NSF-ISR Certification Process
The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.
The benefits of ISO 13485 certification include demonstration of regulatory compliance and more effective risk management. Certification aids compliance to national or international regulatory requirements. Certification also confirms to customers, suppliers and other stakeholders that the organization is in a state of control over its operations.
Third-party certification is preferred in many international markets, and is the accepted basis and starting point to achieve the medical device CE mark. It can also be used as a bench mark to meet good manufacturing practice (GMP) compliance in the United States. An ISO 13485 certified quality management system can aid access to U.S. and international markets.
The International Organization for Standardization (ISO) published the updated ISO 13485 medical devices quality management systems standard on March 1, 2016. ISO 13485:2016 can be used by organizations involved in the production, post-production, storage, distribution, installation, servicing, final decommission and disposal of medical devices. There is also a provision for services associated with the medical device industry.
Key improvements in the 2016 version include:
Timeline for transition:
Use of any NSF International training or consulting service does not, in any way, make NSF-ISR certification simpler, easier, faster or less expensive. NSF-ISR is a wholly owned subsidiary and makes impartial certification evaluations and decisions independent of any NSF International services.
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