ISO 9001 and its related quality standards are all based on the ‘Seven Quality Management Principles’ defined by the organisation in their guidelines and publications. But what’s the best way to embed those standards into the everyday thinking of your company?How can these principles become second nature to your employees and part of your organisational DNA?
What are ISO’s Seven Quality Management Principles?
- A true customer focus in your approach to product development and delivery
- A commitment to quality from the top of your organisation
- The engagement of all employees in the pursuit of quality,
- A process driven approach to realising quality standards,
- A commitment to evidence based decision making
- A commitment to continual quality improvement
- Strong relationship management of customers, suppliers and regulators
Digital Solutions to Quality Compliance
Companies around the world spend vast amounts of money every year on EQMS solutions to ensure they can prove their adherence to the standards set out in ISO and by industry regulators. These heavyweight and expensive EQMS solutions are purchased as tools to control and manage the implementation of regulatory requirements such as training, storage of procedural documentation and product change approval processes.
In practice, these QMS solutions are often imposed by a Quality Management function removed from the teams who are actually charged with complying with their strictures. This approach to quality tends to lead to siloed thinking with systems that are proscriptive, overly bureaucratic in their operation and often unpopular with the teams who must use them.
But there is a new breed of Business Management System (BMS) which can place the pursuit of quality at the heart of your approach to product delivery and customer service.
How a Graphical Business Management System can help
A gBMS (Graphical Business Management System) - powered by a ‘process driven intranet’ - is a series of interactive and dynamic web pages that can detail your entire operational structure, act as a secure digital repository for your quality and product management documentation, as well as operate as a project management tool in its own right.
As an accessible web based QMS, PM and training resource, to which an entire company can contribute, it can be an efficient and scalable way of achieving the overarching aims of the quality approach outlined by the seven principles:
How can a Business Management system help you embed the 7 Quality Management Principles into your organisational thinking?
1 Customer Focus - A business management system necessarily focuses on the relationship between every part of an organisation and the end products you are delivering. The project and product management tools a gBMS offers can help you structure development processes in a more collaborative way. They can help you integrate the customer focused insight of a whole organisation into more iterative designs and agile refinements for new and existing products. You can read more about the quality impact of user-centric design in a medical device context here.
2. Leadership - A graphical Business Management System is intended to sit at the centre of an organisation’s approach, a constantly updated source of best practice for your company. The leadership team who install and champion a BMS, are providing a mechanism for the replication of quality processes across teams, good governance of documentation and a shared understanding of policy, goals and strategy.
3. Engaging your people - A good business management system is a resource for all your teams to pool and refine their knowledge about the tasks they perform every day. These tasks are the lifeblood of your business and ‘ownership of them’ is key to future optimisation. The recent McKinsey study of evolving quality systems points to the centrality of an engaged workforce in delivering innovation and material improvements in quality outcomes.
4. A process driven approach - Achieving consistency in the quality of your end products, demands consistency in the processes you follow to deliver them. A gBMS allows your business to build out interactive flow diagrams that are always available to your team, with deep links to more detailed instructions and specs to help with questions and clarification. They can ensure the proper replication of critical processes even in the face of organisational growth and change.
5 Continual Improvement - When a gBMS becomes the authoritative, collective resource for training and optimisation purposes it can also become the driver for product innovation and change within an organisation. The McKinsey study shows how creating a culture where ‘quality thinking’ is owned and curated by the people who deliver your products, leads to a self-sustaining cycle of continuous improvement in efficiency and standards.
6. Evidence-based decision making - A Business Management System can become a shared resource for everyone in an organisation to make decisions and suggest changes based on the most up-to-date data and an understanding of the wider business context. BMSs are intended to give everyone a holistic view of their role within a business, empowering them to make the best decisions when it comes to maintaining and improving quality.
7 Relationship management - A business management system can give visibility to every person in a workforce of the range of relationships and dependencies that impact upon their work. This, in turn, can lead to better and more informed decision making when it comes to managing third party supplier, client and regulatory relationships.
Understanding the seven principles of Quality Management is key to designing systems and ways of working that reflect ISO’s overall requirements and objectives. Installing a Graphical Business Management System as a central quality resource for your entire organisation is one way of embracing the proactive approach to quality improvement that is replacing an outmoded ‘inspect and correct’ paradigm for regulators around the world.