ISO 9001:2008
Quality Management System:


ISO 9001: 2008 defines quality as ‘the degree to which a set of inherent characteristics fulfils requirements.’ Grade denotes a category or grade attributed to a product, and grades and categories of products having the same functional use can be widely different.
ISO 13485


ISO 13485 is the international standard recognized for medical device regulations around the world. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide.
ISO 14001:2004
Environmental Management System:

EMS defines an effective environmental system which can be applied to all types of companies. Environmental issues have come to the forefront in recent years with greater awareness amongst legislators, insurers, financiers...
CE MARKING:

Conformite Europene

Conformite Europene Why do I need CE ?
Which products need it?
The CE marking is a product certification. CE is a French acronym for "Conformite Europene", which in English means European Conformity. CE mark on product signifies that a product has met EU health, safety, and environmental requirements, which also ensures consumer safety. CE marking is Mandatory for the Products, which are to be placed in EU countries. If product is not CE marked it may be rejected at the port of entry.
At present, 31 countries in EU ask for CE Mark and other countries are likely to ask for the same in the future.
Product must comply with the Directive(s) and the Standards set by the European Union. One ormore Directives may be applicable for the same product. Contact ICSto find out,which directives and standards are applicable to your products.
Which products need it?
The products requiring CE marking include below directives;
• Toy & safety Directives,
• Medical devices Directive
• Machinery Directive,
• LVD Directive,
• EMC Directive
• Radio and Telecom equipment Directive
• Construction Products Regulation,
• In vitro diagnostic devices Directive,
• Lifts Directive
• Personal protective equipments Directive
• There are about 35 Directives requiring CE marking.
Before a manufacturer or importer is allowed to affix CE-marking on his product, there are a few steps to be undertaken by the Manufacturer or his authorized representative.
What should be the content of technical file?
Generally the technical file requires the following things
• Description of the product with model / variants
• Product's Drawing & Component Drawings etc
• Result of Risk Analysis
• Test Reports against applied Harmonized EN Standards
• Product Labels
• Instruction for Use
• Signed Declaration of Conformity
• Affix CE mark