QMS for Medical Device Manufacturing
This standard specifies requirements for a quality management system for organisations that design, produce, install and service medical devices. Like any major industry standard, it addresses aspects that are not addressed by the basic ISO 9001 standard. However, it is built using that as a basis and can be integrated with other standards such as ISO 14001 and OHSAS 18001.
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.
Benefits of Implementing ISO 13485
ISO 13485 provides uncountable benefits - both tangible and intangible. A typical organisation would enjoy the following:
- Meet key requirement to supply to EU clients
- Gain customer recognition and approval and open doors to the worldwide markets
- Set up a systematic approach to manage processes and improve product quality levels
- Reduce customer complaints and improve retention of customers
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