ISO 13485 requirements are based on ISO 9001:2015 standards.
- Systematic requirements
- Management requirements
- Resource requirements
- Realization Requirements
- Remedial Requirements
We Provide the Following Services Corresponding to the ISO 13485 Certification:
- Increased productivity
- Customer satisfaction improved
- Well defined and documented procedures improve the consistency of output
- Quality is constantly measured
- Procedures ensure corrective action is taken whenever defects occur
- Non conformity rates decrease
- Non conformity are caught earlier and are corrected at a lower cost
- Defining procedures identifies current practices that are obsolete or inefficient
- Documented procedures are easier for new employees to follow
- Organizations retain or increase market share.
- Increasing sales or revenues.
Options of Accreditation Available:
- JAZ ANZ