ISO 13485 Section 1: Scope
ISO 13485:2016 is the latest revision of the ISO 13485 International standard, specifying requirements for a quality management system (QMS) that is designed specifically for businesses involved in medical devices such as: design, development, production, storage, distribution, installation, servicing and final decommissioning and disposal.
ISO 13485:2016 is an independent standard based off of ISO 9001:2008. ISO 13485:2016 did not adapt the new structure of ISO 9001:2015, and instead of being based off of 10 clauses, is based off of the old 8 clause structure.
The requirements for ISO 13485:2008 are:
- Normative References
- Terms and Definitions
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
Organizations seek certification in order to show their ability and commitment to provide products and services that meet customer, statutory and regulatory requirements consistently. Certification is granted by accredited bodies, called registrars. Registrars will audit an organization at planned intervals to determine compliance with ISO 13845.