Joytech hian ISO 13485 certification hmangin quality a ti sang a, production facility thar leh product category hrang hrang

Joytech chuan kan ISO 13485 chu a update a. certification neiin production base pawm thar leh product category thar a nei bawk.

Hei hian a awmzia chu a thar zawng zawng . Joytech product hralh chhuah te hi ISO 13485 certified management system hmanga siam a ni a, a man pawh a tlawm hle.

ISO 13485 chu eng nge ni?

ISO 13485 hi internationally recognized standard a ni a, medical device industry tana quality management system bik a ni. Medical device-te’n customer leh regulatory requirement an tlin reng theih nan ruahman a ni. Standard hian damdawi hmanrua pakhat nun kawng zawng zawng a huam a, chung zingah chuan design, siam, siam chhuah, dahkhawm, sem, dah, service, leh disposal te pawh a tel.

ISO 13485-a thil pawimawh tak takte chu:

· Quality Management System (QMS): Process enkawlna tur leh product quality tha tak neih theihna tur QMs nghet tak a din.

· Regulatory compliance: Regulatory requirement kaihhnawih zawm a nih leh nih loh enfiah.

· Risk Management: Product lifecycle pumpuiah risk management principle a dah tel.

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

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

· Hmasawnna chhunzawm zel: Process leh system siam that zelna tur a ngaihtuah.

ISO 13485 hmanga certification pek a ni.

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

ISO 13485 Certification-in a nghawng dan:

· Regulatory Acceptance: Khawvel puma market hrang hranga regulatory requirements tlin theihna tura puitu a ni a, hei hi marketing medical devices tan a pawimawh hle.

· Customer confidence: thil siam quality leh himna chungchangah customer leh stakeholder-te rintlak leh inrintawkna a tipung.

· Market Access: ISO 13485 certification chu regulatory approval atana thil pawimawh hmasa ber a nih theihna tur market thara luh a awlsam phah.

· Operational efficiency: Process mumal tak leh hmasawnna kalpui zel a tichak a, operational efficiency a thlen thin.

· Risk Management: Risk management kalphung chu product lifecycle pumpuiah a taka hman theih a nih leh nih loh a enfiah thin.

Eng hi Joytech-a facility thar ISO 13485-in a certified?

Joytech-in No. 502 Shunda Road-a hmun thar a siam chu kum 2023 aṭang khan siam ṭan a ni. 

Square meter 69,000-a zau, a vaiin square meter 260,000 chuang zeta zau, hman theiha siam, a hmanna tur hmun zau tak, a hmun thara siam, automated production, assembly, leh packaging lines bakah automated three-dimensional warehouse-te dah a ni. Tunah hian Joytech thil zawrh mek tam zawk chu he hmun thara siam mek a ni.

A chipchiar zawka hriat duh chuan kan lo lawm a che . Kan facility !