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 Meghalaya
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 Meghalaya Meghalaya 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 Meghalaya Meghalaya 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 Meghalaya Meghalaya 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 Meghalaya Meghalaya India . ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems in Meghalaya Meghalaya 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 Meghalaya Meghalaya India.
ISO 13485:2013 Consultants near Meghalaya
ISO 13485:2013 Consultants in Meghalaya
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 Meghalaya
CE Marking in Meghalaya
GMP Certificate in Meghalaya
HACCP in Meghalaya
ISI Mark in Meghalaya
ISO 13485:2013 in Meghalaya
ISO 14001:2015 in Meghalaya
ISO 15000-1:2004 in Meghalaya
ISO 22000:2018 in Meghalaya
ISO 27001:2013 in Meghalaya
ISO 45001:2018 in Meghalaya
ISO 9001:2015 in Meghalaya
ISO-TS 16949:2009 in Meghalaya
ISO/IEC 20000-1:2011 in Meghalaya
NABH in Meghalaya
NABL in Meghalaya
ROHS Certificate in Meghalaya
SA 8000 in Meghalaya