ISO:13485-2003


YOUR WAREHOUSE - OUR SOLUTIONS

Compliance Management

(Requirement for regulatory purposes).


ISO 13485:2003 specifies requirements for a quality management system where a business needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.


Objective of ISO:13485


To facilitate harmonised medical device regulatory requirements for quality management systems.


As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.


All requirements of ISO 13485 are specific to businesses providing medical devices, regardless of the type or size of the business.


TGA accepts the following

(Certificates and licenses as conformity assessment evidence).


ISO 13485 Medical devices - Quality management system - Requirements for regulatory purposes certificate issued by:


  • a certification body that is also a Notified Body designated under the IVDD 98/79/EC
  • a CMDCAS (Canadian Medical Devices Conformity Assessment System) recognised Registrar
  • a certification body that is accredited by a signatory member of the International Accreditation Forum (IAF) Multilateral
  • Recognition Arrangement (MRA) to undertake certification to ISO 13485

Our Compliance Services


We can assist you move your logistics from its current state.  With out warehouse documentation you will be ready to audit against ISO:13485. 


Our services include:


  • process alignment
  • documentation
  • training
  • web based quality management system
  • record evidence and results of internal audits
  • warehouse staff training; and
  • CAPA process

Are your logistics and warehouse processes compliant?

Do you need hands-on help to achive ISO:13485?


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