Toggle navigation
Home
About us
Services
CE Marking
GMP Certificate
HACCP
ISI Mark
ISO 13485:2013
ISO 14001:2015
ISO 15000-1:2004
ISO 22000:2018
ISO 27001:2013
ISO 45001:2018
ISO 9001:2015
ISO-TS 16949:2009
ISO/IEC 20000-1:2011
NABH
NABL
ROHS Certificate
SA 8000
Topics
Benifite-of-Rohs-Certification
NABH Certification for Ayurveda Hospitals and Clinics
NABH Certification for Dental Facilities Hospitals and Clinics
NABH Certification for Eyes Hospitals and Clinics
NABH Certification for Hospitals and Clinics
What-is-Ce-Marking
What-is-Quality-Management
Clients
Contact us
Main Services
ISO 13485:2013 Consultants in Leh, Jammu and Kashmir
ISO 134845:2013
BS EN ISO 13485:2003/BS EN ISO 13485:2012 Quality management system certification in the field of medical devices. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls in Leh Jammu and Kashmir India.
ISO 13485:2003 is the medical industry�s equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard in Leh Jammu and Kashmir India. Compliance with ISO 13485: 2003 does not necessarily mean compliance with IS0 9001:2000. ISO 13485:2013 International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services in Leh Jammu and Kashmir India.
ISO 9000 is a family of standards for quality management systems. ISO 13485:2003 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies in Leh Jammu and Kashmir India . ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems in Leh Jammu and Kashmir India.
Some of the requirements in ISO 13485 (which is one of the standards in the ISO 13485:2012 family) include:-
A set of procedures that cover all key processes in the business;
Monitoring processes to ensure they are effective;
keeping adequate records;
Checking output for defects, with appropriate and corrective action where necessary;
Regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services in Leh Jammu and Kashmir India.
ISO 13485:2013 Consultants by Location
leh-jammu-kashmir
ISO 13485:2013 Consultants in Alchi
ISO 13485:2013 Consultants in Bazgo
ISO 13485:2013 Consultants in Biama
ISO 13485:2013 Consultants in Chamray
ISO 13485:2013 Consultants in Chuchot Gongma
ISO 13485:2013 Consultants in Chuchot Shama
ISO 13485:2013 Consultants in Chuchot Yokma
ISO 13485:2013 Consultants in Chuchul
ISO 13485:2013 Consultants in Chuglamsar
ISO 13485:2013 Consultants in Chumathang
ISO 13485:2013 Consultants in Diskit
ISO 13485:2013 Consultants in Dumkhar
ISO 13485:2013 Consultants in Durbuk
ISO 13485:2013 Consultants in Faing
ISO 13485:2013 Consultants in Gia Meru
ISO 13485:2013 Consultants in Hanoo
ISO 13485:2013 Consultants in Hemis Changa
ISO 13485:2013 Consultants in Hemis Shukpacahan
ISO 13485:2013 Consultants in Hemiya
ISO 13485:2013 Consultants in Horzey
ISO 13485:2013 Consultants in Hunder
ISO 13485:2013 Consultants in Igoo
ISO 13485:2013 Consultants in Kairay
ISO 13485:2013 Consultants in Karoo
ISO 13485:2013 Consultants in Khalsi
ISO 13485:2013 Consultants in Khardong
ISO 13485:2013 Consultants in Kubat
ISO 13485:2013 Consultants in Kungyam
ISO 13485:2013 Consultants in Lamayuru
ISO 13485:2013 Consultants in Leh
ISO 13485:2013 Consultants in Leh
ISO 13485:2013 Consultants in Leh City
ISO 13485:2013 Consultants in Likir
ISO 13485:2013 Consultants in Matho
ISO 13485:2013 Consultants in Ney
ISO 13485:2013 Consultants in Nomoo
ISO 13485:2013 Consultants in Nurla
ISO 13485:2013 Consultants in Nyoma
ISO 13485:2013 Consultants in Panamik
ISO 13485:2013 Consultants in Saboo
ISO 13485:2013 Consultants in Sakti
ISO 13485:2013 Consultants in Sasapol
ISO 13485:2013 Consultants in Shara
ISO 13485:2013 Consultants in Shey
ISO 13485:2013 Consultants in Skurbuchan
ISO 13485:2013 Consultants in Spituk
ISO 13485:2013 Consultants in Stok
ISO 13485:2013 Consultants in Takmachik
ISO 13485:2013 Consultants in Temisgam
ISO 13485:2013 Consultants in Terchey
ISO 13485:2013 Consultants in Thiksay
ISO 13485:2013 Consultants in Tia
ISO 13485:2013 Consultants in Tiger Sumur
ISO 13485:2013 Consultants in Turtuk
ISO 13485:2013 Consultants in Wanla
ISO 13485:2013 Consultants by City
ISO 13485:2013 Consultants in Anantnag
ISO 13485:2013 Consultants in Badgam
ISO 13485:2013 Consultants in Baramulla
ISO 13485:2013 Consultants in Doda
ISO 13485:2013 Consultants in Jammu
ISO 13485:2013 Consultants in Jammu & Kashmir
ISO 13485:2013 Consultants in Kargil
ISO 13485:2013 Consultants in Kathua
ISO 13485:2013 Consultants in Kupwara
ISO 13485:2013 Consultants in Leh
ISO 13485:2013 Consultants in Poonch
ISO 13485:2013 Consultants in Pulwama
ISO 13485:2013 Consultants in Rajauri
ISO 13485:2013 Consultants in Srinagar
ISO 13485:2013 Consultants in Udhampur
ISO 13485:2013 Consultants by State
Andaman and Nicobar
Andhra Pradesh
Arunachal Pradesh
Assam
Bihar
Chandigarh
Chhattisgarh
Dadra & Nagar Haveli
Daman and Diu
Delhi
Goa
Gujarat
Haryana
Himachal Pradesh
Jammu and Kashmir
Jharkhand
Karnataka
Kerala
Lakshadweep
Madhya Pradesh
Maharashtra
Manipur
Meghalaya
Mizoram
Nagaland
Orissa
Pondicherry
Punjab
Rajasthan
Sikkim
Tamil Nadu
Tripura
Uttar Pradesh
Uttarakhand
West Bengal
Services in Leh, Jammu and Kashmir
CE Marking in Leh
GMP Certificate in Leh
HACCP in Leh
ISI Mark in Leh
ISO 13485:2013 in Leh
ISO 14001:2015 in Leh
ISO 15000-1:2004 in Leh
ISO 22000:2018 in Leh
ISO 27001:2013 in Leh
ISO 45001:2018 in Leh
ISO 9001:2015 in Leh
ISO-TS 16949:2009 in Leh
ISO/IEC 20000-1:2011 in Leh
NABH in Leh
NABL in Leh
ROHS Certificate in Leh
SA 8000 in Leh