An up-to-date quality management system improves risk management

NewIcon upgraded its quality management system from ISO 9001:2008 to ISO 9001:2015 in June. Customers experience the company’s commitment to quality as excellent products and services. The company’s goal is to improve the efficiency of its customers’ operations through pharmacy automation without compromising on patient safety.

For NewIcon, the most significant practical changes relate to the requirements for the management of risks and opportunities. This translates to developing even smoother and more efficient processes.

“There will always be risks – the important thing is how the company takes them into account in its operations. The aim is to identify risks at a sufficiently early stage that we can take appropriate measures to prepare for them”, says NewIcon’s Quality Manager Joona Turunen, who oversaw the update.

Risks can be related to, for example, the supply chain, competencies or stakeholders. Individual risks can be very low at first, but materialise into something more formidable due to changes in the environment.

“Economic growth can create shortages of certain components on the market, which requires us to safeguard the operation of our supply chain with backup suppliers and buffer stocks. As another example, when developing a product, we could suddenly realise that our organisation lacks the required competencies. The control measures for this risk include recruitment, in-house training and utilising the expertise of our partners”, Turunen says.

A quality management system is a tool for continuous improvement

Before, NewIcon used to address the company’s risks and opportunities by simply discussing them. According to the new procedure, risks are recorded and rated by their impact on the company.

Based on the rating, we then decide whether the situation should be monitored, addressed immediately at the process management level or taken straight to senior management. Opportunities and development ideas are also recorded and processed.

The new quality management system imposes fewer documentation requirements and emphasises results. Annual audits are used to follow the realisation of the company’s quality targets in its products and services.

“The quality management system is a visible part of our everyday work. It is a great tool for continuous learning and improvement.”

“In addition to audits, the system is used in management reviews to determine whether sufficient measures have been taken and to identify potential for improvement”, Turunen says.

Companies can do business without quality certificates, but NewIcon has wanted to make a commitment to improving quality. The quality management system sets certain guidelines that companies can adapt to their own purposes.

“We want to operate according to best practices, because the quality management system helps us to take better heed of the needs and expectations of our customers and stakeholders. For us, the quality of products and services means that the customer gets precisely what they ordered. If a device supplied by us would break or not live up to the customer’s expectations, that would mean that our quality management process was not doing its job”, Turunen concludes.