ISO 13485 Medical Devices Management System
What is ISO 13485?
The ISO 13485 Medical Devices standard is an effective solution to meet the comprehensive requirements for a quality management system in the medical device industry.
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
Certification to ISO 13485 demonstrates commitment to the safety and quality of your organisation’s products, which in turn offers:
- Improved customer satisfaction
- Improved business processes
- Reduced risk
- Improved medical device products
- Reduces cost due to errors and waste
- Business growth and diversification opportunism
- Obtain CE marking for products
Why choose HSEQ Smart?
Our consultants are highly experienced in the implementation of quality management systems such as ISO 9001:2018, and have experience of working within the medical industry, ensuring compliance and risk mitigation at all stages of the product lifecycle. This combined experience ensures the route to certification for ISO 13485.
ISO 13485 Certification
HSEQ Smart can support your organisation from implementation through to certification. The process consists of:
- An initial gap analysis
- Development of an action plan
- Designing of all mandatory documentation and records
- Implementation of the management system
- Performing of the internal audits, reviews, and legal compliance evaluation.
We have a 100% success rate in helping customers achieve certification first time, every time.
HSEQ Smart work with major certification bodies across the UK and can advise on the right certification body for your business.
ISO 13485 Awareness Training
Need a greater understanding of the requirements of ISO 13485 and how it could be implemented into your organisation and integrate with other business management systems? This one-day course will take you through the ISO 13485 standard step by step with a no-nonsense and no-jargon approach, giving you clear understanding and direction. All training is tailored to your specific requirements.
ISO 13485 Internal Auditor Training
Internal auditing of the ISO 13485 standard is not the same as auditing the ISO 9001 standard as there is a much greater focus on regulatory compliance and risk management at each stage.
Whatever your level of training, we can provide the guidance and support required to ensure you have the competency to internally audit the ISO 13485 standard for your organisation.