ISO Certification

Home About TQV News Certificate Check Vacancies Contact Us Staff Login TQV Worldwide





A World Leader in Certification to ISO Standards
Management Systems Quality Management Environmental Management Health and Safety Management Information Security Management IT service management Food Safety Management Systems Sector specific quality management systems Guidelines for complaints handling in organizations Medical Devices - Quality Management System Laboratory Accreditation Cosmetics GMP Instant coffee Criteria HACCP Energy Management Systems Social Responsibility Business Continuity Event Management Systems Product Certification CE Mark International Recognition Customer Transfer to TQV Certification Regulations Use of Logos Downloads Certificate Check Certification Process Scope of Accreditation

ISO 13485 – Medical Devices - Quality Management System


ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation and servicing such as added requirements on record-control, sterilization and risk management.


It is based on ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.


Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from us demonstrates your organization's commitment to provide products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.


Benefits of ISO 13485

  • ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.
  • A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
  • It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.
  • Creates a competitive advantage
  • Ensures a consistent and effective approach to business management
  • Reduces risk factors via the use of risk management techniques
  • Engages top management involvement
  • Provides a robust framework for assuring product consistency

TQV Certification Process


TQV has a unique approach of certification which complies with the requirement for bodies providing audit and certification of management system.


to know about more information of the certification process by TQV

ISO 9001:2008 Click here

Our Offices International Recognition

ascab
ISO 9001 for Small Businesses now available as ePub

ISO 10018 focuses on importance of people in quality management

ISO publishes new standard for business continuity management

ISO standard provides global solution for legal entity identification for financial services

Smile with confidence when you brush your teeth with ISO

From farm to fork - ISO recipe for successful food supply chains

No jolts! Safe electric cars thanks to ISO standard

10 reasons why ISO standards can help SMEs

Safe food from the farm with ISO/TS 22002-3

New ISO standard for emergency management


ISO 9001:2008   |   ISO 14001:2004   |   ISO 18001:2007   |   ISO 27001:2005   |   ISO 20000   |   ISO 22000    |   ISO 10002    |   ISO 13485    |   ISO 22716    |   CE Mark

© Copyright 2011, Design: aisomex.com