Joytech hian Production Facility thar leh Product Category tharte tan ISO 13485 Certification hmangin Quality a tisang

Joytech chuan kan ISO 13485 chu a update ta a ni certification pek a ni . production base pawm thar leh product category thar nena

Hei hian a thar zawng zawng tihna a ni Joytech thil hralh chhuah mek hi ISO 13485 certified management system hmanga siam a ni.

ISO 13485 hi eng nge ni?

ISO 13485 hi international level-a hriat lar tak a ni a, medical device industry bik atana quality management system hmanna tur a ni. Medical device-te hian customer leh regulatory requirement an tlin reng theih nan ruahman a ni. Standard hian medical device nun chhung zawng zawng a huam a, design, development, production, storage, distribution, installation, servicing, leh disposal te pawh a huam tel a ni.

ISO 13485-a thil pawimawh tak takte:

· Quality Management System (QMS): Process enkawltu tur leh product quality enfiahna tur QMS nghet tak a din thin.

· Regulatory Compliance: Regulatory requirement kaihhnawih zawm a nih theih nan a enkawl.

· Risk Management: Product lifecycle chhung zawnga risk management principle te a huam tel thin.

· Product Realization: Design leh development atanga production leh post-market activities thlengin stage zawng zawng a huam vek.

· Process Control: Product quality vawng reng tur chuan process control a pawimawhzia a sawi uar hle.

· Continual Improvement: Process leh system tihchangtlun zel dan tur ngaihtuah a ni.

ISO 13485 hmanga certification pek:

Company pakhat chu ISO 13485 hmanga certified a nih chuan independent certification body chuan company quality management system chu audit a, ISO 13485 standard-a thil phut a tlin leh tlin loh a finfiah tihna a ni. He certification hian company hian a damdawi hmanrua te himna leh a thatna tur atan process leh control tha tak tak a siam tih a tilang a ni.

ISO 13485 Certification-in a nghawng dan:

· Regulatory Acceptance: Khawvel market hrang hranga regulatory requirements tihhlawhtlinna kawngah a pui a, hei hi medical devices hralhna atana pawimawh tak a ni.

· Customer Confidence: Customer leh stakeholder te inkara thil siam quality leh himna chungchangah rinna leh inrintawkna a tipung.

· Market Access: Regulatory approval neihna atana ISO 13485 certification neih hmasak berna market thara luh theihna a siamsak.

· Operational Efficiency: Process mumal zawk leh tihchangtlun zelna tur a tipung a, hei hian hnathawh thatna a thlen thin.

· Risk Management: Product lifecycle chhung zawnga risk management kalphungte chu a taka inzawmkhawm a nih theih nan a enkawl.

Eng hi Joytech hian Facility thar ISO 13485 hmanga Certified a nei em?

Joytech hian No. 502 Shunda Road-a facility thar hi kum 2023 aṭang khan siam ṭan a ni. 

Square meter 69,000-a zau a ni a, a vaiin operational built-up area chu square meter 260,000 chuang a ni a, he hmun thar hi automated production, assembly, leh packaging line bakah automated three-dimensional warehouses hmanga thuam a ni. Tuna Joytech thil zawrh tam zawk hi tunah hian he hmun tharah hian siam chhuah a ni tawh a ni.

A chipchiar zawka hriat duh chuan tlawh turin kan lo lawm a che u kan facility a ni !