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#Iso 13485 updates update
#Iso 13485 updates verification

It is derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 is a stand-alone QUALITY MANAGEMENT SYSTEM standard among other ISO standards. ISO 9001 vs 13485 is not the right debate since most of the time medical device companies need the ISO 13485 for regulatory compliance and then ISO 9001 for business purpose such as tender submissions for instance. Usually, though, certification bodies assess such standards in a similar way.

Introduction of statistical techniques for data analysisĪ new version of 9001 published in 2015 moves that standard to the so-called high-level structure.The standard added a focus on broad risk-based approaches, changing the structure from 8 to 10 standards.Īs ISO 13485:2016 did not move to that new structure, the divergence between the two standards (ISO 9001 2015 and ISO 13485 2016) is increasing.

Increased requirements for “feedback,” including complaint handling.Increased requirements for process validation.Increased controls for outsourced processes and suppliers.

#Iso 13485 updates verification

Increased requirements for design and development, including considerations of usability, use of standards, verification and validation, design and development transfer and design records.

Process controls based on risk management.

Increased focus on compliance with regulatory requirements.

These additional and new elements include the following: The EU Medical Device Regulations (EU-MDR) was also one of the main drivers. Also, the global audit model MDSAP (the IMDRF Medical Device Single Audit Program) has integrated key concepts.

Many elements from the US Quality System Regulations (QSR) that did not make it into the previous version of the standard have now made it in.

#Iso 13485 updates update

The key objective in the update was to align with the global regulatory requirements. In 2016, a new version of the standard was issued: ISO 13485:2016. It will demonstrate a commitment to the safety and quality of medical devices. Adopting this standard provides a practical foundation for manufacturers to address the Medical Device Regulations and responsibilities. The ISO 13485 international standard is an effective solution to meet the comprehensive requirements for a Quality Management System QMS.