ISO — Medical Devices QMS
ISO 13485 certification in Uganda.
ISO 13485:2016 is the international standard for quality management of medical devices, covering design, production, storage, distribution and servicing.
Who needs it
Manufacturers, importers, distributors and service providers for medical devices and equipment.
Why get certified
- Meets regulator and buyer expectations
- Traceability from supplier to patient
- Controlled design and production
How we get you there
Five steps to ISO 13485.
- 01
Gap analysis
We assess current practice against the standard's requirements.
- 02
Implementation
We design and roll out the processes the standard needs.
- 03
Documentation
Policies, procedures and records — written and organized.
- 04
Internal audit
We verify compliance before the auditors arrive.
- 05
Certification
We guide you through the external certification audit.
Led by Mohammed Rizwan, our Head of Certifications. The certificate itself is issued by an accredited certification body after its external audit; we prepare you for it and support you on audit day.
FAQ
ISO 13485 questions.
Is ISO 13485 the same as ISO 9001?
It is based on ISO 9001, with extra requirements for risk management, traceability and regulatory compliance specific to medical devices.
Do distributors need ISO 13485?
Many do, because it covers storage, distribution and servicing as well as manufacturing.