ISO 13485:2016
ISO 13485:2016 Certification Medical Devices – Quality Management System is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2016 certification 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 certification. 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 certification as a standalone or in conjunction with an ISO 9001 certification 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.
ISO 13485:2016 Benefits
- ISO 13485 certification promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.
- A number of countries have incorporated ISO 13485 certification into their regulatory systems. Compliance with ISO 13485 certification 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 certification 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