In most countries, Notified Bodies require the implementation of a QMS within companies operating in the medical device sector. Let’s review our fundamentals and see what to seek when implementing your Quality Management System.

The 7 principles of Quality Management

A good Quality Management System is based on the following seven major principles or key success factors:

  • 1. Customer focus: define, listen and satisfy customers’ needs and expectations.
  • 2. Leadership: establish from the very beginning the strategy to reach your defined goals and give yourself the means to achieve them.
  • 3. People’s engagement: find the appropriate way to encourage the involvement and commitment of teams, by valuing them.
  • 4. Process approach: consider each company activity as an integral part of a broader process, reinforcing the efficiency and coherence of its functioning.
  • 5. Continuous improvement: having a corporate culture focused on searching for improvement everywhere, at all levels of the organization.
  • 6. Evidence-based decision-making: consider reliable data sources and define relevant key performance indicators (KPIs) that contribute to enhance decision-making.
  • 7. Relationship management: ensuring that professional relationships are maintained with all third parties, such as suppliers, external providers and potential business partners.

The success of a quality management system implies that the policy that the company wishes to pursue – as well as the defined objectives resulting from it – are cristal clear from the outset. In fact, the QMS will depend on the managerial line of each company and, moreover, it will then rely on reference tools as to formalize and share any aspect of it within the organization.

The QMS according to the Deming wheel

The ISO 13485 standard stems from the ISO 9001 one, which is based on a “process approach”. Although there is no standardized management technique, companies often use the Deming wheel method (also known as “Plan, Do, Check, Act”). This is a recursive and rigorous quality approach based on 4 steps to be carried out sequentially (and therefore without any backtracking) in order to maximize the control and continuous improvement of both processes and developed products. Here is what the continuous improvement cycle consists of:

  • Plan: define the system’s objectives, processes and resources needed to deliver results that meet requirements and identify/address risks and opportunities;
  • Do: implement what has been planned;
  • Check: monitor and measure the processes, products and services accomplished with respect to the requirements and planned activities as to report your results;
  • Act: undertake actions to improve performance.
deming wheel - quality management and continuous improvement

The main benefits of an agile QMS to enhance your organization

Switching from theory to practice is not that easy, especially when it’s time to define and implement your Quality Management System (QMS). But relying on an agile software solution, adapted to your business functioning and needs, can actually make the difference.

Among other reasons and benefits, an Agile QMS tool effectively helps you:

  • Design the Product AND the Conformity at the same time
  • Educate people that Quality is everyone’s responsibility
  • Verify, validate continuously
  • Create Test Plans early, from the very beginning of the development
  • Promote Lean approaches such as pair-programming, refactoring, continuos integration
  • Monitor Quality (increasing customer satisfaction, decreasing the number of incidents…)

Ultimately, all this makes the enterprise embark on a continuous improvement process of its Quality Management System (QMS).

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