ISO 13485 – Quality Managment Standard for Medical Devices


What is ISO 13485?

ISO 13485 is the international standard relating to Quality Management Systems for organizations involved in the manufacture of Medical Devices.It embraces the FDA's good manufacturing practises and defines such phrases as medical device, active medical device, active implanted medical device, sterile medical device and others.Based on ISO 9001:2008 ISO 13485 is taken from ISO 9001 with two sections excluded – continual improvement and customer satisfaction.

Continual improvement is excluded because most medical device regulations require organizations to maintain their quality management system, not to improve them and customer satisfaction is excluded because committee members considered it too subjective.

Any organization upgrading from ISO 9001 to ISO 13485 and addressing these clauses can also be issued an ISO 9001 certificate.

In addition to documenting, implementing and maintaining a procedure as required by ISO 9001, ISO 13485 also includes requirements, activities and special arrangements and so placing more emphasis on the use of procedures to regulate and control how activities and processes should be performed.

The Benefits of implementing ISO 13485

Implementing ISO 13485 will motivate staff by defining their key roles and responsibilities. Cost savings can be made through improved efficiency and productivity as product or service deficiencies will be highlighted. From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.


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