CAW Consultancy Business Solutions Ltd
At CAW Consultancy Business Solutions we pride ourselves on being the most cost effective and complete ISO and accreditation solution in the UK. We provide a range of services for example ISO 9001, ISO 14001, ISO 45001 and many more.
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Affordable, straight talking consultancy with a twist
What is ISO 13485
ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2016+A11:2021 is to facilitate harmonised medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
The benefits of the ISO 13485 include:
- Increased access to worldwide markets.
- Increased organisational efficiency.
- Increased competence and industry awareness.
- Adopt a systematic approach to meeting the regulations as well as customer expectations.
- Comply with regulatory requirements.
- Providing safe and effective products.
- Effectively manage risks.
