ISO 13485 - Quality Management Systems for Medical Devices
ISO 13485 is the globally recognised standard for medical device quality management.
25, 2016, ISO 13485:2016 focuses on quality management systems and is
recognised and used as a framework by the medical device industry, regulators programs
including the Medical Device Single Audit Program (MDSAP).
The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders. It places more emphasis on risk-based thinking and decision-making while it also offers stronger intra-operability between the clauses and requirements.
Perhaps most importantly, it focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. Persistent pressures from global competition demand that organisations continually improve your products, services, and business processes to remain competitive
Key elements of the ISO 13485:2016 standard include:
- Expands requirements for risk management and process-based decision-making.
- Increased attention on supply chain processes.
- Explicit requirements for software validation.
- Effective alignment of global regulatory requirements.
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