ISO 13485 Quality Management System

1
ISO 13485 CERTIFICATION

• Quality Management System  for Medical Device

http//www.ursindia.com/iso_13485.aspx
2

• ISO 13485 STANDARD

• ISO 13485 Standard requirement not only addresses
  the regulatory requirements applicable for
  medical device realization but also for device
  specific and customer specific requirement that
  have potential adverse impact and risk on the
  product. 

3

• ISO 13485 Standard Certification

We provide ISO 13485 certification, an
international standard that defines quality
management system (QMS) requirements for
manufacturers of medical devices. The primary
objective of the standard is to facilitate
harmonised QMS requirements for regulatory
purposes within the medical device sector
4
Benefits of 13485 certification
1
Gguarantees high quality of provided services and
products
2
Reduces production loss rate
3
Reduces operational costs
4
Increases effectiveness across the whole
organisation
5
Increases your customers trust in you as a safe
supplier or produce
5
ISO 13485

• Planning the Quality System

ISO 13485 Standard includes a requirement for
Quality Planning. Writing a Quality Manual is not
sufficient to meet this requirement. You need
documented Quality Plans for implementing changes
to your Quality Management System, and creating a
new Quality System from scratch is a big change.
There is no required format for quality plans.
Spreadsheets and Gantt Charts are the most common
tools for quality planning.
6
F-3, Sector 06 Noida- 201 301,NCR Delhi,
IndiaTel-91-120-6404223 - 26,Tel[phone]
,Fax[phone]E-info_at_ursindia.com W-http
//www.ursindia.com/
Contact US

• Thank you

• URS Certification Limited