At TYENT, we adhere to stringent quality management standards, following Good Manufacturing Practice (GMP) principles in producing state-of-the-art medical devices throughout our manufacturing processes. We maintain rigorous oversight over the control process within our modernised and automated manufacturing system, ensuring the production of high-quality medical devices. In recent years, we have undergone regular inspections by the Ministry of Food and Medicines to uphold the stringent quality standards required for our medical devices, such as the GMP enterprise certification.
Good Manufacturing Practices (GMP) are the essential guidelines we must adhere to, aligning with the recommendations of regulatory agencies responsible for authorising and licencing the production and sale of food, pharmaceuticals, and medical devices. These practices establish requirements that pharmaceutical or food manufacturers must follow to ensure the products meet high-quality standards and do not pose any risks to users or the environment.
(International Quality Management System)
Taeyong E&T obtained ISO 9001 certification in 2002. We have implemented a meticulously ISO-regulated quality assurance system for all of our products and production procedures at TYENT.
(International Environmental Management System)
Environmental management has evolved from quality management to include the environment as an integral aspect of business philosophy, aiming to minimise businesses’ adverse impact on the environment. TAEYOUNG E&T’s environmental management system establishes comprehensive objectives and programmes for ecological management, defining organisational responsibilities and processes to achieve these objectives. At TYENT, we systematically allocate management resources and meticulously practice these processes to ensure our operations align with our environmental responsibilities.
We at TYENT adopt best practices and leverage innovative technologies to mitigate our environmental footprint. We actively collaborate with regulatory authorities and stakeholders to ensure compliance with all applicable environmental laws and standards. Our overarching goal is to operate as a responsible and sustainable business, upholding the principles of sustainable development while safeguarding the environment for future generations.
Customs authorities provide exporters with the FTA certificate, a certification system that enables them to prove the origin and adherence to pertinent product regulations. At TAEYOUNG E&T, we hold certification as an enterprise that provides evidence of the origin of each of our products, instilling confidence among the public in our export products.
We are committed to innovating our products and setting annual quality goals that align with our core principles. We meticulously adhere to all regulations and laws applicable to manufacturers, diligently following our quality assurance system to ensure the utmost satisfaction of our customers.
Here are the stages of our quality control process:
1. Quality Planning
We systematically manage our products to ensure compliance and safety in product quality delivery.
2. Quality Management
Leveraging the knowledge and data collected through corrective and preventive measures, we maintain the relevance and effectiveness of our products under the Quality Assurance (QA) system.
We execute each plan meticulously, check, take action, and plan again!
3. Quality Assurance
We meticulously review and eliminate all causes of discrepancies, taking all necessary measures to prevent their recurrence and consistently upholding the high quality of TYENT products.
When an inappropriate item surfaces, we promptly correct it by removal or modification to ensure the suitability of our products or processes.
Upon identifying the root causes of inappropriate items, we gather information and take corrective measures to prevent their recurrence. This includes averting the reoccurrence of similar problems and implementing improvements in our processes and systems.
4. Quality Improvement
Although we have not encountered instances of inappropriate items, we proactively analyse potential reasons for such occurrences based on industry statistics. We address and remove these potential issues, ensuring they do not affect the development of our machines.
INSPECTION OF INCOMING MATERIALS
During incoming inspection, the quality and suitability of materials undergo rigorous examination. This may encompass physical measurements, visual inspections, functional tests, and other quality assessment methods. Documentation related to the materials, such as quality certificates and declarations of conformity, is also scrutinised.
Incoming inspection plays a pivotal role in guaranteeing production quality by ensuring that only suitable materials are employed. It preempts problems and inconsistencies in production scenarios and confirms that produced items meet established specifications, standards, and requirements.
INSPECTION OF PROCESSES
Process inspection stands as a crucial component of the quality control and assurance system within the production environment. Its purpose is to determine whether processes are executed correctly and align with established standards and specifications. This inspection is instrumental in averting the transfer of unsuitable products to subsequent phases.
Upon discovering unsuitable materials or semi-finished products, they are promptly removed from circulation and categorised as unsuitable products. Process inspection is pivotal in ensuring product quality and preventing incongruent situations and discrepancies. It aids the organisation in identifying and rectifying the root causes of non-conforming products, thereby enhancing its processes to achieve the highest quality.
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