ISO 13485 Certification Services

Service Details:

ISO 13485

ISO 13485:2016 is a quality management system requirements for medical devices and related services.

The organization should meet with customer and legal requirements the related to manufacturing medical devices and related services.

Requirements for ISO 13485

ISO 13485 requirements are based on ISO 9001:2015 standards.

1. Systematic requirements
2. Management requirements
3. Resource requirements
4. Realization Requirements
5. Remedial Requirements

Benefits:

1. Increased productivity
2. Customer satisfaction improved
3. Well defined and documented procedures improve the consistency of output
4. Quality is constantly measured
5. Procedures ensure corrective action is taken whenever defects occur
6. Non conformity rates decrease
7. Non conformity are caught earlier and are corrected at a lower cost
8. Defining procedures identifies current practices that are obsolete or inefficient
9. Documented procedures are easier for new employees to follow
10. Organizations retain or increase market share.
11. Increasing sales or revenues.

We Provide the Following Services Corresponding to the ISO 13485 Certification:

1. Consulting
2. Training
3. Implementation
4. Certification

Options of Accreditation Available:

1. NABCB
2. UKAS
3. DAKKS
4. DAC
5. JAZ ANZ
6. IAS
7. EGAC