About De System
De System is one of the leading quality certification organizations offering a plethora of quality certifications (management system & product both) services to organizations of all nature and size. We are in the same filed from last many years. We believe in upholding highest standards of business ethics with complete commitment to total quality.
We are a fast growing professional training organization for ISO 9001:2008 (QMS), ISO 14001:2004 (EMS) , ISO 22000:2005 (Food safety management system,FSMS), ISO 27001:2005( Information Security Management System, ISMS), OHSAS 18001:2007 (Occupational health and safety analysis system), ISO 13485 (Medical Devices), ISO 20000:2005 (ISMS), HACCP(Hazard analysis and critical control point) , SA 8000:2001(Social accountability standard), WRAP (Worldwide Responsible accredited Production), BSCI (Business Social Compliance Initiative), CE Marking, TS 16949 (QMS for Auto Mobile Industry), RoHS (Restriction of Hazardous Substances), BRC(British Retail Consortium), Eurepgap, C-TPAT ( Customs- trade partnership against terrorism), GMP (Good manufacturing practices), WHO GMP, FDA, CCC Mark, SIX SIGMA, Kaizen, CMMI, ISI, SSI, Factory Compliance etc. We provide iso certification & training in the most effective, economical, time bound and easy to implement manner.
ISO 13485 (QMS for Medical Devices Industry)
ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers.
ISO 13485 certificate can help you in entering almost any market in the world. It is currently recognized in most major markets (Europe, USA, Canada etc).
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While it is based on ISO 9001, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not guarantee compliance with regulatory requirements, but it can facilitate the audit process for those requirements.
Why to implement ISO 13485?
• Expanded market access
• Reduced cost of sales
• Improved overall performance
• Enhanced product safety
• Proactive error detection and prevention