Medical Devices - ISO 13485
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Overview of ISO 13485
This international standard specifies requirements for a quality management system that can be used by an organisation for the design, production, installation and servicing of medical devices. Internal and external parties, including certification bodies can also use it to assess the organisation’s ability to meet customer and regulatory requirements.
The primary objective of ISO 13485 is to specify quality system requirements that specifically address the requirements of the medical devices industry that are not addressed by the generic quality management system standard ISO 9001.
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements and to gain entry into the European market. The conformity of Medical Devices and In-vitro Diagnostic Medical Device to the European Economic Community (EEC) decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The means to prove conformity is usually by way of certification of the Quality Management System according to ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB).
Benefits of Implementing ISO 13485
ISO 13485 provides uncountable benefits - both tangible and intangible. A typical organisation would enjoy the following:
- fulfil one of the conditions of supply to European Union clients
- gain customer recognition and approval and open doors to the worldwide markets
- have a systematic approach to control all its processes and proven methods that will help to improve product quality levels
- greater transparency and consistency in its output
- and ultimately, a reduction in customer complaints and retention of customers
ISO 13485 Training Programmes
- Understanding ISO 13485 QMS requirements
- ISO 13485 Internal Auditing
.... more training programmes are available here
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