Learn about quality management systems

A Quality Management System is a formal and structured business system used for managing the quality of products and services.  Quality management systems are used by organisations of all sizes, from small (one to two people) to large (multi-nationals). 

Medical device manufacturers use quality management systems for:

• the ongoing management of safety, performance, and quality of their devices
• keeping all documents as controlled and traceable documents
• meeting other regulatory requirements such as ongoing post-market requirements
• meeting customer requirements and expectations.

It is important that manufacturer’s quality management systems work for the manufacturer and the manufacturer’s specific business.

A quality management system includes:

• a quality manual
• policies, objectives, and plans
• processes, procedures, and standard practices
• controlled work environment and facilities
• training and competence requirements
• tools (including IT systems) and equipment
• validation and verification protocols
• internal audits and management review
• measurement and monitoring of product and processes.

A total lifecycle approach

Quality management typically involves putting in a system of controls or checks across the total lifecycle of their products and services, covering all stages, from concept through to obsolescence.

The total lifecycle approach involves:

• the ongoing management of changes
• maintaining state-of-the-art and best practice
• monitoring of products or services supplied
• continual improvement.

Figure 1 shows the operational part of the total lifecycle approach.

Figure 1 - Total lifecycle approach to quality management

Monitoring safety and performance

Manufacturers monitor the performance and safety of their devices through a surveillance program. The program must be appropriate to the use and risks of the device.

Manufacturers collect and assess data from:

• safety and adverse event reports
• customer complaints
• newly identified risks
• regulatory actions
• formal surveillance activities
• literature
• any updated or new investigations.

Standards and certification

Organisations implement their quality management system by complying with, and being certified against, a technical standard and any applicable regulatory requirements. Most quality management system standards have been developed with certification in mind.

In most cases, organisations will obtain certification from an independent body. This is called third-party certification.

As part of the certification process, the independent body will audit the manufacturer’s facilities, IT systems, technical files, and management systems.

Audits are usually every year, but some certifying bodies apply different scheduling patterns.

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