QMS: A business tool
In medical devices, quality refers to the degree to which a device meets specifications, requirements and standards. Quality is achieved through quality management, quality assurance and quality control.
Quality management refers to an organisation’s overall system and framework to ensure its products meet the necessary quality standards. It encompasses all quality aspects, including planning, control, assurance, and improvement.
A Quality Management System (QMS) is a structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It is the internal rulebook for a medical device organisation.
Standards such as ISO 13485:2016 outline the requirements for a QMS tailored explicitly for medical devices. However, creating a QMS is not merely a compliance checkbox exercise. As an organisation’s primary internal rulebook, a well-structured QMS should also strive to achieve high product quality and safety standards suited to the individual business. This promotes a quality-focused culture with reputational and financial benefits.
Agenda: Risk-based QMS design and implementation
This masterclass outlines a risk-based approach to QMS design and implementation with the following aims in mind:
- Tailored: The QMS should be specific to the organisation’s needs and cover all relevant business activities and processes. It should also be compliant with applicable regulations and standards. The quality policy and objectives should be aligned with the organisation’s strategic goals and reflect the organisation’s commitment to quality and compliance.
- Balanced: The size and structure of the QMS should be appropriate to the organisation’s size and complexity. This approach ensures that the QMS is not overly complex or simplistic but just right for the organisation. Consideration should be given to how a QMS can be implemented and updated. The aim should be to design a QMS that is compact, structured, proportional, risk-based and understandable by employees and regulatory authorities.
- Living: A QMS is not a static set of documents but a collection of living documents that need regular updating and maintenance. This is essential to ensure that the QMS remains relevant and effective, reflecting the changing company processes and regulatory changes.
Register for our free masterclass
What: QMS Unleashed: Maximising value beyond compliance
When: Tuesday, 25 March · 16:00 – 17:30
Time zone: Europe/Zurich (CET)