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Advance International Corp Company Profile

Quality Control
Standard:Report on ICAO Compliance
Issue Date:2013-05-21
Expiry Date:2099-12-31
Standard:ISO 13485 Medical devices: Quality management systems - Requirements for regulatory purposes
Number:340120191128 KL62171
Issue Date:2019-11-28
Expiry Date:2022-11-27
Standard:Certificate of Physical Properties
Number:SHAHG 1908496002 A01
Issue Date:2019-05-28
Expiry Date:2099-12-31
QC Profile

Advance International Corp (the AIC) has adopted a high quality standard in all operations, testing procedures and reporting.
The quality management system is based on ISO 9001 and ISO 15189 to comply with regulatory requirements and facilitate regulatory submissions. It is accredited by the Anhui Quality Institution which audits and visits the facilities on an annual basis. Moreover, the quality standards are monitored using an internal auditing scheme and the facilities are regularly audited by customers and contract partners.
Advance International Corp quality control 0
The Quality Assurance System implemented in Advance International Corp particularly focus on following aspects -


1. Training of sufficient employees to ensure redundancy in case of illness or other absence. Functions are substitutable as defined in a formal substitution matrix.


2. Final products are validated prior to release or shipping, and subsequently monitored and maintained on a regular defined basis. Moreover, the quality is monitored based on trending positive controls, conducting proficiency tests and performance of internal in-process audits.


3. Manufacturing Machineries and Equipments are validated prior to be used, and subsequently monitored and maintained on a regular defined basis. Additionally there are multiple instruments for all the needed equipment. In the unlikely event of a breakdown, or unforeseen delays in maintenance, alternative equipment is available for continuation of the protocol.


4. Temperature-regulating equipments (fridges, freezers, incubators) are monitored with a 24/7 alarm system, which in turn is monitored by a chain of personnel, such that there is always redundancy.


5. The quality management system is based on a feedback system, ensuring continuous improvement.

Advance International Corp quality control 1

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