Developing a Comprehensive ISO 13485 Quality Management System

Successful medical companies distinguish themselves from competitors through new and innovative solutions. The result is effective and efficient products.

When companies bundle such efficiencies with improved equipment through intelligent quality assurance, outcomes are then obvious. These include the elimination of flawed products from production lines and decreased production costs. The ultimate gain will be for the patient, receiving a product at a competitive price and at the highest possible quality.

ISO13485 is a key milestone achievement for the industry. This standard has evolved over time since its introduction in 2003, to what has become one of the most referenced documents in the process of establishing a continuous and improving Quality Management System.

The phrase Quality Management System really means that a company that has embraced the elements of ISO13485 has an established system that is continuously managing and improving its product’s quality.

The elements forming the backbone to ISO 13485 are simple.

They are a culmination of a number of documents capturing the validated status quo of multiple processes used to build a product. In other words, a baseline of information, or that starting point to that objective of continuously improving what you already have.

If my accountability is just to produce and sell a product then I fall short of my assessment of the competitive landscape that will improve on what I have. However if my feedback system from internal and external sources leads me to reviewing my day to day tasks, then the outcome will be the integration of improvements to the lifecycle of my product on a continuous basis.

ISO 13485 is not used only for compliance to regulatory requirements and it is not inclusive and stand alone document. In combination with other standards such as ISO 14971, ISO 11135, ISO 10993, EN 1041, to name a few forms, that community of guidance documents required to create that system baseline.

This system that manages your quality is made of the following simple building blocks:

The Quality manual that commits to a system

Procedures and Instructions, that drives your system

Records that substantiate the validity of your system

Its management will ensure:

Compliance to regulatory requirements

Commitment to continually meeting the needs of the end user

Total accountability to all involved in the process