Non-medical systems
ISO 9001-2000 Quality management systems - Requirements
Services
Quality Assurance is a prerequisite to design and
manufacturing controls. AQAS will provide the following
services to assist you to gain third party certification and
recognition as a Quality Organization with the minimum of
fuss and the minimum time frame using a proven cost
effective service.
Documentation
Create and document your Quality Manual, Procedure Manual
and where required, Instruction Manual, including all
recording formats necessary to maintain the required records
for quality audits and your own reference. The complete
documented Quality Assurance system
Medical systems
ISO 13485-2003 Medical devices - Quality management systems
Medical systems documentation includes the vigilance system, Technical File, Declaration of Conformity, Product Recall, MDD Annex I (Essential Requirements), 'CE' Directives (for exporting to the European Communities) and Harmonized Standards (EN). The complete Quality Assurance and Regulatory Affairs system
Systems will comply with the Therapeutic Goods Administration (TGA) requirements and the regulatory requirements of the export destination, where the goods are exported.
Training
Implement training that develops the necessary skills and
cultural acceptance of all the quality assurance elements so
that your personnel are equipped to positively contribute to
the quality system and it's ongoing improvement.
Quality Audits
Provide periodic in-depth internal quality audits, reporting
any non-conformance or improvement areas to executive
management, ensuring certifying audits are a breeze.
Reside on your Management review team to review and execute
corrective actions and implement improvement.
Out Sourcing
Provide short term or long term contracted Quality Assurance
services.
Implement the quality system on your behalf.
Provide the necessary support to take your company
successfully through the accreditation process.
Click the "Auditing", "Out sourcing", "documentation" and "Training" shortcuts at the top of this page for more information.
E-mail: sales@aqas.com.au