ISO 13485 Certification

ISO 13485 – Medical Devices – Quality Management System

Overview

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.

Transition

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

Key Benefits

  • 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

Why BCAGL

Extensive Coverage and Experience

Delivering the best in quality and service globally
  • Operating in over 130 countries
  • Conduct over 100,000 audits annually
  • Offering services in over 50 different schemes

Expertise you can
depend on

Work with the best industry experts in market
  • Average of 13 yrs industry auditing exerience
  • World-class experienced trainers
  • 100% customer satisfaction rate

Need management system certification? Speak to an expert to find out more.

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