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