read some of the conclusions from our field studies.

Some organisations are already well covered to meet the new requirements that follow ISO 9001:2015. Other organisations need to change the way they work with Quality Management. In this article, we will sum up the main findings we found among Quality Managers in Denmark from different industries. We interpret ISO 9001:2015 as an attempt to get the top management more involved – and as you will see in this article, it does bring some big challenges.

The field study in short:

  • Duration from June to December 2014.
  • Contact with more than 344 Danish Quality Managers and Operation Managers.
  • 1-hour semi-structured interview with 119 of them, where we talked about how they work with Quality Management Systems today and which challenges they forecast for 2015.
  • 7 interviews with professionals who are mainly responsible for auditors and certification agencies.

We will in this article only present general conclusions and observations for the sake of the participant’s anonymity. The article is in two parts: Perspectives from the top management and Perspectives from the employees. This article is about the first mentioned. Next week we summarise the employee’s perspectives, primarily how we have heard it be presented from quality managers and operation managers.

“Quality systems are necessary, but do not create value.” – Top Management 

Quality Management is perceived as documentation

Competent organisations have managed to move from Quality Assurance to actually practising real Quality Management – but at many organisations, we found that the function of quality is primarily in relation to external requirements and to meet the new ISO 9001:2015 requirements.

With this underlying basis, it can be hard to practice leadership by strengthening communication, follow-ups and continuous improvements. However, on the other hand, leadership is not something you have – it is something you take.

The management system and improvements are seen as two different things

The most competent organisations have integrated their processes and work instructions into one system alone. Here are the requirements from external standards as ISO 9001, ISO 27001, ISO 14001 and ISO 13485, an implicit part of the organisations’ formal work descriptions. Furthermore, they have integrated Quality Management, cross-functional improvements and sometimes also HR and CSR under the same executive.

In most of the cases has the organisations separated quality from the daily improvement work. Here the quality function works hard to catch frequent changes, which, for example, occurs in board meetings for production. The result is that work descriptions are mainly general and mostly used during audits. In this way the quality work is retrospective.

However, we also found many organisations where cross-functional teams meet frequently to analyse complaints and errors and define corrective actions.

A “formally owned system” apart from the organisation

Most organisations have (more or less) formally defined process owners. In practice, the process owner shall be equal to the function responsible. In this way, the manager of logistics is the process owner for supply chain processes and the sales executive is the process owner of the sales process. Hereby process orientation is more in name than in fact. We heard everywhere that process owners rarely take responsibility for the processes the system describes they should – with exception of the annual management review.

Quality Managers often handle the cross-functional perspective. Even though it is a good position, is it hard to utilise if you are seen as the “documentation boss”.

Our perspective

If Danish Top Management’s view on Quality Management is representative for Top Managers in other countries then the new ISO 9001:2015 is a welcome opportunity to revitalise the management system and how to work with it on a daily basis.

ISO 9001:2015 brings a new focus – the top management needs to be actively involved by taking an active responsibility, rather than delegating the whole task. The revision also brings a focus on increased process orientation and the need to make Risk Management a public property within the organisation. Perhaps the latter is the best starting point of all? In the last year in Denmark, several about Food and Risk Management in listed companies have occurred (OW Bunker). Maybe the time has come where we are mature enough to let quality become a part of leadership rather than control (management).

Frequently Asked Questions

How can a company practically implement the concept of “risk-based thinking” as part of their Quality Management System under ISO 9001:2015?

Implementing risk-based thinking under ISO 9001:2015 involves identifying potential risks, assessing these risks, developing mitigation plans, and incorporating them into strategic planning and operations. Regular reviews and adjustments to risk management elements of the QMS are also necessary.

What specific roles or responsibilities do top management have in contributing towards the Quality Management System, aside from setting an example of leadership?

The top management’s role in the QMS goes beyond just being leaders. They establish and ensure alignment of the quality policy with the organization’s strategy, set achievable and measurable quality objectives, promote a process approach, and risk-based thinking, and secure resources for QMS maintenance and improvement.

Could they elaborate more on the differences between ISO 9001:2015 and its predecessor, ISO 9001:2008, in terms of perspectives from top management?

ISO 9001:2015 emphasizes leadership engagement more than its 2008 version. Top management needs to be actively involved in developing and maintaining the QMS. Additionally, they need to identify and plan actions for risks and opportunities. It also focuses more on aligning the QMS with the company’s strategic direction and the High-Level Structure supporting holistic risk management.

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