ISO 13485

The international standard, ISO 13485:2016
Medical Devices – Quality Management Systems.


What is ISO 13485?

The international standard, ISO 13485:2016 Medical Devices – Quality Management Systems Requirements for regulatory purposes identifies the requirements for a quality management system that is used by an organization involved in one or more stages of the life-cycle of a medical device, including the design and development,
production, storage and distribution, installation, servicing, final decommissioning and disposal of a medical device, design and development, or provision of associated activities.

While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented Quality Management System.


ISO 13485 provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer’s reputation & marketability.
When it comes to medical device manufacturing, patient safety greatly
depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.


Rather than focusing on each individual clause of the standard, read the requirements in terms of inputs and outputs. ISO 13485 uses the Plan, Do, Check, Act methodology; each
key area of the standard, such as quality system, management responsibility, resource management, product realization, and measurement, must be read in terms of inputs to the requirement (i.e. resource requirements) and outputs to the requirement (i.e. measurements). Only through careful study and understanding of
the process model can you achieve this effective thinking approach.

Medical ISO
Welding 3834

Benefits of ISO 13485?

Improve your company’s credibility & identity locally & globally.

Evidence-based decision making. Increased quality and consistency of
medical products.

Continual improvement.Enhanced customer satisfaction

Increased employee involvement.

Increases your company’s marketability.

Minimizes surprises & failure of devices.