ISO 9001:2000, ISO 9001:2000 Certification, Quality Management Systems, ISO 9001:2000 Quality Management Systems, India

ISO 13485 : 2003 Medical Devices - Quality Management System

ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2003 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 9001:2000. 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 9001:2000 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

Requirements

Basic Quality System requirements with several enhancements
Risk Management Approach to product development and product realization
Validation of processes
Consideration of statutory and regulatory requirements
Tracking and record keeping
Assuring positive product traceability and recall