ISO 13485:2013

iso_13485ISO 13485:2013 Certificate

Medical Devices – Quality Management System

Our ISO 13485:2003 Certification is a quality management system that helps a business to produce or

supply medical related devices and services while taking care of the health problems. The key objective

here is to facilitate the conformance to medical device regulatory requirements for quality assurance. This

quality management system inherits some of the particular requirements of medical devices and excludes

some requirements that belong to ISO 9001 as they are not appropriate in the medical industry. ISO

13485 Medical Device Certification specifies equipments a Quality Management system which an

Organization needs to demonstrate ability .Though some of medical devices exclude the requirements of

ISO 9001 Regularity.


3.6.1 Benefits


 Organization can refer to international buyers for verification. A unique Certification No. Is given

on certificate which can be verifies on website.

 Makes Organization systematic. Reduces dependence on individuals.

 Better chances of getting National /International orders through tenders.

 Cost saving due to reduced time and effort.

 Reduces wastage/rejections.

 When systems are implemented properly the organizations profitability increases by 2-4%.

 If organization adopts MIS, the top management saves 40-60% of quality time, which can be used

for expansion/better quality of life.

 When MIS is in place, the monitoring of all-important parameters of business is much better and

it improves profitability by 5-10%.


3.6.2 Organization(Medical Device)


This is for all medical (Orthopedic/Surgical) Manufacturers Companies.


3.6.3 Required Documentations


I) Govt. Registration Copy

II) Pan Card Copy

III) Latter head Copy

IV) Organization Profile

V) Layout Plan

VI) Current Sale Copy-2

VII) Current Purchase Copy-2

VIII) Address Proof

IX) Product Detail/Services Detail

X) Employees Detail (ESI/PF Challan Copy)

XI) Policy/Goals

XII) Infrastructure

XIII) Currently Working Witch States/Country

XIV) Organization Chart/Management chart

XV) Service tax/Tin Number/Vat Tax Registration copy


3.6.4 FEES


Market price: 25000+S.T.

SMT price: 20000+S.T.

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