About us
ISO13485 - What does this mean for our clients?
ISO (International Organization for Standardization) is an independent, non-governmental worldwide federation of national standards bodies that develops international standards. ISO 13485:2016 is a worldwide quality standard that helps organizations demonstrate that they offer products and services of consistently good quality.
The certification demonstrates that NanoHelix provides consistently good quality of services to the customers. A well-structured quality system is very important to the success of customers' work.
- NanoHelix’s documented QM procedures include:
- Control of documents
- Control of records
- Internal audit
- Control of non-conforming products
- Corrective and preventive actions
- Validation of computer software
- Customer specifications (for manufacturing, inspection, packaging, and delivery)
- Monitoring and measurement
- Management review
- Work environment and contamination control
- Identification and traceability
- Preservation of product
- Calibration or verification for measuring equipment
- Feedback and complaint handling
- Reporting to regulatory authorities
- Advisory notices, reworks, data analysis
NanoHelix’s Quality Management System;
Certified by ISO 13485:2016