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ISO 13485: 2016
ISO 13485 the International Quality Management Systems for the design and manufacture of medical devices.
HELPS YOU WITH
Quality Control, Risk Management, Legal Compliance, Traceability and Recall, Process Improvement, Product Improvement, Operational Efficiency
The standard contains specific requirements for manufacture, installation and servicing and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realisation
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.
It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
The benefits of IS13485:
Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
Improved stakeholder relationships – including staff, customers and suppliers
Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management – through greater consistency and traceability of products and use of risk management techniques
Proven business credentials – through independent verification against recognised standards
Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
ISO 13485 the International Quality Management Systems for the design and manufacture of medical devices.
HELPS YOU WITH
Quality Control, Risk Management, Legal Compliance, Traceability and Recall, Process Improvement, Product Improvement, Operational Efficiency
The standard contains specific requirements for manufacture, installation and servicing and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realisation
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.
It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
The benefits of IS13485:
Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
Improved stakeholder relationships – including staff, customers and suppliers
Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management – through greater consistency and traceability of products and use of risk management techniques
Proven business credentials – through independent verification against recognised standards
Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
