7 Steps to leverage ISO 9001

1 | Establish a foundation

A culture of quality starts with core values, guiding philosophies, behaviors, and attitudes that inform day-to-day operations. It matures throughout the decades as norms pass from one generation of employees to the next. Transitioning an organization’s culture requires commitment and deliberate management.

Quality leaders drive differentiation for companies. Quality process engagement across functions must be a high priority with top management. Strategy, data, and analysis can help communicate the importance of quality management to top leaders to drive this culture for the aerospace or defense organization.

2 | Adopt a QMS

An effective quality management strategy (QMS) is a multi-year plan that aligns quality with strategic objectives through people, process, and technology. It considers the information technology (IT) infrastructure, product lifecycle management (PLM), and enterprise resource planning (ERP) in manufacturing and equipment in service. Strategic objective are operational excellence and operational architectures that deliver value to the business.

A transformation framework helps define process, culture, and technology initiatives at different levels of maturity occurring simultaneously.

3 | Build a strategy framework

Strategic objectives set at the C-level re-imagine business process and service delivery. By upholding operational excellence, business leaders can realign people, process, and technology.

Managers must develop a business case to define immediate and long-term return on investment (ROI). Once this is achieved, information technology/operational technology (IT/OT) practitioners can select a solution based on the criteria developed.

4 | Evaluate and change

A positive or negative event can force action. For instance, a manufacturer of signal processing systems for satellite, spacecraft, missile, and airborne platform communications sought to create a safe, quality signal processing system for national security, which required meeting all industry standards. This caused the company to evaluate and change its existing processes for efficiency, traceability, and security. PLM software helped securely manage and track all information to meet regulations throughout the product life cycle. The system managed and reported product information such as configurations, suppliers, bills of materials (BOMs), and documentation.

PLM supported ISO 9001 requirements and streamlined auditing. The event required someone in top management to own the follow-through that directly influenced the business, averting a potential crisis by achieving compliance.

Quality often gets executive priority only in a crisis. It is better to make changes to combat challenges by implementing a quality initiative when everything is going well.

5 | Get consensus

Getting executive sponsorship and management buy-in is important. Find out what key performance indicators (KPIs) management measures and how effectively they are achieving objectives. Align quality initiatives to address management objectives to increase their willingness to follow through.

Companies can have quality cultural issues. In some companies, persons in charge of quality are seen as the police, preventers of defects, and may not be viewed favorably. ISO 9001:2015 can help address such issues.

6 | Climb the maturity model

LNS Research uncovered five levels of quality management maturity (see above). At the top are innovation leaders that drive standards and expectations. Next, agile companies evolve processes and technology. The harmonized level embraces flexibility in the organization. Below that, the controlled level shows repeatability within organizational, process, and/or technology boundaries. Ad hoc, displays significant variation.

How an organization invests in quality makes a difference. If quality is a cost center, the company will invest the minimum possible to achieve compliance. If quality is a value center, companies will try to adopt it into all areas. 

7 | Avoid nonconformities

Core ISO 9001: 2015 management principles can avoid nonconformities during certification audits and help with issues the LNS benchmark study uncovered. The study revealed that 37% of respondents had problems dealing with disparate quality systems and data sources, as well as having quality metrics not effectively measured. More than 35% of respondents felt that quality was a department, not a responsibility. Almost 25% reported that they had no formal process for managing risk. More than 20% of participants admitted that there was a lack of visibility into supplier quality and no defined process for continual improvement, and 16% answered they had no formal process for capturing non-conformance. Overall, there was a lack of executive support, and audit/compliance management was ad hoc.

The statistics show gaps where the industry stands in adopting the core principles of ISO 9001: 2015 – customer focus, leadership, staff engagement, process approach, improvement, evidence-based decision-making, and relationship management.

In summary

Successful organizations are using ISO 9001: 2015 to help drive top management’s priority to quality. Doing so will truly help achieve operational excellence. Companies that can shift from conformance to performance will gain a critical competitive advantage.

Omnify Software
www.omnifysoft.com

About the author: Chuck Cimalore is chief technology officer for Omnify Software. He can be reached at info@omnifysoft.com.