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.
DurationISO 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.
Benefits
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
Training
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.
About Us
With a wealth of knowledge and experience in the health and safety industry, here at HSEQ Smart we have helped clients of varying sizes become compliant, achieve certification to ISO standards and win contracts in excess of £10 million.
Operating since 2009, HSEQ Smart is headed by our Managing Director who has over 20 years’ experience in HSEQ Management, and prior to setting up HSEQ Smart was employed as a Director of HSEQ for a large PLC operating across the UK, Europe and Canada.
Our in-house staff are fully qualified and highly experienced in their field, delivering tangible results to help businesses improve performance, reduce risk and win new contracts through our support services.
Our Process
Our consultancy and training services will identify where business processes within your company can be improved, to ensure you proactively comply with your obligations, without having to compromise on your work.
We promise to deliver results for each and every one of our clients, and have rescued many from losing their certification by maintaining a sense of urgency. What sets us apart from our competitors is our no-jargon, no-nonsense approach, ensuring that everything from site inspections to our training courses are conducted using easy-to-understand terminology.
How We Can Help You
We pride ourselves on our openness and honesty, fully explaining all charges involved upfront, with no hidden costs. We deliver measurable added value with tangible business results to raise the profile and performance of your company.
At HSEQ Smart, we understand that a few of the most common drivers for running a business are money, success and excellent customer service. High standards of health, safety, environmental and quality management can go a long way to achieving these, as ticking all of these boxes will not only help to improve efficiency and productivity, but can also win you new contracts and business.
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.
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