Published: 9 Feb 2018

Meeting the requirements of the latest quality management standard, ISO 9001: 2015, means major changes in adapting to its risk- and opportunity-based approach. Gordon Dunbar, Quality Manager at ETAL Group, explores how this approach requires involvement not just from board room to factory floor, but throughout the organisation’s ecosystem.

ISO9001:2015 is the first major upgrade to the standard since 2000, and increases the emphasis on tailoring quality management systems (QMS) to the organisation’s specific needs. Innovations include measures to ensure that the leaders of an organisation are fully involved with quality management and held accountable. The new standard brings in risk-based thinking to make the systems a preventive tool, as well as a platform for continuous improvement.

To be successful, this thinking needs to extend the approach that is built into the organisation’s environmental management systems. This should be driven from the top, but involve employees at every level. Strategy needs to be shaped by the top (for instance the group’s owners). Supervision of the business units should take place mainly through the setting of explicit goals for their operations and through active and constructive monitoring of outcomes, in relation to the established targets.

QMS objectives need to be derived from the company’s strategy, and a continuous review process that then feeds back into the adjustments to the strategic direction. 

Risk and opportunity register

In accordance with risk-based approaches, a key element in this process is a company-wide register of risks and opportunities, to which every level of staff is encouraged to contribute and review. Weekly management get-togethers and six-monthly reviews drive the improvements forward. Internally, involvement at all levels should be ensured by continuous reviews of staff competencies and training requirements. When an organisation has international operations, this is a challenge, but necessary. Every manager within such an organisation should be responsible for directing the course, actively motivating and involving all employees in assessing and refining the internal quality systems, and taking prompt action when problems or opportunities for improvement arise.

For example, the ETAL Group’s manufacturing facility in Estonia makes a wide range of standard and custom-designed inductive components and assemblies. Thanks to low staff turnover, it has been possible to train people across different disciplines, leading to a more efficient multiskilled workforce.  In Asia, there is a culture of higher staff turnover so, at the ETAL Sri Lanka sites, there are higher training requirements for new recruits. 

Broad scope of stakeholders

Internal management and workforce are just two of the stakeholders within the organisation’s integrated management system (IMS). The extended list of ‘interested parties’ ranges from suppliers, customers and end-users, through to the local communities, and of course certification bodies.

Customers are a primary concern. Therefore, the company has to evolve processes for understanding the customer’s needs and expectations. It needs to measure its perceptions of the services provided through regular customer contact and feedback.

Within the organisation’s integrated management systems, customer orders should be assessed at the production stage. This enables the manufacturer to reduce or eliminate causes of failure in production. Suggestions added to the risk/opportunity register help to identify opportunities for reducing wastage, not just through substandard products (rejects are analysed for process improvement), but also by management looking for any opportunities to reduce the materials used or wasted.  A further category of items listed on the risk register helps the company to identify ways of streamlining the supply chain, thereby offering customers shorter lead times.

The local community should become involved where risks are identified that have an impact outside the company’s operations. For example, machinery operating in unsocial hours risks creating noise annoyance in the neighbourhood.

Involvement of the broad spread of interested parties further streamlines the organisation’s ISO certification cycle. At ETAL Group independent audits are carried out every three years, and this process benefits from the reassurance of regular internal and customer audits.

This involvement  is one of the factors contributing to the successful certification of ETAL Group sites, well-ahead of the September 2018 deadline for ISO 9001: 2015. Throughout the business, the latest IMS standards demonstrate the success of risk- and opportunity-based thinking as a platform for continuous improvement.

Gordon Dunbar is Quality Manager at ETAL Group, experts in magnetic components for electronic and electrical power and signal applications.