ISO 13485 Clause1: Scope
ISO 13485:2016 Clause 1 is the first clause of the standard. This clause is only informational and does not have any requirement that needs to be met. The first clause covers the QMS requirements. In all the standard has 8 clauses, clauses 4-8 need to be met to achieve certification.
The requirements for ISO 13485:2016 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 13485.