CAW Consultancy Business Solutions Ltd
ISO Consultants UK: Certification Support for 20+ Standards
CAW Consultancy Business Solutions Ltd is a UK ISO consultancy with over 20 years of experience helping organisations achieve certification and accreditation first time. We cover more than 20 ISO standards, including ISO 9001, ISO 14001, ISO 45001 and ISO 27001, alongside CHAS, Constructionline, SafeContractor, NSI, SIA Approved Contractor, CQC and tender writing. Fixed fees, fast turnaround and a 100% pass rate at audit with every certification body we have worked with, including all UKAS accredited bodies.
Affordable, straight talking consultancy with a twist
ISO 13485 Consultancy
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 EN 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 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.