· ISO 9001:2015
It is a Quality Management Standard, internationally recognised standard for the quality management of businesses. It applies to the processes that create and control the products and services an organisation supplies. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met.
· ISO 14001:2015
It is an Environmental Management Standard, internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.
· MDSAP (ISO 13485:2016) | · ISO 13485:2016
It is a quality system standard designed specifically for medical device companies. It supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.
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